A Constellation of Tools Supporting the Clinical Trials Process

Research IT supports many of the key tools that drive the clinical trials process at the University of Washington: Advarra EDC, OnCore and Vestigo.  

Clinical Trials Management System (CTMS)

In 2018 UW Medicine, Fred Hutch Cancer Research Center (FH) and Seattle Cancer Center Alliance (SCCA) jointly launched a Clinical Trials Management System, using Advarra OnCore and Advarra EDC to facilitate the needs of Oncology studies, and as of 2020, is also supporting non-Oncology studies.

OnCore

OnCore supports study operations and billing compliance through functionality that allows users to manage study start-up and amendment activities, track regulatory approvals, gain access to study documents, track subject activities and perform subject visit tracking, manage study financials, and invoice study sponsors.

Advarra EDC (Electronic Data Capture)

EDC platform streamlines data management and simplifies form (eCRF- electronic case report form) building and data collection. It can communicate with OnCore studies so no duplicate data entry is needed. It allows end users to design eCRFs and provide means for query management and data export.

Questions about the CTMS or Advarra EDC should be directed at the CTMS Program Office Helpdesk:

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Sometimes your study needs a close integration with medical systems for safety, optimization and impact.

Integrations with OnCore

Vestigo

Vestigo is a helper app for Investigational Drug Service pharmacies providing for inventory management, compliance monitoring and reporting, and real-time integration with the OnCore API.

Questions about Vestigo and the Vestigo-OnCore integration should be directed at the CTMS Program Office Helpdesk: ctms@fredhutch.org

UW Workday

The UW Workday OnCore Integration leverages the OnCore Receivables Interface via the Advarra Integration Bus application to manage sponsor invoices and reconcile receipts for sponsor payments. Research activity-related invoices are created in OnCore and sent to UW Workday for processing. Payments are recorded in Workday, and the data is sent back to OnCore. Connecting these systems ensures that research and finance teams have access to consistent, up-to-date information on study-related invoice receivables.

UW Florence

The UW Florence eBinder Integration enables the automated setup of study binders and user permissions in Florence based on the information recorded in OnCore CTMS. This integration improves the current paper-based file management system and reduces duplicative administrative tasks related to study binder creation and user management.

Epic

The Epic integration leverages the RPE & CRPC interfaces to allow OnCore to pass study and enrollment related details from OnCore into Epic. These interfaces reduce duplicative administrative tasks related to study record creation and management, billing grid creation and management, and enrollment record creation and management.

Our team can help you get the most of our research systems

OnCore CTMS Training

OnCore Training is offered through the CTMS Program Office.  Available classes include:

All OnCore Courses

  • OnCore 100 – Overview
  • OnCore 200 – Protocols
  • OnCore 300 – IRB Reviews
  • OnCore 400 – Calendars
  • OnCore 410 – Billing Grid and Budget
  • OnCore 500 – Subjects and Visits
  • OnCore 510 – Sponsor Invoicing
  • OnCore 520 – Vendor Payables

Use the arrows to the left and right of the screen to find more details on each course.

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OnCore 100 - Overview

This module provides an overview of our CTMS Program including scope, governance, training and support information. All activities covered in this module are applicable to anyone who is interested in learning more about our CTMS efforts at UWFH.  

This module will take approximately 15 minutes to complete. 

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OnCore 200 - Protocols

This module covers basic data entry requirements for maintaining protocol records in our OnCore Clinical Trial Management System (CTMS). All activities covered in this module will apply to OnCore users with Protocol Management permissions. 

This module will take approximately 30 minutes to complete. 

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OnCore 300 – IRB Reviews

This module covers steps for entering IRB reviews, uploading IRB approved documents, and entering other committee reviews in OnCore Clinical Trial Management System (CTMS). All activities covered in this module will apply to OnCore users with Review Update & Document Upload permissions. 

This module will take approximately 35 minutes to complete. 

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OnCore 400 – Calendars

This module covers steps for reviewing and verifying protocol calendars in OnCore. All activities covered in this module will apply to OnCore users with the Subject Management, Pre Award Management, and Post Award Management & Invoicing permissions. 

This module will take approximately 30 minutes to complete

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OnCore 410 – Billing Grid & Budget

This module covers steps for reviewing and verifying the study Billing Grid and Budget. All activities covered in this module will apply to OnCore users with Pre-Award permissions.

This module will take approximately 30 minutes to complete.

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OnCore 500 – Subjects & Visits

This module describes the process to record subject status updates and enter the related visit tracking data in OnCore. All activities covered in this module will apply to OnCore users with Subject Management and Subject Visit Tracking permissions.

Important Note: There are multiple parts to fully managing a subject’s lifecycle for Epic billable studies to help ensure billing compliance. This training covers steps applicable in OnCore. Please, refer to Epic Research Fundamentals training, and other pertinent Epic training materials for steps to take in Epic.

This module will take approximately 90 minutes to complete.

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OnCore 510 – Sponsor Invoicing & Payment Reconciliation

This module covers steps for invoicing the study sponsor for protocol related events and completed subject related activity, entering received payments, and reconciling payments with completed activity in OnCore.

All activities covered in this module will apply to OnCore users with the Post Award Management & Invoicing permissions. Users with studies that are paid based on automatic EDC entry will still benefit from this course due to the institutional requirements to create “dummy” invoices for reconciliation purposes.

This module will take approximately 25 minutes to complete.

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OnCore 520 – Vendor Payables

This module covers the steps involving the Vendor Payables feature in OnCore. All activities covered in this module will apply to OnCore users with the Post Award Management & Invoicing permissions.

This module will take approximately 30 minutes to complete.

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Rates

The UW has Internal and External billing rates based on the Institution supported and their organizations status and funding source of the project. 

Internal UW Rate

With UW Worktags

$150

External Rate

No UW Budget Number

$200

Industry Rate

Internal With Industry

$270

We invoice in the first week of the month for work done in the previous month. This amount will be automatically deducted from the supplied worktag. The billing contact you supply before beginning a consultation will get an invoice (from UW Central Billing) at that time, but generally doesn't have to do a thing.

Examples of our Work

We help researchers every day do great work, here are some examples of what we have accomplished and what we can do together. 

OnCore Document Search

Initially when CTMS program office requested a web application to manage documents and videos, it was meant for program office personnel to manage documents and videos (update, add, delete) and for all OnCore users to view them. Later on, when more and more documents were added in the portal, sometimes it is cumbersome for end users to find what documents they need to refer to. So program office asked whether a elastic search function can be added on top of it. We implemented the search function and the end users were very pleased about it.