Software to build case report forms, from protocol to casebook
Upload your protocol and Capture drafts the visit schedule and the forms behind it. Refine them, approve them, and export the blank eCRF your ethics committee asks for.
- Reads PDF, DOCX or DOC protocols
- Blank eCRF PDF in one click
- Free sandbox
Free sandbox · No credit card · 21 CFR Part 11 compliant
protocol_v3.pdf
- Synopsis
- Schedule of assessments
- Assessments
- Eligibility criteria
- PRO section
- Study drug
Draft study
- Study details
- Visits and windows
- CRF content
- Screening form
- Diaries
- Dispensing setup
6
protocol sections the AI reads
1
schedule matrix for every visit and form
1 click
blank eCRF PDF for ethics review
Per field
audit trail on every data change
How it works
Four steps from protocol to live data entry
- 1
Upload the protocol
PDF, DOCX or DOC. The AI reads the schedule of assessments and builds your visits, windows and draft forms.
- 2
Refine the forms
Adjust questions in the visual builder, add edit checks and calculated fields, or start from templates.
- 3
Approve and export
Approve each form, then download the blank eCRF casebook for your ethics or IRB submission.
- 4
Go live
Sites enter data against the schedule. Monitors and data managers verify, query, freeze and lock fields as they go.
Protocol in
Your protocol already describes the forms. Capture reads it
Upload the protocol and the AI Study Generator pulls out what it needs to build the study. A schedule-only upload is enough to create the visit skeleton, and you can add forms from the template library without sharing the full document.
- Synopsis: study name, protocol number, therapeutic area, enrolment and duration.
- Schedule of assessments: visit columns, timing and windows.
- Assessments and procedures: the CRF content behind each schedule row.
- Eligibility criteria: screening form fields.
- PRO section: diary instruments and frequency.
- Study drug section: dispensing visits and accountability setup.
Structure
See every form at every visit on one screen
The schedule matrix puts visits across the top and forms down the side. Tick a cell to collect a form at that visit. Site forms, participant questionnaires and ongoing logs are kept visibly apart, so the study plan is easy to review with your team.
- Switch the timeline between days and weeks.
- Matrix and list views of the same schedule.
- Add a visit or an activity straight from the grid.
Forms
Refine each CRF without writing code
Open any draft form to fine-tune it. Use AI to draft questions or a lab table from a description or a file, then add the validation that keeps the data clean.
- Ten question types, table sections and show/hide logic.
- Edit checks that raise auto-queries when a value breaks a rule.
- 14 built-in calculators, from BMI to eGFR and QTc.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Ethics submission
A blank eCRF casebook your IRB can read
Ethics committees want to see the empty forms. Capture generates them from your approved CRFs as one PDF, so the document always matches what sites will actually use.
- Cover page with study title, protocol number, casebook version and effective date.
- Form index and a visit by form matrix.
- Every approved form printed empty once, with answer boxes and conditional logic written out in plain language.
- Draft and archived forms are left out automatically.
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.
Have a protocol ready?
Upload it to a free sandbox and see the draft visits and forms Capture builds from it.
Live data
Forms sites can complete and monitors can trust
Once live, each field carries its own controls for queries, source data verification, freeze and lock. Every change is recorded field by field, with who, when and why.
- Verify all, then submit verification in one step.
- Edit history on every form.
- Visit progress shows which forms are done and which are still open.
Buyer checklist
What to look for in software to build CRFs
Use this list when you compare tools. Here is how Capture handles each point.
Build forms without a programmer
Visual builder with AI drafting. Study teams build their own forms.
Validation at the point of entry
Edit checks on each field raise auto-queries as data is entered.
Standard forms to start from
Template library with demographics, vitals, ECG, labs, AEs and more.
Controlled changes
Draft and approved states, locked approved forms, field-level audit trail.
Documents for ethics review
One-click blank eCRF PDF built from approved forms.
Try before you commit
Free sandbox with nearly every feature and sample data.
What software is used to build case report forms?
Teams use anything from Word documents to enterprise EDC systems. Dedicated eCRF software such as Capture lets you design the forms, attach them to visits, validate data as it is entered and keep an audit trail, all in one place.
Can I build CRFs directly from my protocol?
Yes. Upload the protocol as a PDF, DOCX or DOC file. The AI reads the schedule of assessments and related sections and drafts the visits and forms. You review and adjust everything before it is used.
What if I only want to share part of the protocol?
A schedule of assessments on its own is enough to build the visit skeleton. You can then add forms from the template library or build them yourself.
What is a blank eCRF and why do I need one?
A blank eCRF is the empty version of every case report form in your study. Ethics committees and IRBs often ask for it. Capture exports it as a PDF with a cover page, form index, visit by form matrix and every approved form.
Which forms appear in the blank eCRF?
Approved case report forms attached to the schedule, plus approved log forms such as adverse events. Drafts, archived versions and patient questionnaires are excluded.
How are CRF changes controlled once a study is live?
Approved forms are locked for live use, and clinical data changes are recorded in a field-level audit trail with the user, time and reason. Clinical data is never hard deleted.
How long does it take to build a set of CRFs?
The AI produces a first draft in minutes. The time after that depends on how much you refine, but you start from a structured draft instead of a blank page.
Is there a free way to try it?
Yes. The free sandbox includes nearly every feature and sample data, with no credit card.
Keep exploring
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AI in Capture
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REDCap alternative
How Capture compares for academic teams.
Turn your protocol into CRFs today
Free sandbox with nearly every feature. No credit card, no sales call.