An agency, like FDA, would inspect a clinical site typically for 1 of 2 reasons: verify data included in a marketing application (e.g., Pre-Approval Inspection) or for protection of subjects (e.g., "for cause"). FDA uses a risk assessment approach to decide which clinical sites to inspect. Running 2 Phase 1 studies at the same site would not itself likely rise to a risk level leading to an FDA inspection. If that same site is conducting a Phase 3 study on another sponsor's product and that sponsor submits that product for market approval, FDA may inspect that site to verify data, though the inspector would focus mostly on the other sponsor's product.
FDA could learn about problems at a clinical site from a number of sources (e.g., the IRB, from another sponsor who is conducting a clinical study at that site, from a subject participating in a clinical study at that site, a high number of SUSARs from that site as compared with other sites participating in the same study or the opposite-a low number of SUSARs from a given site compared with other sites). If FDA decided to conduct a "for cause" inspection of a clinical site, the inspector may look at all studies being conducted at that site to determine if the site is properly protecting subjects.
Because a sponsor can never be sure if and when an agency may inspect a clinical site (or a manufacturing site), the sponsor should ensure it has proper oversight under the sponsor's obligations.
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Mark De Rosch, PhD, FRAPS
Senior Vice President, Regulatory Affairs and Quality Assurance
Nightstar Therapeutics
Waltham, MA
United States
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Original Message:
Sent: 04-Apr-2019 11:44
From: Anonymous Member
Subject: inspection of clinical investigator
This message was posted by a user wishing to remain anonymous
Dear Forum,
what are reasons for the FDA to inspect a clinical investigator if there have been no complaints? Would conducting two Phase I studies at the same time be a reason?
thank you!