Change a live study with a signed reason
When you save a set-up change on a live study, Capture opens Reason for change and signature. Pick a reason, explain the change in at least 10 characters, type your password and click Sign and continue. Your change is saved, and further changes are allowed for 15 minutes.
Which changes need a signed reason
- The visit schedule: visits, their forms and timing.
- Fields, edit checks and reference ranges of forms that are no longer drafts.
- A team member's role or sites.
- Treatment arms, cohorts, randomization lists, caps and settings.
- Settings such as the blinding level, participant ID format, visit numbering, visit windows and designated forms.
- Corrections of submitted data use the same dialog, with the meaning "Approved data correction".
Draft studies are never affected. New form versions are signed when they are approved (new form version).
Sign the change
Make your change and save it as usual.
The Reason for change and signature dialog opens. Nothing is saved until you sign.
Pick a Reason.
For set-up changes: protocol amendment, regulatory or ethics committee requirement, correction of a set-up error, participant safety, site or monitor request, operational improvement, or other.
Describe what is changing and why in Explanation (at least 10 characters).
Check the signature block (your name, email, date and the meaning "Approved change"), type your password and click Sign and continue.
You see "Changes to this study are allowed for 15 minutes." Your save goes through.
Common messages
| Message | What to do |
|---|---|
| "change_control_required: this study is live..." | You cancelled the dialog, so nothing was saved. Save again and sign. |
| "Describe the reason for the change in at least 10 characters" | Write a fuller explanation. |
| "Choose a reason for the change from the list" | Pick a reason first. |
| "Your password has expired. Change it before signing." | Change your password, then save again. |
Questions
Why does Capture ask for a signature for set-up changes?
Regulations such as 21 CFR Part 11 and EU Annex 11 expect changes to a validated live system to be authorized, justified and traceable. The signed reason is kept in the audit trail with your name and the time. Read more in our audit trail overview.
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Still need help?
Email support@capture.study or use the contact form. Tell us the study name, what you were trying to do and the exact message on screen; a screenshot helps.
Please never send participant names, contact details or health information to support.