Continuous Quality Improvement (CQI) and Post-approval Review (PAR) Programs

Print and post the PDF version of these tips for easy reference.

Your Study Has Been Approved - Now What?

TIPS for Research Study Record Management
from the Office for Research Protection's Continuous Quality Improvement (CQI) and Post-approval Review (PAR) Programs

These suggestions are designed to help you organize and maintain your research study records. They may be especially helpful as you prepare for on-site Post-approval Review (volunteered, selected, for cause or directed).

Accountability and documentation are two necessary components of research protections. Documentation of the communications and the conduct of the approved research study is required and is also one concrete, outward sign that is used to assess compliance with federal and state regulations, and institutional policy.

• Keeping All Institutional Review Board/Office for Research Protections (IRB/ORP) Correspondence!
• Avoiding the Consent Form Problem Area!
  (the most frequently found problem area in reviews)
• Keeping Research Study Information Secure!
• Enrolling Participants - The Numbers Are Important!
• Communicating Is Key!
• Continuing Reviews. . .and a Final Note
• ORP Investigator Manual