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Trial documentation

On this page you will find all relevant documents and resources for setting up and conducting the trial at site.
To help you with this, please find a version control log listing all of our documents here. If you wish to print these documents to create a paper ISF, please find an index hereLink opens in a new window.
Thank you to all of our sites for your hard work so far. Please find a certificate of appreciation here.

Protocol

Participants Documents

Main Ethics

Amendments

Substantial Amendments

Non-Substantial Amendments

Documents for Site Greenlight

Data Collection

Participant Safety

Useful Documents/Guides

Working Instructions

Protocol

Protocol 

Trial SummaryLink opens in a new window

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Participants Documents
Consenting patient prior to treatment
Consent form (on commencement)
Patient Information Leaflet (on commencement)
Short Patient Information Leaflet (on commencement)Link opens in a new window
Easy Read PIS (print)
Easy Read PIS (screen)
Deferred consent
Patient Information Sheet
Short Patient Information Leaflet
Consultee Declaration Form & Cover Letter
Deferred Consent Form
Translated Documents

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Main Ethics

IRAS Application

IRAS Organisation Information DocumentLink opens in a new window

HRA Approval

REC ApprovalLink opens in a new window

Amendments

Substantial Amendments
  • Substantial amendment #1

IRAS Notice of Substantial Amendment_SA#01_21 April 2020

REC approval letter_SA#-01_21 April 2020

HRA Approval Letter_SA#01_21 April 2020

Summary of Changes_SA#01_21 April 2020

    • Consent process updated to enable consent prior to enrolment where patient has capacity
    • Eligibility criteria update to clarify that patients will be eligible with FiO2 more than or equal to 0.4 and SpO2 less than or equal to 94%.
    • Update to protocol to include process for Scottish sites
    • All Patient documentation updated to include reference to collection of race and ethnicity data
    • New information sheets and consent forms added for obtaining verbal informed consent from patients with capacity, prior to randomisation
    • All changes are referenced in full in summary of changes document
  • Substantial amendment #2

SA02 applies only to certain sites.

IRAS Notice of Substantial Amendment_SA02_15 May 2020Link opens in a new window

REC approval_SA02_15 May 2020Link opens in a new window

HRA Approval Letter_SA02_15 May 2020Link opens in a new window

  • Substantial amendment #3

IRAS Notice of Substantial Amendment_SA#03_01 June 2020

REC approval letter_SA#03_01 June 2020

HRA Approval SA#03_01 June 2020

Summary of Changes_SA#03_June 2020

    • Amendment to Protocol, from v3.1 to v4.0
    • Addition of an Easy Read PIS (screen & print)
    • Minor updates to Consultee Consent Form, Consultee Cover Letter, PIS, PIS on Commencement Short PIS & Short PIS on Commencement
Non-Substantial Amendments
  • Non-substantial amendment #1

Sponsor Approval Letter - NSA 01  Link opens in a new window

8th April 2020. Addition of sites. Minor amendment to deferred consent form.

  • Non-substantial amendment #2

Sponsor Approval Letter - NSA 02Link opens in a new windowLink opens in a new window 

14th April 2020. Addition of sites.

  • Non-substantial amendment #3

Sponsor Approval Letter - NSA 03Link opens in a new windowLink opens in a new window 

15th April 2020. Addition of sites.

  • Non-substantial amendment #4

Sponsor Approval Letter - NSA 04Link opens in a new windowLink opens in a new window 

16th April 2020. Addition of sites.

  • Non-substantial amendment #5

Sponsor Approval Letter - NSA 05Link opens in a new windowLink opens in a new window 

17th April 2020. Addition of sites. Minor amendments to PILs and Assent form. Correction of typographical error in Assent form. Minor amendments to consent forms.

  • Non-substantial amendment #6

Sponsor Approval Letter - NSA 06Link opens in a new window

21st April 2020. Addition of sites.

  • Non-substantial amendment #7

Sponsor Approval Letter - NSA 07Link opens in a new window

24th April 2020. Addition of sites.

  • Non-substantial amendment #8

Sponsor Approval Letter - NSA 08Link opens in a new window  

24th April 2020. Addition of sites. Minor amendments to Protocol. Minor amendments to PILs.

  • Non-substantial amendment #9

Sponsor Approval Letter - NSA 09Link opens in a new window

28th April 2020. Addition of sites.

  • Non-substantial amendment #10

Sponsor Approval Letter - NSA 10

30th April 2020. Addition of sites. Addition of twitter account.

  • Non-substantial amendment #11

Sponsor Approval Letter - NSA 11Link opens in a new window 

4th May 2020. Addition of sites.

  • Non-substantial amendment #12

Sponsor Approval Letter - NSA 12Link opens in a new window 

6th May 2020. Addition of sites.

  • Non-substantial amendment #13

Sponsor Approval Letter - NSA 13Link opens in a new window 

11th June 2020. Minor amendment to Consultee Consent Form. Addition of translated PILs and Consent Forms in French, Portuguese, Polish & Urdu.

  • Non-substantial amendment #14

Sponsor Approval Letter - NSA 14Link opens in a new window 

2nd July 2020. Addition of sites.

  • Non-substantial amendment #15

Sponsor Approval Letter - NSA 15Link opens in a new window 

2nd July 2020. Addition of sites.

  • Non-substantial amendment #16

Sponsor Approval Letter - NSA 16Link opens in a new window 

20th August 2020. Translated documents.

  • Non-substantial amendment #17

Sponsor Approval Document - NSA 17Link opens in a new window 

3rd November 2020. Addition of site. New PI at site.

  • Non-substantial amendment #18

Sponsor Approval Document - NSA 18Link opens in a new window 

23rd November 2020. New PIs at site.

  • Non-substantial amendment #19

 Sponsor Approval Document - NSA 19Link opens in a new window

 HRA ApprovalLink opens in a new window

21st September 2021. New PIs at site.

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Documents for Site Greenlight

Site Training Slides

Training Confirmation Form

mNCA

CRN Letter - site targets

Validated SoECATLink opens in a new window

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Data Collection

Data Collection

Non-Compliance FormLink opens in a new window

Eligibility Form

Randomisation FormLink opens in a new window

Baseline Form

Withdrawal FormLink opens in a new window

Notification of Death FormLink opens in a new window

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Participant Safety

SAE Form - Initial

SAE Form - Continuation Link opens in a new window

SAE Form - Follow-upLink opens in a new window

Death Notification

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Useful Documents/Guides

Randomisation Guide

Randomisation Guide

Quick Reference Guide

Quick Reference Guide

Inclusion/Exclusion Criteria

Eligibility Infographic

Trial Assessments

Trial Ax

Trial Participant ChecklistLink opens in a new window

Trial Part ChecklistParticipant Checklist pg2

Quick Guide to Consent: England, Wales & Northern Ireland

Quick Guide to Consent, E, W, NI

Quick Guide to Consent: Scotland

Quick Guide to Consent - S

Inclusions/exclusions cardLink opens in a new window

Infographic: Trial Flexibility

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Working Instructions

SAE Handling Process Working Instruction

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