What is a Medical Record Audit?
The Office of Human Research Protection (OHRP) conducts random audits of research subjects’ medical records on a periodic basis to obtain a sampling of the quality of research compliance. It is not a complete audit of the study itself, but another key component of our institution’s program for the protection of human research subjects. Any subject participating in a HAC or Chesapeake Research Review, Inc. (CRRI) approved clinical trial conducted at the Medical College of Georgia Health Inc., may be randomly selected by the Investigational Pharmacist for audit. The MCG Health Inc., (MCGHI) Investigational Pharmacist will randomly select medical records of research subjects enrolled in studies approved by HAC or CRRI for a medical record audit. The audit is conducted by the Clinical Trials Auditors or the Director or Assistant Director of the Office of Human Research Protection. Compliance with the policies and procedures of Medical College of Georgia and Medical College of Georgia Healt
