Guidelines for Applications to Conduct Clinical Trials in Kenya (Revised version 2014)
(2014; 54 pages)

This document is intended to provide guidance on the format and contents of application for authorisation to conduct clinical trials in Kenya, the amendments to clinical trial application and the declarations at the end of a clinical trial. In Kenya, the Pharmacy and Poisons Board (PPB) is the authority mandated, by Cap 244 Laws of Kenya, to regulate clinical trials. The Pharmacy and Poisons Board recognizes the importance of Research and Development of new medicines, medical devices or procedures in the attainment of national health, social and economic goals. Clinical research must nonetheless be conducted under conditions that satisfy ethical and scientific quality standards. PPB will endeavour to provide a regulatory environment that avoids unnecessary delays in the clinical trial authorisation process while providing safeguards for quality, efficacy and public health. Consequently the Expert Committee on Clinical Trials (ECCT) of the PPB has developed these guidelines to assist clinicians, researchers, pharmaceutical industry, sponsors and investigators to easily navigate the Kenyan clinical trial authorisation process. The guidelines provide information on the current minimum requirements for authorisation to conduct clinical studies involving investigational drugs, medical devices or herbal drugs. It provides an application form and specifies procedures for approval of protocol amendments. It gives requirements for reporting serious adverse events (SAEs) and suspected unexpected serious adverse events (SUSARs). Also provided is information regarding data and safety monitoring board (DSMB), submission of progress reports, procedures for termination of clinical trials and inspection of trial sites. The appropriate forms have been attached as appendices at the end of the guidelines. We hope you find this document beneficial in your daily practice in clinical research.
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