Development, implementation, and evaluation of an innovative clinical trial operations training program for Africa (ClinOps)

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Although the crucial role of training initiatives in building clinical trial capacity in Africa has been documented, current efforts fall short as they lack alignment with local contexts. This study aimed to design, develop, implement, and evaluate an innovative clinical trial operations training program for Africa. Methods We developed ClinOps, a novel 10-week clinical trial operations training program for study coordinators in Africa, intending to enhance their expertise in four fundamental areas: designing, conducting, managing, and reporting clinical trials. We used cloud applications to minimize installation of software, whilst maximizing student engagement with the course, VoiceThread, an interactive collaboration and sharing tool allowed interactive content to be accessed offline. Moodle, an open-source learning management system provided a platform to share learning tools, provide one-on-one mentorship, and multidirectional competency assessment strategies including lesson quizzes, forum discussions, asynchronous tutorials, and group assignments. We used Zoom video conferencing application for live tutorials and mentoring, as required. Program effectiveness was evaluated through quantitative pre-post tests, qualitative end-course evaluations, and a comprehensive monitoring and evaluation. We used Wilcoxon rank test to compare pre-post test scores and thematic analysis to analyze the qualitative data. Results In the initial cohort, 88 study coordinators from 19 countries participated, including 56 (64%) females, with 57 (65%) actively employed as study coordinators during the training, and 85 (97%) possessing prior experience in clinical trial roles. Among these, 71 (81%) successfully completed the course, with 69 (97%) also completing the post-course assessment. Post-training scores demonstrated substantial improvement compared to pre-training scores in each competency area, including in designing (mean rank = 36.27 vs 12.20; Z = 6.799, p < 0.001 ), conducting (mean rank = 31.78 vs 8.0; Z = -6.68, p < 0.001 ), managing (mean rank = 36.89 vs 9.83; Z = -6.813, p < 0.001 ), and reporting (mean rank = 16.94 vs 3.0; Z = -4.897, p < 0.001 ) clinical trials. The program adhered to training best practices, encompassing alignment with local priorities, country ownership, pedagogic innovation, institutional capacity building, sustainability, and ongoing partnerships. Participants acknowledged the program for its structure, content, relevance to their current roles, and the overall delivery methods. Conclusion The ClinOps program, a clinical trial operations training initiative for Africa developed by experts from academia and product development partners, significantly enhanced participants' competency in clinical trials. Transferring the program to a local institution promoted country ownership and established the local partner institution as a sustainable clinical trial training hub for Africa. To effectively build clinical trials capacity in Africa, training initiatives should offer comprehensive competency in designing, conducting, managing, and reporting trials tailored to local contexts. Clinical trial training ClinOps Africa product development partners Figures Figure 1 Figure 2 Figure 3 Figure 4 BACKGROUND Clinical trials in Africa face significant challenges stemming from human resources, infrastructure, regulatory, and financial constraints [ 1 – 2 ]. With a population of 1.5 billion, the continent boasts remarkable genetic and demographic diversity, presenting a unique opportunity to thoroughly evaluate the efficacy and safety of medical interventions across a wide spectrum of origins, age groups, genders, and socioeconomic strata. Despite this advantageous position, the successful initiation and operation of clinical trials in the continent remain challenging, as it necessitates navigating through a complex array of resources and operations [ 3 – 6 ]. Although the number of registered clinical trials in Africa has been steadily increasing, its overall contribution still stands at just two percent of the global total [ 7 , 8 ]. Studies demonstrate that strengthening human resource capacity stands as a primary and critical measure in building the overall clinical trial capacity in Africa [ 9 , 10 ]. By investing in research readiness training programs for clinical trial experts, countries can attract more clinical trials while enhancing the quality, efficiency, and integrity of clinical trial operations [ 11 , 12 ]. Such training initiatives provide professionals with the necessary knowledge and skills to effectively design, conduct, and manage clinical trials. This encompasses a comprehensive understanding of regulatory requirements, ethical considerations, and adherence to international standards. Ongoing training fosters continuous professional development, enabling experts to remain informed of advancements in clinical trial methodologies, regulatory changes, industry standards, and emerging trends in clinical trial approaches. Professionals who undergo thorough training in clinical trials are better positioned to network and collaborate with pharmaceutical companies and individual experts in medicinal product development [ 13 , 14 ]. This collaboration not only mobilizes resources and attracts funding but also strengthens the reputation and competitiveness of a country within the global clinical research landscape. Overall, effective training for clinical trial experts plays a crucial role in advancing medical science, improving patient care, and fostering innovation in healthcare. Recognizing the critical need for high-quality clinical trial training programs, global stakeholders in clinical trials, including academia, industries, research institutions, and non-governmental organizations, have taken proactive steps to design and implement relevant education and training initiatives for Africa and other developing regions [ 15 – 22 ]. These programs are offered either free of charge or for a fee, with the goal of providing professionals with the requisite knowledge and skills to conduct clinical trials effectively. However, publications stemming from these initiatives demonstrate a predominant focus of the courses on broader aspects of clinical trials rather than actual practical skills tailored to local contexts. Trainees then confront the harsh reality that while the practical application of clinical trials appears feasible in theory, it frequently proves complex in real-world scenarios, resulting in a limited contribution of the training programs to the development of clinical trials capacity in Africa. To overcome these limitations, innovative clinical trial training programs are needed. These programs should integrate peer learning, real-life scenarios, and authentic case studies that would enhance the day-to-day efficiency of clinical trial professionals, enabling them to coordinate trials independently with minimal supervision. Given these pressing demands for effective clinical trials training programs, we aimed to design, develop, implement, and evaluate a novel clinical trials operation training program for Africa. This manuscript outlines the innovative strategies we employed in creating and evaluating a clinical trial training program, showcasing the significant accomplishments achieved through the program. METHODS Course design and development A novel training program in clinical trial operations (ClinOps) was designed collaboratively by a team of several academic and product development partners, including the Faculty of Capacity Development (FCD), Foundation for Innovative New Diagnostics (FIND), MMV Medicines for Malaria Venture (MMV), International AIDS Vaccine Initiative (IAVI), Program for Appropriate Technology in Health (PATH), and the Special Programme for Research and Training in Tropical Diseases (TDR), among others. The program’s design and development were informed by the monitoring and evaluation report of the study coordinators course by WHO-TDR, which identified a persistent need among product development partners for training in clinical research operations [ 23 ]. Accordingly, the team opted to tailor the program for individuals already engaged in research, recognizing their ability to promptly apply and transfer the newly acquired skills. The program’s design and learning outcomes were aligned with specific competencies outlined in the WHO/TDR Global Competency Framework for Clinical Research [ 24 ], delineating the essential capabilities required for effective execution of clinical studies. The main goal was to prepare clinical trial study coordinators in trial management skills and optimal provision of operational support at their respective sites. This involved collaborating with and training regional faculty to ensure that expertise was readily available near sites sponsored by product development partners, and subsequently transfer the course and its delivery methods to strategically positioned regional institution. The program followed a framework with the acronym ‘CHAOS’ (Fig. 1 ) , which ironically, contrasts with the serene, deliberate learning journey participants undertake. This framework is derived from the Relationship of Inquiry framework [ 25 ] akin to the Community of Inquiry framework [ 26 ] but tailored to suit a one-to-one learning environment. The course integrates cognitive, constructivist and humanistic learning theories to equip learners with the necessary skills, attitudes, behaviors, and confidence to evolve as professionals and catalyze change within their respective institutions. By employing constructivist-teaching methodologies, the program intended to catalyze a significant enhancement in participants' skills. This approach was based on Lev Vygotsky's sociocultural theory of cognitive development [ 27 ], which emphasizes the impact of culture and social environment on individuals' perception of reality. According to this theory, learners integrate and assign significance to new knowledge by relating it to their personal experiences and social context. Figure 1 : CHAOS framework for the design of ClinOps training program The training program effectively incorporated innovative multimedia learning components (Fig. 2 ), supported by VoiceThread, the Moodle Learning Management System, offline-accessible downloadable content, and the Zoom virtual meeting platform to facilitate effective course delivery. Led by such technologies, the course was specifically designed to be accessible to participants worldwide via an online learning platform. This approach aimed to provide training to individuals who might not have access to similar programs in urban areas, ensuring they could acquire the necessary skills to become proficient trial study coordinators. Figure 2 : innovative multimedia learning components ClinOps Course content The program consisted of a ten-week training course that delved into crucial facets of clinical trials. It comprised ten lessons (Fig. 3 ), each spanning one week in duration. Throughout each week-long lesson, learners embarked on a journey starting with preliminary activities that introduced the concept to be taught. They then engaged in problem-based learning activities, progressing towards deeper analysis. Depending on their prior knowledge and experience, participants were expected to spend between 8–12 hours per week on the course. They were given three-weeks after the course ended to finalize their assessment if not already completed during the course. Figure 3 . ClinOps training program’s ten lessons. Each learner was assigned a mentor throughout the course duration to facilitate interaction, reflective practice, and formative assessments, integral components of the program design. While each lesson was scheduled to span one week, some learners may not have completed the lesson within the designated timeframe. Hence, fostering social presence was crucial to offer positive support, aiding learners in establishing an emotional connection to the course there by encouraging them to persist with the course despite juggling family and work commitments simultaneously. The reference materials provided in the program were freely available under Creative Commons licenses. The core learning components, such as On-Demand Content and tasks, are openly accessible for public use in their original format and can be modified under a Creative Commons CC BY SA license. This license enabled users to freely share, copy, and redistribute the material in various mediums or formats. Furthermore, users had the right to adapt, remix, transform, and build upon the materials for any purpose, including commercial ventures. Participant competency assessment comprised several components, including active participation in forum discussions and live tutorials, performance on quizzes within the lessons, and contributions on group assignments involving the drafting of a risk management plan related to the course material. The majority of assessments were required to be completed during online lessons, with participants granted a three-week period after the course conclusion to finalize and submit any outstanding assignments. Considering the potential background of the participants, the program team meticulously designed the course, continuously incorporating input from all stakeholders. The methodology and curriculum for delivery were formulated by a panel of faculty members from diverse geographic backgrounds, possessing substantial experience in clinical trial development within LMICs. The content remained closely aligned with the distinct requirements of clinical trial stakeholders in LMICs, focusing on resolving common challenges encountered during trial implementation. Insights were gathered from partners including product development organizations, contract research entities, and former TDR fellows. Learning outcomes Upon successful completion of the course, participants were expected to exhibit competency in four fundamental areas of clinical trial operations: designing, conducting, managing, and reporting clinical trials (Fig. 4 ). Two top-performing participants from the 10-week course were offered opportunities to join a two-year MSc program in Clinical Trials at CDT Africa, Addis Ababa University in Ethiopia. Figure 4 . Intended learning outcomes of the ClinOps training program Setting and participants This training program was specifically tailored for participants based in Africa, with a primary focus on study coordinators involved in clinical trial operations or aspiring to work in this field. Applications were open to candidates from across the continent and were evaluated in a merit-based competition. Selection criteria included but not limited to prior experience as a study coordinator, investigator, co-investigator, study manager, or assistant. Ideally, applicants should possess academic qualifications in fields such as medicine, nursing, pharmacy, biomedical sciences, statistics, or related subjects. Priority was given to applicants from sites with limited clinical trial capacity or those initiating a trial in the near future. As part of their application process, applicants were required to submit a letter of motivation, of 400–500 words, delineating how their participation would benefit both themselves and their institutions. Furthermore, they were required to submit a curriculum vitae outlining their academic and professional accomplishments. To substantiate their application, applicants were required to print the letter of endorsement (LOE) signed by their line manager or another authorized supervisor within their institution. Applicants were encouraged to discuss and explore how the training could enhance their skills and address institutional training requirements prior to having the LOE, provided by the program, signed for submission in the application package. Applications were subjected to review by a selection panel, which subsequently recommended enrollment for candidates who met the selection criteria. Implementation and course transfer FCD, with guidance from Product Development Partners (PDPs) and WHO TDR, and essential leadership from two former TDR fellows, established the framework for the course, accessing decades of training materials, which also involved designing and setting up the learning management system to facilitate course delivery. Faculty members, comprising fourteen subject matter experts primarily from LMICs, were appointed. These experts possess a deep understanding of the intricacies involved in conducting high-quality clinical studies within resource-constrained environments. The primary duties of the faculty include designing and delivering lessons. A lead tutor was designated to provide support to both the faculty and the course director. The course was developed using a thorough participatory joint effort across the Global Health Clinical Consortium (GHCC) with piloting and several peer review processes. The team consisting of academic and product development partners and the TDR/WHO initially worked to understand learner requirements, what the graduates of the program should be able to do at the end of the course. Once the requirements were understood, appropriate learning outcomes were agreed that would address those needs. The learning outcomes were then mapped against the TDR global competency framework for clinical research. The faculty developed each lesson according to the same format using FCDs planning templates. The faculty worked in collaboration with weekly meetings to ensure development progressed on time and that each member of the faculty knew what would be taught in other lessons and could adapt their content accordingly. The draft lessons were peer-reviewed by the wider project team and external subject matter experts. Once the lessons were approved, appropriate formative and summative assessments were designed and the content was developed and subsequently published following a thorough quality assurance process. The team delivered three iterations of the course, training students in Africa, Asia and Latin America, and a call for Expressions of Interest was issued to find a suitable partner located on the African continent. Six institutions engaged in the selection process, and CDT-Africa, Addis Ababa University was selected as the preferred partner. Following discussion with all partners, it was decided to transfer the program's administration to CDT-Africa. This transfer included technical, methodological, and administrative capacities. FCD conducted a thorough gap analysis of CDT-Africa, regarding the teaching, technical, and administrative capabilities necessary for delivering the training in the African context. Based on this analysis, CDT-Africa and FCD established their collaboration based on a maturity model informed by the capability approach [ 19 ]. The course was delivered by CDT-Africa nine months after the transfer program commenced. Accordingly, FCD provided training to the faculty at CDT-Africa in online teaching methodologies while concurrently reviewing and updating the course content to meet local needs. FCD extended support to CDT-Africa's Instructional Design Team, offering technical and academic assistance to ensure that all necessary infrastructure for course delivery was effectively established and suited to the purpose. Following this, FCD continued to provide support for the delivery of the course by CDT-Africa. The in-country Program Leader, admin team of CDT-Africa, and tutors from CDT-Africa received guidance on establishing a learning management system and replicating the online pedagogy refining it to meet the capacity-strengthening needs of Ethiopia and the broader region indefinitely. Evaluation The program evaluation consisted of three main components: quantitative pre-post test assessment, end-course qualitative survey, and a monitoring and evaluation framework. Quantitative pre-post training assessment This assessment utilized a closed-ended online survey administered to trainees both before and after commencing their clinical trial operations training. The survey aimed to measure participants' confidence across various domains including clinical trial phases, regulations, ethics, data management, informed consent, project and financial management, internal and external team management, investigational product management, investigational site files (ISF), safety reporting, and patient recruitment and retention. Participants rated their confidence levels on a five-point scale ranging from "1" (Not Confident) to "5" (Extremely Confident). The initial subsection of the online survey questionnaire comprehends each participant’s involvement in clinical trials. Participants were queried about their prior engagement in a clinical trial site coordination course, including details such as the organizer and date. Additionally, they were asked if they had previously worked as a site clinical coordinator, with a focus on their most recent study, including the year and duration. Participants were asked to share any pertinent details regarding events encountered during trial coordination, including protocol deviations, non-compliances including safety reports, audit findings, data entry and reporting timelines, as well as the development and updating of SOPs. The second subsection of the questionnaire is dedicated to assessing the participants' confidence levels in coordinating and leading clinical trials. Participants were asked to express their confidence in various aspects, including their ability to effectively coordinate the conduct of a clinical trial, their understanding of clinical trial data management processes, their adherence to ethical principles and participant protection, their knowledge of international and local regulations, their comprehension of different phases of clinical trials, their familiarity of patient recruitment and retention strategies, their proficiency in managing investigational products at a clinical trial site, and their understanding of the patient safety reporting process. It also captures information on their adeptness in developing randomization and blinding procedures, designing and implementing quality management systems, and developing protocols and SOPs. The third subsection emphasizes participants' confidence levels regarding trial data management. The questions focus on participants' abilities to proficiently handle investigator site files, coordinate clinical trial close-outs, manage financial aspects of trial sites, manage cross-functional teams, oversee project management tasks, handle external partnerships, and effectively communicate scientific findings from studies they've been engaged in. Additionally, supplementary questions address major aspects of the clinical trial they intend to work on at the time of program enrollment. End-course qualitative survey Upon completion of the training program, participants were asked to evaluate various aspects of the course, including content, organization, technological tools, and instructional methods. Open-ended questions were employed to gather their insights on the most beneficial aspects of the course, its practical application in participants' current roles, strategies for disseminating course content within their institutions, and suggestions for enhancing effectiveness. Responses collected from the participants were summarized along selected thematic areas relevant to the respective question. Monitoring and evaluation A monitoring and evaluation approach was employed, utilizing the Framework and Best Practices for Training Initiatives of Health Professionals in Low-income Countries, proposed by Cancedda et al [ 30 ]. This framework incorporates six best practices aimed at addressing the shortage of healthcare workers in low-income countries: alignment with local priorities, country ownership, competency-based training and pedagogic innovation, institutional capacity building, sustainability strategy, and the establishment of long-lasting partnerships with international stakeholders. Therefore, in order to collect relevant data for this evaluation, continuous information was gathered throughout the design, development, and implementation stages of the program, including any challenges encountered by participants. These data were analyzed in conjunction with qualitative course satisfaction surveys, pre-post test evaluations, and feedback from the program team to provide a comprehensive evaluation as proposed by Cancedda et al . Statistical analysis We employed the Wilcoxon rank test using SPSS to assess and compare the differences in participants' scores before and after completing the course. This analysis aimed to examine the pre-post training variations in confidence across various domains. Due to the demand-driven sampling method and the non-normally distributed nature of the scores, we conducted non-parametric tests. The findings of the statistical analysis were presented numerically. Descriptive statistics were computed for sociodemographic variables and crucial course evaluation data. The qualitative data were analyzed thematically. RESULTS Participants characteristics In the initial cohort of the course, 88 study coordinators, 56 (64%) females, hailing from 19 countries across Africa, were enrolled and completed the pre-course assessment questionnaire. Regarding their clinical trials experience, 85 (97%) of the participants had prior experience in clinical trial roles, serving as study coordinators, co-investigators, or research assistants. Moreover, 57 (65%) were actively employed as study coordinators during the training period. Out of the total number of participants, 71 (81%) completed the course, with 69 (97%) of them also finishing the post-course assessment. Findings from pre-post test evaluations The Wilcoxon Signed-Ranks test revealed significant post-training improvements in participants' scores across the four fundamental areas of competence for clinical trials. For conducting clinical trials, post-training scores (mean rank = 31.78) significantly exceeded pre-training scores (mean rank = 8.0) (Z = -6.682, p < 0.001 ). Similarly, in managing clinical trials, post-training scores (mean rank = 36.89) surpassed pre-training scores (mean rank = 9.83) (Z = -6.813, p <0.001). In designing clinical trials, post-training scores (mean rank = 36.27) were notably higher than pre-training scores (mean rank = 12.20) (Z = 6.799, p <0.001). Likewise, for reporting outputs of clinical trials, post-training scores (mean rank = 16.94) exceeded pre-training scores (mean rank = 3) (Z = -4.897, p < 0.001 ) ( Table 1 ). Table 1 : Difference in the score of the participants in the measures of the four dimensions of competence (conduct, manage, design & report) in clinical trials before and after the training Dimension of clinical trial competency Rank n Mean rank Sum of ranks Z-score P-value Conduct CT, post Conduct CT, pre Negative 2 8.00 16 -6.682 .001 Positive 59 31.8 1875 Ties 8 Total 69 Manage CT, post Manage CT, pre Negative 6 9.8 59 -6.813 .001 Positive 62 36.9 2287 Ties 1 Total 69 Design CT, post Design CT, pre Negative 5 12.2 61 -6.799 .001 Positive 63 36.3 2285 Ties 1 Total 69 Report CT, post Report CT, pre Negative 1 3 3 -4.897 .001 Positive 31 16.9 525 Ties 7 Total 39 Post: post-training; pre: pre-training; CT: clinical trial; significance at p < 0.05 Findings from end-course qualitative survey Participants’ responses to the four open-ended questions are summarized as described below. The most beneficial aspects of the course The responses to this question are summarized in four themes: Courses content In this context, participants noted that the course comprehensively addressed nearly all essential aspects of a clinical trial. They found the study materials to be abundant, offering detailed information on clinical trials along with supplementary readings and references. The content was deemed highly informative, covering everything needed from the inception to the conclusion of a clinical trial. Participants felt it provided a robust foundation to build upon. The objectives were well-defined, and the organization and relevance of the course content were praised for their direct applicability to improving their work. Course design Participants expressed appreciation for various aspects of the training design. They found the distribution of course content over time to be appropriate and accessible, with resources related to clinical trials readily available without restrictions. The shared documents and templates used were directly applicable to clinical trial practices, enhancing the realism of the training. Reading materials, checklists, and risk management plans were particularly lauded for their practicality. VoiceThreads explanations, questions, and discussions were deemed helpful. Moreover, the availability of study materials and direct communication with tutors, coupled with flexible timing, enabled participants to progress at their own pace without sacrificing quality. The flexibility to undertake the training at their convenience was highly valued. The online format, featuring virtual interaction with both the audience and tutors, was described as remarkable. Additionally, collaborative activities such as risk management group work and tutorial sessions provided opportunities for active participation and clarification of doubts. Discussions with foreign partners, group forums, and exposure to new methods like Moodle were cited as beneficial experiences. The interactive and practical nature of the sessions allowed participants to express themselves and learn from individuals with diverse backgrounds, facilitating the sharing of ideas. The learning platform's accessibility from anywhere and at any time was commended, as was the ability to listen to recordings offline and meet deadlines. Despite being virtual, the sessions fostered an interactive environment where constructive feedback was provided, enhancing the overall learning experience. Trainers competency In general, trainers were regarded as highly knowledgeable about the course, drawing from significant lived experience in clinical trials. This expertise greatly enriched the learning experience for trainees. Additionally, the tutors were recognized for their subject matter expertise, injecting vitality into the course content beyond what textbooks could offer. They were noted for their approachability and accessibility, with their lectures skillfully presenting course material. Their receptiveness, follow-up, and encouragement were appreciated, as they often shared practical experiences and cases to enhance understanding. Some guest speakers were also praised for their contributions. The availability and effective communication of trainers during virtual training sessions were consistently commended. Coordinators were also lauded for their deep understanding of the subject matter, enabling them to provide insightful examples. Practicality Participants expressed appreciation for the practicality of the course in relation to their clinical trials. They found the content to be directly relevant to their everyday work duties and activities. The course was deemed practical, offering real-life experiences and insights into handling and managing clinical trials. Regarding its practicality, one participant articulated: “It was timely on my part, as I am considering a new career path into research monitoring and CRO management. It encompassed project management, research skills, etc. Further to that, it has helped a lot in my day-to-day execution of study coordination roles at the facility especially on the risk assessment and prioritization (PM52).” The satisfaction with the entire approach, encompassing content, trainers, and methodology, is aptly captured in the following quote from another participant: “The best thing about this course for me was the easy accessibility to study materials and availability of experts in the field to explain them further during tutorials and in comment sections on Voice threads” (YN70).” Another participant stated: “The best thing about the course was the discussion forums where we had to discuss the topics. This part enables me to express my thoughts and understanding about the topics under discussion. It also afforded me the opportunity to know what my colleagues’ thoughts were on issues being discussed. lastly, it allows me to see how diverse people's views are regarding a given matter.” As a concluding remark, the overall evaluation of the training can be encapsulated most effectively with the following quote from one of the participants: “The best thing about this course was that not only content was good but also moderators and other participants were committed to sharing experiences, and much more. Being a part of this course was a great opportunity for me and I would love to get another chance if there is another opportunity (PAB34).” Application in participants' current roles Participants' responses for this section are organized into three themes: improved understanding, improved practice, and improved skill of project management. Improved understanding Participants highlighted that the training facilitated their acquisition of techniques in clinical trials, leading to revisions and enhancements of their existing documents and manuals. Moreover, it aided in refining their ability to teach clinical research methods, particularly focusing on clinical trials. Some participants noted a deepened understanding of specific topics such as pharmacovigilance and safety reporting. They also mentioned an improved comprehension of the organizational aspects of clinical trials. Specifically, participants cited increased knowledge in operations, conducting, and reporting clinical trials, as well as in preparing Investigator ISF. Overall, these improvements contributed to enhancing confidence in their clinical trial-related roles. Improved clinical practice Several participants noted that the training facilitated improvements in their daily clinical trial responsibilities. It provided valuable input for coordinating ongoing studies and proved particularly beneficial for those in roles such as clinical coordinator, allowing them to integrate performance indicators into their work. This enabled them to prepare comprehensive checklists, including quality management checklists, prior to clinical trials, enhancing performance monitoring through key performance indicators. Additionally, the training assisted in the development of SOPs. Participants highlighted an increase in their adherence to clinical trial procedures and improvement in team management. Furthermore, they found that the training equipped them with informed knowledge to support customary practices within clinical trials. Improved project management skills Several participants found the training beneficial for enhancing quality management, data management, and regulatory activities within their clinical trial work. They noted that the training aided in improving documentation practices and streamlining work processes and scheduling. Moreover, participants mentioned that the training equipped them with skills in financial management and risk management, including identifying and implementing mitigating measures for potential risks. Additionally, they learned how to effectively close out a project. Other skills gained included improved preparation for audits and inspections, as well as fostering and maintaining positive relationships with both internal and external partners. Dissemination of course contents within their institutions This question reveals two distinct themes, which are identified and presented as follows: To teach, mentor, or share experience Some participants utilized the course to instruct clinical research methods and ethics to resident students, while others employed it to mentor doctors and junior colleagues in coordinating clinical trials. They provided guidance to staff on maintaining quality standards in clinical trial conduct and shared their course experiences with their team members. In specific instances, they trained peers and colleagues on risk management plans. Furthermore, they shared course documents with individuals engaged in similar practices and distributed modules and templates to colleagues. Participants also indicated using the course material as a training tool for other members. Additionally, some organized their own capacity-building training sessions, which included retraining lab staff, onboarding new personnel, and instructing fellow workers involved in trials they coordinated. Many participants mentioned recommending the course to others. Practical support In addition to teaching and training, participants also emphasized providing direct support in practice. For instance, they assisted their sites in reporting, updating, and distributing data, as well as re-evaluating their site key performance indicators. They trained their assistants in managing ISFs and implemented changes in documentation and reporting within their own organizations. Some participants actively worked to combat fraud, fabrication, and falsification that could compromise the quality of data collection. They also played a role in correcting mistakes made by others and supported colleagues in designing risk management plans for their sites, resulting in significant improvements in planning and performance. Potential modifications to the course to better meet their needs The responses to this question are categorized into three themes: Proceed as it is Some participants expressed their appreciation for the training and conveyed a desire for it to continue without any changes. They indicated that they had no suggestions for improvement. For instance, three participants specifically mentioned that they believe the training is already perfect and should remain unchanged. Satisfaction Expression Rather than providing specific suggestions for improving the training as requested, most participants chose to express their satisfaction by applauding and offering praise such as: informative, well-organized, perfect for current position, effective, simply perfect, meticulously planned, superb content, immediately relevant, comprehensive material, highly engaging, well-crafted, tailored to needs, and so forth. Specific improvement suggestions Although many respondents expressed satisfaction without specific comments and praised the training's quality, there were also constructive suggestions for enhancement. In this section, these suggestions are categorized into four areas. Timing Several participants suggested extending the duration of the course from 10 weeks to 14 weeks to allow for more in-depth discussions of the course material. They recommended extending the one-hour tutorial sessions to provide attendees with additional time for exchanging views. Additionally, some participants found the timing of the live tutorials challenging as they occurred during working hours, highlighting the need for greater time flexibility. There was a consensus on the need to allocate more time to live classes. The current schedule was deemed too tight for busy professionals, with suggestions to break down the program into more manageable modules. Participants proposed allocating two weeks for submission of group work and extending the duration of each lesson to two weeks to accommodate these changes. Group work management One participant identified group work as a significant challenge within an otherwise excellent course. They recommended improving coordination of group projects and enhancing participant interaction, potentially through open forum discussions. The approach to team activities, particularly regarding the risk management plan, was perceived as lacking smoothness. It was suggested that senior management should oversee group work, and if feasible, teams should be organized by country to facilitate communication. Additionally, tutorials and forum discussions should be enhanced. Measures should be implemented for non-responsive participants during group assignments, with coordinators working closely with team leads to clarify requirements. Furthermore, there was a suggestion for more practice and less emphasis on group work, reflecting concerns about its management. Finally, one participant proposed that group meetings should be financially supported by the institution offering the course. Accessibility Another suggestion pertained to accessibility, particularly concerning VoiceThreads. One participant noted difficulty accessing VoiceThreads via phone and recommended improvement in this area. They proposed sharing VoiceThreads in the form of PowerPoint presentations to facilitate easier access. Participants found it challenging to complete VoiceThreads before live tutorials and suggested making presentations readily available for download in PowerPoint format. Furthermore, they recommended incorporating more interactive virtual sessions with colleagues through platforms like Zoom or Microsoft Teams. Additionally, there was a suggestion for a smartphone interface to enhance accessibility. Some participants recommended including more real-life scenarios in assessments to better appreciate practical applications, as well as providing opportunities for participants to observe simulations for real-life applications. A unique suggestion related to access, albeit not directly tied to the current course provision, was the need for regular offering of the course in the future due to its perceived perfection. Participants advocated for the course to be organized annually, with former participants allowed to participate again. Another unique suggestion was coordinating alumni of the course for grant writing. Additionally, two participants suggested that the 10-week duration of the course is too lengthy for a certificate and proposed issuing a diploma instead, as certificates are typically awarded for shorter training durations. Findings from the monitoring and evaluation The routine information collected throughout the various stages of course development, implementation, and evaluation, as part of the program's monitoring and evaluation framework, have documented various opportunities, challenges, and prospects associated with the ClinOps program. These data have been summarized in alignment with the six best practices outlined in the Framework and Best Practices for Training Initiatives of Health Professionals in Low-income Countries ( Table 2 ). Table 2 : Summary of monitoring and evaluation findings based on the six outlined best practices in the Framework and Best Practices for Training Initiatives of Health Professionals in Low-income Countries. Anticipated best practices Findings Alignment with local priorities Participants promptly implemented the new-found knowledge within their professional capacities, effectively serving the objectives of their respective local institutions. Participants exchanged personal insights and problem-solving approaches, with the learning activities tailored to address authentic challenges encountered in their fields. Country ownership Transfer of the program to Addis Ababa University from FCD facilitated country ownership Pedagogic innovation Downloadable content with offline access enabled participants to work offline, uploading their work to forums upon reconnecting. Moodle LMS provided convenient access for participants to course materials, interactions, and submissions. VoiceThread enhanced dynamic teaching, enabling interactive sessions and real-time addressing of academic challenges. Zoom tutorials generally satisfactory, minor audio/connection issues reported. Assessment strategies included forum participation, quizzes, and group assignments, promoting active participation and engagement. Course leaders' proactive follow-up boosted participant confidence, ensuring continued engagement. Institutional capacity building Training local faculty on the design and management of the course as part of knowledge transfer component enhanced local capacity. Utilization of local institution-hosted digital course delivery and management platforms enhanced capacity managing training locally. Sustainability strategy The local partner institution becomes a sustainable clinical trial training hub for Africa . Long-lasting partnerships Involving academic and product development partners in the program team, such as FCD, FIND, IAVI, MMV, PATH, TB Alliance, and TDR, fostered enduring partnerships. The program cultivated formal and informal partnerships among participants, likely persisting post-course. Top students invited to join a two-year MSc in Clinical Trials program at CDT-Africa Addis Ababa University. The transfer of the ClinOps training program from a high-income to a lower-middle-income country—specifically from FDC to Addis Ababa University—spanning administrative, technical, and online teaching functions through knowledge transfer training for local faculty and research staff facilitated the alignment of the program with local priorities. The transfer of the program to Addis Ababa University CDT-Africa, facilitated by FCD and PDPs, ensured sustainability. The local institution gained capacity to sustain and develop new programs, serving as a regional asset for LMIC capacity building. Participants from various countries initially expressed concerns about potential disruptions to their participation in the program due to poor internet connectivity. However, the implementation of innovative teaching and learning platforms in this course helped alleviate these anticipated challenges. By utilizing downloadable content, including a "downloads folder" in each lesson for participants to access all materials at once, individuals were able to work offline and subsequently upload their work to discussion forums upon connecting to the internet. While participants were encouraged to post on forums, and no time limits were imposed, offering maximum flexibility for those encountering internet or utility-related issues. Utilizing Moodle as the learning management system, where participants access course materials, upload their work, and interact with peers and faculty, facilitated convenient access to course resources. Incorporating VoiceThread into the teaching-learning process enabled dynamic lesson presentations, facilitating flipped classrooms and fostering interactive sessions. Participants were able to add comments or questions to any part of the presentation, allowing instructors to address academic challenges or misconceptions in real-time. The use of Zoom for live tutorials has generally been satisfactory, with few participants reporting issues with audio speed or connection. When issues arise, they are often attributed to participants relying on slow, local WiFi. To optimize connection quality for all, participant mics and cameras were typically switched off during tutorials, with participants typing comments or questions to the class instead. The recordings of the live tutorials were also made available immediately after the session. Each tutorial included at least one faculty member tasked with monitoring and engaging with the chat, bringing key points to the presenter's attention as needed. Some challenges reported by participants during the course stemmed from personal issues. Health and family reasons, such as malaria or dengue fever, led some to lag on some specific courses. Other challenges included government internet shutdowns, bereavement, divorce, and pregnancy-related issues. Many faced obstacles but persevered to complete the course, despite these challenges. Issues were addressed through mentor and instructor discussions. The initial three weeks were crucial; participants falling behind during this period tended to withdraw. Vigilance during this period and proactive engagement helped resolve issues. Weekly mentor engagement and peer support fostered success within a positive learning environment. Participants appreciated the course leaders' proactive approach of following up through one-to-one emails and, if necessary, Zoom calls when engagement was lacking. This practice instilled confidence and encouraged continued participation. Initially, the teamwork aspect of the course assessment posed challenges for most groups, particularly in navigating effective remote collaboration across different time zones. It was frustrating when some team members did not fully engage. However, considering time zone differences during team formation helped minimize these issues. With approximately twelve participants and one faculty mentor per team, each group had a private shared space on the Learning Management System for project discussions and file sharing. This setup fostered friendships and trust among team members, facilitating their working dynamics and fostering informal networks that may persist beyond the course. Although proficiency in English was required for all participants, it was not the native language for some. Initially, a few lacked confidence to engage publicly on forums. However, through a positive learning environment and continuous support, their language confidence and verbal skills improved. The tutors clarified that participants didn't need fluent English proficiency. It was more important to communicate effectively, even if it meant making grammatical or spelling errors, rather than refraining from asking questions or sharing experiences. DISCUSSION This study aimed to design, develop, implement, and evaluate an innovative clinical trials operation training program for Africa. In its first cohort, the program enrolled 88 participants from 19 countries. There were significant improvements in participants' post-training scores compared to their pre-training scores across the four essential domains of clinical trials competence: designing, conducting, managing, and reporting clinical trials. Development and implementation of the program demonstrated efficiency across the six best practices for health professional training programs for low-income countries: alignment with local priorities, country ownership, competency-based training and pedagogic innovation, institutional capacity building, sustainability strategy, and the establishment of long-lasting partnerships with international stakeholders. The program's innovative approach, incorporating offline-accessible downloadable content, Moodle LMS, VoiceThread interactive sessions, and multidirectional competency assessment strategies, garnered high satisfaction among participants. Engaging academic and product development partners like FCD, FIND, IAVI, MMV, PATH, TB Alliance and TDR in the program team nurtured long-lasting partnerships. The successful transfer of the program from FCD to Addis Ababa University CDT-Africa facilitated country ownership and positioned the local partner institution as a sustainable LMIC training hub. Previous studies on training initiatives for health professionals in Africa have shown the potential to improve competency and performance [ 30 – 34 ], yet there is limited information on competency in clinical trial capacity. The program's success in enhancing participants' proficiency in clinical trials was notably marked by a significant improvement. This achievement can be largely credited to the effective utilization of innovative teaching strategies, including offline-accessible downloadable content, Moodle LMS, VoiceThread interactive sessions, multidirectional competency assessment strategies, and the TDR Core Competency Framework. Previous studies conducted in Africa suggest that incorporating multiple strategies into training programs has the potential to engage both trainees and trainers, fostering active participation [ 35 – 37 ]. The approach followed in the program addresses a common weakness found in many online courses, which are typically designed for individuals to complete independently, often leading to feelings of isolation and loneliness. The study findings indicated that participants encountered various technical and personal challenges while taking part in the training, including family commitments, health issues, and internet disruptions. Those who faced these challenges early on often experience difficulties and ultimately withdrew from the course. Prior studies conducted in Africa indicate that training initiatives necessitate a comprehensive support system for participants, encompassing the provision of necessary resources, effective mentorship, and ongoing program monitoring to ensure successful outcomes and impacts [ 19 , 38 – 40 ]. In this study, participants were primarily problem-oriented in their approach to learning, seeking to apply new knowledge immediately in their professional roles. This aligns with the goals of their institutions, which prioritized tangible, immediate benefits stemming from the course. This sense of urgency was heightened by the expectation for participants to rapidly acquire the skills necessary to support ongoing projects and future capacity-building initiatives. Consequently, the learning activities were designed within the context of real-world challenges, encouraging participants to share their own experiences and problem-solving strategies. By updating the course content and delivering it through a local institution, the program strategically positioned itself to address regional capacity development needs in clinical research focusing on locally relevant clinical trial issues. This study employed various novel strategies to develop, implement, and assess the effectiveness of the ClinOps training program, incorporating also insights from participants across 19 countries. However, conducting follow-up evaluations of participants in their actual job roles would yield a deeper understanding of the program's broader impact. CONCLUSION The ClinOps program, a clinical trial operations training initiative for Africa led by experts from academia and product development partners, significantly enhanced participants' competency in clinical trials. The program effectively followed the six best practices for health professional training programs for low-income countries, alignment with local priorities, country ownership, pedagogic innovation, institutional capacity building, sustainability, and long-lasting partnerships. Transferring the program to a local institution promoted country ownership and established the institution as a sustainable clinical trial training hub for Africa. Participants in the post-course qualitative evaluation expressed appreciation for the beneficial aspects of the course, its relevance to their current roles, and the dissemination of course content within their institutions. They also provided suggestions for potential modifications to better meet their needs, supporting beneficial aspects of the course and suggesting strategies for improvement. To enhance clinical trials capacity in Africa effectively, training initiatives should provide comprehensive competency in designing, conducting, managing, and reporting trials tailored to local contexts. Declarations Data availability The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. Acknowledgments The authors thank the Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), Addis Ababa University for hosting and managing the ClinOps project successfully. Ethical consideration Ethics approval and consent to participate Scientific and Ethics Review Committee of the Center for Innovative Drug Development and Therapeutic Trials for Africa approved the study. Consent was obtained from the course participants for both the pre-post course survey and the qualitative part. Funding This effort was made possible through funding from Bill & Melinda Gates Foundation. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Bill & Melinda Gates Foundation. Consent for publication Not applicable. Authors’ contributions Study design and conception: DAE, AF, JW, TM, PN, AC, BO, AN, SW, HD, JL, RH, RB, MV, EM, Funding acquisition: DAE, AF, JW, EM. Study implementation and data analysis: DAE, AF, JW, TM, PN, AC, BO, AN, SW, HD, JL, RH, RB, MV, EM. Draft the Manuscript: DAE, TM. Reviewed and revised the manuscript: DAE, AF, JW, TM, PN, AC, BO, AN, SW, HD, JL, RH, SB, RB, BS, MV, EM, All authors read and approved the final manuscript for publication. Competing interests All authors report no potential conflicts. References Saleh M, Sharma K, Shamshudin A, Obayo I, Gondi S, Karimi N. Regulatory approval of clinical trials: is it time to reinvent the wheel? BMJ Glob Health. 2024 Jan 24;9(1):e013727. Saidu Y, Nchinjoh SC, Adidja A, Besong AF, Netongo PM, Ndom P, et al. 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Cite Share Download PDF Status: Published Journal Publication published 24 Jan, 2025 Read the published version in BMC Medical Education → Version 1 posted Editorial decision: Revision requested 17 Jun, 2024 Reviews received at journal 09 Jun, 2024 Reviewers agreed at journal 23 May, 2024 Reviews received at journal 08 May, 2024 Reviewers agreed at journal 19 Apr, 2024 Reviewers invited by journal 19 Apr, 2024 Editor assigned by journal 19 Apr, 2024 Editor invited by journal 04 Apr, 2024 Submission checks completed at journal 04 Apr, 2024 First submitted to journal 03 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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2","display":"","copyAsset":false,"role":"figure","size":48641,"visible":true,"origin":"","legend":"\u003cp\u003einnovative multimedia learning components ClinOps\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4213344/v1/f7a8f2448985d5510409ba3c.jpg"},{"id":54370130,"identity":"cffb90e8-45d2-4c25-979a-2eda04f85b14","added_by":"auto","created_at":"2024-04-09 13:06:31","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":111743,"visible":true,"origin":"","legend":"\u003cp\u003eClinOps training program’s ten lessons.\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4213344/v1/cfee8cc007038e13b83a1bb8.jpg"},{"id":54370131,"identity":"d45f765c-3a0a-4637-beb7-523c34052092","added_by":"auto","created_at":"2024-04-09 13:06:31","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":111262,"visible":true,"origin":"","legend":"\u003cp\u003eIntended learning outcomes of the ClinOps training program\u003c/p\u003e","description":"","filename":"4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4213344/v1/1f88506cba795d3c684bd3bc.jpg"},{"id":74858451,"identity":"b4146bcd-f200-4fd8-b0df-e7c6f4376188","added_by":"auto","created_at":"2025-01-27 16:09:44","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1303130,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4213344/v1/b44df9a3-6d0d-43a3-9489-6679ec243073.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Development, implementation, and evaluation of an innovative clinical trial operations training program for Africa (ClinOps)","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eClinical trials in Africa face significant challenges stemming from human resources, infrastructure, regulatory, and financial constraints [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. With a population of 1.5\u0026nbsp;billion, the continent boasts remarkable genetic and demographic diversity, presenting a unique opportunity to thoroughly evaluate the efficacy and safety of medical interventions across a wide spectrum of origins, age groups, genders, and socioeconomic strata. Despite this advantageous position, the successful initiation and operation of clinical trials in the continent remain challenging, as it necessitates navigating through a complex array of resources and operations [\u003cspan additionalcitationids=\"CR4 CR5\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Although the number of registered clinical trials in Africa has been steadily increasing, its overall contribution still stands at just two percent of the global total [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eStudies demonstrate that strengthening human resource capacity stands as a primary and critical measure in building the overall clinical trial capacity in Africa [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. By investing in research readiness training programs for clinical trial experts, countries can attract more clinical trials while enhancing the quality, efficiency, and integrity of clinical trial operations [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Such training initiatives provide professionals with the necessary knowledge and skills to effectively design, conduct, and manage clinical trials. This encompasses a comprehensive understanding of regulatory requirements, ethical considerations, and adherence to international standards. Ongoing training fosters continuous professional development, enabling experts to remain informed of advancements in clinical trial methodologies, regulatory changes, industry standards, and emerging trends in clinical trial approaches. Professionals who undergo thorough training in clinical trials are better positioned to network and collaborate with pharmaceutical companies and individual experts in medicinal product development [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. This collaboration not only mobilizes resources and attracts funding but also strengthens the reputation and competitiveness of a country within the global clinical research landscape. Overall, effective training for clinical trial experts plays a crucial role in advancing medical science, improving patient care, and fostering innovation in healthcare.\u003c/p\u003e \u003cp\u003eRecognizing the critical need for high-quality clinical trial training programs, global stakeholders in clinical trials, including academia, industries, research institutions, and non-governmental organizations, have taken proactive steps to design and implement relevant education and training initiatives for Africa and other developing regions [\u003cspan additionalcitationids=\"CR16 CR17 CR18 CR19 CR20 CR21\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. These programs are offered either free of charge or for a fee, with the goal of providing professionals with the requisite knowledge and skills to conduct clinical trials effectively. However, publications stemming from these initiatives demonstrate a predominant focus of the courses on broader aspects of clinical trials rather than actual practical skills tailored to local contexts. Trainees then confront the harsh reality that while the practical application of clinical trials appears feasible in theory, it frequently proves complex in real-world scenarios, resulting in a limited contribution of the training programs to the development of clinical trials capacity in Africa. To overcome these limitations, innovative clinical trial training programs are needed. These programs should integrate peer learning, real-life scenarios, and authentic case studies that would enhance the day-to-day efficiency of clinical trial professionals, enabling them to coordinate trials independently with minimal supervision.\u003c/p\u003e \u003cp\u003eGiven these pressing demands for effective clinical trials training programs, we aimed to design, develop, implement, and evaluate a novel clinical trials operation training program for Africa. This manuscript outlines the innovative strategies we employed in creating and evaluating a clinical trial training program, showcasing the significant accomplishments achieved through the program.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eCourse design and development\u003c/h2\u003e \u003cp\u003eA novel training program in clinical trial operations (ClinOps) was designed collaboratively by a team of several academic and product development partners, including the Faculty of Capacity Development (FCD), Foundation for Innovative New Diagnostics (FIND), MMV Medicines for Malaria Venture (MMV), International AIDS Vaccine Initiative (IAVI), Program for Appropriate Technology in Health (PATH), and the Special Programme for Research and Training in Tropical Diseases (TDR), among others. The program\u0026rsquo;s design and development were informed by the monitoring and evaluation report of the study coordinators course by WHO-TDR, which identified a persistent need among product development partners for training in clinical research operations [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Accordingly, the team opted to tailor the program for individuals already engaged in research, recognizing their ability to promptly apply and transfer the newly acquired skills. The program\u0026rsquo;s design and learning outcomes were aligned with specific competencies outlined in the WHO/TDR Global Competency Framework for Clinical Research [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e], delineating the essential capabilities required for effective execution of clinical studies. The main goal was to prepare clinical trial study coordinators in trial management skills and optimal provision of operational support at their respective sites. This involved collaborating with and training regional faculty to ensure that expertise was readily available near sites sponsored by product development partners, and subsequently transfer the course and its delivery methods to strategically positioned regional institution.\u003c/p\u003e \u003cp\u003eThe program followed a framework with the acronym \u0026lsquo;CHAOS\u0026rsquo; (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e, which ironically, contrasts with the serene, deliberate learning journey participants undertake. This framework is derived from the Relationship of Inquiry framework [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] akin to the Community of Inquiry framework [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] but tailored to suit a one-to-one learning environment. The course integrates cognitive, constructivist and humanistic learning theories to equip learners with the necessary skills, attitudes, behaviors, and confidence to evolve as professionals and catalyze change within their respective institutions. By employing constructivist-teaching methodologies, the program intended to catalyze a significant enhancement in participants' skills. This approach was based on Lev Vygotsky's sociocultural theory of cognitive development [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e], which emphasizes the impact of culture and social environment on individuals' perception of reality. According to this theory, learners integrate and assign significance to new knowledge by relating it to their personal experiences and social context.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e: CHAOS framework for the design of ClinOps training program\u003c/p\u003e \u003cp\u003eThe training program effectively incorporated innovative multimedia learning components (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e), supported by VoiceThread, the Moodle Learning Management System, offline-accessible downloadable content, and the Zoom virtual meeting platform to facilitate effective course delivery. Led by such technologies, the course was specifically designed to be accessible to participants worldwide via an online learning platform. This approach aimed to provide training to individuals who might not have access to similar programs in urban areas, ensuring they could acquire the necessary skills to become proficient trial study coordinators.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e: innovative multimedia learning components ClinOps\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eCourse content\u003c/h2\u003e \u003cp\u003eThe program consisted of a ten-week training course that delved into crucial facets of clinical trials. It comprised ten lessons (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e), each spanning one week in duration. Throughout each week-long lesson, learners embarked on a journey starting with preliminary activities that introduced the concept to be taught. They then engaged in problem-based learning activities, progressing towards deeper analysis. Depending on their prior knowledge and experience, participants were expected to spend between 8\u0026ndash;12 hours per week on the course. They were given three-weeks after the course ended to finalize their assessment if not already completed during the course.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. ClinOps training program\u0026rsquo;s ten lessons.\u003c/p\u003e \u003cp\u003eEach learner was assigned a mentor throughout the course duration to facilitate interaction, reflective practice, and formative assessments, integral components of the program design. While each lesson was scheduled to span one week, some learners may not have completed the lesson within the designated timeframe. Hence, fostering social presence was crucial to offer positive support, aiding learners in establishing an emotional connection to the course there by encouraging them to persist with the course despite juggling family and work commitments simultaneously.\u003c/p\u003e \u003cp\u003eThe reference materials provided in the program were freely available under Creative Commons licenses. The core learning components, such as On-Demand Content and tasks, are openly accessible for public use in their original format and can be modified under a Creative Commons CC BY SA license. This license enabled users to freely share, copy, and redistribute the material in various mediums or formats. Furthermore, users had the right to adapt, remix, transform, and build upon the materials for any purpose, including commercial ventures.\u003c/p\u003e \u003cp\u003eParticipant competency assessment comprised several components, including active participation in forum discussions and live tutorials, performance on quizzes within the lessons, and contributions on group assignments involving the drafting of a risk management plan related to the course material. The majority of assessments were required to be completed during online lessons, with participants granted a three-week period after the course conclusion to finalize and submit any outstanding assignments.\u003c/p\u003e \u003cp\u003eConsidering the potential background of the participants, the program team meticulously designed the course, continuously incorporating input from all stakeholders. The methodology and curriculum for delivery were formulated by a panel of faculty members from diverse geographic backgrounds, possessing substantial experience in clinical trial development within LMICs. The content remained closely aligned with the distinct requirements of clinical trial stakeholders in LMICs, focusing on resolving common challenges encountered during trial implementation. Insights were gathered from partners including product development organizations, contract research entities, and former TDR fellows.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eLearning outcomes\u003c/h2\u003e \u003cp\u003eUpon successful completion of the course, participants were expected to exhibit competency in four fundamental areas of clinical trial operations: designing, conducting, managing, and reporting clinical trials (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). Two top-performing participants from the 10-week course were offered opportunities to join a two-year MSc program in Clinical Trials at CDT Africa, Addis Ababa University in Ethiopia.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e. Intended learning outcomes of the ClinOps training program\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eSetting and participants\u003c/h2\u003e \u003cp\u003eThis training program was specifically tailored for participants based in Africa, with a primary focus on study coordinators involved in clinical trial operations or aspiring to work in this field. Applications were open to candidates from across the continent and were evaluated in a merit-based competition. Selection criteria included but not limited to prior experience as a study coordinator, investigator, co-investigator, study manager, or assistant. Ideally, applicants should possess academic qualifications in fields such as medicine, nursing, pharmacy, biomedical sciences, statistics, or related subjects. Priority was given to applicants from sites with limited clinical trial capacity or those initiating a trial in the near future.\u003c/p\u003e \u003cp\u003e As part of their application process, applicants were required to submit a letter of motivation, of 400\u0026ndash;500 words, delineating how their participation would benefit both themselves and their institutions. Furthermore, they were required to submit a curriculum vitae outlining their academic and professional accomplishments. To substantiate their application, applicants were required to print the letter of endorsement (LOE) signed by their line manager or another authorized supervisor within their institution. Applicants were encouraged to discuss and explore how the training could enhance their skills and address institutional training requirements prior to having the LOE, provided by the program, signed for submission in the application package. Applications were subjected to review by a selection panel, which subsequently recommended enrollment for candidates who met the selection criteria.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eImplementation and course transfer\u003c/h2\u003e \u003cp\u003eFCD, with guidance from Product Development Partners (PDPs) and WHO TDR, and essential leadership from two former TDR fellows, established the framework for the course, accessing decades of training materials, which also involved designing and setting up the learning management system to facilitate course delivery. Faculty members, comprising fourteen subject matter experts primarily from LMICs, were appointed. These experts possess a deep understanding of the intricacies involved in conducting high-quality clinical studies within resource-constrained environments. The primary duties of the faculty include designing and delivering lessons. A lead tutor was designated to provide support to both the faculty and the course director.\u003c/p\u003e \u003cp\u003eThe course was developed using a thorough participatory joint effort across the Global Health Clinical Consortium (GHCC) with piloting and several peer review processes. The team consisting of academic and product development partners and the TDR/WHO initially worked to understand learner requirements, what the graduates of the program should be able to do at the end of the course. Once the requirements were understood, appropriate learning outcomes were agreed that would address those needs. The learning outcomes were then mapped against the TDR global competency framework for clinical research. The faculty developed each lesson according to the same format using FCDs planning templates. The faculty worked in collaboration with weekly meetings to ensure development progressed on time and that each member of the faculty knew what would be taught in other lessons and could adapt their content accordingly. The draft lessons were peer-reviewed by the wider project team and external subject matter experts. Once the lessons were approved, appropriate formative and summative assessments were designed and the content was developed and subsequently published following a thorough quality assurance process.\u003c/p\u003e \u003cp\u003eThe team delivered three iterations of the course, training students in Africa, Asia and Latin America, and a call for Expressions of Interest was issued to find a suitable partner located on the African continent. Six institutions engaged in the selection process, and CDT-Africa, Addis Ababa University was selected as the preferred partner. Following discussion with all partners, it was decided to transfer the program's administration to CDT-Africa. This transfer included technical, methodological, and administrative capacities. FCD conducted a thorough gap analysis of CDT-Africa, regarding the teaching, technical, and administrative capabilities necessary for delivering the training in the African context. Based on this analysis, CDT-Africa and FCD established their collaboration based on a maturity model informed by the capability approach [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The course was delivered by CDT-Africa nine months after the transfer program commenced.\u003c/p\u003e \u003cp\u003eAccordingly, FCD provided training to the faculty at CDT-Africa in online teaching methodologies while concurrently reviewing and updating the course content to meet local needs. FCD extended support to CDT-Africa's Instructional Design Team, offering technical and academic assistance to ensure that all necessary infrastructure for course delivery was effectively established and suited to the purpose. Following this, FCD continued to provide support for the delivery of the course by CDT-Africa. The in-country Program Leader, admin team of CDT-Africa, and tutors from CDT-Africa received guidance on establishing a learning management system and replicating the online pedagogy refining it to meet the capacity-strengthening needs of Ethiopia and the broader region indefinitely.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eEvaluation\u003c/h2\u003e \u003cp\u003eThe program evaluation consisted of three main components: quantitative pre-post test assessment, end-course qualitative survey, and a monitoring and evaluation framework.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eQuantitative pre-post training assessment\u003c/h2\u003e \u003cp\u003eThis assessment utilized a closed-ended online survey administered to trainees both before and after commencing their clinical trial operations training. The survey aimed to measure participants' confidence across various domains including clinical trial phases, regulations, ethics, data management, informed consent, project and financial management, internal and external team management, investigational product management, investigational site files (ISF), safety reporting, and patient recruitment and retention. Participants rated their confidence levels on a five-point scale ranging from \"1\" (Not Confident) to \"5\" (Extremely Confident).\u003c/p\u003e \u003cp\u003eThe initial subsection of the online survey questionnaire comprehends each participant\u0026rsquo;s involvement in clinical trials. Participants were queried about their prior engagement in a clinical trial site coordination course, including details such as the organizer and date. Additionally, they were asked if they had previously worked as a site clinical coordinator, with a focus on their most recent study, including the year and duration. Participants were asked to share any pertinent details regarding events encountered during trial coordination, including protocol deviations, non-compliances including safety reports, audit findings, data entry and reporting timelines, as well as the development and updating of SOPs.\u003c/p\u003e \u003cp\u003eThe second subsection of the questionnaire is dedicated to assessing the participants' confidence levels in coordinating and leading clinical trials. Participants were asked to express their confidence in various aspects, including their ability to effectively coordinate the conduct of a clinical trial, their understanding of clinical trial data management processes, their adherence to ethical principles and participant protection, their knowledge of international and local regulations, their comprehension of different phases of clinical trials, their familiarity of patient recruitment and retention strategies, their proficiency in managing investigational products at a clinical trial site, and their understanding of the patient safety reporting process. It also captures information on their adeptness in developing randomization and blinding procedures, designing and implementing quality management systems, and developing protocols and SOPs.\u003c/p\u003e \u003cp\u003eThe third subsection emphasizes participants' confidence levels regarding trial data management. The questions focus on participants' abilities to proficiently handle investigator site files, coordinate clinical trial close-outs, manage financial aspects of trial sites, manage cross-functional teams, oversee project management tasks, handle external partnerships, and effectively communicate scientific findings from studies they've been engaged in. Additionally, supplementary questions address major aspects of the clinical trial they intend to work on at the time of program enrollment.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eEnd-course qualitative survey\u003c/h2\u003e \u003cp\u003eUpon completion of the training program, participants were asked to evaluate various aspects of the course, including content, organization, technological tools, and instructional methods. Open-ended questions were employed to gather their insights on the most beneficial aspects of the course, its practical application in participants' current roles, strategies for disseminating course content within their institutions, and suggestions for enhancing effectiveness. Responses collected from the participants were summarized along selected thematic areas relevant to the respective question.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eMonitoring and evaluation\u003c/h2\u003e \u003cp\u003eA monitoring and evaluation approach was employed, utilizing the Framework and Best Practices for Training Initiatives of Health Professionals in Low-income Countries, proposed by Cancedda \u003cem\u003eet al\u003c/em\u003e [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. This framework incorporates six best practices aimed at addressing the shortage of healthcare workers in low-income countries: alignment with local priorities, country ownership, competency-based training and pedagogic innovation, institutional capacity building, sustainability strategy, and the establishment of long-lasting partnerships with international stakeholders. Therefore, in order to collect relevant data for this evaluation, continuous information was gathered throughout the design, development, and implementation stages of the program, including any challenges encountered by participants. These data were analyzed in conjunction with qualitative course satisfaction surveys, pre-post test evaluations, and feedback from the program team to provide a comprehensive evaluation as proposed by Cancedda \u003cem\u003eet al\u003c/em\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003e We employed the Wilcoxon rank test using SPSS to assess and compare the differences in participants' scores before and after completing the course. This analysis aimed to examine the pre-post training variations in confidence across various domains. Due to the demand-driven sampling method and the non-normally distributed nature of the scores, we conducted non-parametric tests. The findings of the statistical analysis were presented numerically. Descriptive statistics were computed for sociodemographic variables and crucial course evaluation data. The qualitative data were analyzed thematically.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003eParticipants characteristics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the initial cohort of the course, 88 study coordinators, 56 (64%) females, hailing from 19 countries across Africa, were enrolled and completed the pre-course assessment questionnaire. Regarding their clinical trials experience, 85 (97%) of the participants had prior experience in clinical trial roles, serving as study coordinators, co-investigators, or research assistants. Moreover, 57 (65%) were actively employed as study coordinators during the training period. Out of the total number of participants, 71 (81%) completed the course, with 69 (97%) of them also finishing the post-course assessment.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFindings from pre-post test evaluations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Wilcoxon Signed-Ranks test revealed significant post-training improvements in participants\u0026apos; scores across the four fundamental areas of competence for clinical trials. For conducting clinical trials, post-training scores (mean rank = 31.78) significantly exceeded pre-training scores (mean rank = 8.0) (Z = -6.682, \u003cem\u003ep \u0026lt; 0.001\u003c/em\u003e). Similarly, in managing clinical trials, post-training scores (mean rank = 36.89) surpassed pre-training scores (mean rank = 9.83) (Z = -6.813, p \u0026lt;0.001). In designing clinical trials, post-training scores (mean rank = 36.27) were notably higher than pre-training scores (mean rank = 12.20) (Z = 6.799, p \u0026lt;0.001). Likewise, for reporting outputs of clinical trials, post-training scores (mean rank = 16.94) exceeded pre-training scores (mean rank = 3) (Z = -4.897, p \u0026lt; \u003cem\u003e0.001\u003c/em\u003e) (\u003cstrong\u003eTable 1\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1\u003c/strong\u003e: Difference in the score of the participants in the measures of the four dimensions of competence (conduct, manage, design \u0026amp; report) in clinical trials before and after the training\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"648\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.925925925925927%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDimension of clinical trial competency\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.814814814814815%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eRank\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.25925925925926%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean rank\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.962962962962964%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSum of ranks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.88888888888889%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eZ-score\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.037037037037036%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eP-value\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.925925925925927%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eConduct CT, post \u0026nbsp;\u003c/p\u003e\n \u003cp\u003eConduct CT, pre\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.814814814814815%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eNegative\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.25925925925926%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e8.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.962962962962964%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.88888888888889%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-6.682\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.037037037037036%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e.001\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003ePositive\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e59\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e31.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e1875\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003eTies\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003eTotal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e69\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.925925925925927%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eManage CT, post \u0026nbsp;\u003c/p\u003e\n \u003cp\u003eManage CT, pre\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.814814814814815%\" valign=\"top\"\u003e\n \u003cp\u003eNegative\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.25925925925926%\" valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" valign=\"top\"\u003e\n \u003cp\u003e9.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.962962962962964%\" valign=\"top\"\u003e\n \u003cp\u003e59\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.88888888888889%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e-6.813\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.037037037037036%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e.001\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003ePositive\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e62\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e36.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e2287\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003eTies\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003eTotal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e69\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.925925925925927%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eDesign CT, post \u0026nbsp;\u003c/p\u003e\n \u003cp\u003eDesign CT, pre\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.814814814814815%\" valign=\"top\"\u003e\n \u003cp\u003eNegative\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.25925925925926%\" valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" valign=\"top\"\u003e\n \u003cp\u003e12.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.962962962962964%\" valign=\"top\"\u003e\n \u003cp\u003e61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.88888888888889%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e-6.799\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.037037037037036%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e.001\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003ePositive\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e36.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e2285\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003eTies\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003eTotal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e69\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"25.925925925925927%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eReport CT, post\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eReport CT, pre\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.814814814814815%\" valign=\"top\"\u003e\n \u003cp\u003eNegative\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.25925925925926%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.11111111111111%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.962962962962964%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"13.88888888888889%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e-4.897\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"12.037037037037036%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e.001\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003ePositive\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e31\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\" valign=\"top\"\u003e\n \u003cp\u003e16.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e525\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003eTies\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"30.76923076923077%\" valign=\"top\"\u003e\n \u003cp\u003eTotal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"19.23076923076923%\" valign=\"top\"\u003e\n \u003cp\u003e39\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.076923076923077%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.923076923076923%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003csup\u003ePost: post-training; pre: pre-training; CT: clinical trial; significance at \u003cem\u003ep \u0026lt; 0.05\u003c/em\u003e\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFindings from end-course qualitative survey\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants\u0026rsquo; responses to the four open-ended questions are summarized as described below.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eThe most beneficial aspects of the course\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe responses to this question are summarized in four themes:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eCourses content\u0026nbsp;\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eIn this context, participants noted that the course comprehensively addressed nearly all essential aspects of a clinical trial. They found the study materials to be abundant, offering detailed information on clinical trials along with supplementary readings and references. The content was deemed highly informative, covering everything needed from the inception to the conclusion of a clinical trial. Participants felt it provided a robust foundation to build upon. The objectives were well-defined, and the organization and relevance of the course content were praised for their direct applicability to improving their work.\u003c/p\u003e\n\u003col start=\"2\"\u003e\n \u003cli\u003eCourse design\u0026nbsp;\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eParticipants expressed appreciation for various aspects of the training design. They found the distribution of course content over time to be appropriate and accessible, with resources related to clinical trials readily available without restrictions. The shared documents and templates used were directly applicable to clinical trial practices, enhancing the realism of the training. Reading materials, checklists, and risk management plans were particularly lauded for their practicality. VoiceThreads explanations, questions, and discussions were deemed helpful.\u003c/p\u003e\n\u003cp\u003eMoreover, the availability of study materials and direct communication with tutors, coupled with flexible timing, enabled participants to progress at their own pace without sacrificing quality. The flexibility to undertake the training at their convenience was highly valued. The online format, featuring virtual interaction with both the audience and tutors, was described as remarkable.\u003c/p\u003e\n\u003cp\u003eAdditionally, collaborative activities such as risk management group work and tutorial sessions provided opportunities for active participation and clarification of doubts. Discussions with foreign partners, group forums, and exposure to new methods like Moodle were cited as beneficial experiences. The interactive and practical nature of the sessions allowed participants to express themselves and learn from individuals with diverse backgrounds, facilitating the sharing of ideas. The learning platform\u0026apos;s accessibility from anywhere and at any time was commended, as was the ability to listen to recordings offline and meet deadlines. Despite being virtual, the sessions fostered an interactive environment where constructive feedback was provided, enhancing the overall learning experience.\u003c/p\u003e\n\u003col start=\"3\"\u003e\n \u003cli\u003eTrainers competency\u0026nbsp;\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eIn general, trainers were regarded as highly knowledgeable about the course, drawing from significant lived experience in clinical trials. This expertise greatly enriched the learning experience for trainees. Additionally, the tutors were recognized for their subject matter expertise, injecting vitality into the course content beyond what textbooks could offer. They were noted for their approachability and accessibility, with their lectures skillfully presenting course material. Their receptiveness, follow-up, and encouragement were appreciated, as they often shared practical experiences and cases to enhance understanding. Some guest speakers were also praised for their contributions.\u003c/p\u003e\n\u003cp\u003eThe availability and effective communication of trainers during virtual training sessions were consistently commended. Coordinators were also lauded for their deep understanding of the subject matter, enabling them to provide insightful examples.\u003c/p\u003e\n\u003col start=\"4\"\u003e\n \u003cli\u003ePracticality\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eParticipants expressed appreciation for the practicality of the course in relation to their clinical trials. They found the content to be directly relevant to their everyday work duties and activities. The course was deemed practical, offering real-life experiences and insights into handling and managing clinical trials. Regarding its practicality, one participant articulated:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;It was timely on my part, as I am considering a new career path into research monitoring and CRO management. It encompassed project management, research skills, etc. Further to that, it has helped a lot in my day-to-day execution of study coordination roles at the facility especially on the risk assessment and prioritization (PM52).\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe satisfaction with the entire approach, encompassing content, trainers, and methodology, is aptly captured in the following quote from another participant:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;The best thing about this course for me was the easy accessibility to study materials and availability of experts in the field to explain them further during tutorials and in comment sections on Voice threads\u0026rdquo; (YN70).\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAnother participant stated:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;The best thing about the course was the discussion forums where we had to discuss the topics. This part enables me to express my thoughts and understanding about the topics under discussion. It also afforded me the opportunity to know what my colleagues\u0026rsquo; thoughts were on issues being discussed. lastly, it allows me to see how diverse people\u0026apos;s views are regarding a given matter.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAs a concluding remark, the overall evaluation of the training can be encapsulated most effectively with the following quote from one of the participants:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;The best thing about this course was that not only content was good but also moderators and other participants were committed to sharing experiences, and much more. Being a part of this course was a great opportunity for me and I would love to get another chance if there is another opportunity (PAB34).\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eApplication in participants\u0026apos; current roles\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants\u0026apos; responses for this section are organized into three themes: improved understanding, improved practice, and improved skill of project management.\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eImproved understanding\u0026nbsp;\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eParticipants highlighted that the training facilitated their acquisition of techniques in clinical trials, leading to revisions and enhancements of their existing documents and manuals. Moreover, it aided in refining their ability to teach clinical research methods, particularly focusing on clinical trials. Some participants noted a deepened understanding of specific topics such as pharmacovigilance and safety reporting. They also mentioned an improved comprehension of the organizational aspects of clinical trials. Specifically, participants cited increased knowledge in operations, conducting, and reporting clinical trials, as well as in preparing Investigator ISF. Overall, these improvements contributed to enhancing confidence in their clinical trial-related roles.\u003c/p\u003e\n\u003col start=\"2\"\u003e\n \u003cli\u003eImproved clinical practice\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eSeveral participants noted that the training facilitated improvements in their daily clinical trial responsibilities. It provided valuable input for coordinating ongoing studies and proved particularly beneficial for those in roles such as clinical coordinator, allowing them to integrate performance indicators into their work. This enabled them to prepare comprehensive checklists, including quality management checklists, prior to clinical trials, enhancing performance monitoring through key performance indicators. Additionally, the training assisted in the development of SOPs. Participants highlighted an increase in their adherence to clinical trial procedures and improvement in team management. Furthermore, they found that the training equipped them with informed knowledge to support customary practices within clinical trials.\u003c/p\u003e\n\u003col start=\"3\"\u003e\n \u003cli\u003eImproved project management skills\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eSeveral participants found the training beneficial for enhancing quality management, data management, and regulatory activities within their clinical trial work. They noted that the training aided in improving documentation practices and streamlining work processes and scheduling. Moreover, participants mentioned that the training equipped them with skills in financial management and risk management, including identifying and implementing mitigating measures for potential risks. Additionally, they learned how to effectively close out a project. Other skills gained included improved preparation for audits and inspections, as well as fostering and maintaining positive relationships with both internal and external partners.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDissemination of course contents within their institutions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis question reveals two distinct themes, which are identified and presented as follows:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eTo teach, mentor, or share experience\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eSome participants utilized the course to instruct clinical research methods and ethics to resident students, while others employed it to mentor doctors and junior colleagues in coordinating clinical trials. They provided guidance to staff on maintaining quality standards in clinical trial conduct and shared their course experiences with their team members. In specific instances, they trained peers and colleagues on risk management plans. Furthermore, they shared course documents with individuals engaged in similar practices and distributed modules and templates to colleagues. Participants also indicated using the course material as a training tool for other members. Additionally, some organized their own capacity-building training sessions, which included retraining lab staff, onboarding new personnel, and instructing fellow workers involved in trials they coordinated. Many participants mentioned recommending the course to others.\u003c/p\u003e\n\u003col start=\"2\"\u003e\n \u003cli\u003ePractical support\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eIn addition to teaching and training, participants also emphasized providing direct support in practice. For instance, they assisted their sites in reporting, updating, and distributing data, as well as re-evaluating their site key performance indicators. They trained their assistants in managing ISFs and implemented changes in documentation and reporting within their own organizations. Some participants actively worked to combat fraud, fabrication, and falsification that could compromise the quality of data collection. They also played a role in correcting mistakes made by others and supported colleagues in designing risk management plans for their sites, resulting in significant improvements in planning and performance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePotential modifications to the course to better meet their needs\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe responses to this question are categorized into three themes:\u0026nbsp;\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eProceed as it is\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eSome participants expressed their appreciation for the training and conveyed a desire for it to continue without any changes. They indicated that they had no suggestions for improvement. For instance, three participants specifically mentioned that they believe the training is already perfect and should remain unchanged.\u003c/p\u003e\n\u003col start=\"2\"\u003e\n \u003cli\u003eSatisfaction Expression\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eRather than providing specific suggestions for improving the training as requested, most participants chose to express their satisfaction by applauding and offering praise such as: informative, well-organized, perfect for current position, effective, simply perfect, meticulously planned, superb content, immediately relevant, comprehensive material, highly engaging, well-crafted, tailored to needs, and so forth.\u003c/p\u003e\n\u003col start=\"3\"\u003e\n \u003cli\u003eSpecific improvement suggestions\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eAlthough many respondents expressed satisfaction without specific comments and praised the training\u0026apos;s quality, there were also constructive suggestions for enhancement. In this section, these suggestions are categorized into four areas.\u003c/p\u003e\n\u003cp\u003eTiming\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSeveral participants suggested extending the duration of the course from 10 weeks to 14 weeks to allow for more in-depth discussions of the course material. They recommended extending the one-hour tutorial sessions to provide attendees with additional time for exchanging views. Additionally, some participants found the timing of the live tutorials challenging as they occurred during working hours, highlighting the need for greater time flexibility. There was a consensus on the need to allocate more time to live classes. The current schedule was deemed too tight for busy professionals, with suggestions to break down the program into more manageable modules. Participants proposed allocating two weeks for submission of group work and extending the duration of each lesson to two weeks to accommodate these changes.\u003c/p\u003e\n\u003cp\u003eGroup work management\u003c/p\u003e\n\u003cp\u003eOne participant identified group work as a significant challenge within an otherwise excellent course. They recommended improving coordination of group projects and enhancing participant interaction, potentially through open forum discussions. The approach to team activities, particularly regarding the risk management plan, was perceived as lacking smoothness. It was suggested that senior management should oversee group work, and if feasible, teams should be organized by country to facilitate communication. Additionally, tutorials and forum discussions should be enhanced. Measures should be implemented for non-responsive participants during group assignments, with coordinators working closely with team leads to clarify requirements. Furthermore, there was a suggestion for more practice and less emphasis on group work, reflecting concerns about its management. Finally, one participant proposed that group meetings should be financially supported by the institution offering the course.\u003c/p\u003e\n\u003cp\u003eAccessibility\u003c/p\u003e\n\u003cp\u003eAnother suggestion pertained to accessibility, particularly concerning VoiceThreads. One participant noted difficulty accessing VoiceThreads via phone and recommended improvement in this area. They proposed sharing VoiceThreads in the form of PowerPoint presentations to facilitate easier access. Participants found it challenging to complete VoiceThreads before live tutorials and suggested making presentations readily available for download in PowerPoint format. Furthermore, they recommended incorporating more interactive virtual sessions with colleagues through platforms like Zoom or Microsoft Teams. Additionally, there was a suggestion for a smartphone interface to enhance accessibility. Some participants recommended including more real-life scenarios in assessments to better appreciate practical applications, as well as providing opportunities for participants to observe simulations for real-life applications.\u003c/p\u003e\n\u003cp\u003eA unique suggestion related to access, albeit not directly tied to the current course provision, was the need for regular offering of the course in the future due to its perceived perfection. Participants advocated for the course to be organized annually, with former participants allowed to participate again. Another unique suggestion was coordinating alumni of the course for grant writing. Additionally, two participants suggested that the 10-week duration of the course is too lengthy for a certificate and proposed issuing a diploma instead, as certificates are typically awarded for shorter training durations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFindings from the monitoring and evaluation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe routine information collected throughout the various stages of course development, implementation, and evaluation, as part of the program\u0026apos;s monitoring and evaluation framework, have documented various opportunities, challenges, and prospects associated with the ClinOps program. These data have been summarized in alignment with the six best practices outlined in the Framework and Best Practices for Training Initiatives of Health Professionals in Low-income Countries (\u003cstrong\u003eTable 2\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2\u003c/strong\u003e: Summary of monitoring and evaluation findings based on the six outlined best practices in the Framework and Best Practices for Training Initiatives of Health Professionals in Low-income Countries.\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"624\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.115384615384617%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAnticipated best practices\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"77.88461538461539%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Findings\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.115384615384617%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eAlignment with local priorities\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"77.88461538461539%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eParticipants promptly implemented the new-found knowledge within their professional capacities, effectively serving the objectives of their respective local institutions.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eParticipants exchanged personal insights and problem-solving approaches, with the learning activities tailored to address authentic challenges encountered in their fields.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.115384615384617%\" valign=\"top\"\u003e\n \u003cp\u003eCountry ownership\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"77.88461538461539%\" valign=\"top\"\u003e\n \u003cul\u003e\n \u003cli\u003eTransfer of the program to Addis Ababa University from FCD facilitated country ownership\u0026nbsp;\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.115384615384617%\" valign=\"top\"\u003e\n \u003cp\u003ePedagogic innovation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"77.88461538461539%\" valign=\"top\"\u003e\n \u003cul\u003e\n \u003cli\u003eDownloadable content with offline access enabled participants to work offline, uploading their work to forums upon reconnecting.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eMoodle LMS provided convenient access for participants to course materials, interactions, and submissions.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eVoiceThread enhanced dynamic teaching, enabling interactive sessions and real-time addressing of academic challenges.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eZoom tutorials generally satisfactory, minor audio/connection issues reported.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eAssessment strategies included forum participation, quizzes, and group assignments, promoting active participation and engagement.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eCourse leaders\u0026apos; proactive follow-up boosted participant confidence, ensuring continued engagement.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.115384615384617%\" valign=\"top\"\u003e\n \u003cp\u003eInstitutional capacity building\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"77.88461538461539%\" valign=\"top\"\u003e\n \u003cul\u003e\n \u003cli\u003eTraining local faculty on the design and management of the course as part of knowledge transfer component enhanced local capacity.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eUtilization of local institution-hosted digital course delivery and management platforms enhanced capacity managing training locally.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.115384615384617%\" valign=\"top\"\u003e\n \u003cp\u003eSustainability strategy\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"77.88461538461539%\" valign=\"top\"\u003e\n \u003cul\u003e\n \u003cli\u003eThe local partner institution becomes a sustainable clinical trial training hub for Africa\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"22.115384615384617%\" valign=\"top\"\u003e\n \u003cp\u003eLong-lasting partnerships\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"77.88461538461539%\" valign=\"top\"\u003e\n \u003cul\u003e\n \u003cli\u003eInvolving academic and product development partners in the program team, such as FCD, FIND, IAVI, MMV, PATH, TB Alliance, and TDR, fostered enduring partnerships.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eThe program cultivated formal and informal partnerships among participants, likely persisting post-course.\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eTop students invited to join a two-year MSc in Clinical Trials program at CDT-Africa Addis Ababa University.\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe transfer of the ClinOps training program from a high-income to a lower-middle-income country\u0026mdash;specifically from FDC to Addis Ababa University\u0026mdash;spanning administrative, technical, and online teaching functions through knowledge transfer training for local faculty and research staff facilitated the alignment of the program with local priorities. The transfer of the program to Addis Ababa University CDT-Africa, facilitated by FCD and PDPs, ensured sustainability. The local institution gained capacity to sustain and develop new programs, serving as a regional asset for LMIC capacity building.\u003c/p\u003e\n\u003cp\u003eParticipants from various countries initially expressed concerns about potential disruptions to their participation in the program due to poor internet connectivity. However, the implementation of innovative teaching and learning platforms in this course helped alleviate these anticipated challenges. By utilizing downloadable content, including a \u0026quot;downloads folder\u0026quot; in each lesson for participants to access all materials at once, individuals were able to work offline and subsequently upload their work to discussion forums upon connecting to the internet. While participants were encouraged to post on forums, and no time limits were imposed, offering maximum flexibility for those encountering internet or utility-related issues.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eUtilizing Moodle as the learning management system, where participants access course materials, upload their work, and interact with peers and faculty, facilitated convenient access to course resources. Incorporating VoiceThread into the teaching-learning process enabled dynamic lesson presentations, facilitating flipped classrooms and fostering interactive sessions. Participants were able to add comments or questions to any part of the presentation, allowing instructors to address academic challenges or misconceptions in real-time. The use of Zoom for live tutorials has generally been satisfactory, with few participants reporting issues with audio speed or connection. When issues arise, they are often attributed to participants relying on slow, local WiFi. To optimize connection quality for all, participant mics and cameras were typically switched off during tutorials, with participants typing comments or questions to the class instead. The recordings of the live tutorials were also made available immediately after the session. Each tutorial included at least one faculty member tasked with monitoring and engaging with the chat, bringing key points to the presenter\u0026apos;s attention as needed.\u003c/p\u003e\n\u003cp\u003eSome challenges reported by participants during the course stemmed from personal issues. Health and family reasons, such as malaria or dengue fever, led some to lag on some specific courses. Other challenges included government internet shutdowns, bereavement, divorce, and pregnancy-related issues. Many faced obstacles but persevered to complete the course, despite these challenges. Issues were addressed through mentor and instructor discussions. The initial three weeks were crucial; participants falling behind during this period tended to withdraw. Vigilance during this period and proactive engagement helped resolve issues. Weekly mentor engagement and peer support fostered success within a positive learning environment. Participants appreciated the course leaders\u0026apos; proactive approach of following up through one-to-one emails and, if necessary, Zoom calls when engagement was lacking. This practice instilled confidence and encouraged continued participation.\u003c/p\u003e\n\u003cp\u003eInitially, the teamwork aspect of the course assessment posed challenges for most groups, particularly in navigating effective remote collaboration across different time zones. It was frustrating when some team members did not fully engage. However, considering time zone differences during team formation helped minimize these issues. With approximately twelve participants and one faculty mentor per team, each group had a private shared space on the Learning Management System for project discussions and file sharing. This setup fostered friendships and trust among team members, facilitating their working dynamics and fostering informal networks that may persist beyond the course.\u003c/p\u003e\n\u003cp\u003eAlthough proficiency in English was required for all participants, it was not the native language for some. Initially, a few lacked confidence to engage publicly on forums. However, through a positive learning environment and continuous support, their language confidence and verbal skills improved. The tutors clarified that participants didn\u0026apos;t need fluent English proficiency. It was more important to communicate effectively, even if it meant making grammatical or spelling errors, rather than refraining from asking questions or sharing experiences.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study aimed to design, develop, implement, and evaluate an innovative clinical trials operation training program for Africa. In its first cohort, the program enrolled 88 participants from 19 countries. There were significant improvements in participants' post-training scores compared to their pre-training scores across the four essential domains of clinical trials competence: designing, conducting, managing, and reporting clinical trials. Development and implementation of the program demonstrated efficiency across the six best practices for health professional training programs for low-income countries: alignment with local priorities, country ownership, competency-based training and pedagogic innovation, institutional capacity building, sustainability strategy, and the establishment of long-lasting partnerships with international stakeholders. The program's innovative approach, incorporating offline-accessible downloadable content, Moodle LMS, VoiceThread interactive sessions, and multidirectional competency assessment strategies, garnered high satisfaction among participants. Engaging academic and product development partners like FCD, FIND, IAVI, MMV, PATH, TB Alliance and TDR in the program team nurtured long-lasting partnerships. The successful transfer of the program from FCD to Addis Ababa University CDT-Africa facilitated country ownership and positioned the local partner institution as a sustainable LMIC training hub. Previous studies on training initiatives for health professionals in Africa have shown the potential to improve competency and performance [\u003cspan additionalcitationids=\"CR31 CR32 CR33\" citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e], yet there is limited information on competency in clinical trial capacity.\u003c/p\u003e \u003cp\u003e The program's success in enhancing participants' proficiency in clinical trials was notably marked by a significant improvement. This achievement can be largely credited to the effective utilization of innovative teaching strategies, including offline-accessible downloadable content, Moodle LMS, VoiceThread interactive sessions, multidirectional competency assessment strategies, and the TDR Core Competency Framework. Previous studies conducted in Africa suggest that incorporating multiple strategies into training programs has the potential to engage both trainees and trainers, fostering active participation [\u003cspan additionalcitationids=\"CR36\" citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e]. The approach followed in the program addresses a common weakness found in many online courses, which are typically designed for individuals to complete independently, often leading to feelings of isolation and loneliness.\u003c/p\u003e \u003cp\u003eThe study findings indicated that participants encountered various technical and personal challenges while taking part in the training, including family commitments, health issues, and internet disruptions. Those who faced these challenges early on often experience difficulties and ultimately withdrew from the course. Prior studies conducted in Africa indicate that training initiatives necessitate a comprehensive support system for participants, encompassing the provision of necessary resources, effective mentorship, and ongoing program monitoring to ensure successful outcomes and impacts [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan additionalcitationids=\"CR39\" citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn this study, participants were primarily problem-oriented in their approach to learning, seeking to apply new knowledge immediately in their professional roles. This aligns with the goals of their institutions, which prioritized tangible, immediate benefits stemming from the course. This sense of urgency was heightened by the expectation for participants to rapidly acquire the skills necessary to support ongoing projects and future capacity-building initiatives. Consequently, the learning activities were designed within the context of real-world challenges, encouraging participants to share their own experiences and problem-solving strategies. By updating the course content and delivering it through a local institution, the program strategically positioned itself to address regional capacity development needs in clinical research focusing on locally relevant clinical trial issues.\u003c/p\u003e \u003cp\u003eThis study employed various novel strategies to develop, implement, and assess the effectiveness of the ClinOps training program, incorporating also insights from participants across 19 countries. However, conducting follow-up evaluations of participants in their actual job roles would yield a deeper understanding of the program's broader impact.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe ClinOps program, a clinical trial operations training initiative for Africa led by experts from academia and product development partners, significantly enhanced participants' competency in clinical trials. The program effectively followed the six best practices for health professional training programs for low-income countries, alignment with local priorities, country ownership, pedagogic innovation, institutional capacity building, sustainability, and long-lasting partnerships. Transferring the program to a local institution promoted country ownership and established the institution as a sustainable clinical trial training hub for Africa. Participants in the post-course qualitative evaluation expressed appreciation for the beneficial aspects of the course, its relevance to their current roles, and the dissemination of course content within their institutions. They also provided suggestions for potential modifications to better meet their needs, supporting beneficial aspects of the course and suggesting strategies for improvement. To enhance clinical trials capacity in Africa effectively, training initiatives should provide comprehensive competency in designing, conducting, managing, and reporting trials tailored to local contexts.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eData availability\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), Addis Ababa University for hosting and managing the ClinOps project successfully.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical consideration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eScientific and Ethics Review Committee of the Center for Innovative Drug Development and Therapeutic Trials for Africa approved the study. Consent was obtained from the course participants for both the pre-post course survey and the qualitative part.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis effort was made possible through funding from Bill \u0026amp; Melinda Gates Foundation. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Bill \u0026amp; Melinda Gates Foundation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStudy design and conception: DAE, AF, JW, TM, PN, AC, BO, AN, SW, HD, JL, RH, RB, MV, EM, Funding acquisition: DAE, AF, JW, EM. Study implementation and data analysis: \u0026nbsp;DAE, AF, JW, TM, PN, AC, BO, AN, SW, HD, JL, RH, RB, MV, EM. Draft the Manuscript: DAE, TM. \u0026nbsp;Reviewed and revised the manuscript: DAE, AF, JW, TM, PN, AC, BO, AN, SW, HD, JL, RH, SB, RB, BS, MV, EM, All authors read and approved the final manuscript for publication.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors report no potential conflicts.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSaleh M, Sharma K, Shamshudin A, Obayo I, Gondi S, Karimi N. Regulatory approval of clinical trials: is it time to reinvent the wheel? BMJ Glob Health. 2024 Jan 24;9(1):e013727.\u003c/li\u003e\n\u003cli\u003eSaidu Y, Nchinjoh SC, Adidja A, Besong AF, Netongo PM, Ndom P, et al. Anticipating and strategizing to address potential bottlenecks during clinical research projects in sub-Saharan Africa: a case for adapting approaches and tools used in the entrepreneurial and development sectors. 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Am J Clin Pathol. 2017;147(3):285-291.\u003c/li\u003e\n\u003cli\u003eKebebew T, Woldetsadik MA, Barker J, Cui A, Abedi AA, Sugerman DE, Williams DE, Turcios-Ruiz RM, Takele T, Zeynu N. Evaluation of Ethiopia\u0026apos;s field epidemiology training program - frontline: perspectives of implementing partners. BMC Health Serv Res. 2023;23(1):406.\u003c/li\u003e\n\u003cli\u003eMijumbi AO, Mugenyi L, Nanfuka M, Agaba C, Ochieng J. Regulation of community advisory boards during conduct of clinical trials in Uganda: a qualitative study involving stakeholders. BMC Health Serv Res. 2023;23(1):119.\u003c/li\u003e\n\u003cli\u003ePatel LN, Gurumurthy M, Bronson G, Sanders K, Rusen ID. Implementation challenges and lessons learned from the STREAM clinical trial-a survey of trial sites. Trials. 2023;24(1):51.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-education","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meed","sideBox":"Learn more about [BMC Medical Education](http://bmcmededuc.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meed/default.aspx","title":"BMC Medical Education","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Clinical trial, training, ClinOps, Africa, product development partners","lastPublishedDoi":"10.21203/rs.3.rs-4213344/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4213344/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eAfrica's involvement in clinical trials remains very low. Although the crucial role of training initiatives in building clinical trial capacity in Africa has been documented, current efforts fall short as they lack alignment with local contexts. This study aimed to design, develop, implement, and evaluate an innovative clinical trial operations training program for Africa.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe developed ClinOps, a novel 10-week clinical trial operations training program for study coordinators in Africa, intending to enhance their expertise in four fundamental areas: designing, conducting, managing, and reporting clinical trials. We used cloud applications to minimize installation of software, whilst maximizing student engagement with the course, VoiceThread, an interactive collaboration and sharing tool allowed interactive content to be accessed offline. Moodle, an open-source learning management system provided a platform to share learning tools, provide one-on-one mentorship, and multidirectional competency assessment strategies including lesson quizzes, forum discussions, asynchronous tutorials, and group assignments. We used Zoom video conferencing application for live tutorials and mentoring, as required. Program effectiveness was evaluated through quantitative pre-post tests, qualitative end-course evaluations, and a comprehensive monitoring and evaluation. We used Wilcoxon rank test to compare pre-post test scores and thematic analysis to analyze the qualitative data.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eIn the initial cohort, 88 study coordinators from 19 countries participated, including 56 (64%) females, with 57 (65%) actively employed as study coordinators during the training, and 85 (97%) possessing prior experience in clinical trial roles. Among these, 71 (81%) successfully completed the course, with 69 (97%) also completing the post-course assessment. Post-training scores demonstrated substantial improvement compared to pre-training scores in each competency area, including in designing (mean rank\u0026thinsp;=\u0026thinsp;36.27 vs 12.20; Z\u0026thinsp;=\u0026thinsp;6.799, \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e), conducting (mean rank\u0026thinsp;=\u0026thinsp;31.78 vs 8.0; Z = -6.68, \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e), managing (mean rank\u0026thinsp;=\u0026thinsp;36.89 vs 9.83; Z = -6.813, \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e), and reporting (mean rank\u0026thinsp;=\u0026thinsp;16.94 vs 3.0; Z = -4.897, \u003cem\u003ep\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/em\u003e) clinical trials. The program adhered to training best practices, encompassing alignment with local priorities, country ownership, pedagogic innovation, institutional capacity building, sustainability, and ongoing partnerships. Participants acknowledged the program for its structure, content, relevance to their current roles, and the overall delivery methods.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe ClinOps program, a clinical trial operations training initiative for Africa developed by experts from academia and product development partners, significantly enhanced participants' competency in clinical trials. Transferring the program to a local institution promoted country ownership and established the local partner institution as a sustainable clinical trial training hub for Africa. To effectively build clinical trials capacity in Africa, training initiatives should offer comprehensive competency in designing, conducting, managing, and reporting trials tailored to local contexts.\u003c/p\u003e","manuscriptTitle":"Development, implementation, and evaluation of an innovative clinical trial operations training program for Africa (ClinOps)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-09 13:06:26","doi":"10.21203/rs.3.rs-4213344/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-06-17T04:18:14+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-06-09T10:59:06+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"193328379607896080908090022847414294860","date":"2024-05-23T06:43:53+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-08T16:13:18+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"1ad36a8e-5e20-4b9b-827a-f2fd786c31ef","date":"2024-04-19T22:38:14+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-04-19T20:23:16+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-19T20:20:57+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2024-04-04T17:22:57+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-04-04T07:30:48+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Medical Education","date":"2024-04-03T14:13:14+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-education","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meed","sideBox":"Learn more about [BMC Medical Education](http://bmcmededuc.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meed/default.aspx","title":"BMC Medical Education","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"22b38a76-662a-4894-ae1c-c5486fdce57d","owner":[],"postedDate":"April 9th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-01-27T16:03:12+00:00","versionOfRecord":{"articleIdentity":"rs-4213344","link":"https://doi.org/10.1186/s12909-025-06733-7","journal":{"identity":"bmc-medical-education","isVorOnly":false,"title":"BMC Medical Education"},"publishedOn":"2025-01-24 15:57:54","publishedOnDateReadable":"January 24th, 2025"},"versionCreatedAt":"2024-04-09 13:06:26","video":"","vorDoi":"10.1186/s12909-025-06733-7","vorDoiUrl":"https://doi.org/10.1186/s12909-025-06733-7","workflowStages":[]},"version":"v1","identity":"rs-4213344","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4213344","identity":"rs-4213344","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}