Veeva ePRO allows you to assign surveys to participants.
Note Veeva ePRO is only available to sites whose sponsors are using Veeva ePRO in Clinical Operations.
Overview
If your study’s sponsor uses Veeva ePRO to collect patient-reported outcomes, you can use SiteVault to manage your study’s ePRO. Your study’s sponsor can share their ePRO collection with your site. An ePRO collection contains all of the surveys, translations, schedules, and notifications that your study’s ePRO requires. When you connect your study to ePRO in SiteVault, you can add ePRO languages for your study, approve ePRO collections that your study’s sponsor creates, enable participants with ePRO, and manage their study event dates and times.
General ePRO Workflow
The process of using Veeva ePRO in SiteVault uses the following general steps:
| # |
Step |
Role |
Action |
Help |
| 1 |
Create ePRO Collection |
Sponsor Staff |
Create, edit, and approve an ePRO collection, which includes all languages and translations, all surveys, and all schedules and notifications required for the ePROs in your study |
Not Applicable |
| 2 |
Share ePRO Collection |
Sponsor Staff |
Share an approved ePRO collection with your site by creating a connected study within your SiteVault |
Connected Studies |
| 3 |
Add Supported Languages |
Site Administrators |
Add supported languages for your site and study in SiteVault |
Managing ePRO Languages For Your Site and Study |
| 4 |
Approve ePRO Collection Document |
Site Administrators |
Approve the ePRO collection document in SiteVault following local IRB/EC approvals, if applicable
- If none apply, you can approve the ePRO collection document as soon as you receive it in SiteVault.
|
Managing ePRO Collection Documents |
| 5 |
Enable and Manage Participants' ePRO |
Site Staff |
Enable study participants with ePRO and enter study event dates and times in SiteVault in order to send surveys to study participants |
|
| 6 |
Submit Surveys |
Participants |
Receive and submit their assigned surveys in MyVeeva for Patients |
Surveys |
| 7 |
Export Data |
Site Staff |
Export survey, adherence, and system audit trail data as participants submit ePRO data |
Exporting Survey, Adherence, and Audit Trail Data |
ePRO Troubleshooting Resources
See the following pages for additional resources about troubleshooting Veeva ePRO in SiteVault and MyVeeva for Patients: