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Clinical Trials Unit

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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