Purpose

This SOP defines role ownership and handoff for CDS Surveys, from survey configuration and participant group setup through delivery scheduling and response monitoring.

Use this page for operational alignment between Data Managers, CRCs, and study administrators.

Scope

• Module: CDS Surveys (PRO/ePRO)
• Activities: Survey creation, package configuration, participant group setup, delivery scheduling, response monitoring
• Main roles: Study Administrator, Data Manager, CRC / Site Staff

Account Mapping by Role

SOP Role	Typical Permissions
Study Administrator / Data Manager	survey.config, survey.package.create, survey.group.create
CRC / Site Staff	survey.view, survey.monitor
Participant	No CDS login required (public URL or email invitation)

Role Matrix by Activity

Activity	Study Admin / DM	CRC / Site Staff
Create survey definition (title, CRF, stage)	Yes	—
Configure public URL	Yes	—
Create survey packages	Yes	—
Configure email templates	Yes	—
Set delivery schedules	Yes	—
Create participant groups	Yes	—
Assign participants to groups	Yes	Yes
Send surveys manually	Yes	Yes
Monitor completion rates	Yes	Yes
Export survey responses	Yes	Yes
View individual responses	Yes	Yes
Follow up on incomplete surveys	—	Yes

Step-by-Step SOP

Step 1 — Survey Creation (Study Admin / Data Manager)

1. Ensure study is in Design status
2. Navigate to Survey in the study configuration
3. Click + Add a new Survey
4. Configure:
   • Title — clear, participant-friendly name
   • Instructions — guidance for completing the survey
   • Stage — Screening or Enrollment phase
   • Event — the study event this survey belongs to (Enrollment phase)
   • CRF/Version — the form capturing responses
   • Public URL — Yes (shareable link) or No (invitation only)
5. Configure More settings:
   • Survey access restrictions
   • Termination options
   • Email invitation and confirmation templates
6. Click Save

Expected output: Survey appears in the surveys table.

Step 2 — Participant Group Setup (Study Admin / Data Manager)

1. Open Surveys → Configuration → Participant Group
2. Click + Add group
3. Configure:
   • Group name — descriptive (e.g., "Arm A — Week 4 PRO")
   • Site — all sites or specific site
   • Members — select subjects from the list
4. Click Save

Expected output: Participant group appears in the groups list.

Step 3 — Survey Package Configuration (Study Admin / Data Manager)

1. Open Surveys → Configuration → Survey Package
2. Click + Add Package
3. Configure:
   • Package name — descriptive (e.g., "Week 4 PRO Battery")
   • Surveys — select one or more surveys
   • Participant Groups — assign groups to receive this package
   • Email template — customize subject and body
   • Schedule — set delivery timing
4. Click Save

Expected output: Survey package appears ready for delivery.

Step 4 — Survey Delivery & Monitoring (CRC / Site Staff)

1. Monitor the Surveys worklist for sent and pending surveys
2. For manual sends, click Send on the survey package
3. Track completion status:
   • Sent — invitation sent, awaiting response
   • Completed — all responses submitted
   • Expired — link expired before completion
4. Follow up with participants who haven't completed

Expected output: Completion rate tracked and non-responders identified.

Step 5 — Response Review & Export (Data Manager)

1. Access survey responses via Subjects → Event → Survey CRF
2. Review responses for completeness and data quality
3. Export survey data via Export as on the Surveys worklist
4. Generate completion reports for sponsor review

Expected output: Survey data available for analysis.

Quality Governance

Survey Completion Targets

Metric	Target
Overall completion rate	> 80%
Time to complete	< 7 days from send
Partial completion rate	< 10%
Survey invitation bounce rate	< 2%

Data Quality Checks

• Review survey responses for logical consistency
• Check for duplicate submissions (if allowed)
• Verify skip logic and branching work correctly in Production
• Monitor for unusual response patterns

Periodic Review

• Weekly: Review completion rates and follow up on pending surveys
• Monthly: Review survey package schedules — are all still relevant?
• Per protocol version: Verify survey CRFs match current protocol requirements

Related Documentation

• CDS Surveys Workspace
• CDS Surveys Setup
• CDS Surveys Application
• CDS Mobile App