All terms
Case Report Form
Structured paper or electronic forms used to capture protocol-required data for each enrolled subject.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 9, 2026
Definition
A Case Report Form (CRF) is the structured instrument — paper or, almost universally now, electronic (eCRF) within an Electronic Data Capture (EDC) system — used to record protocol-required data for each enrolled subject. CRF design follows the Statistical Analysis Plan and CDISC CDASH standards so that data captured maps cleanly to SDTM datasets for regulatory submission. What the regulation says
FDA 21 CFR Part 11 (electronic records and signatures), ICH E6(R3) GCP, and CDISC standards (CDASH for collection, SDTM for submission). FDA requires SDTM for NDA/BLA and increasingly for device PMA submissions.
What this means in practice
CRF design is one of the highest-leverage activities in trial planning — a poorly designed CRF generates queries, slows database lock, and impairs analysis. Source-data verification (SDV) practices have shifted toward risk-based monitoring rather than 100% SDV. Common pitfalls
- •Letting clinical operations design the CRF without statistician and data-management input.
- •Capturing free-text where coded fields would suffice — generates downstream cleaning burden.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
CDISC·1eCFR·1NIH·1
- 1
CDISC StandardsVerifiedCDISCcdisc.org
- 2
FDA 21 CFR Part 11VerifiedeCFRecfr.gov
- 3
ClinicalTrials.govVerifiedNIHclinicaltrials.gov
Inline markers like [1] jump to the matching reference above.