Creating a Subject in StudyWorks

Creating Subjects

The process for adding subjects differs across studies and eCOA solutions. Consult your study’s Clario Learn curriculum for details.

Press the StudyWorks button relevant to your study’s chosen modality, as explained below.
Complete the required fields that you’re presented.
Press Finish.
Review the notification message and press Continue. Pending success, your new subject will now appear in the data table.

Information Scope

Solution: eCOA

Platform: StudyWorks

BYOD/Handheld only

Press + Create Subject. *Excludes using Web eCOA Tablet for subject management.

Tablet only

Create subjects using the provisioned device.

Web eCOA Tablet

Press Web eCOA Tablet to use this virtual option when the provisioned device is unavailable.

Important Reminders

The + Create Subject and Web eCOA Tablet buttons may be visible but not usable depending on your modalities. Refer to the modality descriptions for creating a subject.

Creating subjects for BYOD and eCOA Handheld

Study Coordinators assisting subjects with Bring Your Own Device (BYOD) or eCOA Handheld devices have the capability to create subjects. To get started, make sure you’re logged into StudyWorks and are viewing your study’s Subjects dashboard.

Create your subject in StudyWorks

Press + Create Subject.
When managing multiple sites, you may be prompted to link the subject to a specific site.
Complete all of the required fields, including entering the password used to login to the Clario Portal.
Keep note of the assigned subject number (i.e., “Subject ID”) because you’ll use that later in the process.
Press Finish.
Press Continue when the message (i.e., “Subject successfully added”) appears. The subject is now displayed in the StudyWorks subject list.
Find and press the assigned subject number, which is shown as the Subject ID (e.g., “8860-5555”).
Press Manage Subject to view the Study URL, Study Code, and the subject-specific QR Code.

Add your subject to the device

These instructions require you to have access to your study in StudyWorks as well as unassigned devices. Prepare by logging into StudyWorks, ensuring that your device is sufficiently charged (i.e., battery level more than 50%), and that you have access to the Clario App.

From Manage Subjects in StudyWorks, press the empty QR Code checkbox to display the QR Code.
Power on an unassigned device — BYOD or provisioned — and open the Clario App.
Press the QR Code icon to activate the device’s camera.
Aim the camera at the QR Code that you’re viewing in StudyWorks.
The subject will be automatically enrolled when the QR Code scan was successful.
Enter the “Study URL” and “Setup Code” into the device if the QR Code scan failed.
Review and respond to each message screen as applicable pressing Next to proceed forward.
Select the subject’s time zone and language.
Give the device to the subject to finish the set up process. They will need to review the Privacy Statement, establish a Password and specify their preferred Security Questions and Answers.