Regulatory inspection – is the process where regulatory authorities or agencies review and evaluate the conduct of clinical trials, research sites, sponsors, or contract research organizations (CROs) to ensure compliance with applicable regulations, guidelines, and standards.
These inspections are typically conducted by regulatory agencies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.
Definitions
ICH E6(R2)
- 1.29 Inspection:
- The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies) [1].
Role of inspections
The purpose of regulatory inspections is to verify that:
- Clinical trials are conducted in accordance with approved protocols, regulatory requirements, and guidelines, including Good Clinical Practice (GCP) standards
- Institutional review board (IRB) or ethics committee (EC) approvals are obtained and maintained as required
- Participant safety and rights are protected throughout the trial
- Informed consent procedures are appropriately implemented and documented
- Investigational products (drugs, devices, etc) are handled, stored, and administered properly
- Data collected and reported during the study is accurate, complete, and in compliance with regulatory standards
Procedures of inspection
Regulatory inspections may be conducted on a routine basis as part of regulatory oversight or in response to specific concerns or complaints. Inspections may be announced or unannounced, and findings may result in regulatory actions, such as warnings, fines, or suspension of clinical trial activities.
See also
Another relevant pages
Links to this page
- Regulatory authority (← links)
- Regulation (EU) No 536/2014 (← links)
- Standard operating procedures (← links)
- Inspection (redirect page) (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
External links