Full CRF Pack

This is a full pack containing the latest versions of all CRFs
Last updated: 24 October 2022
(Zipped archive: 26 pdfs, 16.2mb)

Screening

Screening at Baseline CRF v5.0 31 Oct 2021.pdf
Medication Log CRF v1.0 01 Mar 2019.pdf
EQ-5D-5L CRF v1.0 06 Dec 2018.pdf
EQ-5D-5L Proxy CRF v1.0 06 Dec 2018.pdf

Discharge

Discharge CRF v1.0 01 Mar 2019.pdf

Withdrawal

Cessation of Trial Treatment or Withdrawal CRF v2.0 30 Apr 2020.pdf

Outcome Events

Outcome Event - Extracranial Bleeding v2.0 30 Apr 2020.pdf
Outcome Event - Recurrent Ischaemic Stroke v2.0 30 Apr 2020.pdf
Outcome Event - Symptomatic Intracranial Haemorrhage v2.0 30 Apr 2020.pdf
Outcome Event - Systemic Arterial Embolism v2.0 30 Apr 2020.pdf
Outcome Event - Venous Thrombosis v2.0 30 Apr 2020.pdf

Randomisation

Randomisation (Status at) CRF v1.0 01 Mar 2019.pdf
Initiation of DOAC CRF v1.0 01 Mar 2019.pdf

Follow-Up

OPTIMAS 90 Day Follow-Up CRF v4.0 24 Oct 2022
Follow-Up Questionnaire (GP) CRF v3.0 31 Oct 2020.pdf *
Follow-Up Questionnaire (Participant) CRF v1.0 25 Feb 2019.pdf **
Health & Social Care Resources (HSCR) v1.0 06 Dec 2018.pdf

*The GP Questionnaire should only be sent to the GP if the research team has tried to contact the participant 3 times and received no response
**The Participant Questionnaire should only be sent if the GP Questionnaire has been sent and 14 days have elapsed with no response from the GP

Safety Reporting

Serious Adverse Reaction Initial Report Form CRF v3.0 31 Oct 2021.pdf
Serious Adverse Reaction Follow-Up or Resolution CRF v3.0 31 Oct 2021.pdf
SAEs Unrelated to Study Intervention Log CRF v1.0 01 Mar 2019.pdf

Miscellaneous / When Appropriate

Death CRF v2.0 31 Oct 2020.pdf
Loss of Capacity - Consultee Advice CRF v1.0 01 Mar 2019.pdf
Re-Consent CRF v2.0 18 Feb 2020.pdf