info

For the business definition, see Monitoring Visit in Getting Started.

Configure the Monitoring Visit module before report operations begin. Changes take effect immediately — existing reports are not affected.

Path: Home → Study → Monitoring Visit

Configuration Sections

The configuration screen has two sections:

• Visit Configuration — Define settings per visit type
• Site Branches — Manage branch information for each site

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Configure Visit Types

Each visit type has its own card (e.g., Contact Report, Site Monitoring Visit, Qualification Visit Report, Site Initiation Visit Report). Click Edit on a visit type to configure it.

Visit Configuration Fields

Field	Description	Required
Active switch	Enable or disable the visit type	Yes
Visit name	Display name used in dashboard and report creation	Yes
CRF name	CRF used as the report template	Yes
CRF version default	Default CRF version for new reports	Yes
Email recipients on status update	Role-based notification recipients	Recommended
Specific people	Additional email addresses (separated by semicolons)	Optional

warning

If CRF name or CRF version default is missing for an active visit type, users cannot create new reports for that visit type.

Notification Behavior

Email recipients receive notifications when a report changes status. Best practice:

1. Include operational roles for Draft/Completed transitions (CRA, Reviewer)
2. Include sponsor-facing roles for Reviewed/Finalized/Approved transitions
3. Use Specific people only when role-based recipients aren't sufficient

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Configure Site Branches

Click Edit in Site Branches to open the branch dialog. Use Add more branch to register additional locations per site.

Field	Purpose
Branch name	Identifies the location in reports
Branch address/contact	Supports communication and traceability

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Visit Dependency Rules

Control the order in which visit types can be created to enforce your monitoring plan.

Typical Visit Sequence

Phase	Visit Types	Dependency
Start-Up	Site Qualification Visit (SQV), Site Initiation Visit (SIV)	SQV before SIV
Active Monitoring	Site Monitoring Visit (SMV), Contact Report	SIV before SMV
Close-Out	Site Close-Out Visit (COV)	All SMVs completed

Setting Dependencies

1. In Visit Configuration, click Edit on a visit type
2. Under Dependency Rules, set:
   • Prerequisite Visit Type — which visit must be completed first
   • Prerequisite Status — minimum status required (e.g., Approved)
   • Block Creation — prevent new reports if prerequisites aren't met
3. Click Submit

Example Rules

Visit Type	Prerequisite	Min Status	Effect
Site Initiation Visit	Site Qualification Visit	Approved	Cannot create SIV until SQV is approved
Site Monitoring Visit	Site Initiation Visit	Approved	Cannot create SMV until SIV is approved
Site Close-Out Visit	Site Monitoring Visit	Finalized	Cannot create COV until at least one SMV is finalized

When rules are configured, the Add Report button is disabled for blocked visit types. Users see a warning when attempting to create a report without meeting prerequisites.

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Issue Templates

Standardize findings by defining templates per visit type. Templates pre-fill common issue attributes so monitors spend less time on classification.

Creating Templates

1. In Visit Configuration, click Edit on a visit type
2. Under Issue Templates, define each template with:
   • Name — descriptive label
   • Category — Protocol, GCP, Documentation, Consent, Safety, Process, Data
   • Default Level — High, Normal, Low
   • Default Type — Deviation, Waiver, Violation
   • Description Template — pre-filled finding text
   • Suggested Action — recommended corrective action
3. Click Submit

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Notification Rules

Define who gets notified for key monitoring events.

Event	Suggested Recipients
Issue assigned	Issue owner
Issue due soon	Issue owner, Study Manager
Issue overdue	Issue owner, Study Manager
Response received	Report author (CRA)
Issue closed	Report author, Study Manager
Report submitted	Reviewer
Signature requested	Authorized signers

Configuring Notifications

1. In Visit Configuration → Edit, under Email recipients on status update
2. Select role-based recipients for each transition
3. Add individual emails under Specific people (separated by semicolons)
4. Enable Daily digest to send summaries of overdue actions to Study Managers

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Report Configuration

Each visit type also has report-level configuration:

Email Templates

Customize notification emails per visit type:

Use template variables to personalize content:

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E-Signature Configuration

Enable e-signature to meet compliance requirements for report approval.

1. Go to App Setting → Monitoring Visit → E-Signature
2. Configure:
   • Require e-signature for report approval — enforce signing before Approved status
   • Capture IP and device metadata — record signer context in audit trail
   • Record hash/snapshot — store report content hash at signing time
   • Reopen requires approval — enforce approval for post-signature edits
3. Click Submit

Pre-Sign Checks

Before signing is permitted, the system verifies:

• All required report sections are completed
• No critical issues remain unresolved
• All mandatory fields are filled
• Signer has the appropriate role permission

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SDV Integration

Configure how Monitoring Visit SDV status syncs with the EDC module.

1. Go to App Setting → Monitoring Visit → SDV Integration
2. Configure:
   • Sync SDV status to EDC — bidirectional status updates
   • SDV Delta View — show differences between current and previous visit SDV
   • Risk-based sampling — enable subject selection strategies (random, high-risk, overdue)
3. Click Submit

SDV statuses flow: not started → partial → completed → not applicable. Updates from Monitoring Visit appear on EDC dashboards within the configured sync interval.

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Recommended Setup Order

1. Enable only the visit types your monitoring process uses
2. Assign a CRF and default version for each active visit type
3. Configure notification recipients for each status transition
4. Review site branches and add any missing entries
5. Set up visit dependency rules if your process requires sequencing
6. Configure issue templates to standardize findings
7. Enable e-signature if required by your compliance process
8. Verify by creating a test report and walking through the workflow

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Related Documentation

• Monitoring Visit Overview
• Monitoring Visit User Guide
• Monitoring Visit Role-Based SOP
• Monitoring Visit Report App