The following links are provided here for ease of access:
- Research protocol templates:
- Chief Investigator agreements (also known as CI declarations), which include details of delegated duties, vary according to the type of study. For internal CIs, i.e. those substantively employed by UoB, please use:
- For CIs who are not employed by UoB, or who hold an honorary contract with UoB, an external CI agreement will be required. Please contact the Contracts team for further information.
- mNCAs: A UoB-agreed mNCA template is available, which includes guidance for study teams on how to complete the agreement. Please note that all mNCAs must be agreed with and signed off by the Contracts team, and the Research Governance team cannot sign these off.
- For template variations to the mNCA, please contact the trials unit managing the research.
- A template Organisation Information Document (OID) is available via the HRA website, which includes guidance on how to complete the template.
- The HRA site also has a Schedule of Events (SoE) template, plus information on how to complete it.
- For sites which will be limited to identifying participants and will not be research sites, UoB-specific template PIC agreement is available.
- A simple Risk Assessment template for non-CTIMP studies.
- For a Risk Assessment template for CTIMPs and/or high risk studies, please refer to the UoB QMS.
- For non-laboratory research, information on and templates for Research Risk Assessment and Mitigation Plans (RAMPs) can be found on the RAMP webpage.
- Data protection resources, including a template Data Protection Impact Assessment (DPIA), is available on the data protection resources area.
- Information on and templates for Data Management Plans (DMPs) is available data management plans area.
- Amendments: Information on making amendments to approved studies can be found on our 'After Sponsorship is awarded' page.
- Annual Progress Report forms should be signed off by the Chief Investigator and submitted by the study team to both the UoB as Sponsor and to the REC which originally gave a favourable opinion of the study every year within 30 days of the anniversary of the favourable opinion. The format of the APR varies according to study type:
- 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. See contact information for details.