Thebest practicefor developingelectronic Case Report Forms (eCRFs)is to involvecross-functional team membersthroughout the design process.
According to theGCDMP (Chapter: CRF Design and Data Collection), eCRFs should be collaboratively developed bydata management, clinical operations, biostatistics, medical, and regulatory teams. Each function provides a unique perspective — data managers focus on data capture and validation; statisticians ensure alignment with analysis requirements; clinicians ensure medical relevance and protocol compliance.
Collaborative development ensures that the eCRFs arefit-for-purpose, capturing all required data accurately, minimizing redundancy, and supporting downstream data analysis.
Options A and B violate good data management practice because sites should not directly access coded terms (to prevent bias), and fields shouldnever auto-populate without explicit source verification. Option D is outdated; while paper CRFs may inform structure,EDC-optimized eCRFsshould leverage system functionality rather than mimic paper.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.2 – Collaborative CRF Development
ICH E6 (R2) GCP, Section 5.5.3 – Data Collection and System Validation
FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 3.4 – CRF Design Considerations
