For clinical trials of investigational medicinal products (CTIMPs) and clinical investigations of medical devices carried out on University premises (eg OCMR, FMRIB, CCVTM, OCDEM) a non-NHS/HSC site assessment form may be required. Contact the Research Governance, Ethics & Assurance Team for advice.
All site-specific assessments (SSAs) for non-NHS/HSC sites are undertaken by the main REC carrying out the ethical review of the research ethics application. The Research Governance, Ethics & Assurance Team requires all study documents (see 'sponsorship review' above) as well as the site assessment form for review before authorisation and submission to the REC.
If a non-NHS/HSC site is added to a clinical trial of an investigational medicinal product (CTIMP) or clinical investigation of a medical device after the ethical opinion for the main application has been given, a notice of substantial amendment, site assessment form and associated documents need to be submitted in the first instance to the Research Governance, Ethics & Assurance Team for authorisation, and then to the main research ethics committee (REC) for review and approval.