Introduction

Introduction

Congratulations! You have successfully accessed the ResearchGo Virtual Regulatory Binder sponsored by the UCLA CTSI Office of Regulatory Affairs. We thank Partners Healthcare for providing this invaluable resource so it could be modified for use at UCLA. This binder is applicable for behavioral, FDA, and non-FDA regulatory compliance.

Purposes of the Binder

The ResearchGo 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 UCLA Institutional Review Board (IRB) policies, guidelines, and forms, the Clinical Research Resource ResearchGo, institutional policies, good clinical practices, and Federal Regulations.

Whom to Contact for Help

UCLA CTSI Regulatory Affairs provides individual consultation and educational offerings to both new and experienced members of the research community, including investigators and study staff. To schedule a binder consultation for FDA and non-FDA regulated research, please contact Uma Ganapati.
 

Florence eBinders

Florence eBinders, an electronic regulatory binder system designed to streamline management of study regulatory binders and enhance efficiency.  Available for use as of April 22, 2024.