eReg Training Tip!
Setting up my Study Reg Binder
- The UCSF Regulatory Template is the standard template for studies at UCSF. The standard binder template folders and document types (Sections and Requirements) are outlined in the UCSF eReg Guidance
- Study-specific changes to a binder template can be made at the protocol level by using the Protocol Binder Outline
- Use standard naming conventions for document types (recommendations are included in the UCSF eReg Guidance) – this will ensure consistency in study files and improve the organization of files
How do I know if I need a new template?
- The UCSF Regulatory Template was designed to be compliant with FDA regulatory requirements and meet the needs of most studies.
- If your study or the study sponsor has folder or document type requirements which are not incorporated in the current template or not possible to add using the protocol outline edits, discuss this with your team member with the UCSF Regulatory Manager role, or submit a ticket to [email protected].
Questions?
- Contact eReg Support: [email protected], or
- Join us at eReg Office Hours (2nd & 4th Thursdays, 10:10-11am thru May)