Clinical Trial Site agreements are required for all CTIMPs and high risk studies (i.e. the first four categories listed in question 2 of the IRAS project filter - please see the relevant IRAS help page for information on the categories). The agreement should be based on the UK-wide model Non-Commercial Agreement (mNCA) template available from the mNCA guidance section of the IRAS website.
- The University's Clinical Trials Units have specific arrangements for the generation and approval of site agreements. CTU-managed studies should follow CTU processes to obtain a suitable agreement.
- For other studies, the HRA template linked above will be acceptable so long as it is not substantively modified.
- If modifications to the mNCA are required, please contact the Contracts team to discuss requirements. Please note that the Research Governance team cannot offer advice on contract modifications, and a completed mNCA drawn up with the Contracts will be required before a Sponsor review can commence.
For other study types, i.e. lower risk or non-interventional studies not among the first four categories in the IRAS project filter, the HRA Organisation Information Document (OID) and Schedule of Events (SoE) should be used.
- As part of the Sponsor review, a 'master' OID will be approved, which can then be localised on a per-site basis by the study team and then sent out to sites without further review, provided there are no substantive changes to the approved document beyond localisation. Where more significant changes are required, an updated OID should be submitted to the RG team for approval prior to sending out to sites.
For all other contract or agreement-related queries, including for external Chief Investigator agreements, please contact the Contracts team.