2.4 CDASH CRF Library

The CDASH CRF Library consists of ready-to-use, CDASH-compliant eCRF templates that can be customized or imported as-is to the OpenClinica EDC platform.

The eCRF templates cover most of the key standard forms that are used across the majority of studies. In order to make customizations, download the template and make edits within Microsoft Excel, or use the OpenClinica Form Designer. Please preview each CRF before use to make sure that all the items are adequate for data collection.

Download All Files (.zip):

• CDISC

CDISC Sample Forms:

Foundational CRFs

Common Repeating

• • • CE Clinical Events
    • HO Healthcare Encounters
    • MH Medical History 
    • AE Adverse Events 
    • PR Procedures
    • CM Concomitant Medications 

Common1 – Common Forms with leading prompt

• • • CE Clinical Events – Including Prompt
    • CM Concomitant Medications – Including Prompt
    • PR Procedures – Including Prompt
    • HO Healthcare Encounters – Including Prompt
    • AE Adverse Events- Including Prompt
    • MH Medical History- Including Prompt

Visit

• • • EG_CENTRAL ECG Test Results- Central Reading
    • MB_CENTRAL Microbiology Specimen Central Processing
    • LB_LOCAL Laboratory Test Results- Local Processing
    • IE Inclusion Exclusion Criteria 
    • RP Reproductive System Findings
    • DA_H_RETURNED Drug Accountability Horizontal- Returned Amount
    • MI_CENTRAL Microscopic Findings Central Processing
    • DM Demographics
    • DA_VERTICAL Drug Accountability Vertical
    • LB_CENTRAL Laboratory Test Results- Central Processing
    • MB_LOCAL Microbiology Specimen Local Processing
    • DS Disposition
    • PC_FIXTIME Pharmacokinetics Sampling at Fixed Time Points
    • DD Death Details
    • FA Finidngs About Events or Interventions
    • SU_TOBACCO Substance Abuse-Tobacco
    • EC Exposure as Collected
    • PC_OVERTIME Pharmaconkinetics Sampling Over a Time Interval
    • EG_LOCAL ECG Test Results- Local Reading
    • LOG Log Form Prompt
    • VS_HORIZONTAL Vital Signs
    • PE Physical Examination- Recommended
    • MI_LOCAL Microscopic Findings Local Processing
    • DA_H_DISPENSED Drug Accountability Horizontal – Dispensed Amount

Crohn’s Therapeutic Area

Crohn’s Common

• • • CD_ENPRB Endoscopy Procedure Biopsies
    • CD_CM5ASA Prior Crohn’s Disease Medication Aminosalicylates
    • CD_CMIM Prior Crohn’s Disease Medication Immunomodulators
    • CD_CMBIO Prior Crohn’s Disease Medication Biologics
    • CD_CMCS Prior Crohn’s Disease Medication Corticosteroids
    • CD_PRSGD Prior Crohn’s Disease Surgery Details
    • CD_CMNSD On-Study Crohn’s Disease Background Medication, Non-study Drugs-1

Crohn’s Visit CRFs

• • • CD_ENPR Endoscopy Procedure
    • CD_PREBD Prior Crohn’s Disease Endoscopic Balloon Dilation
    • CD_CMNSDC On-Study Crohn’s Disease Background Medication, Non-study Drug Changes-1
    • CD_CMDCS Prior Crohn’s Disease Corticosteroids – Alternative Dependency
    • CD_PRRLOC Prior Crohn’s Disease Resections, by Locations
    • CD_CMHL Prior Crohn’s Disease Medication Classes
    • CD_GHAS Global Histologic Disease Activity Score (GHAS)
    • CD_MHCD History of Crohn’s Disease
    • CD_PRSG Prior Crohn’s Disease Surgery
    • CD_PREIP Prior Crohn’s Disease Endoscopic Interventional Procedures
    • CD_PREGSI Prior Crohn’s Disease Endoscopic Gastrointestinal Stent Insertion
    • CD_PAUI Procedure Agents Related to Imaging Procedures
    • CD_ENQM Endoscopy – Quality and Measurements