Research Monitoring and Auditing Program

A research audit is a systematic and independent examination of study related documents, processes, and procedures. The purpose of the audit is to ensure study procedures were conducted, data were recorded, analyzed and reported consistent with the protocol, applicable regulations, GCP guidelines, and HMH policies and SOPs. 

HMH’s Research Monitoring and Audit Program provides additional oversight and assurance for human subject research studies conducted at HMH. 

Types of Audits

For-cause: comprehensive evaluation of all research components. Initiated due to allegation of noncompliance. During a for-cause audit, if other issues of noncompliance are identified, they will be documented and escalated to the appropriate HMH department(s). 

Routine: provides assurance that all research processes and protocols are followed. Identification of errors are documented and addressed as part of a corrective action plan. If during a routine audit, potential noncompliance is suspected then a more thorough examination of the study is performed and if necessary escalated to the appropriate HMH department(s). 

Quality Assurance: similar to a routine audit with focus on investigator-initiated studies and multi-site studies. A QA audit can also be conducted as a “dry-run” to prepare for external auditors.