FAQs

The latest version of the South African Good Clinical Practice guidelines (SA GCP) is the 3rd edition, 2020. On 15 June 2021 the updated SA GCP 3rd edition of 2020 was published on the website of the South African Health Products Regulatory Authority (SAHPRA). This version replaces the previous version.
The document has been completely redesigned from the ground up to align it with ICH GCP (R2) and current trends in the clinical research arena.

The SA GCP document needs to be read with the National Health Research Ethics Council (2024) South African Ethics in Health Research Guidelines: Principles, Processes and Structures, 3rd ed.  Adherence to both these documents is a requirement.

Yes, anyone who is part of a clinical research team in any capacity, needs to be GCP certified. 

According to SA GCP, 3rd edition, 2020: 

“4.3.3.10 Evidence of current (i.e. within three years) GCP training as well as general research ethics training. Basic GCP training must be done by means of attendance at a face-to-face course and must include specific SA GCP 2020 training. Thereafter, three-yearly refresher GCP training must occur. Refresher training may be done online; however, the course must be relevant to the South African research environment and must include SA GCP 2020 training. NOTE: Trial staff whose GCP training has expired for more than three months must re-do the basic GCP course

No, in South Africa the training must be based on SA GCP. A good SA GCP course will cover the overlapping content and refer to ICH GCP as well. Therefore, most SA GCP training is valid as ICH GCP certification elsewhere in the world, but the reverse is not true.

No, GCP trainers in South Africa need to issue a GCP certificate that has been accredited by the Health Professions Council of South Africa (HPCSA). Accreditation involves a review of the course content as well as the skills, background, and expertise of the trainer.

SA regulations require that the Beginner or Basic GCP course must have a live component. The Refresher GCP course, however, may be done face to face or online without a live component, if the course is accredited and is based on SA GCP. 
SAHPRA and NHREC have published a directive explaining this provision and must be implemented from June 2024. Download the document here.

Ethics Committees and the South African Health Products Regulatory Authority (SAHPRA) draw up the requirements together with the National Health Research Ethics Council (NHREC). Up until now these requirements have been available only via direct feedback such as via stakeholder meetings, but they do now appear in the SA GCP,3rd edition 2020, guidelines.

If you’ve never done GCP training before you must attend a Beginner GCP course. Every 3 years you need to do a GCP Refresher course (face to face or online). If your previous certification has lapsed by more than 3 months (i.e. more than 3 years and 3 months ago) you need to redo the Beginner course.