The Bedside Worksheets for collecting data in the CLEAR-III trial were recently updated to better match the EDC screens as well as correct a few errors. Please download (see below) this new version and discard any older versions. Here's a summary of the changes.
Table of contents - updated.
Registration - criteria for initial screening matched to wording on EDC screens.
Barthel Index matched to drop-downs of the EDC screens.
NIHSS - matched to drop-down choices of the EDC screens on the Visual Field questions. Added supplemental instruction for assessing best language and dysarthria.
Safety Lab - updated units of measure to match EDC screens and added instruction about holding dose for INR correction.
GRAEB diagram - updated instructions about only selecting expanded when fully-filled with blood. Added instruction to indicate location of catheter tip.
Etiology - added this new form to worksheets to collect data requested by DSMB.
Randomization Eligibility Criteria - updated wording to match EDC.
Dosing - updated to match EDC screen layout.
ICP Management - Added instruction that Day-1 is ALWAYS the date of randomization.
Follow-up Visit Patient Status - removed LTFU option to match EDC screen
Concomitant Medication - corrected inconsistencies
Infection SAE - corrected inconsistencies
Bleeding SAE - corrected inconsistencies