An EDC captures the clinical data a study collects, subject by subject, field by field. An eTMF (electronic Trial Master File) stores the regulatory and administrative documents that prove a trial was run correctly: signed protocols, IRB approvals, monitoring visit reports, delegation logs. Capture is an EDC, eConsent and ePRO platform. It is not an eTMF, and this page explains exactly where that line sits.
Free sandbox · No credit card · 21 CFR Part 11 aligned
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.
EDC
what Capture is: subject-level clinical data capture
eTMF
what Capture is not: a regulatory document vault
1
export that helps your eTMF anyway: the blank eCRF PDF
0
invented claim about document management on this page
The actual split
An EDC exists to capture and clean the data a protocol collects: vitals, labs, adverse events, patient-reported outcomes, the numbers and answers a statistician eventually analyzes. An eTMF exists to prove the trial itself was conducted and documented correctly: the current protocol version, IRB/EC approvals, contracts, monitoring visit reports, training records and delegation logs, organized the way ICH E6 expects a Trial Master File to be organized.
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
Where Capture actually fits
Yes. eCRFs, edit checks, queries, calculated fields, the full casebook.
Yes. On-screen signing, OTP verification, investigator countersignature.
Yes. Diaries and questionnaires, no app install.
No. Capture has no document-vault module for protocols, contracts or delegation logs; use a dedicated eTMF or document management system for that.
Yes, indirectly. Capture exports a blank eCRF PDF (cover page, form index, every approved form printed empty) that is useful evidence for an eTMF binder, even though it comes from the EDC.
Before you switch
The EDC, eConsent and ePRO side is free to build and test in the sandbox; an eTMF is a separate purchase decision either way.
Capture's audit trail and e-signatures cover the data side; your eTMF still needs to meet its own document-control requirements.
The blank eCRF export gives your eTMF binder a starting document without any extra configuration.
Moving the EDC side does not require moving or replacing an existing eTMF.
Email support, typically under 24 hours, for the EDC, eConsent and ePRO side.
No credit card, no sales call. Keep your eTMF decision separate.
No. Capture is an EDC, eConsent and ePRO platform. It has no document-vault module for protocols, contracts, monitoring reports or delegation logs.
An EDC captures the clinical data a study collects. An eTMF stores the regulatory and administrative documents that prove the trial was conducted and documented correctly. They serve different parts of the same inspection-ready record.
Most regulated trials use both, since they cover different content: subject data on one side, regulatory and administrative documents on the other.
Yes, indirectly. The blank eCRF PDF export (cover page, form index, every approved form printed empty) is useful supporting evidence for an eTMF binder.
No. Those documents belong in a dedicated eTMF or document management system, not in Capture.
Yes. The free sandbox includes the full EDC, eConsent and ePRO feature set, with sample data, no credit card required.
Keep exploring
EDC vs CTMS
The same honest-scope question, for trial operations software.
CRF builder for clinical trials
The AI drafting behind the EDC side of this comparison.
Audit trail software
The record-level history an EDC keeps.
How to choose an EDC system
A broader buyer's checklist for the EDC decision itself.
EDC procurement checklist
What to verify before signing with any EDC vendor.
No credit card, no sales call. Keep your eTMF decision separate.