Oversight and Monitoring in Clinical Trials

Oversight and Monitoring in Clinical Trials

This guideline assists sponsors of clinical investigations in developing monitoring strategies and plans for investigational studies of medical products, including human medicine and biological products, medical devices, and combinations thereof. The overarching goal is to enhance human participant protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. While this guideline makes it clear that sponsors, and clinical research organisations (CROs) acting on their behalf, can use a variety of approaches to fulfil their responsibilities for monitoring Principal investigator (PI) conduct and performance in investigational studies. It must be highlighted that the responsibility for adequate oversight of the conduct of a clinical trial, including the justification for and selection of monitoring methods, remains that of the sponsor solely. SAHPRA reserves the right to request any additional information and may make amendments in keeping with the knowledge which is current at the time of consideration. Guidelines and application forms are available from the office of the CEO and the SAHPRA website.


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Document Number: SAHPGL-CEM-CT-04
Version: 4
Date Updated: 01/08/2022
File Type: pdf
Category: Guideline
Unit: Clinical Evaluations Management, Clinical Trials