Data & Quality
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.
Modern EDC platforms (Medidata Rave, Veeva Vault EDC, Oracle Clinical One) integrate with randomization (IRT), ePRO, eConsent, and central laboratory systems. They enforce edit checks at entry, generate query workflows, and produce audit trails meeting 21 CFR Part 11 and EU Annex 11 requirements.
EDC outputs feed downstream into SDTM datasets for regulatory submission and ADaM datasets for statistical analysis, per CDISC standards.
Related terms
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.
Real-World Data (RWD) and Real-World Evidence (RWE)
Real-world data (RWD) is healthcare data collected outside the context of a controlled clinical trial; real-world evidence (RWE) is the clinical evidence about an intervention derived from analyzing RWD.
FHIR (Fast Healthcare Interoperability Resources)
FHIR is the HL7-published standard, expressed as a RESTful API and resource-based data model, that enables interoperable exchange of structured healthcare data between EHRs, payers, registries, research systems, and patient applications.
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