Sending Documents to Sponsor/CRO

Learn how to send documents from SiteVault to your sponsor or contract research organization (CRO).


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Overview

Documents that are eligible to be sent to a sponsor or CRO have the Send to Sponsor/CRO or Send Document to Sponsor/CRO option in the document’s All Actions menu. Depending on the document type, you can send the document from the following lifecycle states:

  • Steady-State Documents: Documents in a steady state, such as Current, Approved for Use, and Final.
  • Documents in an Initial State: You can send select documents in the Draft or Received from Sponsor/CRO state to facilitate back-and-forth collaboration or negotiation until the document is ready to be finalized or approved. When you send a document from an initial state, SiteVault automatically updates the state of the document to In Sponsor Review.

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

See the sections below for more information on sending documents to a sponsor or CRO’s vault from SiteVault.

Sending Profile Documents

Profile documents are those that are specific to a person or organization such as a CV or IRB/IEC Compliance document. SiteVault automatically transfers a subset of profile documents when the following conditions are met:

  • An active study invitation exists.
  • The status of the person or organization profile document is Current.
  • The person or organization is assigned to the study in an Active state.

When the above conditions are met, the following person and organization profile documents are transferred automatically:

  • CV
  • IRB/IEC Compliance
  • IRB/IEC Composition
  • Lab Certification
  • Lab Normal Ranges
  • Medical License
  • Training Evidence (non study-specific)

Note Profile documents for organizations with the role of either Central Lab or Central IRB are not transferred automatically.

As documents are updated and up-versioned over time, the new major version (such as 2.0) is automatically sent to the sponsor or CRO.

On rare occasions, the profile document may not transfer automatically. If needed, you can select Send to Sponsor/CRO from the document’s All Actions menu to send the document.

For other profile documents that are not transferred automatically, select Send to Sponsor/CRO to transfer the documents as needed. The document must be in its Current state.

To see a list of profile documents that can be transferred, see the SiteVault Document Types Reference spreadsheet. Filter the spreadsheet by the Organization Profile and Person Profile lifecycles.

You can send the following legal and financial documents to a sponsor or CRO:

  • Budget: Can be sent from the Received from Sponsor/CRO and Finalized states.
  • Confidentiality Agreement: Can be sent from the Draft and Fully Executed states.
  • Contract: Can be sent from the Draft, Received from Sponsor/CRO, and Fully Executed states.
  • Invoice: Can be sent from the Draft and Finalized states.

To send one of these documents, select Send to Sponsor/CRO from the document’s All Actions menu.

Note that Site Staff users without the Site Profiles add-on are unable to send a legal or financial document to a sponsor or CRO.

Sending Study Documents

Certain study documents can be sent from their steady state (Approved for Use, Current, or Final). See the SiteVault Document Types Reference spreadsheet for the full list of study documents on the Draft to Approved for Use, Draft to Current, and Draft to Final lifecycles that can be sent to a sponsor or CRO. To send a document, select Send to Sponsor/CRO or Send Document to Sponsor/CRO from the document’s All Actions menu.

In addition, you can also send the following documents that are often used as study or study and country templates when in the Draft state:

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

This enables you to make a copy of a template, update as needed, then send it to the sponsor or CRO while still in a Draft state for review.

Complete the following steps to copy and edit a document from a template and send it to a sponsor or CRO:

  1. Select Make a Copy from the document’s All Actions menu, then select Continue in the dialog box.
  2. Enter any required or additional document information, then select Save. A new draft of the document is created.
  3. Select Check Out from the All Actions menu of the new draft document. The template is downloaded to your computer.
  4. Open the downloaded file and update as needed.
  5. Select Check In from the All Actions menu, upload the updated document using the dialog box, then select Check In.
  6. Select Send to Sponsor/CRO from the document’s All Actions menu.

If the original template document is updated, you can use the Create Draft from Original Document action on the copied document to update it to the original document. See the help for Working With Document Templates for more information.


Overview of Connected Studies
Overview of Digital Delegation