Connected Studies

Learn how to exchange study documents with a sponsor or contract research organization (CRO) directly in SiteVault.

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Overview of Connected Studies

Connected Studies are studies where you can send and receive study documents to and from a sponsor or 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 is 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 open 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 Regulatory users for your site will receive an email notification and a task to accept a study agreement. Once accepted, an active study agreement 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 agreement, 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 Studies agreement. 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.

Managing Study Agreements

Study agreements are used to allow the flow of information between your SiteVault and a sponsor or CRO vault. Study agreements are always sent from the sponsor or CRO to you. During acceptance of the study agreement, the Regulatory user will determine whether the incoming study already exists in your SiteVault. If the study does not exist, SiteVault automatically creates the study and populates the study ID, sponsor site ID, and sponsor ID fields. You may overwrite the study ID to be something of your choosing. In some cases, accepting a study agreement will create study products.

Approving a Study Agreement

Accepting a Study Agreement

You can approve a study agreement only after you’ve reviewed and confirmed that all study information is accurate. Complete the following steps to review and approve a study agreement:

  1. Select Accept then Complete on the Approve Agreement task. SiteVault displays the Review Details section of the study agreement.
  2. Review the study agreement details, then select Next.
  3. Select one of the options below in the Resolve Study section depending on whether a record for the study already exists in your SiteVault.
    1. If the study exists, select Yes then search for and select the study.
    2. Select No if the study doesn’t exist. SiteVault will create the incoming study as a new record.
  4. Select Complete.
  5. In the Approve Agreement dialog, select Approve then Complete.

Rejecting a Study Agreement

Rejecting an Agreement

Rejecting an agreement should only occur if errors are found while completing the approval process. It is recommended that you reach out to the sponsor or CRO point of contact before rejecting any agreements.

To reject a study agreement, complete the steps in the Approving a Study Agreement section but select Reject in Step 5.

Completing Regulatory Document Packages

Once a study agreement is active, sponsor and CRO teams will send you a regulatory document package for the study, which are displayed as tasks for your site’s Regulatory users and can be viewed in the Documents > Regulatory Document Requests.

All documents received from a sponsor or CRO are also displayed in your Library in a Received from Sponsor/CRO state. From this state, Regulatory and Study Team users can initiate actions according to the document’s lifecycle, for example, changing the document’s state to Current or sending the document for eSignature. Once all the individual document requests in a package have been completed, you can mark the Regulatory Document Package task as complete. Each package contains several individual document requests. There are three types of requests you may receive:

Request Description Illustration
Revise and Return A document sent for you to update or sign (for example, Protocol Signature Page) then return to the sponsor or CRO.
Revise and Return
Provide Original A request for a site-original document (for example, IRB/IEC Composition for a Local IRB). These require the selection of a document from your Library that is in a steady state (Current, Approved for Use, Final, and so on).
Complete Document Requests
Receive Document (for filing only) A sponsor-original document for which a copy should be kept on file at the site (for example, Procedure Manual). When received, these are listed in the Other Received Documents section and with the exception of a financial disclosure form template (see the following section) should be processed appropriately to a steady state (Current, Final, and so on).
Receive Documents for Filing

View the videos on Connected Studies here to learn more about each request type.

Completing Financial Disclosure Forms

A financial disclosure form is sent as an approved template from the sponsor or CRO and is listed in the Other Received Documents section.

Complete the following steps to complete a financial disclosure form for each individual:

  1. Open the financial disclosure form template, and select Make a Copy from the Actions menu.
  2. Select Continue in the Make a Copy dialog.
  3. In the document’s Person field, select a staff member, then select Save.
  4. Select Check Out from the Actions menu. The template is downloaded to your computer.
  5. Open the downloaded file and complete the form.
  6. Select Check In from the Actions menu, upload the completed form using the dialog, then select Check In.
  7. Finalize the document using the most appropriate option (if not already signed, you can send for electronic signature).
  8. Select Send Document to Sponsor/CRO from the Actions menu to return the completed form.

Sending a Document

Sending a Document

Note This action is only available when an active study agreement exists and will not send any past document versions.

Documents that are eligible to be sent to a sponsor or CRO have the Send to Sponsor/CRO option in the document’s Actions menu. This applies to the following document states:

  • Steady-State Documents: Documents in a steady state, such as Current, Approved for Use, Final, and so on.
  • Documents in a Draft State: Nonsteady-state documents in a Draft state such as 0.1 can be sent to a sponsor or CRO to facilitate back-and-forth collaboration or negotiation until the document is ready to be approved for use. SiteVault automatically updates the state of the document to In Sponser Review when you send a Draft document. The following document types can be sent in a Draft state:

    Click here to view or hide the document types.

    Study or Study and Country Templates:

    • Advertisement for Recruitment
    • Diary (blank)
    • Informed Consent Form (blank)
    • Participant Materials - Other
    • Participant Questionnaire (blank)
    • Study Participation Card

    Site-Level Documents:

    • Confidentiality Agreement
    • Contract
    • Invoice

To send a document to a sponsor or CRO, select Send to Sponsor/CRO from the document’s action menu. SiteVault moves the document from the Documents to Return section to the Returned Documents section. Sending a document can take a few minutes to process.

See the Managing Regulatory Documents page for more information on uploading and managing regulatory documents in SiteVault.

Editing a Document and Moving It to In Sponsor Review

Complete the following steps to edit a document from a template and move it to In Sponsor Review:

  1. Open the template, and select Make a Copy from the Actions menu.
  2. Select Continue in the Make a Copy dialog.
  3. Enter any required or additional document information in the Information panel, then select Save.
  4. Select Check Out from the Actions menu. The template is downloaded to your computer.
  5. Open the downloaded file and complete the form.
  6. Select Check In from the Actions menu, upload the completed form using the dialog, then select Check In.
  7. Select Send to Sponsor/CRO from the document’s action menu.

Sharing Read and Understand Documents

Rejecting a Document

Rejecting a Document

Note While rejecting a document removes it from the request, it does not remove it from SiteVault.

You can reject documents or requests that are duplicates, not needed, or incorrect to remove them from the regulatory document request.

Complete the following steps to reject a document or request:

  1. In the Documents to Return section, select Reject from the document’s Actions menu in the Name column.
  2. Select Yes in the Reject Document Request dialog.

Managing Safety Documents

On a connected study, the sponsor or CRO can distribute safety documents such as INDSRs or Dear Investigator Letters directly to your SiteVault. You will receive a notification to either confirm the receipt of the safety documents or, if enabled for your site, the safety documents were automatically acknowledged as received. If more than one document is distributed to your site from a given sponsor or CRO, the documents are grouped into a daily digest envelope specific to that sponsor or CRO.

Confirming the Receipt of Safety Documents

Complete the following steps to confirm the receipt of safety documents:

  1. From either your All Tasks or Notifications view, select Continue on the Please Acknowledge Safety Documents task.
  2. Review the document or documents and associated information (such as product and study) as needed, select Accept, then select Complete.
  3. Select the Acknowledged option in the Please Acknowledge Safety Documents dialog, then select Complete. The sponsor is notified that you acknowledged the documents.

Enabling Auto-Confirmation of Safety Documents

Note The receipt of the documents is automatically confirmed, but you must still finalize the documents to consider them filed in your investigator site file.

If the auto-confirmation functionality is enabled, safety documents (of document type Expedited Safety Report) are displayed in your Library in the Received From Sponsor/CRO status.

Complete the following steps to enable the auto-confirmation of safety documents:

  1. Navigate to Profiles > Sites, and select the site in the Name column.
  2. Select Edit, select the Auto-Confirm Receipt of Safety Documents check box in the Site Settings section, then select Save.

Managing Profile Documents

Sending a Document

Profile documents include person and organization documents. Profile documents are automatically sent to sponsor and CRO teams when a study team member or study partner is moved to an Active state and their associated documents are in a Current state in SiteVault. As documents are updated and up-versioned over time, the new versions are automatically sent to the sponsor or CRO team.

To see a list of documents that are automatically sent, see the document types associated with the Organization Profile and Person Profile lifecycles.

Viewing Documents Sent to SiteVault

Documents for a connected study that have been received are in a Received from Sponsor/CRO state. Creating a shared view for documents in this state will help you to easily identify these documents in the Library. You also can view the documents in the Regulatory Documents Request

These documents can also always be found in the Regulatory Document Requests tab for that study.

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