Research Compliance Audit and Monitoring Program (RCAMP)

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 Compliance Audit and Monitoring Program (RCAMP) provides additional oversight and assurance for human subject research studies conducted at HMH. RCAMP SOPs can be found here.

Types of Audits

Routine Reviews are a combination of an on and off site review of records. These reviews assess the study conduct, identify potential errors and oversights, share best practices, and provide partnership with the study team to ensure compliance. As part of the Research Compliance annual work plan, a sampling of approved research studies will be reviewed for quality assurance and compliance. When a study is selected for a Routine Review, the assigned RCAMP auditor will contact the PI and study team regarding the upcoming review. It is expected the PI and team fully cooperate with the review. Study teams or department leaders may request a Routine Review (“mock audit”) ahead of an anticipated external audit by completing this request form. RCAMP will do its best to accommodate such requests.

For-Cause Audit can be requested by anybody at HMH who has research oversight responsibilities (e.g. members of research regulatory review committees (such as IRB, IACUC, and other similar committees), department chairs, division chiefs, principal investigators, research administration, etc) by submitting the request form. The objective of a for-cause audit is to seek an impartial and independent opinion on the state of compliance and records of a particular study. The scope of the audit may be limited to the area(s) of concern.

Investigation can only be initiated by the Chief Research Officer when presented with credible and reasonable indication that non-compliance has occurred and/or is occurring during the conduct of the study which has the potential to significantly impact subject safety, institutional reputation, and/or terms and conditions of a contractual agreement. An investigation does not include Allegations of Research Misconduct which are detailed elsewhere.

More information on RCAMPs Standard Operating Procedures, types of reviews and audits, and responses to RCAMP reports can be found in the RCAMP SOPs.