Purpose

This SOP defines role ownership and handoff for the Monitoring Visit lifecycle, from report drafting to sponsor approval.

Use this page for operational alignment between CRA/Monitor teams and sponsor-side reviewers/approvers.

Validated account set for this SOP:

• site01_monitor, site02_monitor (Monitor/CRA)
• site01_reviewer (Reviewer)
• study_sponsor (Sponsor)
• study_admin (Configuration owner)

Scope

• Module: Monitoring Visit
• Main statuses: Draft -> Completed -> Reviewed -> Finalized -> Approved
• Main roles in this SOP:
  • CRA / Site Monitor
  • Monitor / Reviewer
  • Sponsor (Monitoring Sponsor or Sponsor-side approver)

Account Mapping by Role

SOP Role	Account
CRA / Site Monitor	site01_monitor, site02_monitor
Reviewer	site01_reviewer
Sponsor Approver	study_sponsor
Study Configuration Owner	study_admin

Role Matrix by Status

Status	Primary Role Owner	Typical Actions	Exit Criteria	Next Status
Draft	CRA / Site Monitor	Create report, complete CRF fields, add comments/issues/reviews, attach evidence, update activities note	Content is complete and internally checked	Completed
Completed	Monitor / Reviewer	Perform quality and clinical operations review, verify report completeness and consistency	Reviewer confirms report quality for escalation	Reviewed
Reviewed	Monitor / Reviewer (with sponsor-facing readiness check)	Consolidate review outcomes and prepare final package for sponsor decision	Report is ready for sponsor approval package	Finalized
Finalized	Sponsor-side approver (or authorized equivalent)	Sponsor review, compliance check, approval decision	Sponsor accepts finalized report	Approved
Approved	Sponsor + Study Operations	Archive/reference, downstream follow-up and issue closure governance	No further state escalation	End state

Permission Matrix (Operational)

This matrix is based on Monitoring Visit permission groups used in the application (monitoringVisit.*) and status-change flow in report detail.

Capability	CRA / Site Monitor	Monitor / Reviewer	Sponsor
View list/detail	Yes	Yes	Yes
Add report	Yes (if role granted)	Typically limited	Yes (if role granted)
Edit report content	Yes	Role-dependent	Role-dependent
Create comment	Yes	Yes	Yes
Create issue	Yes	Yes	Yes
Create review notes	Optional by role	Yes	Yes
Change status	Yes (if monitoringVisit.status.change)	Yes (if monitoringVisit.status.change)	Yes (if monitoringVisit.status.change)
Set Reviewed	Requires dedicated permission gate	Primary role	Role-dependent
Set Finalized	Usually reviewer/lead monitor gate	Primary role	Role-dependent
Set Approved	Usually sponsor/approver gate	Role-dependent	Primary role

Minimum permissions to validate this SOP end-to-end:

• monitoringVisit.report.view
• monitoringVisit.report.create
• monitoringVisit.report.update
• monitoringVisit.review.create
• monitoringVisit.status.change
• monitoringVisit.export

Step-by-Step SOP

Step 1 - Create and Maintain Draft (CRA / Site Monitor)

Recommended account: site01_monitor

1. Open Monitoring Visit -> Reports.
2. Click Add Report and select site + visit type.
3. Complete report content in Report detail.
4. Save draft progress continuously.
5. Add section-level comments/issues where evidence is required.

Expected output: a complete Draft ready for quality review.

Step 2 - Mark Complete for Review (CRA / Site Monitor)

Recommended account: site01_monitor

1. Verify all mandatory CRF content and supporting evidence are present.
2. Confirm no unresolved critical inconsistencies remain.
3. Move report from Draft to Completed according to your workflow controls.

Expected output: report enters reviewer queue.

Step 3 - Reviewer Assessment (Monitor / Reviewer)

Recommended account: site01_reviewer

1. Open report in Completed status.
2. Validate quality, consistency, and operational readiness.
3. Click Set as Reviewed and provide status note.
4. If not acceptable, use Reject to return report to Draft with note.

Expected output: report is either corrected (back to Draft) or promoted to Reviewed.

Step 4 - Finalization Handoff (Monitor / Reviewer)

Recommended account: site01_reviewer

1. Confirm all review comments are resolved or documented.
2. Click Set as Finalized with clear note.
3. Notify sponsor-facing recipients if required by SOP.

Expected output: sponsor-ready package in Finalized.

Step 5 - Sponsor Decision (Sponsor)

Recommended account: study_sponsor

1. Sponsor/approver opens Finalized report.
2. Perform sponsor-side review and compliance checks.
3. Click Set as Approved with approval note.
4. If not acceptable, use Reject to return to Draft for correction cycle.

Expected output: Approved report as final state.

Email and Notification SOP

Notification rules are configured in:

• Home -> Study -> Monitoring Visit -> Visit Configuration -> Edit

Recommended setup:

1. Add operational recipients for Draft/Completed handling.
2. Add sponsor-facing roles for Reviewed/Finalized/Approved transitions.
3. Use Specific people only for exceptions and named stakeholders.
4. Require meaningful status notes so notification emails carry useful context.

Audit and Governance Rules

• Every status change must include a note.
• Use Reject to enforce correction loop instead of undocumented side-channel changes.
• Keep issue/comment/review records attached to relevant report section for traceability.
• In view-only studies, operations are read/export only; use a writable study for active workflows.

Execution Checkpoints for Documentation Team

1. Verify one report exists in each status (Draft, Completed, Reviewed, Finalized, Approved).
2. Verify one rejected report cycle exists (Reviewed/Finalized -> Draft).
3. Verify status note modal is completed at each transition.
4. Verify export actions work for monitor-level account.

Related Documentation

• Monitoring Visit Overview
• Monitoring Visit Configuration
• Monitoring Visit User Guide