The Office of Education and Compliance (OEC) provides clinical research training and the compliance activities for the CCR’s clinical research staff (e.g., clinical investigators, research nurses, data managers, patient care coordinators, administrators and support staff). The main responsibilities of OEC are to:

• Coordinate, develop and evaluate orientation programs for clinical research staff. Orientation is based on adult learning theory including self-paced web modules, independent readings and classes.
• Coordinate, develop, and evaluate on-going educational programs. The programs relate to clinical research and clinical trials including regulatory components, data management and the roles and expectations of the research team.
• Coordinate, develop, and evaluate the CCR’s comprehensive clinical research quality management program in accordance with the requirements of regulatory and accrediting organizations (e.g., FDA, OHRP, Association for the Accreditation of Human Research Protection Program); DHHS and NIH policies, practices, and procedures, and state of the art practices for quality assurance and clinical research. This includes:
  • Developing and maintaining CCR clinical research SOPs
  • Auditing of non-IND treatment trials and observational trials
  • Assisting in the development of CAPA plan
  • Assisting with monitoring visits and FDA inspections
• Coordinate, develop, and evaluate the results reporting program to ClinicalTrials.gov for the CCR.
• Coordinate CCR clinical records management.
• Provide consultative services related to clinical research.
• Serve on trans-NIH committees.