Recommendations and guidance related to the implementation of GCP
These recommendations and guidance documents are for the attention of sponsors, CROs, clinical investigators and other parties involved in the conduct of clinical trials. They have been prepared by the GCP Inspectors Working Group in conjunction, where needed, with other Working Groups and Committees of the European Regulatory Network.
Inspection procedures and guidance for GCP inspections conducted in the context of the Centralised Procedure
The GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections carried out in the context of the Centralised Procedure.
These inspections are adopted by the CHMP and may be routine or may be triggered by issues arising during the assessment of the dossier or by other information such as previous inspection experience.
They are usually requested during the initial review of a Marketing Authorisation Application, but could arise post-authorisation (e.g. inspection of studies conducted or completed as part of the condition of a marketing authorisation, or because of concerns arising about the studies previously submitted).
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