What are the current SA GCP guidelines?
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 document needs to be read with the Ethics in Health Research, Principles, Processes and Structures (SA Dept. of Health, 2nd Edition, 2015) policy document.
Is Good Clinical Practice (GCP) certification a requirement for researchers in South Africa?
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:
“22.214.171.124 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
Is ICH GCP training or the USA online HPP/HSP (Human Participant/Subject Protection training) alone adequate?
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.
Can anyone provide SA GCP training and issue a GCP certificate?
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.
How about online GCP courses?
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.
Who regulates the requirements for GCP training in South Africa?
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.
How often do I need to attend GCP training?
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.