Monitoring Visits help ensure a study is conducted ethically and in compliance with regulations.
Veeva Clinical Basics supports the creation and conduct of Pre-Study, Site Initiation, Interim Monitoring, and Close Out Visits.
Create a Monitoring Visit
Creating a visit sets its status to Planning.
To create a monitoring visit:
Navigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.
In the Monitoring Plan section, click Create.
Select the Visit Type and click Continue.
Enter a Visit Name.
Select the Monitor who will be attending the visit and click Save.
The status of the visit is Planning.
Confirm a Monitoring Visit
When you know the visit will take place, review the Monitoring Visit Participants and Activities before confirming the visit.
Confirming a visit creates and classifies a Visit Confirmation Letter in eTMF. When ready, this letter should be sent to the Principal Investigator.
Confirming a visit changes its status to Confirmed.
To confirm a monitoring visit:
Navigate to the Study Management homepage. Use the study selector to navigate to the correct country and site.
In the Monitoring Plan section, click the Visit you want to confirm.
Open the Monitoring Visit Participants section. Site personnel are automatically added as visit participants. Click Create to add additional participants, if needed.
For each participant, set Invited? to Yes if they should be included in the Visit Confirmation letter that gets sent to the site ahead of the visit.
Best Practice If you don’t want a participant to display on the Confirmation Letter, set Invited? to No. If you leave this field blank, the participant will still display on the letter.Open the Monitoring Activities section and review the list of activities planned for the visit. The activities will be listed in the Visit Confirmation letter.
Click Add to add an additional activity for the visit.
Hover over an activity and select Remove from the All Actions menu if it will not be done at this visit.
Select Confirm Monitoring Visit from the Workflow Actions menu.
Specify the Planned Start and End Date for the visit and click Start.
Confirmation Letter
Confirming a visit creates and classifies a confirmation letter specific to the visit in eTMF.
You can make certain additional changes to the body of the letter by editing the document.
- Site Number
- Site Location
- Study Number
- Protocol Title
- Visit Dates
- Monitoring Visit Participants
- Monitoring Activities
- Monitor’s Name, Email, and Phone Number
If you notice any of this information is incorrect after the confirmation letter has been generated, correct it in Vault first and then refresh the confirmation letter.
When ready, the confirmation letter should be sent to the Principal Investigator to confirm the visit.
Refresh Confirmation Letter
To refresh a confirmation letter:
Navigate to the confirmed monitoring visit you want to refresh the confirmation letter for.
Select Refresh Confirmation Letter from the All Actions menu.
The document will be upversioned and any new information will be reflected in the confirmation letter.
What is the next step?