Request an ePRO data change from Veeva if you need to correct errors with your study's data.
Note Veeva ePRO is only available to sites conducting a study whose sponsor is utilizing Veeva ePRO in a Clinical Vault.
Overview
If you or your study’s sponsor notice or are informed of an error with ePRO data entered by a study participant or site staff, your site can submit an ePRO data change request to Veeva. Only site administrators or site staff can request data changes from Veeva. Requests submitted by sponsor staff won’t be processed.
These requests must be for changes that you can’t make in SiteVault.
Managing ePRO Data in SiteVault
You can update the following data in SiteVault without contacting Veeva:
- Participant ID:You can update the Participant ID associated with a patient.
- ePRO Event Datetimes: You can update Participant Event dates and times.
Requesting ePRO Data Changes
To submit an ePRO data change request to Veeva for other data, complete the following steps:
- Download the Veeva ePRO Data Change Request Form.
- Complete the form. Only one change can be requested per form, and the following fields must be completed if they’re applicable. You can include the other information if it’s needed for the change.
| Field |
Description |
| SiteVault Username |
Enter your SiteVault username.
To locate your SiteVault username in SiteVault eRegulatory or Study Connect, select the account icon in the upper-right corner. Select User Profile from the drop-down menu. Your user name is displayed on the left side of the page. |
| Study Identifier |
Enter the study identifier as it appears in SiteVault.
To locate the Study Identifier in SiteVault eRegulatory or Study Connect, complete the following steps:
- eReg: Navigate to Studies and select the study. Locate the Study Identifier on the study record.
- Study Connect: On the Studies tab, look beneath the Study Identifier column and locate the study.
|
| Universal Site Number (USN) |
Enter your site’s Universal Site Number (USN) as it appears in SiteVault.
To locate your Universal Site Number, complete the following steps:
- eReg: Navigate to Administration > Sites and locate your site. The USN is displayed beneath the USN column.
- Study Connect: Select your site’s name in the upper right-corner. When the drop-down menu appears, hover over the name of your site. The USN is displayed.
|
| Participant ID |
Enter the Participant ID of the affected participant as it appears in SiteVault.
To locate the Participant ID, complete the following steps:
- eReg: Navigate to Studies and select the study. On the study record, select Participants (Subjects) on the left-hand menu. The Participant ID is displayed beneath the Study Participant ID column.
- Study Connect: Navigate to Studies and select the study. Select ePRO on the left-hand menu and select the Participants tab. Locate the participant’s record. The Participant ID is displayed.
|
| Event Name (If Applicable) |
Enter the event name of the affected participant event as it appears in SiteVault and your ePRO data exports. If you aren’t changing any data related to a participant event, leave this field blank.
To locate the Event Name, export Survey or Adherence Data and look beneath the Event Name column. See Exporting Survey, Adherence, and Audit Trail Data in SiteVault eRegulatory Help or Exporting Survey, Adherence, and Audit Trail Data in Study Connect Help for more information. |
| Survey Unique ID (If Applicable) |
Enter the survey unique ID for the affected survey as it appears in SiteVault and your ePRO data exports. If you aren’t changing any data related to a survey, leave this field blank.
To locate the survey unique ID, export Survey Data or Adherence Data and look beneath the Survey Unique ID column. See Exporting Survey, Adherence, and Audit Trail Data in SiteVault eRegulatory Help or Exporting Survey, Adherence, and Audit Trail Data in Study Connect Help for more information. |
| Question Unique ID (If Applicable) |
Enter the question unique ID for the affected question as it appears in your ePRO data exports. If you aren’t changing any data related to a question, leave this field blank.
To find the question unique ID, export Survey Data and look beneath the Survey Unique ID column. See Exporting Survey, Adherence, and Audit Trail Data in SiteVault eRegulatory Help or Exporting Survey, Adherence, and Audit Trail Data in Study Connect Help for more information. |
| Current Value |
Enter the incorrect value that requires a data change exactly as it appears in SiteVault or your ePRO data exports. |
| New Value |
Enter the correct value that the data should reflect. |
| Reason for Change |
Enter the reason for the change. |
- Print the form, and have the study’s principal investigator or their designated representative sign it. It is your responsibility to store the signed paper form.
- Email the signed form to dcr@veeva.com with a title of ePRO Data Change Request. We’ll review your request and, if approved, process the change in our system. If we have questions, we will contact you through Zendesk and your email.
- After we process the data change, we’ll send you a confirmation through Zendesk and your email.
- View the audit trail entries we provide you, and export the ePRO data from SiteVault to verify that the change is correct. The exported data includes the updated data and an entry for the data change. See Exporting Survey, Adherence, and Audit Trail Data in SiteVault eRegulatory Help or Exporting Survey, Adherence, and Audit Trail Data in Study Connect Help for more information.
- If the change is correct, respond to the Zendesk message or email to confirm it. If we don’t receive confirmation after three follow-up attempts, we’ll close the ticket.