After completing data entry, reviewing data, resolving all queries, and finalizing data, it’s time to lock and sign the eCRF data. This action marks the final step in the process. This guide explains how to perform these actions in Datacapt.
Prerequisite :
Lock and Sign eCRF are separate permissions that must be configured under Roles Management.
Data must be collected, reviewed, and all queries must be closed before locking or signing an eCRF.
Lock eCRF forms
🛠️ Step-by-step guide
How to lock an eCRF form
How to lock an eCRF form
Navigate to your EDC clinical study,
Go to the eCRF "Inclusion List",
Open an eCRF,
Navigate to the form,
Select the bulk option using the🔒 icon
Note: It is possible to lock an entire visit by using the left panel and selecting the bulk action directly under the visit name.
A bulk lock action can be performed by selecting one or multiple eCRF forms on the "Inclusion List" page. A Lock/Unlock button will appear at the top of the screen.
All queries must be closed before locking an eCRF form.
Sign eCRF forms
🛠️ Step-by-step guide
How to sign an eCRF
How to sign an eCRF
Navigate to your EDC clinical study,
Go to the eCRF "Inclusion List",
Open an eCRF,
Navigate to the form,
Select the bulk option using the 🖋️ icon
Select the forms to sign,
Tick the declaration box: "I declare that I fully (...)",
Select "Submit",
Enter your password (if using SSO, simply select your account),
Confirm.
Note :
It is possible to sign an entire visit by using the left panel and selecting the bulk action directly under the visit name.
A bulk sign action can be performed by selecting one or multiple eCRF forms on the "Inclusion List" page. A Lock/Unlock button will appear at the top of the screen.
Only the user who signed an eCRF can un-sign it.