The UAHS RA Regulatory team has developed several policy and standard operating procedure (SOP) documents that are available for use by UAHS research teams. These documents may be shared with sponsors and research collaborators as documentation of UAHS or departmental research policies.
UAHS Required Policies
Policies and SOP applicable to all UAHS researchers. Departments or research teams may be able to adopt stricter policies but should at a minimum follow the policies as outlined in these documents.
- Monitoring SOP (including information regarding remote monitoring)
UAHS RA Regulatory Policies
Policies and SOPs followed by the UAHS RA Regulatory team. They are optional for use by other regulatory coordinators.
- Regulatory Management Responsibilities
- External Safety Reports SOP
- External Regulatory Portal Policy
Optional Team-Specific Regulatory Policies
Template policies and SOPs that study teams may choose to adopt.
- FDF Note to File – policy to only provide sponsors with PI and sub-I FDFs
- CV Note to File – policy to only provide sponsors with PI and sub-I CVs
Study Start-up Templates
These templates serves as a guide for the collection of pertinent site information in the early stages of study start up. This information can help in the assessment of research team, site capabilities, facilities, and overall preparedness for successful execution of study specific protocol requirements. Known information is pre-filled to assist the site in completion. Template sections that are not relevant can be eliminated or updated to reflect study specific requirements.
Other SOP resources: