The following documents are provided here as an easy place to access university documents.
- Delegated Trial Duties: Delegation is documented in the CI declaration for non-CTIMPs and the CI-CTU-University agreement for CTIMPs.
- DSUR Template: The University of Birmingham delegates the responsibility for submission of Development Safety Update Report (DSUR) to the Chief Investigators on CTIMPs. This report must be completed annually and submitted within 60 days of the anniversary of the Clinical Trial Authorisation.
- Essential Document Checklist: This document lists the documents that must be kept for a CTIMP, listing what should be kept on the trial master file at site, and what should be sent to the Research Governance team.
- IMP listings for University of Birmingham Sponsored Studies can be requested by contacting the Research Governance Team.
- The UoB trials Insurance and Liabilities process document describes the process for securing insurance where your trial falls outside of the University’s standard arrangements. It also describes what the standard arrangements and cover in place for various liabilities.
- The following spreadsheet should be used to inform research governance of the required information for insurance referral