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
Trial SummaryLink opens in a new window
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
Main Ethics
IRAS Organisation Information DocumentLink opens in a new window
REC ApprovalLink opens in a new window
Amendments
Substantial Amendments
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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
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- 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
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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
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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
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- 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
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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.
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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.
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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.
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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.
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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.
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Non-substantial amendment #6
Sponsor Approval Letter - NSA 06Link opens in a new window
21st April 2020. Addition of sites.
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Non-substantial amendment #7
Sponsor Approval Letter - NSA 07Link opens in a new window
24th April 2020. Addition of sites.
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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.
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Non-substantial amendment #9
Sponsor Approval Letter - NSA 09Link opens in a new window
28th April 2020. Addition of sites.
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Non-substantial amendment #10
Sponsor Approval Letter - NSA 10
30th April 2020. Addition of sites. Addition of twitter account.
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Non-substantial amendment #11
Sponsor Approval Letter - NSA 11Link opens in a new window
4th May 2020. Addition of sites.
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Non-substantial amendment #12
Sponsor Approval Letter - NSA 12Link opens in a new window
6th May 2020. Addition of sites.
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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.
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Non-substantial amendment #14
Sponsor Approval Letter - NSA 14Link opens in a new window
2nd July 2020. Addition of sites.
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Non-substantial amendment #15
Sponsor Approval Letter - NSA 15Link opens in a new window
2nd July 2020. Addition of sites.
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Non-substantial amendment #16
Sponsor Approval Letter - NSA 16Link opens in a new window
20th August 2020. Translated documents.
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Non-substantial amendment #17
Sponsor Approval Document - NSA 17Link opens in a new window
3rd November 2020. Addition of site. New PI at site.
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Non-substantial amendment #18
Sponsor Approval Document - NSA 18Link opens in a new window
23rd November 2020. New PIs at site.
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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.
Documents for Site Greenlight
Validated SoECATLink opens in a new window
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Data Collection
Non-Compliance FormLink opens in a new window
Randomisation FormLink opens in a new window
Withdrawal FormLink opens in a new window
Notification of Death FormLink opens in a new window
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Participant Safety
SAE Form - Continuation Link opens in a new window
SAE Form - Follow-upLink opens in a new window
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Useful Documents/Guides
Inclusions/exclusions cardLink opens in a new window |
Infographic: Trial Flexibility |
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Working Instructions
SAE Handling Process Working Instruction