Overview

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The Delegation of Authority (DoA) log provides a record of a principal investigator’s (PI) decisions to allow specific site staff members to perform one or more of the PI’s study responsibilities. Instead of having to manually manage a paper-based, handwritten DoA log, the Digital Delegation feature enables users at your site to delegate, accept, and approve responsibilities directly in SiteVault, and SiteVault creates or updates the DoA log document for you.

For more information on SiteVault’s solution for managing delegations and responsibilities, see SiteVault’s Digital Delegation Vision and Design.

The Digital Delegation feature includes 24 standard responsibilities and a template DoA document based on the industry-standard TransCelerate Site Signature and Delegation of Responsibilities log template. You can also create your own research organization-wide, site-specific, or study-specific responsibilities to best serve the needs of your site.

The process of managing responsibilities in SiteVault follows these general steps:

1. Review and adjust the list of responsibilities for your research organization or site.
2. Assign responsibilities to persons at your site.
3. Enable the Digital Delegation feature for your study or studies.
4. Review and adjust the list of responsibilities for the study.
5. Assign site staff to the study.
6. Review and adjust the list of delegated responsibilities for study team members.
7. Send the proposed delegations to study team members for review and acceptance.
8. Send the accepted responsibilities to the PI for review and approval.
9. Review the new or updated DoA document in SiteVault.

Getting Started

See the following pages for more information on how to get started with the Digital Delegation feature in SiteVault:

• Manage Research Organization & Site Responsibilities: See the Manage Research Organization & Site Responsibilities page to learn how to define a default list of responsibilities for studies at your site.
• Managing Person Responsibilities: See the Managing Person Responsibilities page to learn more about defining a default list of responsibilities for a person at your site.
• Managing Study Responsibilities and Staff Delegations: See the Manage Study Responsibilities Manage Staff Delegations pages to learn how to manage delegated responsibilities for study team members.
• Sending Delegations for Acceptance and Approval: See the Sending Delegations for Acceptance and Sending Delegations for Approval pages to learn how to send proposed delegations to study team members for acceptance and accepted delegations to the PI for approval.
• Accepting or Approving Delegations: See the Accepting Delegations and Approving Delegations pages to learn how to accept your delegated responsibilities as a study team member or review and approve the delegations as the PI on a study.