Purpose

This SOP defines role ownership and handoff for the Pre-Screening and eConsent lifecycle, from participant intake through consent signing and study enrollment.

Use this page for operational alignment between CRC/site staff, investigators, and study administrators.

Scope

• Module: Pre-Screening & eConsent
• Activities: Participant creation, invitation, consent signing, enrollment, re-consent, withdrawal
• Main roles: CRC / Site Staff, Investigator, Study Administrator

Account Mapping by Role

SOP Role	Typical Permissions
CRC / Site Staff	screening.create, screening.invite, screening.view
Investigator	All CRC permissions + consent.witness, screening.approve
Study Administrator	screening.config, econsent.config

Role Matrix by Activity

Activity	CRC / Site Staff	Investigator	Study Admin
Add screening participant	Yes	Yes	—
Edit participant details	Yes	Yes	—
Send consent invitation	Yes	Yes	—
Sign consent (on behalf)	Yes	Yes	—
Witness consent	—	Yes	—
Enroll participant	Yes	Yes	—
Withdraw consent	—	Yes	—
Reject participant	Yes	Yes	—
Send re-consent invitation	Yes	Yes	—
View consent audit trail	Yes	Yes	Yes
Configure screening settings	—	—	Yes
Publish consent forms	—	—	Yes
Configure auto-invite	—	—	Yes

Step-by-Step SOP

Step 1 — Participant Intake (CRC / Site Staff)

1. Open Pre-Screening and eConsent from the study navigation
2. Verify the Screening List for existing participants
3. Click + Add Screening
4. Enter participant details: Site, Full Name, Birthday, Phone, Email
5. Click Submit

Verification: Participant appears in Screening list with auto-assigned Screening Code.

Step 2 — Consent Invitation (CRC / Site Staff)

1. Open the participant record
2. Scroll to Consent Information section
3. Click Invite
4. Select the Published consent form from the Document dropdown
5. Set Send invitation to Yes
6. Click Send

Verification: Consent Status changes to Invited, Send invitation shows Sent.

Step 3 — Consent Signing (Participant or CRC on Behalf)

Self-signing (participant):

1. Participant opens invitation email and clicks the form link
2. Reviews ICF content
3. Fills in Date, Full Name, and Signature
4. Form submits automatically

Staff-assisted signing (on-site):

1. CRC opens participant record → clicks View consent
2. Participant reviews ICF on site device
3. Participant fills in Date, Full Name, and draws Signature
4. Form submits automatically

Investigator-witnessed signing:

1. Investigator is present during the consent process
2. Investigator verifies participant understanding
3. Investigator may add witness signature if configured
4. Consent recorded as witnessed

Verification: Consent Status changes to Consented, timestamps recorded.

Step 4 — Enrollment (CRC / Site Staff)

1. Return to participant record after consent is signed
2. Click Enroll
3. Select Treatment Arm from dropdown
4. Click Submit

Verification: Status changes to Enrolled, Participant ID (Subject ID) assigned.

Step 5 — Re-Consent (CRC / Site Staff)

When protocol amendments require updated consent:

1. Study Admin publishes new ICF version and archives old version
2. Identify participants who signed the old version
3. Open each participant record → click Invite
4. Select the new consent form version
5. Send invitation
6. Participant signs new version following Steps 3–4

Verification: Both old (Archived) and new (Consented) versions retained in audit trail.

Step 6 — Consent Withdrawal (Investigator)

When a participant decides to withdraw consent:

1. Open participant record
2. Click Withdraw Consent
3. Enter withdrawal date and reason
4. Confirm withdrawal

Verification: Consent Status changes to Withdrawn, no new data collection allowed.

Quality Governance

Consent Completeness Checks

Checkpoint	Criteria
Before Enrollment	Consent Status must be Consented
After Enrollment	Participant ID assigned, treatment arm recorded
Protocol Amendment	All previously consented participants flagged for re-consent
Study Close-Out	All consent records complete and archived

Compliance Requirements

• 21 CFR Part 11 — electronic signatures must be attributable, legible, contemporaneous, original, and accurate (ALCOA)
• ICH GCP E6(R2) — informed consent must be documented before any study procedures
• HIPAA / GDPR — participant personal data handled per authorization

Periodic Review

• Weekly: Review Invited but not yet Consented — follow up with participants
• Monthly: Review consent form versions — are any updates needed?
• Pre-audit: Verify all consent records have complete audit trails

Related Documentation

• Pre-Screening & eConsent Overview
• Screening & eConsent User Guide
• eConsent Setup
• Screening Setup