EMA Issues New Guidance Documents for GCP Inspections

by ECA Academy Jun 22, 2022

On January 31, 2022, the EMA's Clinical Trials Information System (CTIS) went live in accordance with the Clinical Trials Regulation (EU) No 536/2014 (CTR). Following the previously published List of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. These are the following annexes to the GCP Inspection Guide:

  • Annex I: Investigator site
         

  • Annex II: Clinical laboratories: The guidance may be applied to the inspection of laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial.
         

  • Annex IV: Sponsor and Contract / Clinical Research Organizations (CROs): The annex compiles specific items that may be verified at the sponsor site or the CROs performing sponsor's trial-related duties. There could be two different approaches:
         • System inspection,
         • Specific clinical trial inspection.

  • Annex VI: Record keeping and archiving of documents: The annex includes trial related documents provided by the applicant/sponsor (e.g. protocol and amendments, clinical study report, investigator's brochure, blank patient informed consent forms, patient listings and audit trails)
         

  • Annex VII: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials: The documents and data relating to the following topics are generally reviewed during the inspection:
         • Storage of biological samples,
         • Validation of bioanalytical methods,
         • Performance of assays,
         • If requested, pharmacokinetic and statistical analyses of the trial data.

More information is available under Inspection procedures and guidance on at EMA´s Good clinical practice (GCP) inspection procedures website.


Disclaimer: This article is originally published by ECA Academy.

ECA Academy
+ FOLLOW
Copyright: unless otherwise stated all contents of this website are ©2022 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com