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Amendments

DISCLAIMER: The below documentation is intended for the use of NHS Hospital Sites and Ambulance Services open to the SIS trial only.

Amendment Description Approval(s) Documents
SA01 Update to protocol Version 6.0, 18Jul2024 (ALL SITES)

REC: 09Oct2024

HRA: 10Oct2024

Amendment Tool

Submission

SA02 Change in trial sample size & Amendments to Core Study Documentation (ALL SITES)

REC: 23June2025

HRA: 27June2025

Amendment Tool

Submission

Cover Letter

SA03 Submission of new study documents & Amendments to Core Study Documentation (ALL SITES/WAST)

REC: 22Jul2025

HRA: 28Jul2025

Amendment Tool

Submission

Cover Letter

NSA02 Addition of NHS Sites (Bart's, St George's, MKUH, Barking, UCL, Royal Berkshire and Imperial) & Change of PI to existing NHS site (OUH) Confirmation Email

Amendment Tool

NSA03 Addition of NHS Sites (King's College, Salisbury, Epsom & St Helier) Confirmation Email Amendment Tool
NSA04 Addition of NHS Sites (London North West NHS Trust) & Change of PI at LAS Confirmation Email Amendment Tool
NSA05 Addition of NHS Site (Portsmouth NHS Trust) Confirmation Email Amendment Tool
NSA06 Update to Protocol version 4.0, 05Sep2023 (ALL SITES) Confirmation Email Amendment Tool
NSA07 Addition of NHS Site (Lewisham and Greenwich) Confirmation Email Amendment Tool
NSA08 Update to Protocol version 5.0, 25Oct2023 (ALL SITES) Confirmation Email Amendment Tool
NSA09 Addition of NHS Sites (Hampshire Hospitals, Croydon Health, Great Western, Guy's & St Thomas) Confirmation Email Amendment Tool
NSA10 Addition of NHS sites (NWAS & IWAS) Confirmation Email Amendment Tool
NSA11 Addition of NHS sites (WAST) Confirmation Email Amendment Tool
NSA12 Addition of NHS sites (Southport, Countess of Chester, Stockport, NCA Salford) Confirmation Email Amendment Tool
NSA13 Addition of NHS collaborator sites (WAST, Aneurin Bevan, Betsi Cadwaladr, Cwn Taf Morgannwg, Cardiff & Vale, Hywel Dda, Swansea Bay) Confirmation Email Amendment Tool
NSA14 Addition of NHS sites (Bolton, Liverpool Royal, Aintree) Confirmation Email Amendment Tool
NSA15 Addition of new Organisation Information Document (OID) template (Isle of Wight NHS Trust) Confirmation Email Amendment Tool
NSA16 PI Change - Epsom and St Helier University Hospitals NHS Trust Confirmation Email Amendment Tool
NSA17 Addition of NHS site (Warrington Hospital) Confirmation Email Amendment Tool
NSA18 Addition of NHS site (Royal Albert Edward Infirmary) Confirmation Email Amendment Tool
NSA19 Addition of NHS site (Manchester Royal Infirmary) Confirmation Email Amendment Tool
NSA20 Addition of NHS site (Royal Blackburn Teaching Hospital) Confirmation Email Amendment Tool
NSA21

Trial Documentation translated to Welsh (WELSH SITES)

Addition of NHS Site (Blackpool Teaching Hospital)

Confirmation Email Amendment Tool
NSA22 Addition of NHS site (Shrewsbury and Telford) Confirmation Email Amendment Tool
NSA23 Study end date extension to 30Apr2026 and minor amendment to the protocol. Confirmation Email Amendment Tool
NSA24 Change of PI at Salford Royal Hospital Confirmation Email Amendment Tool
NSA25 Study end date extension to 28Feb2027 and minor amendment to the protocol. Confirmation Email Amendment Tool

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