FDA And EMEA INSPECTIONS OF CLINICAL INVESTIGATORS
By Michael Donatelli
Inspections of Clinical Investigators are often conducted to verify the integrity of data submitted in support of a marketing application for a new drug or indication and to assess regulatory compliance.
This cGXP Information Sheet is intended to be an aid in the preparation of a pending FDA/EMEA clinical investigator inspection.
Ideally, the sponsor will have a good working relationship with the clinical investigator. Investigators that are contacted by a regulatory authority should inform the sponsor of the contact so that the sponsor’s QA group has the opportunity to prepare the clinical investigator and staff on inspectional practices. Conversely, the sponsor should immediately inform investigators of pending EMEA inspections.
FDA [US Inspections] - Inspectors generally schedule the inspection with the clinical investigator and do not contact the study sponsor.
FDA [ex-US Inspections] – For inspections conducted outside of the US, the FDA will typically schedule the inspection with the assistance of the sponsor.
EMEA [Member State & non-Member State Inspections] – At the moment, all inspections of clinical investigators are performed at the request of the Committee for Medicinal Products for Human Use (CHMP). By process, the EMEA must contact the sponsor to secure a contract for the inspection.
Preparing for the Inspection - Sponsor
It is in the sponsor’s best interest to help prepare the clinical investigator for a pending inspection. The only exception to this is if the investigator is suspected of misconduct or violations of Title 18 of the United States Code.