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GCP Training in South Africa

October 10, 2019

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Q: Is Good Clinical Practice (GCP) a requirement for researchers in South Africa?
A: Yes, anyone who is part of a clinical research team in any capacity needs to be GCP certified. This means that you need to have attended a training course facilitated by an accredited GCP trainer.
Q: Is ICH GCP training or the USA online HPP/HSP (Human Participant/Subject Protection training) alone adequate?
A: No, in South Africa the training has to 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.
Q: Can anyone give SA GCP training and issue a GCP certificate?
A: No, GCP trainers in South Africa need to be accredited by the Health Professions Council of South Africa (HPCSA). Accreditation involves an in depth review of the course content as well as the skills, background and expertise of the trainer.
Q: How about online GCP courses?
A: SA regulations require that the Beginner or Basic GCP course must be in person face to face (this is a 2 day course). The Refresher GCP course however, may be done face to face or online if the course is accredited and is based on SA GCP.
Q: Who regulates the requirements for GCP training in South Africa?
A: 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 upcoming SA GCP 2019 guidelines (still in draft but hopefully finalized before the end of 2019).
Q: How often do I need to attend GCP training?
A: If you’ve never done GCP training before you have to attend a Beginner 2 day face to face training. 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.
Q: Isn’t GCP training boring?
A: No! When the facilitator is dynamic and the course material is well designed GCP becomes alive and the training is both meaningful and fun.

 

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How long is GMP certification valid for?

January 19, 2015

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Q: How long is GMP certification valid for?

A: 2 years

Reference: MCC: GMP http://www.mccza.com/dynamism/

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How long is IATRA training certification valid for?

January 19, 2015

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Q: How long is IATRA training certification valid for?

A: 2 years

Reference: FAQ –SACRA; http://www.sacraza.com/

 

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What is the Declaration of Helsinki?

January 19, 2015

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Q: What is the Declaration of Helsinki?

A: “The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.” We are currently using the October 2013 (Brazil) version, which replaced the 2008 version of the declaration.

Reference: http://www.wma.net/en/30publications/10policies/b3/

 

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