A live study should never run on a form nobody approved. Capture moves every form from draft to approved, locks approved forms for live use and shows only approved forms in the casebook, so a mid-study change is a deliberate, reviewable step.
Free sandbox · No credit card · 21 CFR Part 11 aligned
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
The control Capture gives you, in four facts
Scope of this page
The protocol amendments page is about who makes the change and what it costs: your team edits the study instead of raising a vendor change order. This page is about how you control the change once you are making it yourself: the sequence from draft to approved, what the lock protects, and what you should document around it. If your question is "how do we stop an unreviewed edit reaching a live form", you are in the right place.
A note on terms. Different organisations use "version" to mean a numbered release of the whole CRF, a revision of one form or a change to the visit schedule. Capture's control point is the form lifecycle: draft, approved, locked for live use. Where your SOP requires a version number or a change log, keep it in your own study documents alongside the approval; this page does not claim a built-in version-numbering scheme.
Protocols change: a new assessment is added, an inclusion criterion is refined, a safety signal prompts an extra lab, a field turns out to be ambiguous. These are normal. The risk is not the change; it is a change that arrives in the live form without review, or a change that nobody can later date.
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
Procedure
A procedure you can adapt to your own SOP. The product-specific parts are the draft, approval and lock; the surrounding steps are good practice.
The protocol amendment or change request is approved by whoever your SOP names, and where required by the ethics committee or regulator. The software does not replace that decision.
Make the edit on a draft form. If the change is large, describe it or upload the revised source and let the AI propose the fields, which you review before they are saved. AI only works on draft forms.
Check skip logic, ranges and calculated fields with sample data. Use a separate sandbox study if you want to rehearse without touching the live one.
A second person reviews the draft against the amendment. Then the form is approved. Approval is the point at which it becomes available for live use.
Only approved forms appear in the casebook. Tell sites what changed and from which date, and file the briefing in your study documents.
Add the change to your change log and trial master file: what changed, why, who approved and the date. Data changes themselves are recorded in the field-level audit trail.
What can go wrong
| Risk | Control | Where it comes from |
|---|---|---|
| Unreviewed edit reaches live data entry | Only approved forms appear in the casebook | Capture form lifecycle |
| Live form edited accidentally | Approved forms are locked for live use | Capture form lifecycle |
| Change cannot be dated later | Approval record plus your change log | Your SOP and study documents |
| Sites unaware of the change | Briefing filed with the date | Your SOP and study documents |
| Data value altered without trace | Old value, new value, user, time and reason on every field change | Field-level audit trail |
| Change not authorised | Amendment approved before the draft is made | Your governance |
Draft a change, approve it and see which form the casebook shows. No credit card.
Data and analysis
A form change has statistical consequences. A new field exists only for participants who complete the form after the change, so the analysis plan must say how participants before and after the change are handled. Decide this with your statistician before the change is approved, not after the export. Record the date of the change so the two groups can be identified.
Plan the export too. The export produces one wide row per submission with an automatic data dictionary, so check the codebook after approving a change and confirm it reads as your analysis plan expects. If the change affects a calculated field or an edit check, retest both on sample data.
Keep the audit trail in mind when an inspector or monitor asks questions. It records data changes with their reasons, and your own change log records form changes; together they answer "what did the form look like when this value was entered". The audit trail software page and the 21 CFR Part 11 checklist show what is expected.
Governance
Separate the person who drafts a change from the person who approves it wherever your team size allows. In a small study that may be the data manager drafting and the principal investigator approving; in a larger one, a clinical lead and a quality reviewer. Capture's roles (researcher, site coordinator and admin) determine who can do what in the study, so decide in advance which role approves forms and record the decision in your data management plan. The data management plan template has a place for it.
Distinguish changes by their impact. A change to a label or help text is not the same as a new endpoint or a changed visit schedule. Your SOP can grade changes (minor, moderate, major) and attach different review steps to each, such as a second reviewer for any change that affects data collected for a primary endpoint. The product gives you the same lifecycle for all of them; the grading is your governance.
Check whether a change needs regulatory or ethics notification. Substantial amendments often do, and the blank eCRF PDF is a convenient attachment for resubmission because it shows every approved form empty. Planning the resubmission before approving the form avoids a period where sites are collecting on a form the committee has not seen. For a view of the wider study-start process, see protocol to study setup software and rapid study setup EDC.
Before you approve
Amendment or change request approved under your SOP.
Against the amendment text, not just against the previous form.
Skip logic, ranges, calculated fields and edit checks.
How pre- and post-change participants are handled.
What changed and from which date, filed in study documents.
What, why, who approved and when.
For ethics or IRB resubmission where needed.
Forms move from draft to approved. Approved forms are locked for live use, and only approved forms appear in the casebook.
No. Only approved forms appear in the casebook.
This page does not claim a built-in version-numbering scheme. Keep version identifiers and the change log in your own study documents alongside the approval.
Yes, on draft forms only. Describe the change or upload a revised source and review what it proposes; nothing is saved without human review.
Use the free sandbox: build the study there, draft and approve the change and check what the casebook shows, with demo data.
In the field-level audit trail: timestamp, user, old value, new value and reason for change, exportable and not editable in the interface.
Yes. The blank eCRF PDF includes a cover page, form index, visit-by-form matrix and every approved form printed empty, useful for ethics or IRB resubmission.
That page is about doing the amendment yourself without a vendor ticket. This one is about the control procedure: draft, review, approve, lock and document.
Keep exploring
Protocol amendments without change orders
Who makes the change and what it costs.
CRF builder for clinical trials
Drafting, edit checks and calculated fields.
Audit trail software
How data changes are logged.
21 CFR Part 11 compliance checklist
What controls to document.
Query management software
Edit checks and auto-queries.
Database lock and unlock workflow
Closing the study.
Draft, approve, lock. Free sandbox with every feature, no credit card.