eCRF
Pronunciation: E-C-R-F
Also written as: eCRF — Electronic Case Report Form
Electronic Case Report Form, a digital data collection instrument used in clinical trials to capture patient information in a standardized, regulatory-compliant format.
Full Definition
An eCRF (Electronic Case Report Form) is a digital version of the traditional paper case report form used in clinical trials to systematically collect patient data according to study protocol requirements. These electronic forms are designed with built-in validation rules, edit checks, and audit trails to ensure data quality and regulatory compliance. In oncology trials, eCRFs capture complex information including tumor measurements, biomarker results, treatment administration details, adverse events, and outcome assessments. Modern eCRF systems integrate with electronic health records and other clinical systems to reduce manual data entry and improve accuracy. The forms are designed to meet FDA 21 CFR Part 11 requirements for electronic records and signatures, ensuring data integrity throughout the clinical trial process.
Usage
Usage note: Spell out on first use; acceptable to abbreviate in subsequent references within clinical trial contexts.
In Context
- "The clinical research coordinator completed the eCRF for the patient's 12-week tumor assessment visit." — Clinical trial documentation
- "Design of the eCRF should minimize data entry burden while capturing all protocol-required endpoints." — Clinical trial design specification