Research involves a heavy workload of administrative oversight to achieve compliance with local, state, and/or federal regulations. This includes required training activities, submitting study-related documents to oversight committees, completing regulatory audits, conflict of interest reporting, providing project updates to sponsors, and more. Most compliance crises are predictable and avoidable through proactive attention. Therefore, the purpose of this tool is to help investigators pursue a proactive approach to successfully manage administrative demands. The benefit is lower stress regarding study oversight, fewer compliance crises, and audit-ready management of study files. The elements of this tool are intended to be used continuously throughout the life of a study and/or throughout a research program. The Administrative & Regulatory Oversight Tool helps investigators transform compliance from a reactive burden to a stable and effective operating procedure.
This tool introduces the CORE framework for administrative and regulatory oversight. For a downloadable PDF preview of the framework, click the button below. To purchase the full tool (approximately 6 pages), return to the homepage.