Office of Research Integrity

HRPP 10.1 Human Research Audit Policy and Procedures

Policy Name:  Human Research Audit Policy and Procedures
Approved:
Effective Date: 01/27/2011Page 1 of 4Section: HRPP 10.1
Replaced Policy: 02/20/2009

I.  POLICY

A. Introduction

The MUSC University Compliance Office conducts audits on research projects involving human participants .

B. MUSC Policy

Audits are a tool to assist the Medical University in achieving compliance with applicable federal regulations and laws and MUSC policy and procedures during the conduct of research involving human participants. This mechanism of post-review monitoring also serves as a vehicle for continuing education, increased operational awareness and quality improvement. Audits consist of record review of both the Institutional Review Board (IRB) and the applicable Principal Investigator's HR study files.

II. PROCEDURES

A. The University Compliance Office initiates audits based on the following criteria:

1. Priority 1: For-Cause-Audit: Study where allegations of human participants' violations have been lodged against a Principal Investigator.

2. Priority 2: Administrative Audit: Study where the IRB Chair has identified a potential administrative problem with study documentation.

3. Priority 3: Random Audit: Study randomly selected using a random number generator. Each study has an equal chance of selection.

B. The University Compliance Office maintains files to document the selection of studies involving human participants for audit.

C. Once a study has been selected for audit, the University Compliance Officer will assign the audit to the appropriate Compliance Auditor with the Compliance Auditor conducting the highest priority audit first.

D. Compliance Auditors will use IRB approved checklists as guidance to conduct the audit.

E. Once a study is assigned for audit, the Compliance Auditor will contact the IRB Program Manager or the appropriate IRB Administrator to gain access to the IRB study file. The Compliance Auditor will review the study file and Xerox copies as necessary in the Office of Research Integrity. While reviewing the study file, the Compliance Auditor completes the applicable checklist. Prior to contacting the Principal Investigator, the study file review should be completed and any questions related to the study addressed by the IRB Office or University Compliance Officer as necessary. Upon completion of the review the Compliance Auditor will return the study file to the IRB Program Manager or IRB Administrator.

F. Upon completion of the checklist, the Compliance Auditor will prepare a written audit report and forward to the IRB Program Manager. The IRB Program Manager will provide a written response on audit findings within 14 calendar days and forward to the University Compliance Officer who will review the audit report and response. The University Compliance Officer will approve and/or return the report to the IRB Administrator if any additional action or information is needed to resolve any finding(s). Upon approval by the University Compliance Officer, a copy of the audit report and response will be filed in the University Compliance Office.

G. The Compliance Auditor will contact the Principal Investigator by phone or e-mail to schedule the audit. In most instances, the Principal Investigator will have no more than ten working days to prepare for and schedule the start of the audit. Once the audit is scheduled, the Compliance Auditor will confirm the time, date, and place of the audit and provide the Principal Investigator a copy of the checklist used to conduct the audit.

H. The Principal Investigator and/or the Study Coordinator will:

1. Provide the following study files for the auditor's review.

a) All study related regulatory documents

b) Research Participant Screening/Enrollment log (as appropriate)

c) Case Report Forms

d) Case Report Forms source documents

e) Informed Consents and HIPAA for all enrolled/screened subjects

f) Study drug and drug accountability logs (as applicable)

g) Device accountability logs (as applicable)

h) Lab logs (as applicable)

i) Other documents/files supporting the conduct of the study.

2. The Principal Investigator and/or Study Coordinator will arrange for a private work area for the conduct of the audit.

I. The Compliance Auditor reviews all pertinent study documents and records and completes the checklist to document the audit finding(s).

J. The Compliance Auditor keeps the Principal Investigator and/or Study Coordinator informed of the progress of the audit. The Compliance Auditor informally debriefs the Principal Investigator and/or Study Coordinator at the completion of the audit.

K. After completion of the audit, the Compliance Auditor prepares a final audit report that is forwarded directly to the University Compliance Officer.

L. The University Compliance Officer reviews the audit report and adds comments as appropriate. The approved audit report is then forwarded to the Principal Investigator for a response. The Principal Investigator's response includes a correction action plan to reflect the audit findings. Once the audit report and response are returned to the University Compliance Office, a copy of the audit report and response are forwarded to the appropriate IRB Chair for information and/or action and a copy retained by the University Compliance Office files.

M. If so warranted, the IRB Chair/IRB Office may take immediate action to prevent any further enrollment in the study until the audit report is reviewed by the full IRB.

N. The IRB Chair will present the audit report and Principal Investigator response at the next scheduled IRB meeting.

1. Within 10 working business days of the IRB meeting, the IRB Office will notify the University Compliance Office of the IRB's acceptance of the audit report finding(s) or of any action(s) initiated in response to these finding(s).

2. The IRB Office will keep the University Compliance Office informed regarding the progress of all assigned action(s) until all action(s) are resolved to the satisfaction of the IRB.

O. The University Compliance Office will document the conduct of audits from initiation to resolution of audit finding(s) on the Audit Status Report.

III. REFERENCES