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Monitoring Visit Role-Based SOP

# Monitoring Visit
Last updated: 04/14/2026

Purpose

Purpose​

This page defines who does what at each stage of the Monitoring Visit lifecycle. Use it to align your team on role ownership, handoff procedures, and approval requirements.

Report Statuses​

Draft → Completed → Reviewed → Finalized → Approved

Role Matrix by Status​

Draft​

  • Who: CRA / Site Monitor
  • What: Create the report, fill in CRF sections, add comments and issues, attach evidence
  • Done when: All content is complete and checked
  • Next: Completed

Completed​

  • Who: Reviewer
  • What: Review report quality, consistency, and operational readiness
  • Done when: Reviewer confirms the report is ready for escalation
  • Next: Reviewed

Reviewed​

  • Who: Reviewer
  • What: Consolidate review outcomes, prepare final package for sponsor
  • Done when: Report is ready for sponsor approval
  • Next: Finalized

Finalized​

  • Who: Sponsor (or authorized approver)
  • What: Sponsor review, compliance check, approval decision
  • Done when: Sponsor accepts the finalized report
  • Next: Approved

Approved​

  • Who: Sponsor + Study Operations
  • What: Archive, downstream follow-up, issue closure governance
  • Done when: End state — no further escalation

Permission Reference​

Minimum permissions needed for each role:

CapabilityCRA / MonitorReviewerSponsor
View reportsYesYesYes
Create reportsYes——
Edit report contentYes——
Add commentsYesYesYes
Create issuesYesYesYes
Set Reviewed—Yes—
Set Finalized—Yes—
Set Approved——Yes
Reject to Draft—YesYes

Step-by-Step Handoff​

Step 1 — CRA Creates and Submits Report​

  1. Open Monitoring Visit → Reports
  2. Click Add Report, select site and visit type
  3. Complete all report sections
  4. Add comments, issues, and attach evidence as needed
  5. Move report from Draft to Completed using the status button
  6. Confirm all mandatory content is present

Step 2 — Reviewer Assesses and Finalizes​

  1. Open the report in Completed status
  2. Review quality, consistency, and operational readiness
  3. If acceptable: Click Set as Reviewed, add a review note, then Set as Finalized
  4. If not acceptable: Click Reject, return to Draft with a note explaining what to fix
  5. The report re-enters the CRA's queue for correction

Step 3 — Sponsor Approves​

  1. Open the report in Finalized status
  2. Perform sponsor-side review and compliance checks
  3. If acceptable: Click Set as Approved with an approval note
  4. If not acceptable: Click Reject to return to Draft for correction

Notification Setup​

Notifications should be configured in the visit type settings to keep the right people informed at each stage:

  1. Add operational recipients for Draft/Completed transitions (CRA, Reviewer)
  2. Add sponsor-facing roles for Reviewed/Finalized/Approved transitions
  3. Use individual email addresses only for named stakeholders
  4. Require meaningful status notes so notification emails carry useful context

Configuration path: Home → Study → Monitoring Visit → Visit Configuration → Edit

E-Signature​

E-signature is required to complete the approval workflow. The signer must have the appropriate role permission. After signing, the report is locked — any changes require reopening with a documented reason. All signature events are recorded in the audit trail.

For details, see E-Signature in the User Guide.

Governance Rules​

  • Every status change must include a note explaining the decision
  • Use Reject for corrections — don't bypass the workflow with side-channel changes
  • Keep issues, comments, and reviews attached to the relevant report section
  • In view-only studies, reports are read/export only
  • Reopening a signed report requires authorization and a documented reason
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