Documents required for Sponsorship Review

Documents required for CTRG Sponsorship Review

• Additional Documents Required for Ethics Submission - researchsupport.admin.ox.ac.uk
• Studies with NHS Involvement (NHS SSI form) - researchsupport.admin.ox.ac.uk
• University Hosted Studies (non-NHS SSI form) - researchsupport.admin.ox.ac.uk

Documents required for Research and Development Sponsorship Review

• IRAS full dataset - (for NRES applications) - researchsupport.admin.ox.ac.uk
  
• CUREC application forms - (if applying to Medical Sciences IDREC) - researchsupport.admin.ox.ac.uk
  
• Detailed Protocol - researchsupport.admin.ox.ac.uk
  
• Participant Information Sheet - researchsupport.admin.ox.ac.uk
  
• Informed Consent Form - researchsupport.admin.ox.ac.uk
  
• Principal / Chief Investigator CV - Guidance on submission of CV (Word, 15 KB) - researchsupport.admin.ox.ac.uk
• GP Letter (if applicable)
• Advertisement(s) including posters and texts of email or radio adverts (if applicable)
• Any other media text used to provide information to participants (e.g. reminder texts/emails)
• Study-specific documents, e.g. questionnaires, web-based tools
• Investigator's Brochure (IB - for unlicensed IMPs) or Summary of Medicinal Product Characteristics (SmPC - for marketed IMPs) if research involves drug administration
• Confirmation of Funding

Additional documents required for Ethics Submission

The Research Ethics Committee(s) will require you to send additional relevant documentation, as follows.

Studies with NHS Involvement (NHS SSI form)

This is required if there is NHS involvement in the research and is generated from the IRAS full dataset. SSI Forms must be submitted as part of the application for NHS permission for all NHS sites for all study types.

University Hosted Studies (non-NHS SSI form)

For studies carried out on University premises, a non-NHS SSI form may be required.

All Site Specific Assessments (SSAs) for non-NHS sites are now undertaken by the main REC carrying out the ethical review of the research ethics application. R&D require all study documents for review before authorising your SSI form.

If a non-NHS site is added to a Clinical Trial of an Investigational Medicinal Product (CTIMP) after the ethical opinion for the main application has been given, a Notice of Substantial Amendment and SSA documents need to be submitted to the main Research Ethics Committee (REC) for review.

If a non-NHS site is added to a non-CTIMP at this stage, the SSA documents only need to be submitted to the main REC.