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Download a guide to completing the electronic case report forms
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TABLE OF CONTENT A GUIDE TO COMPLETING THE ELECTRONIC CASE REPORT FORMS (ECRF) ...... 0 TABLE OF CONTENT............................................................................................................ 1 INTRODUCTION .................................................................................................................... 3 PART 1: CROMIS-2 ELECTRONIC DATA SYSTEM .......................................................... 4 ACCESSING THE ELECTRONIC DATA SYSTEM............................................................................................ 4 Forgotten passwords ....................................................................................................................................... 5 Changing password or PIN............................................................................................................................. 5 Auto time-out .................................................................................................................................................... 5 Creating your account ..................................................................................................................................... 6 Editing accounts ................................................................................................................................................ 7 Deleting accounts ............................................................................................................................................. 7 Logging in ............................................................................................................................................................ 7 PATIENTS .................................................................................................................................................................... 9 Viewing existing patient data.......................................................................................................................... 9 New patients...................................................................................................................................................... 9 Allocating Study Numbers ............................................................................................................................ 10 Overdue forms ................................................................................................................................................ 12 View Schedule.................................................................................................................................................. 12 Data entry of forms........................................................................................................................................ 13 Validation .......................................................................................................................................................... 14 QUERIES ..................................................................................................................................................................... 16 Opening queries .............................................................................................................................................. 16 Adding messages ............................................................................................................................................. 17 Email notifications ........................................................................................................................................... 18 Listing queries .................................................................................................................................................. 19 PART II: USER MANUAL .................................................................................................... 22 STUDY ENTRY FORM ........................................................................................................................................... 23 PATIENT ELIGIBILITY ............................................................................................................................................ 24 Inclusion Criteria ............................................................................................................................................ 24 Exclusion Criteria ........................................................................................................................................... 25 SCREENING LOGS ................................................................................................................................................. 26 PATIENT INFORMATION .................................................................................................................................... 28 CLINICAL PRESENTATION ................................................................................................................................. 30 PREVIOUS EVENTS AND VASCULAR RISK AND VASCULAR RISK FACTORS ................................. 32 HISTORY OF STROKE/TIA OR ICH.................................................................................................................. 33 1
