Overview of Connected Studies

Learn about and how to get started with Connected Studies in SiteVault.


Overview

Connected Studies are studies where you can send documents to and receive documents from a sponsor or contract research organization (CRO) directly in SiteVault. Veeva sells technology to sponsors and CROs that powers these connected studies. This technology is known to sponsors and CROs by the name Veeva Site Connect.

Sponsors and CROs will communicate that a study will be connected during site selection. The sponsor or CRO’s vault is connected to your SiteVault using your Universal Site Number (USN, a unique number for your site that’s assigned by Veeva after your SiteVault signup is approved). If a sponsor or CRO requests your USN, you can find it by navigating to the Profiles > Sites tab and opening the record for your site (by selecting it). The USN is displayed in the USN field in the Details section.

Finding your site's Universal Site Number (USN)

The Site Administrator users for your site will receive an email notification and a task to accept a connected study invitation. Once accepted, an active connected study allows you and the sponsor or CRO to send documents to each other directly in Vault. Once the study is completed, the sponsor or CRO will inactivate the connected study, which will end the exchange of documents for the study.

A Connected Studies icon (Connected Study Icon) is displayed on the study record page for studies with an active connected study. The icon indicates that users can use SiteVault to exchange study documents directly with a sponsor or CRO’s vault.

See the SiteVault Document Types Reference spreadsheet for the document types that can be sent to a sponsor or CRO on a connected study.

Getting Started

The process of getting started and exchanging documents with a sponsor or CRO on a connected study uses the following general steps:

1

Provide Your SiteVault USN If requested, you can find your SiteVault USN to provide to your sponsor or CRO by following the steps in the section above. The USN is what the system uses to connect your sponsor or CRO’s vault to your SiteVault.

2

Accept the Study Invitation Review and accept the Connected Study Invitation. See the Accepting Study Invitations page for more information.

3

Add Study Team and Profile Documents If not already completed, use the Setup Assistant to create user accounts for your study staff, upload their profile documents, and assign them to the study. The uploaded profile documents are then automatically transferred to your sponsor or CRO. See the Setup Assistant page for more information.

4

Complete Revise and Return Requests From your Regulatory Document Request package, revise and return the documents that were sent from the sponsor or CRO for you to update or sign then return, for example, a Protocol Signature Page or 1572. See the Revising and Returning a Document help topic for more information.

5

Provide Site-Original Documents From your Regulatory Document Request package, send the sponsor or CRO your site-original documents that the sponsor must also keep a copy of, for example, IRB submissions. See the Providing an Original Document help topic for more information.

6

Complete Financial Disclosure Forms For each staff member, copy and complete the template financial disclosure form, which can be found in the Other Received Documents section of the Regulatory Document Request package. See the Completing Financial Disclosure Forms help topic for more information.

7

Review Study Training Materials Have each study team member complete a Read and Understood task in SiteVault to provide evidence that training materials sent by the sponsor or CRO have been reviewed. See the Initiating or Completing Training Workflows page for more information, and see the Sending Training Documents help topic to learn how to send evidence of the training back to your sponsor or CRO once complete.

8

File Sponsor-Original Documents For any other received sponsor-original documents that should be kept on file at your site (for example, a protocol, investigational brochure, or study manual) move the document to its steady state. This ensures that the document is filed to your study’s eBinder. See the Processing Other Received Documents help topic for more information.

9

Work With Your Monitor Ensure that your monitor has access to your study and resolve any remote monitoring feedback on your documents. See the Granting Monitor Access page to learn how to ensure that your monitor has access to your study documents, and see the Managing Remote Monitoring Reviews page to learn how to resolve monitor feedback.

The following resources are available to help you get started with Connected Studies:

  • Connected Studies Videos: See the Connected Studies page to watch short how-to videos on how to get started with a connected study and exchanging documents.
  • Accepting Study Invitations: For Site Administrator users, see the Accepting Study Invitations page to learn how to review and accept a study agreement sent from a sponsor or CRO.
  • Managing Regulatory Document Requests: For Site Administrator users, see the Managing Regulatory Documents Requests page to learn how to complete a regulatory document package request.
  • Sending Documents to Sponsor/CRO: See the Sending Documents to Sponsor/CRO page to learn how to send documents to a sponsor or CRO.
  • Confirming the Receipt of Safety Documents: For Site Administrator users, see the Confirming the Receipt of Safety Documents page to learn how to acknowledge the receipt of safety documents or enable the auto-confirmation of safety documents.

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