Six trainees from three Trials of Excellence in Southern Africa (TESA) sites recently received a five-day practical Clinical Research Associates (CRA) training in Clinical Trials Monitoring at Botswana Harvard Health Partnership (BHP). This practical training was aimed at bridging the gap between theoretical concepts and real-world application in the monitoring of clinical trials.
The trainees were Ngozana Seonyatseng and Tshepo T. Frank from BHP, Agness Farai Nhidza and Ashley N. Chizema from Biomedical Research & Training Institute (BRTI) in Zimbabwe, and Valdemiro Novela and Vasco Sambo from Centro de Investigação em Saúde de Manhiça (CISM) in Mozambique.
Participants were randomly divided into three groups of two and assigned to various studies conducted at BHP, working alongside principal investigators and study teams to monitor clinical trials. This experience highlighted the critical processes and importance of effective monitoring in clinical trials.
The five-day training included desk review of ethics and regulatory compliance, focusing on the Investigator Site File (ISF). Trainees reconciled the ISF with the Trial Master File (TMF) using an ISF monitoring tool. This activities were conducted in the first day of the training.
On the second day, activities included the review of informed consent forms (ICFs), including understanding assessment, screen failures, and withdrawals against the ICF tracker, screening, and enrollment logs. Teams performed source data verification, safety tracking and reporting, and followed participants through the pharmacy and the laboratory.
Day three was for facility tour, which included a visit to the pharmacy to review the pharmacy file, IP shipment documentation, storage temperature measures, dispensing procedures, and equipment calibration. In the laboratory, trainees followed samples from reception to storage, verifying the chain of custody and linking samples to participant consent preferences.
On the fourth day, trainees compiled monitoring reports and had one-on-one discussions with the trainer. On the last day, trainees wrote an examination followed by a debriefing. The training comprised of daily debriefs where groups presented their findings. The training concluded with a certification event and closing remarks from Laboratory Director, Prof. Sikhulile Moyo.
