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Previous Trial Documents

Please find below copies of previous trial documents that you can download for your records. Please note all of the below are previous versions and are no long in use.

Previous Version Logs

Version log V1.0 20Apr2018

Version log V2.0 16May2018

Version log V3.0 22Oct2018

Version log V4.0 30Oct2018

Version log V5.0 31Oct2018

Version log V6.0 17Jan2019

Version log V7.0 02May2019

Version log V8.0 02Jul2019

Version log V9.0 29Aug2019

Version log V10.0 28Oct2019

Version log V11.0 21Jan2020

Version log V12.0 21Apr2020

Version log V13.0 22May2020

Version log V14.0 28Aug2020

Version log V15.0 10Mar2021

Version log V16.0 25May2021

Version log V17.0 27Jul2021

Version log V18.0 15Mar2022

Version log V19.0 03Apr2022

Version log V20.0 01Jul2022

Version log V21.0 29Jul2022

Version log V22.0 09Feb2023

Version log V23 22May2023

Version log V24 03Aug2023

Version log V25 31Aug2023

Previous Case Report Forms


CRF V4.1 11Oct2019

CRF V3.1 29Oct2018

CRF V3.0 07Sep2018

CRF V2.0 06Jul2018

CRF V1.1 17May2018

CRF V1.0 12Apr2018

Essential Recruitment Documentation:

ERD CRF V2.1 03May2019

ERD CRF V2.0 16Oct2018

ERD CRF V1.1 21Jun2018

ERD CRF V1.0 17May2018

Participant Contact Details Form:

Participant Contact Details Form V1.2 18Sep2018

Participant Contact Details Form V1.1 21Jun2018

Participant Contact Details Form V1.0 17May2018


Eligibility guidance V3.0 05Oct2021

Eligibility guidance V2.0 09Aug2021

Eligibility guidance V1.0 15Oct2019

Trial flow diagram V2.1 21Jan2020

Trial flow diagram V2.0 29Aug2019

Trial flow diagram V1.0 05May2019

CRF Completion Guidelines V4.1 21Jan2020

CRF Completion Guidelines V4.0 28Oct2019

CRF Completion Guidelines V3.0 10Sep2019

CRF Completion Guidelines V2.0 16Jul2018

CRF Completion Guidelines V1.1 20Jun2018

Database Entry Guidelines V1.2 11Feb2020

Database Entry Guidelines V1.1 19Mar2019

Database Entry Guidelines V1.0 22Oct2018

Previous Consent Forms

RCT consent form V3.1 01Nov2018

RCT consent form V3.0 22Aug2018

RCT consent form V2.2 09Aug2018

RCT consent form V2.1 14Jun2018

RCT consent form V2.0 12Apr2018

RCT consent form V1.1 12Feb2018

Cohort consent form V3.1 01Nov2018

Cohort consent form V3.0 22Aug2018

Cohort consent form V2.2 09Aug2018

Cohort consent form V2.1 14Jun2018

Cohort consent form V2.0 12Apr2018

Cohort consent form V1.1 12Feb2018

Previous Delegation Log

Delegation log V2.1 13Nov2018

Delegation log V1.0 07Mar2018

Previous GP Letter

GP Letter V2.0 06May2020

GP Letter V1.0 13Jan2018

Previous Participant Information Sheets

PIS V8.0 13Apr2021

PIS V7.1 17Jul2020

PIS V7.0 10Feb2020

PIS V6.0 28Feb2019

PIS V5.1 09Jan2019

PIS V4.0 30Oct2018

PIS V3.1 15Oct2018

PIS V2.0 12Apr2018

PIS V1.1 12Feb2018

Tri-Fold leaflet V2.0 13May2019

Tri-Fold leaflet V1.2 25Sep2018

Tri-Fold leaflet V1.1 18Jun2018

Tri-Fold leaflet V1.0 12Jan2018

Previous Poster

Poster 2 V2.0 22Aug2018

Poster 2 V1.1 18Jul2018

Poster 2 V1.0 10Jan2018

Previous Protocol

Protocol V14.0 23Jun2023

Protocol V13.0 21Apr2023

Protocol V12.0 12Jan2023

Protocol V11.0 31May2022

Protocol V10.0 31Jan2022

Protocol V9.0 13Apr2021

Protocol V8.0 17Jul2020

Protocol V7.1 21May2020

Protocol V7.0 10Feb2020

Protocol V6.0 16May2019

Protocol V5.0 19Dec2018

Protocol V4.0 30Oct2018

Protocol V3.0 22Aug2018

Protocol V2.0 12Apr2018

Protocol V1.1 12Feb2018

Previous Questionnaire

Baseline Questionnaire V1.2 17Oct2018

Baseline Questionnaire V1.1 19Jun2018

Baseline Questionnaire V1.0 12Apr2018

Previous SAE Form

SAE Form V2.0 17Oct2018

SAE Form V1.1 20Jul2018

SAE Follow up form V2.0 17Oct2018

SAE Follow up from V1.0 23Jul2018

Previous Translations


RCT Consent Form V3.1 01Nov2018 Polish

Cohort Consent Form V3.2 17Jul2020 Polish

Cohort Consent Form V3.1 01Nov2018 Polish

PIS V8.0 13Apr2021 Polish

PIS V7.1 17Jul2020 Polish

PIS V6.0 28Feb2019 Polish

PIS V5.1 09Jan2019 Polish


RCT Consent Form V3.1 01Nov2018 Romanian

Cohort Consent Form V3.2 17Jul2020 Romanian

Cohort Consent Form V3.1 01Nov2018 Romanian

PIS V8.0 13Apr2021 Romanian

PIS V7.1 17Jul2020 Romanian

PIS V6.0 28Feb2019 Romanian


RCT Consent Form V3.1 01Nov2018 Urdu

Cohort Consent Form V3.2 17Jul2020 Urdu

Cohort Consent Form V3.1 01Nov2018 Urdu

PIS V8.0 13Apr2021 Urdu

PIS V7.1 17Jul2020 Urdu

PIS V6.0 28Feb2019 Urdu

Previous Screening Log

Screening Log V1.0 25Jun2018