Virtual Regulatory Binder

Announcing UCSF Clinical Trials Day!
May 15 at Mission Bay, May 16 at Parnassus. See flyer

Last revised: 
09/21/2015

Introduction

Congratulations! You have successfully accessed the UCSF Human Research Quality Improvement Unit (QIU) Virtual Regulatory Binder. We thank Partners Healthcare for providing this invaluable resource so it could be modified for use at UCSF. This binder is applicable for behaviorial, FDA, and non-FDA regulatory compliance.

Purposes of the Binder

The QIU Virtual Regulatory Binder assists sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research. The binder also provides:

  1. Guidance for organization and record keeping.

  2. Assistance with proper study documentation and successful study management, including guidance on electronically stored records. 

  3. Links to on-line resources, such as the UCSF Committee on Human Research (CHR) policies, guidelines, and forms, the Clinical Research Resource HUB, institutional policies, good clinical practices, and Federal Regulations.

Whom to Contact for Help

The QIU provides individual consultation and educational offerings to UCSF's new and experienced investigators and study staff. To schedule a binder consultation, please email the IRB.