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January 12, 2026
Approximately 5 minutes
GCP Inspections Unit at BfArM
GCP Inspections Unit at BfArM
Mandate and Responsibilities
The Good Clinical Practice (GCP) Inspections Unit within BfArM conducts independent inspections to verify that clinical trials of investigational medicinal products in Germany comply with GCP principles as laid down in Directive 2005/28/EC, ICH E6 guideline, and the EU Clinical Trials Regulation (EU) No 536/2014. Inspections ensure the protection of rights, safety, and well-being of trial subjects, the credibility of trial data, and the ethical conduct of research. GCP Inspections Unit - BfArM
Scope of Inspections
BfArM GCP inspections cover:
- Investigator sites (clinics, hospitals, practices) where trial activities are performed.
- Sponsors and Contract Research Organisations (CROs) managing trials.
- Trial-related facilities (e.g., laboratories, depots).
- Trials conducted under national authorisation or as part of multinational applications via CTIS.
- Routine, for-cause, and systems inspections.
Inspections may be announced or unannounced, national or joint with other EU authorities.
Inspection Process
- Preparation: Risk-based selection of sites/trials; request for documentation.
- On-site Inspection: Review of source data, informed consent, trial master file, investigational medicinal product accountability, adverse event reporting, and protocol adherence.
- Reporting: Inspection findings are documented in a report; critical/major findings require corrective and preventive actions (CAPA).
- Follow-up: BfArM monitors implementation of CAPA and may re-inspect if necessary.
- Consequences: Non-compliance can lead to trial suspension, rejection of data, or regulatory sanctions.
EU Collaboration and Harmonisation
BfArM participates in the EU GCP Inspectors Working Group and coordinates joint inspections under the Clinical Trials Regulation. Inspection reports are shared via the EU database, contributing to mutual recognition and consistent enforcement across Member States.
Guidance and Transparency
BfArM publishes inspection procedures, checklists, and annual reports on GCP inspection activities. Sponsors and investigators are encouraged to prepare using EU and national guidance documents.
Through rigorous GCP inspections, the unit upholds high standards of clinical research integrity and participant protection in Germany, aligning with EU-wide efforts to ensure reliable clinical trial data for medicinal product authorisation. GCP Inspections Unit - BfArM
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