Stanford

Clinical Research Quality

OTC

Spectrum serves faculty and clinical research personnel at Stanford School of Medicine, Stanford University Medical Center, Lucile Packard Children's Hospital, and the Veterans Affairs Palo Alto Health Care System.

Services Provided
  • Budget & Billing Support
  • Regulatory/Compliance Support
  • Training & Education
  • Point of Contact for questions about clinical research

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Contact Information

Spectrum
Operations, Training & Compliance
800 Welch Road
MC: 5737
Palo Alto, CA 94304
Fax (650) 723-8552

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 ClincalTrials.gov 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.

Clinical Research Quality program

  • This program, currently being developed, will provide:
      • Quality audits of clinical research
      • Assistance with corrective and preventive action (CAPA) plans
      • Standard Operating Procedure (SOP) and Best Practice guidance
      • Training

  • Contact Clinical Research Quality  email to:
      • Request a quality audit
      • Suggest an SOP
      • Request best practice guidance
      • Request CAPA assistance
      • Request consultation prior to regulatory audit (FDA, external, sponsor)

Clinical Trials Disclosure (ClinicalTrials.gov)

    • Access to Stanford's Protocol Registration System (PRS)
    • ClinicalTrials.gov registration information and support
    • Biostatistics referrals for protocol development or results reporting support
    • News
    • Literature
    • Training

Clinical Research - Protocol Templates and Guidance


  • ClinicalTrials.gov questions?