INFECTIOUS DISEASES INSTITUTE

Clinical Trials Monitoring

Course Duration: 3 Years
Delivery Mode: Online
Eligibility: REC,& NRRA Members, Clinical trials Monitors and Researchers
Course availability: Ongoing, Restricted

Overview

This course was developed for training of regulatory and monitoring officers on technical competences in research scientific designs, ethical and safety considerations, product development and regulations, clinical trial operations, site management and data informatics in order to gain knowledge, attitude and skills that would enable them to work more efficiently and to overcome challenges in regulatory and monitoring processes, thus helping to improve research ethics applications at the Institute.

This training in the EAC partner states aims to develop a critical mass of scientists with knowledge and skills for review of research protocols as well as conduct of research with emerging and complex research study designs including adaptive platform trials, as well as studies in vulnerable populations, epidemics and emergency situations.

Course Aim

By the end of the training, Participants should be able to:
Knowledge Objectives

1. Understand the scientific concepts underlying research and research operations
2. Elaborate on the ethical and participant safety considerations in planning, regulating and implementing research studies
3. Explain regulatory processes involved in Investigational product (drug or device) development and approval
4. Understand the clinical trial operations during research implementation
5. Understand the site management principles during research implementation
6. Understand the data management principles in research

Attitude objectives

1. Accept standards of national and international research ethics in the conduct of regulatory and monitoring activities
2. Respect the role of science in conduct of regulatory and monitoring activities
3. Guide the study team with respect and informed knowledge base on regulatory and monitoring findings and recommendations
4. Express interest in preparation of teaching sessions for internal capacity building for regulatory and monitoring members as well as for study teams based on monitoring findings and recommendations
5. Express confidence in working independently during the conduct of regulatory and monitoring activities
6. Demonstrate commitment to regulatory and monitoring best practices based on the relevant frameworks, guidelines and policies
7. Provide good judgement in resolving issues arising during the conduct of regulatory and monitoring activities
8. Innovative ways of improving regulatory and monitoring practice with in the institute

Skills Objectives

1. Prepare tools and documents necessary in the conduct of regulatory and monitoring activities (REC submissions, SOPs, visit and assessment reports, logs, etc)
2. Conduct regulatory and monitoring activities in line with the guiding frameworks, guidelines and policies (feasibility studies, monitoring visit activities, TMF reviews, etc)
3. Train fellow regulatory and monitoring team members as well as study teams on ethical guidelines
4. Manages relationships with study teams appropriately

Course Modules