IRB-HSR PAM & Ed Review Process

Study selection process for Post Approval Monitoring (PAM)

Any study under the purview of the University of Virginia IRB-HSR is subject to review. Studies are chosen:

At random or per other requests or indications (i.e. per Cancer Center requirements or other request)
Has an active approval status
Has a full board, expedited, or exempt review

Studies may be reviewed for:

Research where compliance concerns have been raised based upon information provided in continuing review reports, adverse events or other sources;
Research approval expires due to failure by the investigator to submit continuation status report and PI is requesting the study to be re-opened;
Research where paperwork submitted to the IRB was felt to be inadequate;
Studies monitored by the Cancer Center DSMC under their institutional Data Safety Plan;
Protocols with junior investigators or inexperienced team members who may benefit from post-approval monitoring assessment and education;
For any change in PI after initial study approval and study remains open to enrollment

Notification process that a protocol has been chosen:

A letter is sent via email to the principal investigator, and if applicable to:

Study coordinator
IRB-HSR coordinator
Department contact

During the PAM visit:

The post approval monitor will meet briefly with the PI/study coordinator to become familiar with the study set-up and files. The post approval monitor will review all of the study materials and documentation. A final report of the findings will be written after the audit.

Materials reviewed:

Correspondence with the IRB-HSR
Correspondence with any other institutional oversight committees, such as GCRC, PRC, etc. (if applicable)
Regulatory documents and correspondence with the Federal authorities and/or sponsor (if applicable)
Original copies of the signed and dated consent forms for each subject or a sample of subjects
Written documentation of the consent process for each subject
Subject study records and any source documents (e.g., hospital and clinic charts; x-rays, scans, and other special studies required by protocol; and operative, pathology and radiotherapy reports)
Adherence to protocol
Serious and/or Unexpected Adverse Event documentation and copies of required reports to the IRB, and to the federal authorities (if applicable)
Drug receipt, storage, labeling, and dispensing log (if applicable)
Research records (e.g., screening log, subject enrollment log, exclusion log and case report forms)
Lab certification, normal laboratory values, and staff training or certification documentation (as applicable)
Data entered for analysis (if applicable)

Time required for PAM visit:

The amount of time needed for an audit varies greatly. Generally, the post approval monitor would like to meet with the PI for about 15-30 minutes either before, during or after the review of the study documents. The time needed to review the study documents depends on the amount of material and the number of subjects.

After the monitoring visit

When the audit is complete, the post approval monitor will:

Meet with the PI/study coordinator if necessary to discuss the findings
Write a report of the findings
Send a copy of the report to the PI, the IRB and study coordinator, the School of Medicine Clinical Trials Educator and the IRB-HSR.

Actions after the review

There are several actions that could result from a PAM review. They include:

No follow up needed
The School of Medicine Clinical Trials Office Educator to follow-up with minor issues
The IRB-HSR to follow up with major issues

If you are unavailable within a few weeks after receiving a PAM notification:

That is okay! Please inform the post approval monitor of your situation and a date in the future can be arranged for the visit. For most of the PAMs, there is no specific deadline.

IRB-HSR PAM & Ed Contacts:

Jane Lehmbeck, RN, CCRC, CIP
Director of the Post Approval Monitoring & Education Program
University of Virginia
Office of the Vice President for Research

Messenger Mail: Box 801011

Physical Address: 1 Morton Drive, Charlottesville, VA 22901

Phone: 434.924.8660
Fax: 434.924.1992
jlehmbeck@virginia.edu

Elaine Dube, BS, CCRP
Senior Post Approval Monitor
Post Approval Monitoring & Education Program
University of Virginia
Office of the Vice President for Research