Once your randomization configuration is saved, you can start randomizing participants: on the dummy list while the study is in Draft, on the production list once it is Live.
Allocate a participant to an arm
đ ď¸ Step by step guide
Add a new subject to the study.
Complete the eligibility checks in the relevant forms.
Open the form that holds the randomization action.
Click Randomize and confirm. The system assigns the next available slot, following your configuration.
â ď¸ Warning: complete the eligibility checks before you randomize, not after. Randomization consumes a slot, and a participant randomized in error has still taken their place in the sequence.
Where randomization details appear
Once a participant is randomized, the information shows up in six places:
The eCRF inclusion dashboard, in list view.
The eCRF details.
The eCRF export.
The ePRO dashboard, randomization ID only.
The eConsent dashboard, randomization ID only.
The randomization list.
đĄ Tip: randomization IDs are incremental, for example R-0001, and are used together with the Subject ID to identify a participant uniquely. Neither is sufficient on its own when you are reconciling across modules. For the vocabulary, see Randomization Essentials.
Emergency unblinding
On a Double-Blind randomization, the treatment arm stays hidden in the eCRF. In a medical emergency, a user whose role holds the Emergency Unblind permission can reveal the arm of one participant.
đ ď¸ Step by step guide
Open the participant's eCRF.
Open the menu next to the randomization status and select Unblind.
Confirm with your password, or through SSO if your organization uses it, and type a Reason for unblinding. Both are required.
Click Unblind subject.
What happens next:
The arm of that participant becomes visible in the eCRF to every user whose role holds Emergency Unblind, and in the Randomization list to roles with Unblind Access or Emergency Unblind. Users without these permissions still see nothing.
The eCRF shows a banner with the name of the user who performed the unblinding and the date, in UTC.
The study audit trail records the action with the reason.
The unblinding is permanent and concerns this participant alone. Every other participant stays blinded.
â ď¸ Warning: several wrong passwords in a row block your account for a while, as they do for an electronic signature. Datacapt sends no alert on unblinding by itself, so agree beforehand on who must be informed. See Keep a study blinded.