Clinical Research Quality

Set-Up Your Study

The STUDY SET-UP stage includes activities that occur after the study has been designed and developed, and before you begin to enroll patients.

This stage includes activities in areas such as:

  • contracts & grant proposals
  • IRB approval
  • research management compliance
  • study budgeting & billing
  • required registration of trial

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.

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 (

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

Clinical Research - Protocol Templates and Guidance

  • questions?