About the DSMB Training
The training aims to expand the pool of qualified data safety monitoring board (DSMB) members by upscaling the availability of trained experts in safety monitoring. The program works to support the ethical oversight of vaccine clinical trials in Africa and improve global preparedness for emerging health threats. The program is an 8-week training that includes self-paced learning and live virtual sessions facilitated by leading experts in vaccine safety and clinical trial monitoring. Upon successful completion, participants can then join the DSMB global pool, where they may be considered for future clinical trial oversight roles.
Safety monitoring in clinical trials is crucial to ensure ethical research practices and protecting participant’s well-being. Adverse events can arise during the administration of investigational products, requiring rigorous oversight to assess risks and ensure timely interventions. DSMB plays a vital role in reviewing clinical trial data, safeguarding trial participants, and maintaining the integrity of study results. To strengthen DSMB expertise continentally, Africa CDC, in collaboration with the Safety Platform for Emergency Vaccines (SPEAC), will offer a structured DSMB training course that will robustly build the capacity of training participants to undertake the very crucial role of monitoring clinical trials for vaccines and other new treatment platforms in Africa and elsewhere to confront emerging and reemerging public health threats.
What the Training Covers
The eight-week-long intensive training course will employ a modular format, combining recorded lectures with live virtual sessions, an approach that ensures flexibility while maintaining interactive learning environment. Expert trainers and subject matter specialists drawn from across the world will facilitate sessions, leveraging their real-world experience to provide high-quality instruction.
- Introduction to Clinical Trials & DSMB
- Vaccine Clinical Trials & Safety Monitoring
- DSMB Roles & Decision-Making
- Regulatory & Ethical Considerations
- Safety Monitoring & Risk Assessment
- Statistical Methods for DSMB
- DSMB Meetings & Case Discussions
- Practical Applications, quizzes and final assessment
- Stronger Regulatory and Ethical Compliance.
- Better equipped to align clinical trial practices with Good Clinical Practice (GCP), regulatory requirements, and ethical guidelines.
- Reduction in protocol deviations or violations that compromise study integrity.
- Strengthened regional capacity to conduct high-quality trials without over-reliance on external expertise.
- Enhanced ability to analyze interim data and make informed safety decisions during clinical trials.
- Sustained Capacity for Vaccine Safety Surveillance.