Setting a study Live takes one click and you cannot undo it. Datacapt deletes all test data at that moment and locks the eCRF Builder. Run this checklist first, in order.
đ Prerequisite: a study in Draft, and the permission to edit the study Settings.
What the switch to Live does
The confirmation window says: "All builders and draft data will no longer be accessible, all inclusions and files will be removed. This action cannot be undone."
Datacapt deletes | Datacapt keeps |
Every test subject and their eCRF answers | The eCRF, ePRO and eConsent forms you built |
Test ePRO records and test eConsent records | Study settings, centers, users and roles |
Files uploaded on test subjects | Translations |
Medical codes applied to test verbatims | Medical coding mappings |
| Randomization configuration |
Datacapt also resets the subject ID counter and the randomization list, so your first real subject gets the first ID and the first slot.
â ď¸ Warning: users who hold a role with the Draft Study feature lose their access when the status changes to Live. That feature exists for builders and testers. Give them a regular study role before go-live if they stay on the study.
The checklist
Settings you cannot change later
Enable GCP. Decide now whether sites must give a reason for every change. You can set this option in Draft and at no later point.
eCRF Review. Switch it on if monitors will review forms or perform SDV. You can switch it on later, but you cannot switch it off once the study leaves Draft.
Subject ID pattern. Check the pattern and the center abbreviations. Both end up in every subject ID.
The form
Test each visit on a test subject with an investigator role, not with your admin role. Role-based visibility and excluded roles show their effect when you log in as the role concerned.
Trigger each data validation once with a wrong value and once with a right value.
Trigger each conditional logic rule in both directions.
Run a full export and open the Items Dictionary sheet. Read the variable names as your statistician will. Renaming after go-live changes the export columns.
If you applied a template, set the role restrictions again. Templates do not carry them.
The modules around the form
Randomization: run the test allocation, then check the blinding permissions of each role.
Medical coding: check that each mapped question points to the right dictionary.
Translations: open a test record in each language.
The paperwork
Click Print empty eCRF and Save as a template, and file both with your validation report as version 1.0. See Change an eCRF after the study is Live for why you need them.
Set the study Live
đ ď¸ Step by step guide
Open the study and go to Settings.
Stay on the General tab.
Change the study status to Live.
Read the confirmation window and confirm.
Save your changes.
After go-live you can publish your ePRO forms and open recruitment. Both stay unavailable while the study is in Draft.
đĄ Tip: keep one test center in the study, for example TEST01. After go-live you will use it to try an ePRO or an eConsent on a fake subject before you send it to real participants.
Frequently asked questions
Can I go back to Draft?
Can I go back to Draft?
No. From Live you can move to Suspended or Ended.
I forgot to test something. What now?
I forgot to test something. What now?
Set the study to Suspended, which reopens the Builder. See Change an eCRF after the study is Live.
Is there a separate training or UAT environment?
Is there a separate training or UAT environment?
No. Draft status is your test environment, inside the same study. This is why Datacapt wipes test data at go-live.