Emergency Procedures for Clinical Trial Sites

Emergency Procedures for Clinical Trial Sites

This document highlights the importance of having emergency standard operating procedures in place during the conduct of clinical trial at sites and also includes the minimum requirements for emergency proc edures. This guideline represents the Health Product Regulatory Authority South African ’s current thinking on the measures to be taken to ensure that patients gain access to emergency procedures during the conduct of clinical trial. SAHPRA reserves the r amendments in keeping with the knowledge which is current.

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Document Number: SAHPGL-CEM-CT-03
Version: 3
Date Updated: 17/08/2022
File Type: pdf
Category: Guideline
Unit: Clinical Trials