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.

EMA has published a notice for clinical trial sponsors to highlight the requirements for the qualification and validation of computerised systems used for managing clinical trial data. This is based on inspection findings and taking into account implications on the integrity, reliability, robustness and acceptability of data in marketing authorisation applications:

In line with this notice, EMA has also updated questions 8 and 9 on this page, which provide further related guidance on computerised systems. 

Investigational medicinal products (IMPs) in bioavailability and bioequivalence trials

GCP matters

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

Records of study subject data relating to clinical trials

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