New Guidance Documents for GCP Inspections

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.

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