The Monitoring Training course was held from 28th August to 1st September 2023 at Uganda Virus Research Institute- International AIDS Vaccine Initiative premises. It aimed at equipping participants with comprehensive insights into effective monitoring practices within the context of clinical research. The course was designed to equip attendees with the skills and knowledge necessary to ensure the quality, integrity, and compliance of clinical trials. The course provided a comprehensive understanding of monitoring techniques, tools, and strategies for various studies and projects. The course defined Good Clinical Practices (GCP) as a globally recognized standard for conduct of clinical research. It was emphasized that adhering to GCP is essential for researchers to uphold ethical principles, maintain data integrity, comply with regulations, and ensure the safety of study participants. It was also emphasized that GCP enhances the credibility of research findings, promotes collaboration, and contributes to the overall advancement of scientific knowledge.
Rationale: The course aimed at empowering participants with skills of overseeing clinical trial implementation to verify that participant rights, safety and integrity of data are protected.
The facilitators of the training were;
1. Dr. Annet Nanvubya
2. Dr. Robert Balikudembe
3. Dr. Miriam Nakitto
Course Objectives: The primary objectives of the Monitoring Training course were as follows:
1. To familiarize participants with the regulatory framework and ethical considerations in clinical research monitoring.
2. To introduce participants to the roles and responsibilities of clinical research monitors.
3. To provide in-depth knowledge of monitoring methodologies, tools, and best practices.
4. To enhance participants' ability to identify and manage deviations, adverse events, and protocol violations.
5. To equip participants with skills to ensure data accuracy, subject safety, and protocol adherence.
6. To promote the use of monitoring data for evidence-based decision-making and clinical trial quality improvement.
Course Highlights: The training course encompassed a comprehensive curriculum that covered various aspects of clinical research monitoring, including:
1. Overview of Clinical Research Monitoring
2. Importance and Scope of monitoring
3. Ethical Guidelines and Regulatory Requirements in Clinical Trials
4. Monitoring Plan Development and Implementation
5. Source Data Verification and Documentation
6. Risk-based Monitoring Strategies
7. Adverse Event Reporting and Protocol Deviations Management
8. Effective Communication with Investigators and Study Teams
9. Skills of a good Clinical Research Associate/Monitor Training
Methodology: The course employed a combination of didactic lectures, interactive case studies, role-playing exercises, and group discussions. Participants engaged in hands-on activities to simulate real-world scenarios they might encounter during clinical research monitoring. Experienced clinical research professionals and monitors were invited as guest speakers to share practical insights and experiences. (A detailed Agenda of the training is hereby attached).
Participants: The training course welcomed a diverse group of participants, including quality assurance officer, laboratory technologist, Medical Doctors, regulatory professionals, and other professionals involved in clinical trials. The mix of backgrounds facilitated dynamic discussions and a holistic understanding of the monitoring process. It allowed sharing of past experiences, challenges and lessons.
Outcome: Upon completion of the Clinical Research Monitoring Training course, participants gained a deep understanding of the intricacies of clinical research monitoring. They acquired skills to effectively design and implement monitoring plans, identify potential risks, manage deviations, and ensure data quality. Participants were also well-versed in the ethical and regulatory considerations that underpin clinical trial monitoring. They acquired skills needed to maintain the rights, safety, and well-being of study participants. They were each issued a training certificate. Conclusion: The Clinical Research Monitoring Training course achieved its objectives by providing participants with a comprehensive understanding of clinical research monitoring practices. The practical and interactive nature of the training empowered participants to apply their learning to real-world situations. The participants' active engagement and enthusiasm underscored the success of the training program.