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