A protocol amendment lands, or a site reports a question nobody can answer. You need to change a form that already holds patient data. Datacapt keeps one eCRF per study and does not number versions, so you edit the form in place. The sequence is: suspend the study, make the change, return to Live.

🔑 Prerequisite: eCRF Builder (Edit) on the study, and the permission to edit the study Settings.

How a mid-study change works

Study status	eCRF Builder	Data entry at sites
Live	Locked. The Builder shows "The eCRF builder is locked during a Live study."	Open
Suspended	Open	Blocked for every site
Ended	Locked	Blocked, export stays available

While the study is Suspended, no site can enter or correct data. Plan the change so the suspension lasts minutes, and tell your sites before you start.

🛠️ Step by step guide

Open the study and go to Settings.
Stay on the General tab.
Change the study status to Suspended. Datacapt warns you that eCRF changes in a Live study can affect data integrity. Confirm.
Open the eCRF Builder and make your changes.
Click Save.
Go back to Settings and set the status to Live.

⚠️ Warning: returning to Live from Suspended keeps every subject and every answer. The deletion of test subjects happens once, on the first move from Draft to Live.

Which edits are safe

When the study already holds answers, the Builder displays this message: "You have collected data and answers. Deleting sections, subsections or questions will result in deletion of your data!" Take it at its word.

Edit	Effect on collected data
Add a question, a form (sub-section) or a visit (section)	None. The new question appears empty on existing records.
Change a title, a description or an instruction	None.
Add an option to a radio, checkbox or dropdown question	None.
Rename a variable	Answers stay. The column name changes in your next export, so warn your statistician. If the question feeds medical coding, existing verbatims and codes stay too.
Add or edit a data validation	Answers stay.
Add or edit conditional logic	Answers stay. A question that becomes hidden no longer shows at the site.
Delete a question, a form or a visit	Datacapt deletes the answers collected under it.

💡 Tip: to retire a question without losing its history, open its Advanced tab and switch on Hide in eCRF. Sites stop seeing the question and the answers already collected still come out in the export.

Edits Datacapt refuses

Changing a question used in randomization stratification. The Builder answers "Cannot change question used in stratification".
Changing the type of a question that another question references, for example in a calculation or a reminder.
Saving two questions with the same variable name.

Settings you cannot switch after Draft

Enable GCP (reason for change on every edit) can change in Draft, and at no later point.
eCRF Review can be switched on at any status. You can switch it off in Draft and nowhere else.

Test the change before you touch the real study

A Live study has no test subjects, so you cannot rehearse inside it. Rehearse in a copy.

🛠️ Step by step guide

In the Live study, open the eCRF Builder and click eCRF to template. Name it with the study reference and the date.
Create a new study and keep it in Draft.
In its eCRF Builder, select Choose from templates and pick the template you saved.
Make the planned change, add a test subject, and check every condition and validation fires.
Repeat the same change in the real study during the suspension.

💡 Tip: when the change is a whole new visit or form, save that section as a template in the Draft copy, then insert it in the real study with + > Sections. You avoid rebuilding it by hand under time pressure. Role restrictions do not travel with a template, so set them again after inserting.

Keep a record of what changed

An inspector will ask which version of the eCRF a site used on a given date. Since Datacapt does not number eCRF versions, you build that history yourself with three files per change.

Before the change	After the change
Print empty eCRF (printer icon in the Builder), saved as "eCRF v1.0"	Print empty eCRF again, saved as "eCRF v2.0"
eCRF to template, named with the version and date	Same
A full data export. Its Items Dictionary sheet lists every variable, validation and condition at that date	Same

File the three in your Trial Master File with the amendment reference and the date of the suspension.

The study Audit trail records the change on its side. Filter Event type on eCRF to list each question, form or visit that a user created, updated or deleted, with the user and the timestamp.

Frequently asked questions

Do I need to suspend the study to fix a typo in a question title?

Yes. The Builder stays locked for any edit while the study is Live.

What do sites see during the suspension?

They can open records and read them. Datacapt blocks data entry until the status returns to Live.

Can I see the difference between two versions of my eCRF inside Datacapt?

No. Compare the two blank eCRF PDFs or the two Items Dictionary sheets you saved before and after the change.

A subject already completed the visit I am adding a question to. What now?

The question shows empty on that record. Ask the site to complete it if the source holds the information, or to declare it as missing data with a reason.