Many IRB submission delays trace back to the data management section: no blank CRF for reviewers to see, no documented consent workflow, no clear answer on data security or who can access participant data. This checklist covers what an IRB or ethics committee typically asks for on the data capture side, and where Capture already has the answer.
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.
1
exportable blank eCRF PDF packet for reviewers
4
things most IRBs ask about the data plan: security, access, consent, retention
0
credit card required to prepare your packet
1
audit trail across consent, CRF and any amendments
What reviewers ask to see
Ethics reviewers routinely ask to see the forms a study will use before it starts collecting data. Capture exports a blank eCRF PDF packet built for exactly this: a cover page, a form index, a visit-by-form matrix, and every approved form printed empty.
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.
Before you submit
Describe how data is captured, stored, and who can access it. Capture provides one platform with a documented audit trail to reference.
eConsent with two-step participant verification, investigator countersignature and a Fully Executed status only after countersignature.
Researcher, site coordinator and admin roles with PII segregation, enforced at the database layer.
AES-256 encryption at rest, TLS/SSL in transit, hosted in the EU (Frankfurt) or USA (N. Virginia).
A field-level audit trail on every record, always exportable, that cannot be edited from the UI.
Export the full blank eCRF PDF packet directly from your study build.
Getting ready
Build the visit schedule and forms, or upload the protocol and let the AI draft a first pass to review.
Once forms are approved, export the cover page, index and every empty form as a single PDF.
Choose from the eConsent template library, or adapt your own, and document the signature workflow.
Attach the packet to your IRB submission. Test everything free in the sandbox before your study goes live.
Before you switch
Free sandbox to prepare your full submission packet; no credit card required.
21 CFR Part 11-aligned controls and GDPR-ready infrastructure documented for your submission.
Export the blank CRF packet directly from your build, no separate document to maintain.
Bring an existing protocol design across if you are switching from another system.
Email support, typically under 24 hours.
Build your study and export the blank CRF packet before you submit. No credit card.
Yes. You can export a blank eCRF PDF packet with a cover page, form index, visit-by-form matrix and every approved form printed empty.
Yes. The free sandbox lets you build and test the full eConsent workflow with sample data before your study is live.
In the EU (Frankfurt) or the USA (N. Virginia), depending on your setup, with AES-256 encryption at rest and TLS/SSL in transit.
No. This checklist and the blank CRF export support the data management portion of your submission; your IRB's own application form and process still apply.
Yes. The field-level audit trail is always exportable and cannot be modified from the UI.
Nothing to start. The free sandbox has no credit card and no time limit.
Keep exploring
CRF builder for clinical trials
How the forms behind your blank CRF packet get built.
eConsent for academic clinical research
The consent workflow reviewers ask about.
EDC for academic clinical trials
The broader academic EDC fit.
GDPR-compliant clinical trial software
The data security and access-control answers reviewers ask about.
Build your study and export the blank CRF packet before you submit. No credit card.