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