Electronic Data Capture
Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms.
Definition
Electronic Data Capture (EDC) systems are validated software platforms used to design electronic Case Report Forms (eCRFs), collect clinical data from investigator sites, run edit checks, manage queries, and produce locked datasets for analysis. Common platforms include Medidata Rave, Veeva Vault EDC, Oracle InForm, and Castor. EDC systems generate audit trails, enforce role-based access, and integrate with related systems, Clinical Trial Management Systems (CTMS), eConsent, ePRO, randomization (IRT/IWRS), safety databases, and electronic Trial Master Files (eTMF).What this means in practice
EDC is foundational to modern clinical trial conduct. Sponsors must validate EDC systems per 21 CFR Part 11 (electronic records and signatures), maintain audit trails, and demonstrate data integrity meets ALCOA+ principles. For IDE device trials, EDC validation, user training records, and source data verification approach are routinely inspected by FDA bioresearch monitoring inspectors. The shift toward Risk-Based Monitoring (RBM) and Decentralized Clinical Trials (DCT) is built on EDC capabilities including remote source data review and real-time anomaly detection.- •Treating EDC validation as a vendor responsibility, sponsors are accountable for the validation evidence in their environment, with their configuration.
- •Skipping or shortcutting 21 CFR Part 11 audit-trail review during inspection readiness.
- •Underestimating data migration risk when switching EDC platforms mid-study, FDA expects defensible mapping and re-validation.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsData integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
Structured paper or electronic forms used to capture protocol-required data for each enrolled subject.
A trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits.
Monitoring strategy that targets oversight resources to the highest-risk sites, processes, and data based on a documented risk assessment, replacing 100% source data verification.
More in Clinical & Trials
· Same categoryProcess 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.
Trial 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.
Primary references
3 sources- 1
21 CFR Part 11VerifiedeCFRecfr.gov
- 2
Electronic Systems in Clinical Investigations GuidanceVerifiedFDAfda.gov
- 3
ClinicalTrials.govVerifiedNIHclinicaltrials.gov
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