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 SA07 before downloading these documents or implementing this amendment.
As a Substantial amendment REC/MHRA/HRA approvals were required, and have been provided below
Documents
02.11.2023 – HRA & HCRW approval for SA07
22-SS-0009 AM09 IRAS Project ID 307862 – Favourable Opinion
307862_Substantial Amendment 07_locked
EVIS Clinical Information Sheet USUAL CARE v4.0 10.10.2023
EVIS PIS ICF Personal Legal Rep (England, Wales & NI) v2.1 10.10.23 CLEAN FINAL
EVIS PIS ICF Personal Legal Rep (England, Wales & NI) v2.1 10.10.23 TC FINAL
EVIS PIS ICF Prof Legal Rep (England, Wales, NI) v2.1 10.10.23 CLEAN FINAL
EVIS PIS ICF Prof Legal Rep (England, Wales, NI) v2.1 10.10.23 TC FINAL
EVIS PIS ICF Prof Legal Rep (Scotland) v2.1 10.10.23 CLEAN FINAL
EVIS PIS ICF Prof Legal Rep (Scotland) v2.1 10.10.23 TC FINAL
EVIS PIS ICF v2.1 10.10.23 CLEAN FINAL
EVIS PIS ICF v2.1 10.10.23 TC FINAL
EVIS PIS ICF WA & Guardian (Scotland) v2.1 10.10.23 CLEAN FINAL
EVIS PIS ICF WA & Guardian (Scotland) v2.1 10.10.23 TC FINAL
EVIS PIS Summary v2.1 10.10.23 CLEAN FINAL
EVIS PIS Summary v2.1 10.10.23 TC FINAL
EVIS Protocol V2.1 – 10.10.2023 CLEAN FINAL
EVIS Protocol V2.1 – 10.10.2023 TC FINAL
EVIS Protocol V2.1 10 Oct 2023 Schedule of Assessments
EVIS Summary of Protocol Changes V2.1 to V2.0 10 Oct 23
SWB EVIS Clinical Information Sheet
Note: A Clinical information sheet (SWB EVIS Clinical Information Sheet INTERVENTION V1.0 10.10.2023) for the intervention arm was updated for Sandwell and West Birmingham NHS Trust sites, to match their local policy for the preparation and administration of peripheral norepinephrine and was submitted to the REC/HRA for review and approval as part of SA07.
These sites have now withdrawn from EVIS, and the document is not applicable to any other EVIS participating site. As a result, although this document was part of the SA07 amendment pack and is listed on the REC FO, it has not been provided above as part of the SA07 amendment documents, and does not need to be retained in the ISFs. All participating sites should continue to use the currently approved version of the “EVIS Clinical Information Sheet INTERVENTION”.
If you have any questions regarding this or need this document for any reason please contact a member of the EVIS Trial Team via email to ggc.evistrial@ggc.scot.nhs.uk