Q&A: Good clinical practice (GCP)

The European Medicines Agency (EMA) provides guidance in forms of questions and answers (Q&As) on good clinical practice (GCP), as discussed and agreed by the GCP Inspectors Working Group.

A. Investigational medicinal products (IMPs) in bioavailability and bioequivalence trials

B. GCP matters

C. Expectations of European Union (EU) competent authorities on the use of electronic trial master files

D. Records of study subject data relating to clinical trials

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