Randomisation

Randomisation

This section includes documentation and processes to assist clinical teams in randomising patients into REMAP-CAP

Randomisation system

Randomisation is carried out at the following url (or the below QR code: https://remapcap.spinnakersoftware.com/



Each hospitals shoud have a generic account that allows you to login to the system and randomise patients. You can also use your individual accounts if you have one. Please contact your local PI or research nurse to obtain this. Randomisation to all domains takes a maximum of 5 minutes.

Eligibility worksheet

To enable randomisation, we have produced a template flyer, a pandemic eligibility checklist and platform eligibility worksheet (ward and ICU) to allow you to assess the eligibility of a COVID-19 patient prior to entry onto the randomisation system.

Non-pandemic eligibility checklist and worksheet are available to assess eligibility of CAP patients.

Coenrolment

REMAP-CAP co-enrols with RECOVERY, details can be found here.

Intervention delivery

Administration guides can be found on the 'Pharmacy page'

Case Record Form (CRF)

• REMAP-CAP CRF V10.0 (paper copy)
• REMAP-CAP CRF V10.0 Data Completion Guidelines

 

Consent documentation (COVID-19)

Professional legal representative (across all sites) 

• Professional Legal Representative Consent Form
• Information summary for Professional Legal Representative
• Patient - Brief Information Summary

Patient/relative for sites in England and Wales

• Patient Information Sheet/Consent Form
• Personal Legal Representative Information Sheet/Consent Form
• Retrospective Patient Information Sheet/Consent Form

Patient/relative for sites in Northern Ireland

• Patient Information Sheet/Consent Form
• Personal Legal Representative Information Sheet/Consent Form
• Retrospective Patient Information Sheet/Consent Form

Patient/relative for sites in Scotland

• Patient Information Sheet/Consent Form
• Welfare Attorney/Welfare Guardian/Nearest Relative Legal Representatives Information Sheet/Consent Form
• Patient Information (Recovered capacity) Sheet/Consent Form

Current translated versions of the patient information sheets:
Previous translated versions of the patient information sheets (no longer updated):

• Bulgarian - For sites in England & Wales, Northern Ireland or Scotland
• Chinese - For sites in England & Wales, Northern Ireland or Scotland
• Hindi - For sites in England & Wales, Northern Ireland or Scotland
• Italian - For sites in England & Wales, Northern Ireland or Scotland
• Romanian - For sites in England & Wales, Northern Ireland or Scotland
• Somali - For sites in England & Wales, Northern Ireland or Scotland

Consent documentation (CAP)

Patient/relative for sites in England and Wales

• Patient Information Sheet/Consent Form
• Personal Legal Representative Information Sheet/Consent Form
• Professional Legal Representative Information Sheet/Consent Form
• Retrospective Patient Information Sheet/Consent Form

Patient/relative for sites in Northern Ireland

• Patient Information Sheet/Consent Form
• Personal Legal Representative Information Sheet/Consent Form
• Professional Legal Representative Information Sheet/Consent Form
• Retrospective Patient Information Sheet/Consent Form

Patient/relative for sites in Scotland

• Patient Information Sheet/Consent Form
• Welfare Attorney/Welfare Guardian/Nearest Relative Legal Representative Information Sheet/Consent Form
• Professional Legal Representative Information Sheet/Consent Form
• Patient Information (Recovered capacity) Sheet/Consent Form