Regulatory binders are a vital way to keep all required documentation related to conducting a clinical trial. It is best practice to keep one for all studies but especially important in FDA regulated research. When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg). eReg functions like a central binder and a study specific binder.
UCSF has several eReg options to consider using including Complion and Advarra. For Complion, reach out to your Department to determine if they already have an agreement in place with Complion, if not contact Supply Chain Management to set this up. For Advarra, reach out to OCTA for more information and resources for eReg. You can find detailed information in the UCSF eReg Guidance.
A regulatory binder typically contains:
1. Protocol
2. Investigator's Brochure
3. IRB documents
4. Informed consent form
5. Regulatory
a. 1572
b. Financial disclosure
c. Investigator license/registration and certifications
d. Staff CVs and certifications
6. Lab documents
7. Sponsor communications
8. Logs
9. Data collection and CRFs
10. DSMB reports
11. Monitoring visit reports
12. FDA documents
Some additional guidance:
https://trialactivation.ucsf.edu/content/ereg-resources
https://irbo.nih.gov/conducting-your-study/regulatory-binder/