Background: Ensuring the two common goods of GCP, i.e., safety of participants and credible data in clinical trials requires training trial staff effectively. Competency-based training in clinical trials should be given due attention to prepare site staff for conducting clinical trials. This paper critically appraises the ClinOps training program conducted by CDT Africa.
Alignment to local priorities
Alignment of course contents to the local priorities of low to middle income countries (LMICs) is critical to ensure effective training in clinical research training programs in these countries.. It starts right from curriculum development. During the course delivery, all tutors were from Ethiopia, and all were aware of the common problems faced during the conduct of clinical trials.
joint planning and coordination
The ClinOps training program was planned jointly with product development partners (PDPs) participating in the global health clinical consortium (GHCC) which played a very crucial role in the curriculum development. PDPs reviewed the learning objectives and the detailed lesson plans and gave inputs before the courses were delivered.
The competency framework developed jointly by Research and Training in Tropical Diseases (TDR) and The Global Health Network (TGHN) were used when the curriculum was developed. The competency details on each skill sets needed for the various roles within clinical trial sites.
The ClinOps training used pedagogic innovative tools for delivering the course as well as following up trainees’ performance. The training used VoiceThread (VT), an online tool for uploading power points and tutors recorded explanation on each slide. The trainees after going through the slides, they were able to put their questions and comments on the slide either as a text or voice recording. The training also used Learning Management System (LMS), i.e., Moodle as its plat form where VT links, resources, tasks, forum discussions and other assignments were uploaded for trainees to access. The trainees were able to submit their feedbacks on the LMS. We also used zoom for one-hour live tutorial.
Conclusion: ClinOps training program helped trainees acquire relevant knowledge in conducting clinical trials in LMICs.