FDA AUDIT CHECKLIST

At least one week before the scheduled visit, the Research Coordinator should complete the following activities[1]:

COMMENTS
Step 1- Gather and review study documents – detailed list follows
Step 2- Secure/reserve work space for FDA representative away from other study/clinical records and research staff
Step 3- Coordinate with appropriate affiliate institutions to confirm plans for site visit support.
Step 4- Prepare the following documents:
  1. Study overview

  1. A general overview of the study

  1. List of all personnel and delegated responsibilities

  1. Subjects list

  1. List of all subjects enrolled, including name, study number, date enrolled and completed, medical record number

  1. List of all subjects screened

  1. Current Active Studies

  1. List of Principal Investigator’s current active studies

Step 5Gather and organize the following documents:
  1. Organize all Regulatory Files by general heading arranged in chronological order (or reverse chronological order)

  1. Protocol, include all versions

  1. Investigator’s Brochure, all versions

  1. Informed Consent Form, all versions

  1. Protocol Amendments

  1. Form FDA 1572 or Declaration of Investigator (DOI- device studies), all versions

  1. CVs for PI and Sub-investigators listed on all versions of Form FDA 1572, DOI

  1. Communications (where applicable)

  1. Sponsor Correspondence

  1. CRO Correspondence

  1. Monitoring Log

  1. IRB Files - Note: Pay attention to date of IRB notification and date of IRB acknowledgment and/or approval

  1. Approval Letter (initial) for initial protocol with original informed consent

  1. Amendment approval(s) with the approved informed consent

  1. Approvals for:

  1. Periodic or Annual Reports

  1. Renewal Documents

  1. Notification of:

  1. Adverse Events

  1. Deaths

  1. Acknowledgement of:

  1. IND Safety Reports

  1. Study Termination

  1. Final Summary

  1. Laboratory

  1. Laboratory Certification and normal ranges, or waiver as applicable

  1. CV of laboratory director

  1. Drug Accountability - drug log to include:

  1. Receipt of Drug

  1. Dispensing

  1. Return

  1. Device Accountability- device log to include

  1. Receipt of Device

  1. Dispensing (where applicable, includes implants)

  1. Return (where applicable)

  1. Subject Documents

  1. Informed Consents for screened/enrolled subjects

  1. Consents obtained prior to any study procedures?

  1. Source documents for each subject enrolled (including labs, x-rays, scans, etc.)

Step 6- Complete the following review and note any issues to discuss with PI, CTRC, ORC
  1. Review for each subject enrolled

  1. Review Inclusion/Exclusion Criteria

  1. Document reason for excluded subjects

  1. CRFs completed for each enrolled subject

  1. Source documentation for all CRF entries

  1. Data Clarification issues satisfied

  1. Consent obtained for all subjects screened/enrolled

  1. Verify correct version of informed consent signed

  1. Confirm ‘Notes to File’ present as appropriate

  1. Medical Records and/or Study Files

  1. Condition of subject at time of entry into the study (i.e. all inclusion/exclusion criteria met)

  1. Exposure to Study Drugs

  1. Concomitant medications

  1. Laboratory reports

  1. Diagnostic tests

  1. Dose Modifications

  1. Adverse Events/Deaths

  1. Protocol Exceptions

  1. Early Termination

[1] Activity checklist is taken in part from “Pre-FDA Audit Checklist”; Pre-FDA Audit Investigator Site Preparations training class by GA International Donald Ashbrook and Robert Kagon; Nov. 13, 2002.