EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A
The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A).
EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors Working Group.
The March 2022 updates relate to:
Investigational medicinal products (IMPs) in bioavailability and bioequivalence trials:
✔️ labelling of Investigational Medicinal Products (IMPs),
✔️ deviations from inclusion/exclusion criteria of an approved protocol,
✔️ subcontracting and related sponsor & investigator responsibilities,
✔️ the definition of source data,
✔️ contractual agreements with vendors for electronic systems,
GCP matters:
✔️ audits of IMP manufacturers by the sponsor,
✔️ GCP inspectors’ right to inspect trial participants’ medical records and associated implications for Informed Consent Forms,
Records of study subject data relating to clinical trials:
✔️ considerations when transferring copies of medical records to clinical trial sponsors or their service providers.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
