Office of Human Research
Page Title

SOP No.: 801   QA 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:  Internal audits that are conducted by the OHR, or to external audits conducted by external authorities (e.g., NIH or other funding authority). This procedure does not apply to FDA inspections (Refer to SOP 602, FDA Inspections).

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 to follow for initiating or otherwise participating in a QA audit to assess compliance with applicable regulatory requirements and guidelines for conducting Food and Drug Administration (FDA)-regulated human subject research within Thomas Jefferson University.

2. GENERAL INSTRUCTIONS

  1. The OHR is responsible for securing a trained and qualified Auditor to conduct the periodic audit of the clinical or other research program, either an employee or an outside contractor, for reviewing the audit report with the Investigator if requested, and for participating in the development of a corrective action plan.
  2. The Investigator and his/her key personnel are responsible for fully cooperating with all QA audits by any authorized party.
  3. The Auditor is responsible for preparing for the internal QA audit, conducting it according to applicable standard operating procedures and regulatory requirements, reviewing his/her preliminary observations with the Investigator, documenting his/her observations in an audit report, and submitting that report to the Investigator.
  4. The Investigator is responsible for maintaining a record of audit/ dates, for maintaining audit reports and corrective action plans, and for implementing corrective actions for any objectionable or otherwise non-compliant audit observations.  The Investigator will maintain all audit reports in a confidential file.

3. SPECIFIC PROCEDURES

3.1 Internal QA Audits

  1. The OHR should ensure that the Investigator's program is periodically audited.
  2. When an audit date is scheduled, the Investigator should ensure that all key personnel are available on that date to participate in the audit.
  3. The Investigator should request the auditing group prepare and provide to him/her, an audit schedule and/or audit plan to ascertain the scope of the program that is to be audited.
  4. A meeting of all key personnel should be held prior to the audit to ensure that all necessary documentation is available for the audit.
  5. The Investigator will ensure that the auditor is not left unattended and arrange for him/herself and/or appropriate study staff be available to answer questions, retrieve documents, and facilitate the completion of the audit.
  6. The Investigator should request a verbal summary of all relevant audit observations from the Auditor and review those findings at the completion of the audit.
  7. The Investigator should request and should receive a complete audit report from the Auditor as soon as possible after the audit is completed.
  8. The audit report may be reviewed with the OHR, if appropriate.
  9. The Investigator will develop a plan for the implementation of corrective actions and process improvements arising from objectionable audit observations, with consultation from the OHR.
  10. The Investigator will implement those corrective actions and improvements within a mutually agreed upon time period.
  11. The Investigator will maintain a record of internal QA audit dates and a copy of the procedure used for conducting those audits in the appropriate section of the Regulatory Master File for viewing by the FDA, if requested.
  12. The Investigator will maintain a file of audit reports and their follow-up corrective action plans in a clearly labeled 'Confidential Quality Assurance' File.
  13. Internal QA audit results (reports, corrective action plans) are NOT provided to the FDA, and the FDA personnel are NOT entitled to request them.
  14. The Investigator will consult with the OHR and/or the Office of University Counsel (OUC) concerning requests from outside auditors for internal audit reports and corrective action plans.

3.2 External Audits by Third Parties

  1. If contacted by an external authority such as the FDA, or the NIH to schedule an audit, the Investigator will inform the OHR, and the OUC and may request that an OHR participant be available (refer to SOP 802 for FDA Inspections).
  2. For external audits noted above the Investigator should also immediately notify:
    • Director, TJU Office of Research Administration
    • Department/Chair/Institute Director or Dean as appropriate
    • Investigational Drug Service (if applicable)
  3. If an external Auditor has direct access to any participant source data or source documents, he/she must be reminded to respect the confidentiality of that information, and not be permitted to make copies of any information that has participant identifiers on it.
  4. If a written response to the audit is requested, it should be prepared and submitted to the auditing authority as soon as possible after the audit.
  5. The Investigator will draft the audit response, circulate it for review and approval to the OHR, and other institutional officials to be determined, and retain a copy of the response in the appropriate file.

 

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 312.50

General responsibilities of sponsors

21 CFR 312.60

General responsibilities of investigators

21 CFR 812.40

General responsibilities of sponsors

21 CFR 812.100

General responsibilities of investigators

21 CFR 812.110

Specific Responsibilities of Investigators

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

ICH E6, section 5.19

Audit

ICH E6, section 5.20

Noncompliance

5. REFERENCES TO OTHER APPLICABLE SOPs

103

Investigator Responsibility and Delegation of Responsibility

602

FDA Inspections

6. ATTACHMENTS

None

7. DEFINITIONS AND GLOSSARY

The following definitions from the International Conference on Harmonisation, Good Clinical Practice:  Consolidated Guideline apply to this SOP.

Audit: A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).

Audit Trail: Documentation that allows reconstruction of the course of events.

Compliance: Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.

Direct Access: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsors, monitors, and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects’ identities and sponsor’s proprietary information.

Documentation: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Essential Documents: Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Quality Assurance (QA): All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s).

Quality Control (QC): The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).

Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function.

 

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