Case Report Form (CRF / eCRF)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The document, paper or electronic, used to record all protocol-required information on each trial subject for transmission to the sponsor. The eCRF is the electronic version, typically captured directly into a validated clinical data management system, and is the primary source of subject-level data feeding statistical analysis and the clinical study report.
A CRF captures the data points the protocol requires: demographics, dosing and exposure, laboratory results, efficacy assessments, and adverse events. Each entry must be traceable back to a source document — the CRF is a transcription and structuring layer over source data, not a substitute for it.
The eCRF version runs on a validated electronic data capture (EDC) system with an audit trail, role-based access, and electronic signatures under Part 11 controls. Built-in edit checks flag out-of-range or inconsistent entries, and any discrepancy generates a query that a site must resolve before the field is considered final.
CRF quality is inspected closely because it is the bridge between what happened at the bedside and what regulators ultimately see in the clinical study report — errors, late entry, or unresolved queries at this layer propagate directly into the analysis dataset.
- —Must reflect source documents; discrepancies trigger source data verification or source data review.
- —eCRFs run on validated EDC systems with audit trails and edit checks under 21 CFR Part 11 controls.
- —Queries raised against CRF entries are tracked and resolved through query management before database lock.
- —The investigator, or a formally delegated designee, is accountable for CRF accuracy and completeness, evidenced by signature.
ICH E6(R3) GCP; 21 CFR Part 11; 21 CFR 312.62 (Investigator Recordkeeping and Record Retention)
Frequently asked questions
What is Case Report Form (CRF / eCRF)?
The document, paper or electronic, used to record all protocol-required information on each trial subject for transmission to the sponsor. The eCRF is the electronic version, typically captured directly into a validated clinical data management system, and is the primary source of subject-level data feeding statistical analysis and the clinical study report.
Which regulations cover Case Report Form (CRF / eCRF)?
ICH E6(R3) GCP; 21 CFR Part 11; 21 CFR 312.62 (Investigator Recordkeeping and Record Retention)