This guide walks through the complete screening-to-enrollment workflow: adding a participant, collecting eConsent, and enrolling them in the study.

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Prerequisites

Before starting, ensure the following are in place:

Requirement	Where to check
Study status is Available	Study home → status badge in the top bar
At least one eConsent form is Published	Pre-Screening and eConsent → e-Consent Settings → Consent Forms table
You have a role with Screening write permissions	System Settings → Roles & Permissions

note

eConsent forms in Draft status do not appear in the invitation dialog. Publish the form before inviting participants.

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Step 1 — Add a Screening Participant

1. Navigate to your study and open Screening from the top navigation.
2. Click + Add Screening (top-right of the participant list).

3. Fill in the participant's details:

   Field	Notes
   Site	Select the site where the participant will be enrolled
   Screening Code	Auto-generated or entered manually, depending on your configuration
   Full Name	Participant's legal name
   Birthday	Format: DD/MM/YYYY
   Phone Number	Include country code (e.g., +1 617 555 0012)
   Email	Used to send the eConsent invitation

4. Click Save. The participant is created with a status of Screening.

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Step 2 — Send an eConsent Invitation

1. Open the participant record (click the participant row in the list).

2. In the Consent Information section, click Invite.

3. In the invitation dialog:

   • Document — select the Published consent form (e.g., CARDIO-RELIEF Informed Consent v1.0 (English)).
   • Send invitation — set to Yes to dispatch the invitation email immediately.
   tip

   The Send invitation toggle is disabled until a document is selected. Select the document first.

4. Click Send. The Consent Status updates to Invited and the Send invitation field shows Sent.

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Step 3 — Sign the Consent Form

The participant (or an authorized staff member on their behalf) signs the consent form. Staff can access the form directly from the participant record.

1. In the participant record, click View consent next to the consent form.
2. The consent form opens showing the full ICF text. Scroll to the Subject Signature section at the bottom.

3. Fill in the three required fields:

   Field	Notes
   Date	Select the date the consent is being signed
   Full Name	Participant's full legal name
   Signature	Draw the signature in the canvas area using mouse or touch input

4. Once all three fields are complete, the form submits automatically (no separate Submit button is required — the system processes the signature on completion).

The consent status updates to Consented, and the following details are recorded:

• Consented on — timestamp when the form was submitted
• Consent signed on — the date entered in the Signature section
• Signature method — Electronic

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Step 4 — Enroll the Participant

After the consent is signed, the participant can be enrolled in the study.

1. Return to the participant record (use the breadcrumb: Screening / [Participant ID]).
2. Click Enroll in the top action bar.
3. In the Add Subject dialog:
   • Site — pre-filled from the screening record (read-only).
   • Treatment Arm — select the appropriate arm from the dropdown (e.g., CardioRelief CRF-101 or Placebo).
4. Click Submit.

The participant status updates to Enrolled and a Participant ID is assigned (e.g., CR-1).

note

If the consent form has not been signed, the enrollment attempt will fail with the message "Screening subject is not consented". Complete Step 3 before enrolling.

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Consent Status Reference

Status	Meaning
(none)	No invitation has been sent
Invited	Invitation email sent; waiting for signature
Consented	Consent form signed and submitted
Withdrawn	Participant withdrew consent after signing

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Participant Status Reference

Status	Meaning
Screening	Participant created; awaiting consent and enrollment
Enrolled	Participant successfully enrolled; subject ID assigned
Rejected	Participant was rejected during pre-screening
Withdrawn	Participant withdrew from the study