Sync Study PI With Study Assignments

With this feature, when you add and activate a user on a study as a study team assignment with the role of Principal Investigator, the Principal Investigator field on the study is automatically updated to that PI.

User Administration Enhancements

This release includes the following updates to managing user access and permissions in SiteVault:

• When you update a user’s status to Inactive, the user is inactivated for all sites they are assigned to.
• Research Organization Administrator users can now manage user permissions with the research organization selected in the vault selector. This enables you to manage user permissions across multiple sites at the same time.

Research Organizations Selectable in the Vault Selector

All SiteVault users can now select their research organization in the vault selector. The information and documents that you can access or manage are determined by the context that’s selected.

New Document Type

The IP Quality Complaint document type is now available. The document follows the Draft to Final document lifecycle.

General

This release also includes general usability enhancements to annotations, reporting, workflow, and search capabilities.

Veeva eConsent and MyVeeva for Patients

Additional Signatories

This feature introduces additional signatories to the Veeva eConsent workflow. You can now send eConsent forms to guardians, proxies, witnesses, and translators to sign on behalf of or in conjunction with participants. SiteVault stores the signatures captured in MyVeeva for Patients during the eConsent process.

See the following help for more information:

• Consenting Participants
• Working With Sections and Content Blocks section in Clinical Operations Help

Share Documents With Participants

This feature enables you to share non-eConsent documents with study participants or their signatories through MyVeeva for Patients. You can share the documents with new or existing participants, proxies, guardians, and representatives; and you can retract the documents as needed.

The option to share a document with participants is available on the following document types:

• Advertisement for Recruitment
• Diary (blank)
• Participant Information Sheet
• Participant Materials - Other
• Participant Questionnaire (blank)
• Study Participation Card

Sending eConsent Forms

Research Organization Administrator users can no longer send eConsent forms to participants when their research organization is selected in the vault selector. To send an eConsent form, ensure that the appropriate site is selected in the vault selector. When the research organization is selected, an error message is displayed.

Connected Studies

Identifying Sponsor-Provided Templates

When a study document is received from a sponsor or CRO on a connected study, you can now decide whether to approve the document as a sponsor-provided template. If approved as a template, SiteVault prepends [Sponsor Template] to the name of the document, and you can make copies of the document to edit as needed. This ensures that any copies are permanently linked to the original template document.

This option to designate a received document as a sponsor-provided template is available on the following document types when in the Received from Sponsor/CRO state:

• Advertisement for Recruitment
• Diary (blank)
• Financial Disclosure Form
• Informed Consent Form (blank)
• IP Accountability
• IP Quality Complaint
• Participant Materials - Other
• Participant Questionnaire (blank)
• Participant Information Sheet
• Study Participation Card

See the help for Identifying Sponsor-Provided Templates for more information.

Working With Document Templates

This feature makes it easier to manage template documents such as informed consent forms and financial disclosure forms. After you make a copy of a template, a new Create Draft from Original Document action is available in the All Actions menu of the copied document. If the source document template is updated, you can select the action to update the copied document to the new template version.

Products in Connected Study Invitations

When reviewing a Connected Study Invitation, you are now prompted to reconcile the products on the study. This enables you to choose whether to merge the study invitation product with an existing product in your SiteVault or to create a new product if it doesn’t already exist.

See the Accepting Study Invitations page for more information.

Regulatory Document Request Enhancements

With this release, you can sort, search, and paginate the document sections of the Regulatory Document Requests page. Additionally, SiteVault automatically closes the Regulatory Document Request task after you complete the last item in the Documents to Return section.

See the Managing Regulatory Documents Requests page for more information.

Exchangeable Organization Profile Document Update

With this feature, SiteVault no longer automatically transfers profile documents for central labs or central IRB/IECs to a sponsor or CRO’s vault.

New Exchangeable Document Types

This feature enables you to exchange the following document types with a sponsor or CRO on a connected study:

• Budget
• IP Destruction
• IP Quality Complaint
• Signature & Initials
• Specimen Tracking

Deleting Connected Study Documents

You can now delete documents that are received from a sponsor or CRO if needed, for example, duplicate or incorrect documents.