OTP: Castor eConsent > Participant Consent > CDMS

1. The site manually creates the participant record in Castor eConsent.
2. The participant receives an email invitation to review their consent form documentation 

3. Upon clicking “Review Documents” within the email invitation, the participant is redirected to a registration screen
4. On the registration screen, the participant enters their first name and last name
5. After submitting their first name and last name, the participant is redirected to a screen to enter their email address
6. After entering their email address, the participant is redirected to a screen where they need to enter a one-time password (OTP) that will be sent to their email address.
7. Once the OTP code is confirmed, the participant is redirected to a Castor eConsent Participant Portal.
8. The participant can then review & sign the required eICF.
9. To electronically sign the ICF, the participant enters their email address and confirms the OTP code one more time.
10. Upon an agreed trigger, the record is created in CDMS (real study).
    • Trigger is either 1) Participant signs ICF or 2) ICF is countersigned by study staff.

Order of Events

1. The Participant Record is created in eConsent.
   1. When a user is invited to Castor eConsent, both their eConsent and Castor Identity accounts are created simultaneously.
2. Participant clicks on the Castor eConsent email invitation link
   1. The user account is only "verified" in Castor Identity and Castor eConsent after the user has clicked on the Email Invitation (Registration) Link.
3. User encounters the OTP workflow and is asked to enter the OTP code
4. User is then logged into Identity and is redirected to the participant facing portal of Castor eConsent
5. The record is created in CDMS (real study) upon a defined trigger.