The Quality Assessment & Improvement Program (QAIP) was established in the fall of 2005 to assist investigators in attaining full compliance with governmental and institutional rules and regulations pertaining to human subject research.

Investigators and Institutional Review Boards share the important responsibility of protecting human subjects in research. The IRB reviews all research involving human subjects prior to initiation and periodically thereafter. The PI is responsible for conducting the research study properly and safely, according to the IRB approved protocol, and with the highest level of ethical conduct.

The QAIP is a post (IRB) approval monitoring program aimed at providing subjects with an extra level of protection by reviewing the conduct of the study in real time. The program also provides assistance and ongoing education to investigators and their staff with regard to human subject research and compliance issues.

Due to the complexities of the research process, investigators are encouraged to contact the Quality Assessment & Improvement Program Coordinator and the IRB Coordinator or Administrator if any questions arise during the conduct of a trial or if in doubt about any compliance issue.

• Study Initiation Visit: Preventive Care for Your Study Site
  • FDA Audit Checklist Guidance