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Clinical Research Compliance Office (CRCO)

Clinical Research Compliance Office (CRCO). Development of CRCO . Responding to and investigating complaints and allegations Oversees Clinical Research Quality Assurance Program Analyzing Risks and Trends in Clinical Research Compliance

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Clinical Research Compliance Office (CRCO)

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  1. Clinical Research Compliance Office (CRCO)

  2. Development of CRCO • Responding to and investigating complaints and allegations • Oversees Clinical Research Quality Assurance Program • Analyzing Risks and Trends in Clinical Research Compliance • Coordination of investigation, audits and University responses to compliance findings • Clinical Research Policy Development, Maintenance, and Revision • Clinical Research Training and Education

  3. Background of CRCO CRCO was created in 2010 in effort to: • Consolidate and initiate university-wide QA of human subjects research • Provide strategic initiatives and internal assessments of compliance in the area of human subjects research with applicable regulations governing human subjects research • Coordinate the Human Subjects & HIPAA audit functions as well as the GCP, GTP and Biologics standards as applied to human subjects for clinical research

  4. CRCO Initiatives & Current Services • Quality Assurance • International Research • Research Integrity • Statewide Partnerships • Education and Outreach • http://researchadmin.iu.edu/CRCO/index.html

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