A case report form is the document, printed or electronic, in which a clinical trial records all the data the protocol requires for each participant. An electronic version is called an eCRF.
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Case report form
noun · clinical research
A printed or electronic document designed to record all protocol-required information to be reported to the sponsor for each trial participant.
Related terms
In short
Explained
A CRF contains exactly what the protocol says must be collected: demographics and eligibility at screening, assessments at each visit, and logs of events that happen on their own timeline, such as adverse events and concomitant medications. Anything not required by the protocol or the analysis plan generally does not belong on it.
CRFs are organised into forms. Visit forms hold data collected at scheduled visits, such as vital signs or questionnaires. Log forms hold repeating records, such as adverse events, with one row per event. Standard forms usually follow CDISC CDASH conventions so that data maps cleanly to SDTM datasets later. See how to design an eCRF for design rules, and the eCRF templates for worked examples such as the adverse event form.
Source documents are the original records of clinical findings: hospital notes, lab printouts, ECG tracings, participant diaries. The CRF records the protocol-required subset for the sponsor. Monitors check CRF data against source through source data verification. When data is entered directly into an eCRF with no earlier record (for example ePRO answers), the eCRF entry itself is the source.
A blank CRF (every form, printed empty) shows ethics committees and auditors what will be collected. An annotated CRF labels each field with its dataset variable name and is part of the documentation submitted with study data to regulators.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
In Capture
Capture builds eCRFs without code, with ten question types plus table sections, skip logic, edit checks that raise auto-queries and fourteen built-in calculators. Forms move from draft to approved, and only approved forms reach the casebook. The blank eCRF PDF (cover page, form index, visit-by-form matrix and every approved form) exports in one click, and data exports include an annotated CRF and data dictionary.
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
Case report form. An electronic case report form is an eCRF.
Usually not. Source documents are the original records; the CRF records the protocol-required data for the sponsor. Direct electronic entry can make the eCRF the source for that data.
Site staff such as research coordinators and investigators, and participants themselves for ePRO forms.
A CRF labelled with the dataset variable for each field, used to document how collected data maps to submission datasets.
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