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Clinical & Trials

Case Report Form(CRF)

In one line

Structured paper or electronic forms used to capture protocol-required data for each enrolled subject.

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.

Why it matters

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.

Sources

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MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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