Clinical Trial Case Report Form Development Questionnaire
Use this form to define the requirements for a clinical trial case report form (CRF) development project. Share the study context, the data domains to capture, and any build constraints or delivery notes.
Project Overview
Study or Project Name
*
Therapeutic Area or Indication
*
Phase / Stage of Trial
I
II
III
IV
Other
Primary Purpose of the CRF Development Request
*
Data Capture Requirements
Key data domains to be captured in the CRF
*
Demographics
Eligibility
Study Visits
Adverse Events
Concomitant Medications
Efficacy Endpoints
Laboratory Data
Vital Signs
Other Study-Specific Domains
Expected source data format
*
Paper
EDC
Both
Visit schedule or visit structure notes
Build Constraints and Delivery
Preferred CRF platform or output format
*
Please Select
REDCap
Medidata Rave
Oracle Clinical
OpenClinica
PDF
Excel
Word
Other
Desired timeline or target delivery date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Special instructions, assumptions, or exclusions for the CRF build
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