FDA inspections for clinical trials are generally conducted when the studies are part of a marketing application submitted to FDA and provide data critical to decision-making on product approval. Primarily, the inspection will evaluate whether the following criteria are met:
- The study is well-designed and well-conducted.
- The study is conducted in accordance with Good Clinical Practice (GCP).
- The study has been reviewed and approved (or provision of a favorable opinion) by an independent ethics committee (IEC) prior to study initiation, continuing review of an ongoing study by an IEC.
FDA Audit Checklist for Clinical Trials
To face the FDA audit for clinical trial, following points are to be checked or reviewed:
- Purpose of the audit
- Contact information of auditor(s)
- Planned number of auditor(s)
- Anticipated number of days or duration of audit
- Primary point of contact for scheduling and organizing the audit
- SOPs and Protocol are up-to-date
- Each subject has consented to direct access to his/her original medical records for clinical research study-related monitoring, audit, IRB review, and regulatory inspection
- Protection of human subjects
- Source documentation, case histories, CRF entries and other clinical research study records are accurate, complete, current, and maintained
- The investigational product storage conditions are acceptable and supplies are sufficient throughout the clinical research study
- The studies are conducted in conformance with the "Declaration of Helsinki"
- Other applicable regulatory requirements
- Quality Management System (QMS)
The research team member should provide the auditor with all clinical research study documents requested for review and check in with the auditors throughout the day to address any questions or arrange any requested meetings with key personnel. FDA validates the authenticity and accuracy of data and confirms compliance during an inspection.
If any FDA 483 form is issued from the audit, the PI is responsible for writing a formal response addressing how the deficiencies will be corrected and prevented from occurring in the future. The response may be in collaboration with key clinical research stakeholders (e.g., ORRP, COM-Office of Research), if needed. This response will be sent to the appropriate FDA District Office within 15 business days of receiving the inspection results.
