Select campus:UKDubai
University of Birmingham
Menu

Templates for researchers

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 University of Birmingham, 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 research support team in your College for further information.
  • mNCAs: A University of Birmingham-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 research support team in your College, 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, University of Birmingham-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 University of Birmingham 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.

  • Update to REC Annual Progress Reports: Effective as of 1 August 2024, the HRA have removed the requirement for Annual Progress Report forms to be submitted to the REC. Updated HRA guidance is available via the `Important Changes to progress reports and safety reports’ link.

    For studies with Confidentiality Advisory Group (CAG) approval: Annual reviews should continue to be submitted to the Confidentiality Advisory Group (CAG) using the `annual review report template’ on IRAS.

    Researchers may still be required to submit annual updates to the Sponsor for certain study categories and the UoB QMS procedures for this are in the process of being updated with further instructions.

    In addition to the above, the HRA have also updated the process for how they acknowledge SUSARs, further guidance is available via the `Important changes to progress reports and safety reports’ link.
  • 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.