Section X: Monitoring Activities		WPP #: X-3
Title 3: Post-Approval Monitoring of IRB-Approved Protocols
Effective Date: 3-1-11	Revision History: 12-06-04; 6-21-06; 11-1-06; 2-5-07

Objective

To describe the function and process of monitoring VCU IRB-approved research activities.

Description

1. VCU employs a comprehensive approach to post-approval monitoring and education through:
   • IRB Continuing Review, review of modifications, and review of unanticipated problems
   • Post-Approval Study Self-Evaluation Tool (PAME SET)
   • Post-Approval Monitoring and Education (PAME) Site Visits
1. Continuing Review, review of modifications, and review of unanticipated problems

VCU IRB-approved research is monitored through the continuing review process, review of changes to research, and required reporting processes:

VCU IRB WPP VIII-4 Continuing Review
VCU IRB WPP VIII-5 Review of Modifications to Research
VCU IRB WPP VIII-7 Required Reporting of Unanticipated Problems Involving Risk

2. Post Approval Monitoring and Education (PAME) Site Visits

The PAME program augments post-approval monitoring activities by the IRB and is managed by the Research Liaison Specialist (RLS) for Human Research Protection in the Offce for Research Compliance and Education (ORCE). PAME provides an additional layer of protection for human subjects in research, education for investigators and research staff, and identifies areas of strength and needs for improvement in research policy and practice. PAME visits are conducted by the RLS who may be joined by IRB reviewers and coordinator. The PAME process is tailored to each protocol and the PAME method includes identifying issues, resolving them, and providing educational support. PAME visits usually include suggestions for research Best Practices. For more information the VCU Human Research Protection Program Post approval monitoring and education (PAME) Process

There are 2 types of PAME visits: “Not for Cause” visits and “For Cause” visits.

1. Not for Cause Site Visits:

   The “not for cause” visit is designed to involve the PI and research staff in reviewing the terms of their IRB approval and the status of their protocol. It is an opportunity for the PAME visitors, the PI and staff to discuss the research protocol generally, especially as it impacts human subject protections, to ask questions about the study under review or future studies, and to share updates in the IRB process.
   “Not for Cause” PAME Visits are conducted on an ongoing basis. Records and reports are retained within the ORCE and the IRB protocol file. Protocols involving greater than minimal risk and/or involving volnerable popolations or unique circumstances are the main targets for “Not for Cause” IRB PAME Visits.

2. “For-Cause”or Requested Site Visits:

   “For Cause” PAME Visits are schedoled at the request of the VCU IRB, the ORSP, VCU administration, or as determined to be warranted by the ORCE. While similar to the "not for cause” visit, these visits may include a more in-depth evaluation, consisting of audits of study records at the study site, contact with the research sponsor and/or monitoring organizations, contact with other IRB panels, interviews with research staff and research participants, and/or review of records within the IRB.

3. Post-Approval Study Self-Evaluation Tool (PAME SET)

The Post-Approval Study Self-Evaluation tool (PAME SET) is designed as a tool for human research investigators and staff to aid in:

1. Training new research personnel
2. Preparing for a VCU, sponsor, or regolatory agency site visit
3. A routine quality improvement exercise

There are 2 versions of the PAME SET. One is designed for use by biomedical researchers and the other is for social science researchers. The PAME SET form focuses upon issues regarding quality documentation and recordkeeping consistent with managing overall VCU IRB compliance for non-exempt IRB-approved protocols.

The primary elements of the PAME SET) are derived from the VCU IRB Written Policies and Procedures, Good Clinical Practice requirements, and the Office of Human Research Protection.

4. Education Visits

In addition to post approval site visits, the RLS may conduct educational visits as follow up to IRB and/or investigator requests.

2. Other Sources of Post Approval Monitoring:

Anytime a research study has a monitoring visit from an entity outside the ORCE PAME program, the monitoring report shoold be included in the Continuing Review submission.

If the monitoring visit identifies a problem that fits the definition of an unanticipated problem or a protocol deviation, the investigator is required to follow the IRB Written Policies and Procedures for reporting those issues (http://www.research.vcu.edu/irb/wpp/flash/VI-3.htm)

• Western IRB, a central IRB which provides IRB services for industry-sponsored research as part of the VCU Human Research Protections Program, conducts on-site monitoring visits of VCU research approved by WIRB at least annually. The resolts of these visits are reported to the ORSP and the ORCE. When VCU conducts post-approval monitoring of a WIRB-approved study, the report is promptly provided to WIRB.
• National Cancer Institute (NCI) Central IRB (CIRB) approves protocols meeting specific criteria and which receive a facilitated review by the VCU IRB. The ORCE PAME program, together with Massey Cancer Center, oversee post approval monitoring of NCI protocols.
• End-of-year audit reports from Massey Cancer Center and the Clinical Research Center are maintained in ORCE as part of a comprehensive VCU PAME repository.

Responsibility

It is the responsibility of the ORCE to plan for and oversee ORCE PAME Visits, monitor post approval monitoring conducted by the WIRB, facilitate formal investigations (which typically will combine one or more approaches), and monitor the continued development of the PAME program.

References & Resources

Post approval monitoring and education (PAME) Process