The Office of Research Affairs conducts audits on research projects involving human participants. The ORA conducts both random post-approval monitoring audits and for-cause audits, which are a tool to provide insight to research related conduct at CCHHS and achieve compliance with applicable federal regulations and laws as well as CCHHS policies and procedures. Audits are also a vehicle for quality improvement, awareness of operations, and continuing education.
The purpose of the audit is to review and inspect the ethical conduct of human participant research, adherence to the study protocol, and adherence to what is presented to the IRB as well as to participants in the informed consent process. Audits typically involve the review and inspection of informed consent forms, HIPAA authorization forms, IRB records, training documentation, and data management/documentation with an emphasis on confidentiality and privacy procedures. Please click on the link below to access a checklist to help you prepare for your audit.