What it is
The Pre-Screening and eConsent app supports participant intake and informed consent in one workflow. Study teams configure screening logic, publish consent forms, invite participants, and track consent status before or alongside main study enrollment.
Who uses it
| Role | Typical use |
|---|---|
| Study Administrator | Configure screening codes, consent forms, and invitation rules |
| CRC / Site staff | Screen participants and manage consent invitations |
| Participant | Review and sign e-consent documents (web or mobile) |
| Investigator | Approve or witness consent where required by protocol |
Key capabilities
- Configurable screening ID generation (prefix, separator, digit count)
- Digital consent form publishing with multi-language support
- Participant invitation and consent status tracking
- Optional CRF data collection during screening
- Re-consent workflow — issue updated consent forms when protocols change
- Remote consent — participants can sign electronically from any device
- Full audit trail — every consent action recorded with timestamps and signatures
- Multi-language forms — publish the same ICF in multiple languages
Consent Lifecycle
| Status | Meaning | Next Action |
|---|---|---|
| (none) | No invitation sent | Send invitation |
| Invited | Email invitation sent to participant | Participant reviews and signs |
| Consented | Consent form signed and submitted | Participant can be enrolled |
| Withdrawn | Participant withdrew consent | Document withdrawal reason |
| Re-consented | New consent version signed | Updated consent on file |
Re-consent Workflow
When a protocol amendment requires updated informed consent:
- Study Admin publishes new consent form version
- Previously consented participants are flagged for re-consent
- New invitation is sent with the updated form
- Participant reviews and signs the new version
- Both old and new consent versions are retained in audit trail
Remote Consent
Participants can complete eConsent remotely without visiting the site:
- Receive invitation via email
- Review ICF on any web browser or mobile device
- Sign electronically using mouse, touch, or stylus input
- CRC/site staff can assist via phone/video while participant signs remotely
Audit Trail
Every consent action is recorded:
- Invitation sent — when, by whom, to which email
- Consent viewed — timestamp of form access
- Consent signed — signature image, date, IP address
- Consent withdrawn — date, reason, user
- Re-consent — old version archived, new version linked