Access Path
- From the My Tasks page, identify the study you are working on in the Current study area.
- Open the Study Overview for your study.
- Access the Pre-Screening and eConsent application from the Applications menu.
- Switch to the e-Consent Setup tab.
If the study is in Available or Frozen status, the system displays the message "To set it up, please change the status of Study to Design" and fields will be read-only.
e-Consent Configuration Components
1) Enable e-Consent Features and Consent Forms
When you enable the e-Consent features toggle, the following main areas appear:
- Consent options: Configure e-Consent behavior and related settings
- Consent forms: Manage the list of consent forms
- Auto invite: Automatically send signing invitations to new participants
2) Consent Forms and Form Status
In the Consent forms table, each row represents a version of a form with the following key columns:
| Column | Meaning |
|---|---|
| Name | Name of the consent form |
| Version | Version of the form |
| Consent Method | Signing method (e.g., Electronic) |
| Status | Form status (Draft, Published, Archived) |
| Country | Country scope (if applicable) |
| Language | Language of the form |
| Action | Actions such as View, Edit, Publish |
3) Auto Invite
The Auto invite section is used to automatically send e-Consent signing invitations to new participants when configured conditions are met.
Operational notes:
- Email must be enabled in the Collect Personal Data section of Screening Setup.
- At least one consent form must be in Published status for participants to be able to sign.
How to Sign e-Consent Step-by-Step
Step 1: Open the Screening List
Select the appropriate participant and open their detailed record.
Step 2: Check Consent Information in the Participant Record
In the Consent Information section, click View consent to open the form that needs to be signed.
Step 3: Open the Consent Form
Review the form content before proceeding with the signing process.
Step 4: Fill in Signature Information
Complete all required fields in the Subject Signature area.
Step 5: Sign in the Signature Area
Sign directly on the signature canvas according to your study's procedures.
Step 6: Confirm Consented Status
After successful signing, return to the Participant record to confirm:
- Consent Status: Consented
- Consent signed on and Consented on have recorded timestamps
- Signature method displays Electronic
Important Notes
- If a participant does not have a signing invitation, you need to send an invitation first within the screening workflow.
- If a form is not in Published status, the participant will not be able to complete the e-Consent signing.
- For studies in read-only mode, you cannot make configuration changes directly on the e-Consent Setup tab.