It is a local site responsibility to check which versions of the study documents are the currently approved versions at site (i.e. have local R&D approval in place). Please ensure that your site has received local R&D approval to implement SA08 before downloading these documents or implementing this amendment.
As a Substantial amendment REC & HRA approvals were required, and have been provided below. MHRA Approval was not required.
Approvals
Documents
Process Evaluation Documents
There is an embedded process evaluation as part of EVIS, which is looking to establish the extent to which the intervention is implemented as intended, ascertain how feasible and acceptable the intervention is to clinical staff and patients; and identify any facilitators and barriers to recruitment.
This involves observations of EDs and AMUs, review of key documentary data, and semi-structured interviews with clinical and trial staff. As part of SA08 the methodology and description of this process evaluation was expanded in the EVIS protocol and a interview guide, PIS and ICF were submitted to the REC/HRA for review and approval.
Note: These documents are for use by the EVIS Process evaluation staff only, when conducting their interviews with clinical and trial staff. They are not patient facing documents and are NOT applicable for use by EVIS clinical or trial staff, with EVIS patients. As a result, although these are part of the SA08 amendment pack and are listed on the REC FO, they have not been provided to sites as part of the amendment documents, and do not need to be retained in the ISFs.
If you have any questions regarding this or need these documents for any reason please contact a member of the EVIS Trial Team via email to ggc.evistrial@ggc.scot.nhs.uk