Office of Human Research
Page Title

SOP No.: 802   FDA AUDITS

Author:    Office of Human Research

Effective Date:  October 1, 2007

Supercedes document dated:              N/A

Last Reviewed on:     N/A                                 

Results of Review:               N/A

This SOP pertains to All personnel participating in an inspection of FDA-regulated human subject or other related research within Thomas Jefferson University.

Responsibility for executing this SOP:  Investigator and Designated Research Personnel

Approved By:

 

J. Bruce Smith, MD

 

Associate Vice President for Research

 

(signature on file at OHR)

Approved By:

 

Steven E. McKenzie, MD, Ph.D.

 

Vice President for Research

 

(signature on file at OHR)

 

1. PURPOSE

This procedure describes the process for conducting business with representatives of the FDA before, during and after an inspection of FDA-regulated human subject or other related research within Thomas Jefferson University.

2. GENERAL INSTRUCTIONS

  1. The Investigator and other key study personnel are responsible for fully cooperating with all FDA personnel engaged in the inspection.
  2. The Investigator may request the OHR to help in preparation for the audit.
  3. The Investigator is responsible for carrying out all follow-up actions and responses with consultation from the Office of Human Research (OHR).
  4. The Investigator is responsible for maintaining the FDA inspection files, to include copies of the Form FDA 482, Form FDA 483 (if provided), copies of all documents provided to the FDA Inspector, response letter(s) to the Form FDA 483, the FDA Establishment Inspection Report (EIR) and inspection classification correspondence. The Investigator will ensure copies of these records are provided to the OHR.

3. SPECIFIC PROCEDURES

3.1 Opening the Inspection

  1. If contacted by the FDA to schedule an inspection, the Investigator should inform the OHR and the Office of University Counsel (OUC) of the inspection and may request that the OHR participants be available.
  2. When scheduling the inspection date with the FDA, the Investigator must ensure that all key study personnel will be available before confirming a date.
  3. On the first day of the inspection, the Investigator must ask to see the the FDA Inspector's credentials (identification with photograph).
  4. Do not begin the inspection until the FDA Inspector has provided Form FDA 482, Notice of Inspection, to the Investigator and the purpose of the inspection has been ascertained. The Investigator is required to sign the Form FDA 482.
  5. The Investigator or designee will assemble other participating individuals for the inspection.
  6. Documents that the FDA may not inspect, absent voluntary production by the Investigator, include but are not limited to:
    • Financial data
    • Personnel data (other than that needed to establish the qualifications of technical and professional personnel performing functions subject to the Act)
    • Internal QA audit records (written certification may be provided that audits are performed)
  7. The University's official policy is to forbid the use of the following unless within an IRB approved protocol or institutionally approved media coverage.
    • still or video cameras, or voice recording apparatus, on University premises
    • If an the FDA Inspector has such equipment, he/she should be asked to store the equipment in his/her car or in a secured location on the premises.
    • If the FDA Inspector insists on using such equipment, the Investigator, in consultation with the OHR and the OUC, should decide whether this request should be honored.
    • If the decision is made to allow the use of the equipment, the OUC must first be satisfied that University rights and privileges will not be waived, the University will be given equal opportunity to use the same equipment, and appropriate measures have been taken to ensure the protection of proprietary or confidential information of the University and/or its employees and research participants.
  8. The FDA Inspector may request to view electronic data files on a computer, and to make copies of electronic data files on a disk to be provided to him/her as part of the inspection document collection process. The Investigator and other institutional officials should be prepared to respond to that request as appropriate.
  9. The Investigator will designate an individual to take notes of activities and discussions during the inspection.
  10. The Investigator will designate an individual to make copies and obtain documents and records as requested.
  11. The Investigator must approve all FDA requests for copies of documents and records and review the copies of documents and records before handing them to the FDA Inspector. He/She must first be satisfied that appropriate measures have been taken to ensure the protection of proprietary or confidential information contained in those documents and records.
  12. If the Investigator is unsure if such a request is appropriate, the Investigator will consult with the OHR for advice.
  13. The Investigator will provide the FDA Inspector with adequate space to review documents and records.
  14. The Investigator should review the policies and guidelines for the conduct of the inspection with the FDA Inspector.
  15. The Investigator will work with the FDA inspector to develop a proposed schedule (estimated number of days, times) for the inspection (to the extent possible).

 

3.2 Conducting the Inspection

  1. The Investigator will ensure that the inspector is not left unattended and arrange for him/herself and/or appropriate study staff be available to answer questions, retrieve documents, and facilitate completion of audit. Alternatively the Investigator will arrange to have the audit take place in an area supervised by the OHR.
  2. The Investigator or designee should document all relevant discussion and requests.
  3. The designee will make two copies of every document that is requested by the FDA Inspector, one for FDA and one for the inspection file.
  4. The Investigator will review the copies to redact any proprietary or confidential information before the copy is given to the FDA.
  5. The Investigator should request an opportunity to immediately correct objectionable observations.
  6. The Investigator should respond to the FDA Inspector's questions as they occur and request additional time to respond if necessary.
  7. The Investigator should permit the FDA Inspector to speak with other key personnel, as requested.
  8. If the FDA Inspector asks to inspect an area or document that is outside the "legally permissible" scope of the current inspection under Section 704, a request must be made in writing and the matter referred to the OUC.
  9. Under no circumstances may an FDA Inspector remove an original document or record from University premises, nor may an FDA Inspector make any copies him/herself nor make any marks on original documents and records.
  10. The Investigator should meet with all relevant key personnel to discuss and summarize the day's events after the FDA Inspector has departed.

3.3 Concluding the Inspection

  1. At the conclusion of the inspection, the FDA Inspector will summarize any objectionable observations on Form FDA 483, Inspectional Observations.
  2. If certain observations can be corrected before the end of the inspection, the Investigator should attempt to do so, and the FDA Inspector may annotate the Form FDA 483 to document that the observation was corrected or a corrective process was put into place.
  3. The signed Form FDA 483 will be provided to the Investigator.
  4. At any time during the inspection, if the FDA Inspector requests that an affidavit or any other document be signed (with the exception of the FDA 482), initialed or otherwise ratified, the Investigator or other representatives should not comply until the OUC has been consulted.
  5. All relevant personnel should be reconvened for the closeout meeting with the FDA Inspector.
  6. The Investigator's inspection team should review the Form FDA 483 (if one is provided) carefully and confirm that corrected items are either not listed or the Form FDA 483 is annotated to show a correction was implemented.
  7. The Investigator should request such deletions or annotations of the Form FDA 483 if they are not already present.
  8. During the discussion, the Investigator should ask the FDA Inspector to clarify any items and provide as much detail as appropriate for items that need such clarification.
  9. The Investigator should express explanations or disagreements about any items or issues clearly, assertively, and respectfully.
  10. The Investigator should advise the FDA Inspector that a written response to the Form FDA 483 will be sent to the office the FDA Inspector specifies.
  11. The Investigator will ensure that all promised corrective actions are carried out expeditiously and within promised timeframes.
  12. A written response to the FDA will be developed by the Investigator with assistance from the OHR.
  13. The Investigator will submit a full, written response to the Form FDA 483, item by item, within 10 days of the inspection's conclusion, indicating all corrective actions taken to date, and summarizing actions yet to be taken, with a proposed time frame for completion.
  14. Thirty days after the inspection, the Investigator should send a written request to the FDA for a copy of his/her Establishment Inspection Report (EIR).
  15. If a letter from the FDA officially classifying the inspection (No Action Indicated, Voluntary Action Indicated, Official Action Indicated) is not received within 45 days of the inspection, the Investigator should contact the FDA office and request the status of the letter.
  16. The Investigator will confer with the OHR about reporting FDA inspection occurrence/results to other relevant regulatory authorities or funding sponsors.

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 312.58

Inspection of sponsor’s records and reports

21 CFR 312.68

Inspection of investigator’s records and reports

21 CFR 812.145

Inspections

ICH E6, section 2.13

The Principles of ICH

ICH E6, section 4.1

Investigator’s Qualifications and Agreements

ICH E6, section 5.1

Quality Assurance and Quality Control

ICH E6, section 5.15

Record Access

FDA Compliance Program Guidance Manual, 7348.811

Clinical investigators

5. REFERENCES TO OTHER APPLICABLE SOPs

103

Investigator Responsibility and Delegation of Responsibility

503

Documentation and Records Retention

601

Quality Assurance Audits

6. ATTACHMENTS

None

 

 

back to QA-800 index


Click to leave feedback
feedback