Site-Specific Assessment (SSA)

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Research sites & HRA Approval

The review of site-specific issues is the responsibility of the NHS R&D Office and is confirmed through assessing and arranging capacity and capability. The favourable opinion from the REC is given on condition of the confirmation by the R&D Office.

 

Management permission at NHS sites

The review of site-specific issues is the responsibility of the NHS R&D Office and is an integral part of the organisation’s oversight of the set-up of studies. The favourable opinion from the REC is given on condition that the organisation has confirmed its permission for the study to proceed.

 

SSA at non-NHS sites

This is the responsibility of the REC system.

The REC undertaking the review of the main application will undertake the SSA(s) for non-NHS site(s), generally at the same time as the review of the main application.  Alternatively, an SSA can be reviewed separately by a Sub-Committee of the REC.  For more information see the documents below:

Where a SSA application(s) is submitted at the same time as the main application, the REC will review the documentation when undertaking the ethical review.  Therefore there will no longer be a timeframe for reviewing the SSA application in these cases.

Where a SSI form is submitted after a favourable ethical opinion, the REC has 14 days (for a Phase 1 trial where there is no intended therapeutic benefit for subjects) or 25 days (for other studies) from receipt of a Site Specific Assessment application to notify the Chief Investigator for the study of the decision for the SSA.

Exemption from the requirement for SSA at non-NHS sites  – RECs have discretion to waive the requirement for SSA in some instances, as set out in Section 4 of the Standard Operating Procedures.