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Trial Documents

Please find below copies of trial documents that you can download and print as required. (Please localise before use).

Version Log

Version Log v21

Case Report Forms and Guidelines

CRF v5.0Link opens in a new window

Essential Recruitment Documentation CRF V2.2Link opens in a new window

Participant Contact Details Form V1.3Link opens in a new window

End of trial form V1.0Link opens in a new window

CRF completion guidelines v5.0Link opens in a new window

Database data entry guidelines v2.0Link opens in a new window

Consent Forms

RCT consent form V3.2Link opens in a new window

RCT consent form V3.2 (Scottish sites)

RCT verbal consent form V1.0Link opens in a new window

RCT verbal consent form V1.0 (Scottish sites)

Remote consent email V1.0

Remote consent letter V1.0

Remote consent confirmation email V1.0

Remote consent confirmation letter v1.0

Delegation log

Delegation log V3.0

GP Letter

GP notification letter V3.0

Participant Information Sheets

Tri-Fold Leaflet V3.0

Participant Information Sheet V9.0 (English)

Participant Information Sheet V9.0 (Polish)

Participant Information Sheet V9.0 (Romanian)

Participant Information Sheet V9.0 (Urdu)

Poster

Poster V1.0 15 May 2019Link opens in a new window

Poster 2 V3.0 13 Feb 2019Link opens in a new window

Clinician poster V1.0 15 May 19Link opens in a new window

Protocol

Big Baby Protocol V11.0

Questionnaires

Baseline Questionnaire V1.3Link opens in a new window

SAE Form

SAE Form V3.0Link opens in a new window

SAE Continuation form V1.0Link opens in a new window

SAE Follow up form V3.0Link opens in a new window

AE Guidelines V1.0

SAE guidelines V1.0

Translations

Polish

RCT consent form V3.2Link opens in a new window


Romanian

RCT consent form V3.2Link opens in a new window


Urdu

RCT consent form V3.2Link opens in a new window


Referral form

Sonographer referral formLink opens in a new window


Certificates

Recognition certificateLink opens in a new window


SIV Slides

SIV slides V9.0

SIV slides Non-GAP sites V9.0

Guidelines

Screening log guidance V1.0

Eligibility guidance V4.0

Trial flow diagram V3.0

Guidance on taking remote consent V1.0

Guidance on remote recruitment V1.0