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Clinical Research Quality (CRQ)

Clinical Research Quality (CRQ), established in 2016 and administered by Spectrum under the direction of the Senior Associate Dean for Research, facilitates clinical research regulatory compliance and contributes to school-wide quality and compliance-improvement initiatives.

Overview

CRQ is responsible for:

  • Developing standard operating procedures, clinical trial policies, and best practices within the School of Medicine.
  • Conducting quality audits, both routine and upon request.
  • Assisting with corrective and preventive action when needed.
  • Education and training via Spectrum's  programs for researchers, faculty, trainees, and staff on Good Clinical Practice and Clinical Research Operations; and ad hoc upon request.
  • Tracking and trending clinical trial compliance from a variety of internal and external sources.

 

CRQ is advised by a Faculty Advisory Committee appointed by the Senior Associate Dean for Research, and collaborates with Stanford University School of Medicine departments, institutes and centers; with the Research Compliance Office and Institutional Review Board, and with University Internal Audit Services and the Privacy Office.

Questions?

CRQ ClinicalTrials.gov Support Services

Clinical Research Quality (CRQ) provides training and support to Stanford investigators and staff who need to submit information to ClinicalTrials.gov.

IND/IDE and Regulatory Affairs Services

CRQ offers IND/IDE and Regulatory Affairs Services for supporting clinical research on FDA regulated products at Stanford University.

Regulatory Knowledge and Support

Regulatory Knowledge and Support (RKS) offers expert consultation in Good Clinical Practice, Stanford policies and procedures, and research systems.

Policies and Procedures

These policies and procedures are intended to guide clinical research in the School of Medicine. These SOPs are meant to align with related policies and procedures for the conduct of clinical care that research participants receive.

Quality Assurance and Quality Improvement

Clinical Research Quality facilitates clinical research regulatory compliance through a variety of methods, from developing operating procedures, policies, and best practices to conducting quality reviews and assisting with corrective and preventive action when needed.

Quality and Compliance Improvement Program

The Quality and Compliance Improvement Program (QCIP) brings together clinical research personnel from across the School of Medicine to identify gaps and obstacles in administrative processes, to prioritize solutions, and make recommendations to leadership.