The Pre-Screening and eConsent app manages the full journey from adding a new participant through collecting their electronic informed consent (e-Consent) and enrolling them into the study.

This guide walks through each step of that workflow with screenshots from the live interface.

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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 Setup → 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 in the top-right of the participant list.

3. The New Screening dialog opens. Fill in the participant's details:

   Field	Notes
   Site	Select the site where the participant will be enrolled
   Full name	Participant's legal name
   Birthday	Select the date (format: DD/MM/YYYY)
   Phone Number	Include country code (e.g., +1 617 555 0012)
   Email	Used to send the eConsent invitation

4. Click Submit. The participant is created with a status of Screening and a Screening Code is automatically assigned.

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Step 2 — Send an eConsent Invitation

1. Open the participant record by clicking the row or clicking View in the Action column.

2. Scroll down to the Consent Information section.

3. Click Invite to open the invitation dialog.

4. 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.

5. Click Send. The Send invitation field updates to Sent and the Consent Status becomes Invited.

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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 completed, the form is submitted automatically. No separate Submit button is needed — the system records the signature on completion.

After signing, the Consent Information section in the participant record updates to:

Field	Value
Consent Status	Consented
Consented on	Timestamp when the form was submitted
Consent signed on	The date entered in the Signature section
Signature method	Electronic
Send invitation	Sent

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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). The top bar of the record shows the Screening Code, Status, Participant ID, and timestamps.

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

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Re-Consent Workflow

When a protocol amendment or updated ICF requires participants to re-consent:

Prerequisites

• New consent form version is Published in e-Consent Setup
• Previous consent form version is Archived (not deleted — retained for audit)
• Auto-invite is configured (optional) or manual invitation is planned

Step 1 — Identify Participants Needing Re-Consent

1. Open Screening from the top navigation
2. Filter by Consent Status: Consented
3. Participants who signed the old form version need re-consent

Step 2 — Send Re-Consent Invitation

1. Open the participant record
2. In the Consent Information section, click Invite
3. Select the new consent form version from the Document dropdown
4. Set Send invitation to Yes
5. Click Send

The participant's consent status updates to Invited for the new version.

Step 3 — Participant Signs New Consent

The participant follows the same signing process as the original consent:

1. Open invitation email → click link to access form
2. Review updated ICF content
3. Fill in Date, Full Name, and Signature
4. Form submits automatically on completion

Step 4 — Verify Re-Consent Status

After signing, the participant record shows:

• Consent Status: Consented
• Consented on: New timestamp
• Consent signed on: Date entered in signature section
• Previous consent: Archived with old version reference

Re-Consent Audit Trail

Both consent versions are preserved:

• Old version — status changes to Archived, retains original signature and dates
• New version — shows current Consented status with new signature and dates
• Full history visible in the participant's Consent Information section

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Consent Withdrawal

Participants may withdraw consent at any time during the study.

Withdrawal Process

1. Open the participant record from the Screening list
2. In Consent Information, click Withdraw Consent
3. In the withdrawal dialog:
   • Withdrawal Date — date the participant requested withdrawal
   • Reason — select from configured reasons or enter free text
   • Confirm — acknowledge that withdrawal stops further data collection
4. Click Submit

After Withdrawal

Aspect	Behavior
Consent Status	Changes to Withdrawn
Data already collected	Retained per regulatory requirements
New data collection	Stops — no new CRFs can be submitted
Re-enrollment	Not possible without new consent
Audit trail	Withdrawal date, reason, and user are recorded

Withdrawal Reporting

• Withdrawn participants remain in the Screening list
• Filter by Status: Withdrawn to review all withdrawals
• Export screening list for regulatory reporting

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Remote Consent

When participants cannot visit the site in person:

How It Works

1. CRC/site staff creates the participant and sends the eConsent invitation
2. Participant receives email with a link to the consent form
3. Participant opens the form on any web browser or mobile device
4. CRC can guide the participant via phone or video call while they review the ICF
5. Participant signs electronically on their own device
6. Signature is recorded with timestamp and device information

Best Practices for Remote Consent

• Schedule a video call to walk through the ICF with the participant
• Verify participant identity before sending the invitation
• Document that consent was obtained remotely in the participant record
• Ensure the participant has a stable internet connection during signing

Remote vs. On-Site Consent

Aspect	On-Site	Remote
Device	Site tablet/computer	Participant's own device
Identity verification	Staff verifies in person	Video call or pre-verified email
Signature method	Mouse, touch, stylus	Mouse, touch, stylus
Staff presence	In person	Via video/phone call
Audit trail	Same	Same + remote flag