Case Report Form
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.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.- •Letting clinical operations design the CRF without statistician and data-management input.
- •Capturing free-text where coded fields would suffice, generates downstream cleaning burden.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsData integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
International standard for the design, conduct, and reporting of clinical trials.
Process of comparing data in case report forms against original source records.
The collection of essential documents that demonstrates the conduct of a clinical trial complies with GCP and applicable regulatory requirements.
More in Clinical & Trials
· Same categoryTrial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Any untoward medical occurrence in a subject, whether or not related to the device.
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Trial design that uses Bayesian statistics, often incorporating prior data from related studies or registries.
Primary references
3 sources- 1
CDISC StandardsVerifiedCDISCcdisc.org
- 2
FDA 21 CFR Part 11VerifiedeCFRecfr.gov
- 3
ClinicalTrials.govVerifiedNIHclinicaltrials.gov
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