Clinical Operations Overview

The Vault Clinical Operations Suite is the industry’s first cloud platform that unifies clinical operations across CTMS, eTMF, and Study Startup, enabling true end-to-end management of the clinical trial process, accelerating trial execution, and delivering real-time visibility.

  • Vault CTMS gives you the ability to track and manage your clinical trial operations end-to-end. Vault CTMS provides for study management, study monitoring, and issue management. With the Vault Payments add-on product, you can track payable items, study budgets, and study expenses.
  • Vault eTMF enables tracking of trial document completeness and timeliness. eTMF has full support for the latest versions of the TMF Reference Model, giving sponsors and CROs real-time access to clinical documentation at every point in a trial’s set-up, execution, and archival process. With TMF Transfer, you can easily transfer data from CROs to sponsors.
  • Vault Study Startup accelerates time to site activation by tracking the collection of site documents, contracts, and budgets, and ensuring local approvals are complete.
  • Veeva Site Connect is an add-on product available for all Clinical Operations Vaults that supports the easy sharing of documents and data with study sites on SiteVault.
  • Veeva eConsent is an add-on product available for all Clinical Operations Vaults that supports the easy creation and sharing of electronic informed consent (eConsent) forms with study sites on SiteVault.

Shared Data Model

Clinical Operations applications share a common data model, which allows you to consolidate data for all of these applications in one Vault.

Clinical Operations Shared Data Model

Objects

This is not a complete list of all Clinical Operations objects but provides some explanation of some important shared objects in the data model.

  • Study: This object allows for designating the study attributes such as phase, status, and study type. In the object hierarchy, Study is the top level, Study Country: is the second highest level, and Study Site is the lowest level object.
  • Study Country: This object defines the countries in which you are conducting your Study.
  • Study Site: This object represents the place you are conducting a clinical trial or study.
  • Study Organizations: This object tracks the specific roles assigned to an organization throughout a clinical trial or study.
  • Milestone: This object defines, tracks, and manages pertinent points in time during a Study, at the study-, country-, and site-level. Milestones can also manage expected, planned, and actual monitoring visit start and end dates.
  • Milestone Dependency: This object represents pre-conditions for a Milestone ‘s status. For example, you can have a milestone depend on the completion of three other milestones.
  • Clinical User Task: This object represents an individual unit of work. For example, a CRA may create user tasks to represent work involved with bringing a site up to compliance after a site visit.
  • Organization: This object stores information for the Institutions, Sponsors, Vendors, and other business groupings and their locations.
  • Study Organization: This object allows you to assign specific roles to an organization at the study-, study country-, or study-site level.
  • Study Organization Role: This object tracks an organization’s role throughout a study.
  • Person: This object stores all persons associated with studies. This can include but is not limited to investigators, site staff, internal staff, and vendor personnel. These persons are associated with studies through the Study Person object.
  • Contact Information: This object allows persons to have multiple addresses and relationships with multiple organizations.
  • Study Person: This object assigns a person and their appropriate contact information to a study, study country, or study site.
  • Study Team Role: This object stores the various roles, such as CRA, associated with study and study site personnel. You can associate team roles with application roles in support of security administration.

There are numerous other objects that make up the Clinical Operations data model. These are all available for use and configuration within your Vault. To accurately maintain the real-world relationships between these data elements, the data model includes several many-to-many and parent-child relationships linking objects together.

The following articles apply to all applications in the Clinical Operations family:

Admin Articles

The following configuration articles apply to all applications in the Clinical Operations family: