Pharma-Ethics operate according to written Standard Operating Procedures ( SOP's) which are updated regularly to comply with both national and international Good Clinical Practice and Ethics guidelines and regulations. In granting its approval, the committee must be satisfied that the proposals conform to these guidelines and regulations [Declaration of Helsinki, ICH Harmonised Tripartite Guidelines E6: Note for the Guidance in Good Clinical Practice (CPMP/ICH/135/95), Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa, FDA Code of Federal Regulation Parts 50, 56 and 312, South African Ethics in Health Research: Principles, Structures and Processes – 2015].
Please refer to the documents below for further information:
- Department of Health: Ethics in Health Research: Principles, Structures and Professes
- South African Good Clinical Practice Guidelines
- Trial Participant Compensation Model
- Post-Trial Access