When a protocol changes, most EDC vendors put you in a change-order queue that costs weeks and fees. In Capture.Study, your own team edits visits, forms and logic directly, with every change recorded.
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
0
vendor change-order tickets to amend a form
Self-serve
edits to visits, forms and logic
Field-level
audit trail on every amendment
Free
sandbox to test an amendment first
The pain
Protocols change: a new safety signal, a refined inclusion criterion, an added assessment. With a vendor-managed EDC, even a small form change often means a change order, a queue, and a wait measured in weeks, billed by the hour.
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.
The fix
Capture.Study puts the visit schedule, forms and logic in a visual builder your own team uses directly. Add a field, adjust a visit window, or update an edit check the moment the amendment is approved internally, not weeks later.
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
Still controlled
Amending a live study still needs a record. Here is what Capture.Study keeps in place.
Field-level audit trail on every form, visit and logic change, with a reason for the change.
Draft and approved states mean an amendment is a deliberate step, not a silent edit.
Adding or changing fields does not overwrite data already collected.
You still follow your SOPs for approving an amendment internally; Capture.Study removes the vendor bottleneck after that approval, not your own governance.
Add a field or adjust a visit window yourself and see exactly what the audit trail records.
The difference
Yes. Your study team edits visits, forms and logic directly in the visual builder. Approved forms are locked for live use, so an amendment is a deliberate, recorded step rather than a silent edit.
Yes. Every change to a form, visit or logic rule is recorded in the field-level audit trail with who made it, when, and the stated reason.
No. You still follow your own SOPs for approving an amendment internally. Capture.Study removes the vendor queue and fee after that approval, not your governance process.
Existing data is not overwritten. Adding or changing fields extends the form going forward; historical entries remain as they were recorded.
Yes. Describe the change or upload a revised source document, and the AI proposes the updated questions or lab table for you to review before it is applied.
Yes. Build a free sandbox study, make the change there first, and see exactly what gets recorded in the audit trail.
Keep exploring
CRF builder for clinical trials
AI drafting, edit checks and calculated fields.
Audit trail software
How field-level logging works on every change.
21 CFR Part 11 compliance checklist
What a controlled amendment still needs to satisfy.
Clinical trial software without setup fees
The same self-serve model applied to getting started.
Rapid study setup EDC
The same self-serve model applied to the initial build.
eCRF software
Where amended forms show up for data entry.
Free sandbox with every feature. No credit card, no change-order fee, no sales call.