I. Upon notification that a FDA inspection will occur
- Complete the Initial Intake Form (see Appendix 1) and collect the specific documents requested in the Form.
- Ensure all requested documents are available for inspection when the inspector arrives.
- Do not volunteer additional information or documentation.
- If some of the documents are not immediately available (i.e., offsite storage), obtain them as soon as possible, preferably at least 2-3 days before the scheduled inspection.
- Maintain an itemized list with the status of any missing documents.
- Review guidance documents on the FDA website, including the:
- FDA Compliance Program Guidance Manual and Guidance for the FDA Staff
- FDA Inspections of Clinical Investigators: Information Sheet Guidance
- Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
- Electronic Source Data in Clinical Investigations
- Reserve a meeting room(s) for the duration of the inspection – keeping in mind the following recommendations.
- The room should have a phone, and allow convenient access to study staff.
- The room should be located away from the clinical/research area to avoid such activities from being conducted near the inspector.
- The room should NOT contain any other study or medical records, other than the study records that the inspector has requested.
- The room should be able to be locked when the inspector leaves.
- The requested staff should be readily available to the inspector at all times. (The inspector generally will not want the study staff coordinating the investigation in the room while s/he works.)
Links:
[1] http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133562.htm
[2] http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126553.pdf
[3] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM464506.pdf
[4] http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf