Skip to main content

Pre-Screen & e-Consent Overview

Overview

Last updated: 04/14/2026

Overview​

The Pre-Screening and eConsent app manages participant enrollment from initial screening through electronic informed consent. It combines a configurable screening intake form with a built-in ICF (Informed Consent Form) builder, enabling fully digital participant consent workflows.

Key Features​

  • Screening code generation — Automatically generates unique screening IDs (e.g., SITE-00001) with configurable prefix, separator, and digit count
  • Personal data collection — Captures participant name, date of birth, phone, email, and supporting ID documents during screening
  • Reject reason tracking — Records why a participant was rejected during pre-screening (required, optional, or disabled)
  • Electronic informed consent (eConsent) — Build multi-section ICF documents using a rich text editor with support for participant signatures, investigator signatures, LAR sections, and participant agreements
  • Consent versioning — Manage multiple consent form versions (Draft → Published → Archived) with language and country scoping
  • Auto invite — Automatically send consent invitation emails to new participants created via public survey, using the email collected during screening

Who Uses This App​

RoleActions
Study AdministratorConfigure screening settings, build consent forms, publish ICF versions
Investigator / CRCScreen participants, collect personal data, initiate consent workflow
ParticipantComplete screening, review and electronically sign the ICF
Monitor / SponsorReview screening records and consent status

Workflow​

  1. Configure — Set up screening code format, personal data fields, and eConsent settings in Design mode
  2. Build ICF — Create one or more consent form versions using the Add Consent Form dialog
  3. Publish — Activate the consent form to make it available for participant enrollment
  4. Screen — Site staff create screening records; participants receive an auto-invite or manual invitation to sign
  5. Sign — Participants review the ICF and apply their electronic signature
  6. Track — Monitor consent status and version history from the Consent forms table

Documentation​

  • Configuration — Configuration overview
  • Screening Settings — Screening code format, personal data collection, attachments, and CRF data collection
  • e-Consent Settings — Enable eConsent, consent options, consent form builder, and auto invite