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Clinical Trial Guidelines, SA GCP version 3 dated 15 Jul 2020.
The official implementation dates thereof will be 01 January 2022. All trial personnel will need to have documented proof of training on this updated guideline prior to this date.
Citation: Department of Health, 2019. South African Good Clinical Practice: Clinical Trial Guidelines Pretoria, South Africa
SACRA training: To request SACRA training on the SA GCP contact admin@sacraza.com
The updated ICH E6(R3) “Good Clinical Practice” Guideline
This guideline provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.
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Changes to note:
1. Emphasis on design quality and risk management- stronger focus on actively identifying and managing risks critical to participant safety and data reliability.
2. Expanded Guidance on data requirements- dedicated section addresses data integrity and traceability throughout the entire data life cycle
3. Flexibility for diverse trial designs and technological Advances— recognizing the growing use of innovative designs, and encouraging electronic informed consent, and remote monitoring.
4. Clearer definition of Roles and Responsibilities - further detailed descriptions of sponsor, investigator, and service provider obligations.
5. Enhanced requirements for ethical and participant protections - reinforced obligations for REC/IRBs, focusing on independence, protocol review, and continuing safety oversight.
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