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Do I have to follow the GCP guidelines when my study does not involve any experimental drug and what is the scope of the SA GCP guidelines?

January 19, 2015

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Q: Do I have to follow the GCP guidelines when my study does not involve any experimental drug and what is the scope of the SA GCP  guidelines?

A: “These guidelines focus on the management and regulation of drug trials on human participants. These guidelines have not specifically addressed clinical trials on complementary medicines, traditional medicines, and non-pharmacological interventions including surgical procedures, medical devices and X-rays. However, these guidelines are such that, in the absence of alternatives, the basic principles outlined in this document may be used to guide any research involving human participants, particularly research involving experimental study designs.” The SA GCP guidelines are guided by at least 8 other guidance documents. Most Ethics committees in SA will probably require some proof of GCP training for all research involving human participants regardless of the involvement of experimental or registered drugs in the study.

Reference: SA GCP guidelines, 1.3; p.12

 

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Do we have any guidelines for the payment of trial participants in South Africa?

August 29, 2013

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Q: Do we have any guidelines for the payment of trial participants in South Africa?

A: Yes, the South African Health Products Regulatory Authority or SAHPRA published a June 2018 document on the compensation of participants. “This document has been prepared to serve as a guidance to applicant/sponsors of clinical trials during the use of registered or unregistered medicines in approved clinical trials. It represents the South African Health Products Regulatory’s (SAHPRA) current thinking on participant re-imbursement during clinical trial participation and proposes a minimum compensation that can be paid. It is not intended as an exclusive approach and SAHPRA reserves the right to request any additional information and may make amendments in keeping with the knowledge which is current at the time.”

Reference:

  • NHREC (2012). Payment of trial participants in South Africa: Ethical considerations for Research Ethics Committees (RECs). NHREC.
  • SAHPRA (2018).Clinical trial participant TIME, INCONVENIENCE and EXPENSE (TIE) Compensation Model.

 

 

 

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The SA National Clinical Trials Registry

December 14, 2011

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Q: What is the SANCTR and why is it important to the researcher?

A: The South African National Clinical Trials Register (SANCTR) covers the full spectrum of clinical trials and provides the public with updated information on trials conducted in SA.

The SANCTR forms part of international calls for making trial information publicly available. The International Committee of Medical Journal Editors, which includes peer reviewed journals from around the world, made a statement that from 1 Jul ’05 no trials will be considered for publication unless they are included on a research register. In Nov ’05 the DOH issued a notice that as from the
1st Dec. 2005 all new clinical trials to be conducted in the country must be registered.

Although it is a requirement for all trials to be registered on the SANCTR, to ensure innovation and competitiveness is not compromised those trials whose primary goals are to assess
major unknown toxicity or determine pharmokinetics (Phase I trials) are excluded from being made publicly available.

All trials however whose primary purpose is to affect clinical practice (Phase III) will be publicly accessible. Sponsors/Principal investigators can apply for an exemption for the public recording of Phase II trials if there is potential for innovation, competitiveness, intellectual property rights to be compromised.

Reference: www.sanctr.gov.za/

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