Study Connect is an application in Veeva SiteVault empowering site users to connect with their sponsors, contract research organizations (CRO), and patients who are also using Veeva technology.
Study Connect includes the following features:
- Document Exchange: Exchange study documents with sponsors or CROs who are using Veeva Clinical Vault.
- Safety Documents: Receive, review, and acknowledge safety reports with sponsors or CROs who are using Veeva Clinical Vault.
- eConsent: Manage the consent process electronically with patients using the MyVeeva for Patients app.
- ePRO: Collect patient data electronically with patients using the MyVeeva for Patients app.
See the Introduction and Overview: Study Connect training video for more information.
- Only studies connected to a sponsor or CRO’s vault are displayed in the study list.
- Studies requiring attention are displayed at the top of the list.
- Studies with pending invitations are prioritized at the top of the list.
In Study Connect, an orange icon indicates that an item requires attention.
Connected Study Invitations
- Study invitations are used to allow the flow of information between your SiteVault and a sponsor or CRO’s vault.
- Study invitations are always sent from the sponsor or CRO to a SiteVault.
- New study invitations are displayed in the studies list with a status of Pending Invitation.
Connected Study Invitations Process Overview
The process for receiving and accepting connected study invitations uses the following general steps:
- Sponsor or CROs using Veeva Clinical Vault seek to conduct a study where study sites use Veeva SiteVault to connect with their Clinical Vault.
- During site selection, the sponsor or CRO requests that study sites sign up for Veeva SiteVault (if not already in use).
- Sites sign up for Veeva SiteVault.
- The sponsor or CRO requests the site’s Universal Site Number (USN). The USN is a unique number for your site that is assigned by Veeva after your SiteVault signup is approved.
- Site provides the sponsor or CRO the site’s USN, which is found by positioning your pointer over the site name in the upper-right corner of SiteVault.
- Sponsor or CRO vault sends a study-specific invitation to the SiteVault seeking to collaborate on the study.
- Invitation lists the Study Connect features used in the study.
- SiteVault Site Administrators receive and respond to the pending invitation in Study Connect.
- Once the invitation is accepted, Study Connect functionality can be used and the study is considered a connected study. If needed, a sponsor or CRO can resend an invitation.
Universal Site Number
- Unique number for your site that’s assigned by Veeva after your SiteVault signup is approved.
- Sponsor or CRO Vault Clinical uses the USN to connect to your SiteVault.
- Finding your USN:
- In Study Connect, the USN is located by positioning your pointer over the site name in the upper-right corner of SiteVault.
- In the eReg Application, navigate to the Administration > Sites tab and select the record for your site. The USN is displayed in the USN field in the Details section.
Study Connect and eRegulatory
Interaction with SiteVault eRegulatory
- SiteVault is comprised of two applications: Study Connect and eRegulatory.
- The SiteVault eRegulatory application contains features to manage an electronic Investigator Site File (eISF), staff responsibilities, remote monitoring, and more.
- If you have initiated the use of SiteVault eRegulatory, you can access eRegulatory by selecting the Switch to eReg link in the upper-right corner of Study Connect.
- When a document is created or received in Study Connect, a draft copy is generated and stored in eRegulatory, even if eRegulatory is not in use.
- When a principle investigator (PI) is assigned to a Study Connect study, the eRegulatory study record is also be updated.
Study Connect and eRegulatory Permissions
- Users granted study access in Study Connect are also granted access to the study in eRegulatory in the Other Non-Investigator role.
- Users granted study access in eRegulatory are also granted access to the study in Study Connect.
- Site Staff records created in eRegulatory are displayed in the Study Connect application and inherit the study assignments in Study Connect.
- Site Staff records created in Study Connect are displayed in the eRegulatory application and inherit the study assignments in eRegulatory, but may require an administrator user to review and update as eRegulatory tasks require a more robust system role and permission structure than most Study Connect tasks.
- Sites using both Study Connect and eRegulatory are encouraged to create their Site Staff records in the eRegulatory application for maximum flexibility and to reduce the administrative effort.