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    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.

    Examples

    • During a clinical trial for a new therapeutic device, researchers use a Case Report Form to systematically collect patient demographics, adverse events, and primary outcome measures.
    • Investigators developing a novel diagnostic MedTech platform design a comprehensive eCRF to capture highly granular data, ensuring all necessary information for regulatory submission is recorded efficiently.
    • Before commencing a study, the clinical team meticulously reviews the CRF design to confirm it aligns with the protocol, captures all essential data points, and minimizes potential for data entry errors.
    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.

    Frequently asked questions

    The source document is the original record of a clinical observation, a clinic chart note, a lab report, or a device log, while the Case Report Form (CRF) or electronic CRF (eCRF) is the structured instrument used to transcribe or directly capture that data for the trial database. Source data verification checks that CRF entries match source, and increasingly relies on direct data entry (eSource) to eliminate transcription error. Sponsors must maintain traceability between CRF fields and source so that FDA or notified body auditors can reconstruct any data point back to its origin.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 1Tier 3Peer-reviewed and registry evidence· 1
    Link health: 3 verified· last checked 2026-06-20
    CDISC·1eCFR·1NIH·1
    1. 1
      CDISC Standards
      Tier 2 Verified
      CDISCcdisc.org
    2. 2
      FDA 21 CFR Part 11
      Tier 1 Verified
      eCFRecfr.gov
    3. 3
      ClinicalTrials.gov
      Tier 3 Verified
      NIHclinicaltrials.gov

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