Transfer of Site-Specific Assessment responsibility for NHS sites
From 1st April 2009 forms do not need to be submitted to RECs for Site-Specific Assessment (SSA) in relation to NHS sites. Instead, from that date, SSA requests should be submitted only to the relevant NHS R&D Office.
Please note, there is no change to the arrangements for SSAs in relation to non-NHS sites. Where such SSAs are required, they should continue to be submitted to RECs (either a NHS REC or a designated non-NHS REC in the case of a Phase 1 trial site).
Migration from the NRES to IRAS systems continues:
NRES form system will be closed to new applications from 1st April 2009. Users with unlocked forms at that time will be able to complete their forms and submit them up until 1st September 2009. It will be possible to generate and submit new SSI Forms for ongoing studies until that date. Access to data held within the NRES on-line form system will continue after 1st September 2009, but it will no longer be possible to make applications.
New functionality will be added to IRAS before 1st September 2009 to allow users to create a minimal dataset for older studies where the original application was made using the NRES on-line form and to enable SSI Forms, Notices of Amendment and ARSAC forms to be generated for those studies where necessary.
Full details of the new procedures is set out on the document below.
For further information please contact the local REC or the R&D office.
R&D Office submission
Site Specific Assessment