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 here.

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 Summary

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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)

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 Document

HRA Approval

REC Approval

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 2020

REC approval_SA02_15 May 2020

HRA Approval Letter_SA02_15 May 2020

• 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  

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

• Non-substantial amendment #2

Sponsor Approval Letter - NSA 02 

14th April 2020. Addition of sites.

• Non-substantial amendment #3

Sponsor Approval Letter - NSA 03 

15th April 2020. Addition of sites.

• Non-substantial amendment #4

Sponsor Approval Letter - NSA 04 

16th April 2020. Addition of sites.

• Non-substantial amendment #5

Sponsor Approval Letter - NSA 05 

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 06

21st April 2020. Addition of sites.

• Non-substantial amendment #7

Sponsor Approval Letter - NSA 07

24th April 2020. Addition of sites.

• Non-substantial amendment #8

Sponsor Approval Letter - NSA 08  

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

• Non-substantial amendment #9

Sponsor Approval Letter - NSA 09

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 11 

4th May 2020. Addition of sites.

• Non-substantial amendment #12

Sponsor Approval Letter - NSA 12 

6th May 2020. Addition of sites.

• Non-substantial amendment #13

Sponsor Approval Letter - NSA 13 

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 14 

2nd July 2020. Addition of sites.

• Non-substantial amendment #15

Sponsor Approval Letter - NSA 15 

2nd July 2020. Addition of sites.

• Non-substantial amendment #16

Sponsor Approval Letter - NSA 16 

20th August 2020. Translated documents.

• Non-substantial amendment #17

Sponsor Approval Document - NSA 17 

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

• Non-substantial amendment #18

Sponsor Approval Document - NSA 18 

23rd November 2020. New PIs at site.

• Non-substantial amendment #19

 Sponsor Approval Document - NSA 19

 HRA Approval

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 SoECAT

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Data Collection

Data Collection

Non-Compliance Form

Eligibility Form

Randomisation Form

Baseline Form

Withdrawal Form

Notification of Death Form

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Participant Safety

SAE Form - Initial

SAE Form - Continuation

SAE Form - Follow-up

Death Notification

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Useful Documents/Guides

Randomisation Guide	Quick Reference Guide
Inclusion/Exclusion Criteria	Trial Assessments
Trial Participant Checklist
Quick Guide to Consent: England, Wales & Northern Ireland	Quick Guide to Consent: Scotland
Inclusions/exclusions card	Infographic: Trial Flexibility

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Working Instructions

SAE Handling Process Working Instruction

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