Section X:

Monitoring Activities

WPP #: X-3

Title 3:

Post Approval Monitoring and Quality Improvement Program (PAMQuIP)

Effective Date:

7-23-15

Revision History:

12-06-04; 6-21-06; 11-1-06; 2-5-07; 3-1-11; 9-15-13; 10-22-13

Policy Statement

The Post-Approval Monitoring and Quality Improvement Program (PAMQuIP) is situated within the Office of Research Subject Protection (ORSP) and functions independently of the Institutional Review Board (IRB). The purpose of the program is to assist the university and investigators in conducting human research that is of the highest ethical quality. The PAMQuIP provides investigators with recommendations for best practices in protecting human subjects in research. The program has the authority to:

  • Identify human research studies for post approval monitoring visits;
  • Conduct for-cause, not for-cause, and educational study visits;
  • Enforce procedures for conducting study visits; and
  • Require investigator reporting to the IRB and changes to study procedures via IRB amendments to ensure compliance with federal, state, and local requirements.

Description

  1. Program Objectives

    The primary objectives of the PAMQuIP are to:

    • Conduct post approval monitoring and quality improvement study visits
    • Perform quality assurance reviews of the IRB process and documentation
    • Liaise between investigators and the IRB panels
    • Provide educational resources for the human research community
    • Research, develop and evaluate quality improvement initiatives to foster efficiencies in human subject protections

Resources

Regulations and Guidance

Food and Drug Administration (FDA)
International Conference of Harmonization: Good Clinical Practice
Office of Human Research Protections – U.S. Department of Health and Human Services (OHRP)
National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)