Research Quality

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Quality Improvement Program

Clinical Research Quality facilitates clinical research regulatory compliance by developing operating procedures, policies, and best practices within the School of Medicine; tracking FDA, GCP, and compliance; educating and training researchers, faculty, trainees, and staff; conducting quality reviews and assisting with corrective and preventive action when needed. CRQ collaborates with Stanford University SoM departments, institutes and centers, as needed, with the Research Compliance Office, and internal audit offices.

Quality Improvement Program

  • This program, currently being developed, will provide:
    • Internal quality audits of clinical research in the areas of Good Clinical Practice and clinical trial compliance
    • Assistance with corrective and preventive action (CAPA) plans following internal or external audits
    • Standard Operating Procedure (SOP) and Best Practice guidance for the School of Medicine, both for investigator-initiated research and industry-sponsored research
    • Education and training support, both within Spectrum’s Education Program and on an as needed basis
  • Contact Quality Improvement to:
    • Request an internal quality audit
    • Suggest an SOP
    • Request best practice guidance
    • Request CAPA assistance
    • Request consultation prior to an external regulatory audit (FDA, sponsor) or monitoring visits from NIH or other funding agencies