Data & Quality
Case Report Form (CRF)
A Case Report Form (CRF) is the printed, optical, or electronic document designed to record all protocol-required information about each clinical trial participant, supporting regulatory submission and statistical analysis.
Modern trials use electronic CRFs (eCRFs) within an EDC system, with edit checks, audit trails, and electronic signatures meeting 21 CFR Part 11. CRF design follows CDISC CDASH standards to support downstream SDTM mapping.
Source data verification compares CRF entries against source documents (medical records, lab reports, ePRO entries) to confirm accuracy; risk-based monitoring strategies minimize 100% SDV in favor of targeted sampling.
Related terms
Electronic Data Capture (EDC)
Electronic Data Capture (EDC) is the system used to collect, manage, and store clinical trial data electronically via electronic case report forms (eCRFs), replacing paper-based data collection.
CDISC (SDTM and ADaM)
CDISC (Clinical Data Interchange Standards Consortium) is the global non-profit that develops the data standards required by FDA and PMDA for regulatory submission, including SDTM (Study Data Tabulation Model) for raw observed data and ADaM (Analysis Data Model) for analysis-ready datasets.
Clinical Trial Monitoring
Clinical trial monitoring is the act of overseeing the progress of a clinical trial and ensuring it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
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