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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.
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

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Participants Documents
Consent form
Patient Information Leaflet
Patient Invitation Flyer
Patient Invitation Letter
Baseline Questionnaire Form
3 Month Questionnaire Form
6 Month Questionnaire Form
12 Month Questionnaire Form
Translated Documents

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Main Ethics

IRAS Application

HRA Approval

REC Approval

Organisation Information Document

Amendments

Substantial Amendments
  • Updates to documents:
    • Participant Follow-up CLMHD Letter V1.0 26Oct2020
    • Participant Workbook Letter V1.0
    • Participant Consent Form v3.0 29Oct2020
    • Participant Interview Consent Form V3.0 04Dec2020,
    • Participant Information Sheet v3.0 29Oct2020,
    • Participant Interview PIS V3.0 27Oct2020,
    • Practitioner Interview PIS V3.0 29Oct2020,
    • Protocol v3.0 20201029.
Non-Substantial Amendments
  • Non-substantial amendment #1
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Documents for Site Greenlight

Site Training Slides

Training Confirmation Form

mNCA

CRN Letter Site Targets

Validated SoECAT PIC Sites

Validated SoECAT UHCW Activities

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Data Collection

Template Screening Dataset

Eligibility Form

Randomisation Form

Notification of Death Form

Baseline Form

Non-compliance Form

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Participant Safety

SAE Form - Initial

SAE Form - Follow-up

SAE Form - Evaluation

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Useful Documents/Guides

PIC Activities Flow Chart

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Working Instructions

SAE Handling Process Working Instruction 

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