I. Upon notification that a FDA inspection will occur

  1. Complete the Initial Intake Form (see Appendix 1) and collect the specific documents requested in the Form.
    1. Ensure all requested documents are available for inspection when the inspector arrives.
    2. Do not volunteer additional information or documentation.
    3. 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.
    4. Maintain an itemized list with the status of any missing documents.
  2. Review guidance documents on the FDA website, including the:
    1. FDA Compliance Program Guidance Manual and Guidance for the FDA Staff
    2. FDA Inspections of Clinical Investigators: Information Sheet Guidance
    3. Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
    4. Electronic Source Data in Clinical Investigations
  3. Reserve a meeting room(s) for the duration of the inspection – keeping in mind the following recommendations.
    1. The room should have a phone, and allow convenient access to study staff.
    2. The room should be located away from the clinical/research area to avoid such activities from being conducted near the inspector.
    3. The room should NOT contain any other study or medical records, other than the study records that the inspector has requested.
    4. The room should be able to be locked when the inspector leaves.
    5. 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.)