For-cause audits will be a priority for the Monitoring Program. However, special emphasis may be placed on studies that include vulnerable populations or have activities that may place participants at greater risk than what may be anticipated in ordinary circumstances. Monitoring will be done with an emphasis on quality improvement and support for researchers.

Categories of Audits

• Routine: Studies will primarily be randomly selected by the IRB Monitor. However, selection may include monitoring only certain elements of study activities.
• Informed consent: This audit is intended to support researchers in conducting the informed consent process. It may include observation (when possible) of the consent process and/or a thorough review of the process including training of people obtaining consent, and review of signatures and storing.
• For-cause: Under 45 CFR 46.113 requirements, this review is performed when concerns regarding compliance, protocol adherence, or subject safety are brought to the attention of the IRB or the IRB Monitor. This would be an on-site review that may include a review of all or any related study activities.
• Investigator Initiated: A PI may request an on-site review to help keep records and procedures in compliance with federal regulations and institutional policies or to prepare for an external audit by a sponsor or federal agency.

Audit Notice

Except in cases where the safety of subjects is a concern, or where the IRB specifically requests an unannounced audit, written notification of an audit will be sent from Research Compliance Services. Depending on the nature of the research study, an IRB member who has experience in the study topic may also be present at the audit. The Investigator will contact the Post Approval Monitor to arrange a visit within the following estimated timeframes:

• Routine: At least two weeks’ notice in advance of the initial meeting of the audit.
• Informed Consent: At least one week notice in advance of the monitoring.
• For-cause: At least twenty-four (24) hours’ notice by a telephone call and email to the PI from the Institutional Official or his/her designee.
• Investigator Initiated: A time will be arranged by mutual convenience.

Elements of Audit Review

Before Audit: Investigators will receive a letter informing them that their study has been chosen for an audit. The investigator will then contact the Monitor, and a time will be scheduled for the audit.

Before the audit the Monitor will review the Study Protocol and all documentation related to the study in the IRB file including:

• Grant Application, if applicable; the grant application may be compared to the IRB approved protocol.
• The IRB File. IRB Meeting issues (quorum, diversity, expertise, conflict of interest); adequacy of review.
• IRB file to determine whether it contains all correspondence/amendments, adverse events, and protocol deviations the investigator submitted.
• Whether annual continuing review was completed.
• Elements of Informed Consent/Assent documents, as well as review of the required elements of informed consent according to the federal regulations and IRB requirements.
• Subsequent publications resulting from IRB approved protocols may also be reviewed.

Investigators can prepare for the audit by reviewing the checklist of questions below. (Please note that not all items on the checklist apply to all research studies)

Audit preparation questions for PI and research study team

• Does the researcher have available the most recently approved protocol, consent form, and study documents?
• How many participants are currently enrolled? How many have been approved by the IRB?
• Are all key personnel listed on Appendix A?  Are personnel conducting procedures according to their role in the study?
• Have any participants withdrawn/dropped from study? If so, why?
• Have any adverse events occurred? Were any reported to the IRB?
• Are participants consented with the most recently IRB approved stamped version? Have all the consent forms been signed and dated by the participant and the person obtaining

consent?

• Have all study measures and procedures been approved by the IRB before implementation?
• Are all study records stored as indicated in the protocol?
• Are all advertisements and methods of recruitment being used IRB-approved?
• Are study documents maintained as outlined in the protocol?
• Are participant ID numbers generated per protocol?
• Have all enrolled participants met eligibility criteria? Is there documentation of eligibility?
• Have there been any protocol deviations? Have they been reported to the IRB?
• Have there been any unanticipated problems with protocol implementation?
• Has participant compensation been documented?
• Have there been any participant complaints?
• Are raw data files organized, complete, and legible?

During the Audit: At the time of the audit, the Monitor will meet with the PI to briefly discuss the study. The PI will provide the Monitor with study files. The PI must make available the use of a quiet space for the Monitor to review the study files. The PI or designee who is familiar with the study will be available during the audit in case the Monitor has questions.  As needed, during the audit, the Monitor will provide recommendations and educational support on record retention and documentation, and other compliance related issues. Documents pertaining to research will be held strictly confidential.

Review of Regulatory Compliance may include review of: (See Monitoring Review Form)

• Roles and responsibilities of investigators and key personnel
  1. Protocol file/regulatory documentation.
  2. IRB Documentation.
  3. Consent/Assent Forms.
  4. Individual Participant Records. A random sample to determine if :
     • The participants met the inclusion/exclusion criteria for the study.
     • Study related procedures are performed according to the protocol.
     • Study related procedures are scheduled and performed per the study time line.
     • Data are recorded and stored securely as described in the Consent Form.
     • Adverse Events have been reported according to institutional policy.
     • Protocol deviations have been reported to the IRB.
     • Payments were made to participants as described in the protocol.
     • Participant ID numbers are assigned according to the protocol.

After the Audit: After the audit is complete the Monitor will meet with the PI and provide a brief summary of findings.

 

Report of Findings

A Summary Report will be drafted by the IRB Monitor and sent to the PI for his/her review and responses. The report will provide a detailed summary of the audit identifying areas of improvement and recommendations for improvement. The PI and the IRB Monitor will sign the report. A copy of the signed report will be provided to the Director of Research Compliance, the PI, and the IRB Chair. When indicated, the PI will be invited to respond to each indication of non-compliance listed in the summary with a plan of corrective action for each item. This plan will be submitted to the IRB within 2 weeks of the date of the summary.

• It is anticipated that in most cases serious violations involving risk of injury to participants will have already been reported to the IRB. However, if an audit demonstrates that a serious violation involving risk of injury to participants has not been reported, it will be reported immediately to the IRB Chair, Director of Research Compliance, and to the Vice President of Research (or his/her designee).

Audit of Informed Consent/Assent Process

Investigators can request an overview of the consent process at any time before or during initiation of a study. During an audit of consent, the IRB Monitor will review:

• The timing of recruitment and screening in relation to informed consent.
• The appropriateness of the person obtaining consent.
• The consent process to meet the needs of vulnerable populations.
• Steps to aid participants with barriers to understanding or lack of capacity to consent (language, reading level, etc.)
• Steps to see if the participant understands the research purpose, risks, benefits, voluntary participation, withdrawal, confidentiality, costs/compensation, and contacts for questions or injuries.

If you have questions regarding the auditing process or would like to schedule a time to meet with the Post Approval Monitor for an individual or group education session please contact:

Joan Levine, MPH Post Approval Monitor
University of Connecticut
Research Compliance Services
438 Whitney Road Extension, Unit 1246
Storrs, CT  06269-1246
Tel: (860) 486-7145 –
Fax: (860) 486-1044
e-mail: joan.levine@uconn.edu