FDA AUDIT CHECKLIST
WHEN FDA CALLS TO SCHEDULE A SITE VISIT, OBTAIN THE FOLLOWING INFORMATION 1:
Call date
Starting date
Expected Duration
Name
Telephone FDA
Investigator Contact Information Title Additional FDA Investigators’ Names?
ASK:
Who / what is being inspected? Wait for specific answers. Do not make suggestions . Clinical trial(s)/study Principal Investigator Co-Investigator(s)
Other
Details?
Why is the inspection being done? Wait for the answer. Do not make suggestions . Routine? (i.e. IND)
Directed (for cau)? Follow-up (i.e. 483; warning letter ?)
Other
Details?
Does the FDA want specific personnel available? no yes →if yes, then list Who When
Does the FDA want specific documents available? (List on parate sheet if needed)
Does the FDA want any of the documents nt prior to their arrival? no yes →then: How?
overnight registered certified Address:
Delivery by when?
1
Permission to adapt and u this form is granted by Emory University, Office of Rearch Compliance.
IMMEDIATELY,
CONTACT AND SEND NOTIFICATION TO THE FOLLOWING:
Sponsor
Phone: _____________
Principal Investigator (name)
Email: _____________________________________ Phone: _____________ Rearch Coordinator (name)
Email: ______________________________________ Phone: __________
UTHSC-H Office of Rearch
Catey Carter, RN, Clinical Trials Resource Coordinator
Catharine.V.du, Phone: 713-500-3524, Fax: 713-500-0335
The notification will be distributed by the Office of Rearch to:
1. UTHSC-H Office of Rearch Support Committees
Cynthia Edmonds, Manager
Cynthia.L.du, Phone 713-500-3977, Fax: 713-500-0319
2. UTHSC-H Office of Institutional Compliance
Karen Parsons, Director of Institutional Compliance
Karen.K.du, Phone: 713-500-3294, Fax: 713-500-0326
3.UTHSC-H Office of Auditing and Advisory Services
Lois Pierson, Assistant Vice President, Internal Audit
Lois.K.du, Phone: 713-500-3162, Fax: 713-500-3170 Affiliate Institutions
Memorial Hermann Center for Clinical Innovation and Rearch
Linda Brown, Clinical Rearch Education and Compliance Specialist
Linda., Phone: 713-704-3430
Harris County Hospital District
Julie Thompson, PhD, RN, Director, Rearch & Sponsored Programs
julie_du, Phone: 713-566-6473
At least one week before the scheduled visit, the Rearch Coordinator should complete the following activities2:
Check Comments
Step 1 Gather and review study documents – detailed
list follows
Note any problems (e.g. missing or incorrect
documents)
Step 2 Secure/rerve work space for FDA
reprentative away from other study/clinical
records and rearch staff
Optional: Contact the Office of Rearch to rerve
audit work space
Step 3 Coordinate with appropriate affiliate
institutions to confirm plans for site visit
support
Step 4 Prepare the following documents:
A. Study overview
A general overview of the study
List of all personnel and delegated responsibilities
B. Subjects list
List of all subjects enrolled, including name, study
number, date enrolled and completed, medical
record number
List of all subjects screened
C. Current Active Studies
List of Principal Investigator’s current active
studies
Step 5 Gather and organize the following documents:
A. Organize all Regulatory Files by general heading
arranged in chronological order (or rever
chronological order)
Protocol, include all versions
Investigator’s Brochure, all versions
Informed Connt Form, all versions
Protocol Amendments
Form FDA 1572, all versions
CVs for PI and Sub-investigators listed on all
versions of Form FDA 1572
2 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.
B. Communications
Sponsor Correspondence
CRO Correspondence
Monitoring Log
C. IRB Files
note: pay attention to date of IRB notification and date of IRB acknowledgment &/or approval
Approval Letter (initial) for initial protocol with
original informed connt
Amendment approval(s) with the approved
informed connt
Approvals for:
Periodic or Annual Reports
Renewal Documents
Notification of:
Adver Events
Deaths
Acknowledgement of:
IND Safety Reports
Study Termination
Final Summary
D. Laboratory
Laboratory Certification and normal ranges
CV of laboratory director
E. Drug Accountability - drug log to include:
Receipt of Drug
Dispensing
Return
F. Subject Documents
Informed Connts for screened/enrolled subjects
Connts obtained prior to any study procedures?
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, CTO, ORC
A. Review for each subject enrolled
Review Inclusion/Exclusion Criteria
Document reason for excluded subjects
CRFs completed for each enrolled subject
Source documentation for all CRF entries
Data Clarification issues satisfied
Connt obtained for all subjects screened/enrolled
Verify correct version of informed connt signed
Confirm ‘Notes to File’ prent as appropriate B. Medical Records and/or Study Files
Condition of subject at time of entry into the study
(i.e. all inclusion/exclusion criteria met)
Exposure to Study Drugs
Concomitant medications
Laboratory reports
Diagnostic tests
Do Modifications
Adver Events/Deaths
Protocol Exceptions
Early Termination
