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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 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 

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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. If your site is involved with this amendment, the RECOVERY-RS team will contact you directly.

  • 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.

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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

Randomisation Guide

Quick Reference Guide

Quick Reference Guide

Inclusion/Exclusion Criteria

Eligibility Infographic

Trial Assessments

Trial Ax

Trial Participant Checklist

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

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Working Instructions

SAE Handling Process Working Instruction

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