10/11 April 2024
The EMA published guidance for applicants / MAHs involved in Good Clinical Practice (GCP) inspections. It includes a detailed list of documents to be provided to GCP inspectors.
According to the guideline, the Trial Master File (TMF) is the basis for GCP inspections and should be complete and readily available. The TMF may consist of trial relevant documentation held in files of various departments (e.g. pharmacovigilance, data management, statistics, R&D etc.) and various electronic systems. In the case the sponsor has subcontracted activities (e.g. the TMF management itself) to a contract research organization (CRO), the TMF and all the documentation that comprises the TMF will need to be available for inspection. This includes any electronic documentation, for example email correspondence. In addition, any equipment and software etc. to access any electronic documentation will need to be made available during GCP inspections.
A detailed list of needed documents for the inspection team is provided in the guidance, which includes, for example:
Documents should be provided in separate files, with meaningful filenames, and should be searchable. Scanned copies are not acceptable for documents that already exist in electronic format. However, for paper documents scanned copies are acceptable.
For a sponsor / CRO site inspection, a separate list of documents is provided in the guidance (e.g., risk-based monitoring strategy plan, trial & safety / pharmacovigilance management plan, documentation of data review meetings). Additional documents may be requested by the GCP inspector after receipt of the documentation. Measures should be put in place ensuring that the unblinded data are made available to the inspectors but still remain blinded as appropriate for the trial staff, when providing documents at any stage of the inspection.
For further details please see the GCP Q&A, and the draft guideline on computerized systems and electronic data in clinical trials, which provide useful guidance in relation to GCP inspectors expectations regarding some key aspects in the conduct of clinical trials and the format of the documents to be provided.
More information is available in EMA´s Guidance for applicants / MAHs involved in GMP and GCP inspections published on EMA´s GCP website.