Guidelines for the Conduct of Clinical Trials in Kenya

Clinical trials are a very important part in the process of drug development. In the recent past, Africa and Kenya in particular has seen increased numbers of requests for approval to conduct clinical trials. In order to facilitate research and the continuous discovery of medicines, but to also ensure the safety, well-being of participants and integrity of the data generated, PPB has developed this new guideline.

As the institution responsible for the regulation of medicines and also the final approval of conduct of clinical trials in Kenya, the Pharmacy and Poisons Board developed the first guidelines on conduct of clinical trials in the year 2011. Since then, there are a number of changes that have taken place necessitating the development of this second edition.

Some of the additions in this edition are;

• Further clarification on safety reporting timelines
• Clarification on protocol amendments
• Requirements concerning reporting of protocol deviations and protocol violations
• Requirements concerning IB, DSUR and IMPD
• Requirements concerning Post Trial Access Program
• Guidance on pre-submission meetings
• Information on Controlled Human Infection Studies
• Requirement for Clinical trial insurance
• Labelling and relabeling of investigational products in order to guide investigators on this important activity, a section has been dedicated to labelling and relabeling of the investigational products
• Information on Data Safety and Monitoring Boards
• Product Accountability and Disposal
• Submission of final study report
• Updated checklist for submission of applications; for efficient review of the submitted protocols, the checklist for submission has been updated taking note of the frequent finding of the previous reviews
• Updated checklists for submission of application for annual approval
• Updated declaration forms
• Editorial edits to comply with QMS requirements

This guideline has been developed to address the concerns that clinical trials investigators had with the previous edition and to also update the document as per the current practice around the world.

In addition, the guideline also gives the process of review approval and monitoring of the clinical trials in Kenya