Using the Monitoring Features

Site Monitoring provides the ability to manage all aspects of routine monitoring visits (Pre-Study Visit, Site Initiation Visit, Interim Monitoring Visits, and Close Out Visit), including confirmation and follow up letters, monitoring visit reports, and tracking on-site monitoring activities.

Prepare a Visit

1. From the Study Homepage, select the desired study. Use the study selector to navigate to the correct country and site.
2. In the Monitoring Plan section, click Create.
3. Select a Monitoring Event Type from the drop-down list.
4. Click Continue to display the Monitoring Visit Details.
5. Complete the required information and click Save to create the new Monitoring Event.
6. Click the desired event. The system displays the selected Monitoring Event in the Planning state.
7. Review the personnel expected for the visit:
   • Click Monitoring Visit Participants to view the list of expected participants.
   • Click +Create to add new people to the list as needed.
   • Navigate to Study Person > Create Study Person and type in required information for the new participant.
   • Click Save to confirm changes and return to your list.
   • Select the Invitation status as appropriate and click Save to confirm the new participant.
8. Review and update the pre-populated list of activities.
   • Click +Add to view the full list of monitoring activities.
   • Click the checkbox to add or remove items from the list, as needed.
   • Click OK to confirm changes and return to your list.
9. When your list contains the desired activities, select Confirm in the workflow drop-down to accept the planned visit.

The system displays the Start dialogue box. Type the Planned Start and Planned End dates and click Start. The Monitoring Event is now in the Confirmed state. The system generates a visit confirmation letter, and automatically files it in the eTMF.

All generated items include the key information from the visit setup.

Conduct a Visit

On visit day, you will use the pre-planned visit to assess the progress of the site. The questions will vary depending on the visit type.

1. Open the desired monitoring visit.
2. Select Start Monitoring Visit from the workflow menu.
3. Enter the Actual Start Date and the Actual End Date. Click Start.
4. Click under Attended? to confirm the personnel present for the visit.
5. As you conduct your visit, complete all questions and comments as necessary.

Send a Trip Report for Review

1. After visit in complete, select Start Visit Report & Approval from the workflow menu.
2. Select a Reviewer and a Due Date for the review.
3. Click Start. The system generates a task and a notification email for the reviewer. The monitoring visit report is automatically filed in the eTMF.

Reviewing a Trip Report

As a reviewer, you should now see a task notification on your Study Homepage.

1. Click the notification to open the monitoring visit.
2. Review the populated monitoring visit.
3. Where corrections are needed on the visit report, add a review comment. The system generates a count of the comments for reviewers and displays the tally in the Review Summary.

Rejecting or Approving a Trip Report

After your review, click Complete. The system displays a dialogue box with two options.

To Reject a Report

1. Click Changes Requested and enter comments to send the report back to the Monitor for changes.
   • The monitoring visit returns to the In Progress state.
2. Repeat the review process to complete the document.

To Approve a Report:

1. Click Approved, and select your Capacity to accept the document and send it back to the Monitor for final signature.
2. Click Complete, and enter your e-signature. The system then prompts the Monitor to complete an e-signature.

After the Monitor adds their e-signature, the Monitoring Event is now in Approved state. The system generates a visit follow-up letter and automatically files it in the eTMF. The monitoring visit report also moves to the Approved state in the eTMF.

Recording Issues and Follow-up Items

While conducting a visit, you can use Vault to note issues. These issues are connected to the visit and are stored in the system for future evaluation. Locate the Issues and Follow-Up Items section of a Monitoring Event to view these items:

• New Issues
• Open Issues
• Closed Issues Since Last Visit
• New Follow Up Items
• Open Follow Up Items
• Closed Follow Up Items Since Last Visit

To log an issue:

1. Click New Issue.
2. Click Create and select an Issue Type:
   • Protocol Deviation - something that breaks the protocol standards.
   • Observation - something that should be checked, but is not a direct violation of protocol.
3. Fill in the details and click Save. The new issue is added to your New Issues list.

Resolving Open Issues

1. To resolve an issue, navigate to the desired study and site.
2. In the Monitoring Plan section, click the related visit.
3. Under Issues and Follow-Up Items, click Open Issues and the system will display the Open Issues list.
4. Click on the issue you want to resolve.
5. Select Resolve Issue from the Workflow drop-down.
6. Type in the Resolution description and click Start. The issue is now resolved.