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Trial Documentation

Below you will find the protocol and regulatory documents regarding the BASIL-3 trial.  If you require any trial documentation including CRFs, please contact Rebecca Record (Clinical Trial Manager) 0121 415 8444 who can provide you a link to download the CRFs.  Alternatively, please contact the Basil-3 Trial office.

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Below are the CRFs required to collect BASIL-3 trial data.  Please contact the trial manager for any of these: 

CRF pack E (contains all forms required by all trial participants between randomisation and intervention)
Patient-completed booklet (to be completed at baseline and each follow-up session)
Follow up form (to be completed 1m post intervention then 6m & 12m post randomisation, then annually) 
PEDIS form (complete if tissue loss is recorded at baseline or any follow up timepoint)
WiFi form (complete if tissue loss is recorded at baseline or any follow up timepoint)
Inpatient form
Intervention form
Endovascular form
Amputation form
Surgical Bypass form
Non-bypass Vascular form
Exit form
SAE
 

Other documents for local trial teams