OnCore: WISC Single Instance

Single Instance Plan

The OnCore Single Instance plan, known as WISC, combines the existing Oncology and Non-oncology separate instances into a unified database for all clinical trials at the University of Wisconsin and UW Health. 

Benefits

• Directly supports UW Clinical Trials Strategic plan: Build systems and processes that support enterprise-wide clinical research today and allow for future growth
• Improve Patient, PI, Study Team, and Sponsor experience and satisfaction
• Advance strategic initiatives focused on accreditation, marketplace agility, and growth
• Streamline and automate processes and workflows to increase efficiency and decrease administrative burden and costs
• Enhance compliance, quality, outcomes, and reputation
• Scale processes and infrastructure to support future growth
• Enable metrics, reporting, and analytics across all Clinical Trials to optimize operations and inform opportunities for quality improvement, innovation, and growth

To watch informational session on move from Non-oncology to WISC instance click here: https://mediaspace.wisc.edu/media/OnCore+Single+Instance/1_wqztwrra

Single Instance Timeline

 

Timeline

Link to new WISC OnCore	Oncology Revision Doc Non-onc Revision Doc	New Protocol Workflow	Data Migration	Migration Checklist  for study teams	Non-oncology instance closeout
Jan - Feb 2022	Mar - Apr 2022	May 1st 2022	Jun - Sep 2022	Sep - Nov 2022	Dec 2022
Move to vendor, Advarra, hosted cloud environment. Reconfigure OnCore to host Oncology and Non-oncology protocols in a single instance.	Create documentation to outline revisions to fields, drop-down lists and other areas of OnCore. Separate document for Oncology and Non-oncology users.	NEW Non-oncology protocols begin entry in  WISC Instance	Data Migration work in progress. Final Data Migration:     September 30, 2022. Advarra has created script to migrate protocols from ICTR to WISC instance.	Study teams export eCRF data, subject visit history and other financial information to retain.	Study teams closeout protocols in Non-oncology with study completion date on or before 12/31/2022. Non-oncology Instance goes offline on 12/31/2022.

 

Changes to new protocol creation

When creating a new SMPH protocol in WISC OnCore, see Questions to Answer Before Creating a New SMPH Protocol

New Organizational Units

UWCCC

• • Choose for all protocols run by the UW Carbone Cancer Center

SMPH

• • Choose for all protocols run by other Departments within SMPH, School of Pharmacy, School of Nursing, etc.

New Libraries

Determines options available in drop down lists, protocol annotations, notifications and sign offs available for the protocol. Cannot be changed once the status of protocol changes from NEW

Non-oncology Library

• • For all other protocols

Oncology Library

• • For any oncology-related protocol*

*ePRMS (Protocol Review Management System) is only configured for the Oncology Library. Any protocol that should be included in Data Table 4 NCI reporting should be included in the Oncology Library.

Structural Divisions drive:

Reporting

• • Oncology Library used for any oncology-related protocols and for cancer center grant renewal reporting purposes
  • Can report out by Organizational Unit (OU) to reviewe those protocols run by UWCCC and all other SMPH or other Departments

Permissions

• • Roles and permissions within OnCore are assigned to users based on OU - SMPH or UWCCC (or BOTH for any central services)

Which Organizational Unit and Library should be used?

• Select the appropriate Library based on the type of protocol

Example

Example	Library	Organizational Unit
Cancer-related study run by Chemoprevention	Oncology	UWCCC
Cancer-related study run by Department of Surgery	Oncology	SMPH
Non-cancer-related study run by Department of Surgery	Non-oncology	SMPH

What will be migrated?

Protocol Information

• PC Console tabs
• Details
• Management
• Staff
• Sponsor
• IND/IDE
• Treatment
• Institution
• Status
• Reviews
• Documents/Info
• Eligibility Checklist (if using)
• Annotations

Protocol Specifications/Calendar

CURRENT version of the protocol specification/calendar can be exported and imported into WISC instance.

• Will performed manually by central staff
• Previously released calendar versions cannot be migrated

Subject Information

Subject information will be migrated to protocol including;

• Subject status
• Status dates
• Subject attachments

Items that CANNOT be migrated are:

• Subject visits previously documented cannot be migrated. Study teams will begin documenting NEW subject visits in the new WISC OnCore instance. Study teams can save Subject visit details report to retain history of subject visits.

Financials Console

Financials information, including the budget and cost centers, need to be manually documented to match the version of the imported calendar.

• Internal support staff will migrate the current version of calendar and cost centers for study teams.
• Previously documented Invoicing and Milestone information cannot be migrated.
• Study teams will begin documenting NEW invoices in the new WISC Oncore instance. Study teams can save previous invoices as .pdf for historical purposes.

Reporting Changes

Report Parameters and Fields

You will find many reports have new options to filter including:

• Organizational Unit (OU): SMPH or UWCCC
• Library: Oncology or Non-oncology
• Department

Protocol Search

Update your saved Protocol Searches for any fields that have changes Some of the most impactiful change include:

• Institution name: updates from 'UW' to 'UW-Madison'
• Study site names: updated to include 'UW Health', e.g. UW Health 1 S. Park
• Department

*To view a comprehensive summary of changes you can view the WISC Revision documents creation for Oncology and Non-oncology.

Naming Conventions and Reporting Groups

Standardizing the naming of reports and new reporting groups avaiable Any reports created by our support team include custom prefix:

• UWCC## - custom reports created for UWCCC
• SMPH## - custom reports created for SMPH
• WISC## - custom reports for both UWCCC and SMPH