OnCore Current Status and Implementation Project Plan June 2017

Advantage: InfoEd OnCore EPIC Integrated billing system Minimize duplication by maximizing systems: OnCore EPIC

OnCore Functions Financials Invoicing Budgeting Document Retrieval Protocol Management Protocol Details Document Retrieval Committee Review History Public Information Portal Automated Notifications Subject Management Subject Tracking Subject Calendars Subject Specific Document Retrieval Document SAE’s Administration Staff Profiles and Credentials Staff Searches Permissions Integrations Application Configuration Financials Invoicing Budgeting Document Retrieval Reports Protocol Specific Active Subjects Invoiceable Items Custom Reports Continuing Review Metrics Bio Specimen Banking Specific Storage Location Specimen History Monitoring SAE Review Form Query

Advantages: Workflow data is consistent and process flow is transparent Parallel pre-approval process using same documents Track study expiration Document management system Store all regulatory documents in once space Virtual electronic binder for protocol training Maintain study team license

Contracting task list View contract tasks (Tasks get BIGGER) View who is assigned to these tasks and when they are targeted to be complete See any communication notes or attachment to the task See which tasks do not apply to this contract, for example here no IP language needs to be reviewed by CU innovations The overall status of the task list is at the top

Document management IRB Reviewed items are saved in the IRB Review tab, specific to the appropriate review Descriptions for documents Version date Expiration date (when appropriate)

Advantages: Single system to manage clinical research portfolio Study teams who track subjects in OnCore can use recruitment tool to advertise Single system to manage clinical research portfolio Move away from using excel spreadsheets to track financials Integrated financial management

Calendar – Protocol Level Procedures Their schedule and whether they should be billed to the study or standard of care

Calendar – Subject Specific

Financial milestones Screen failure ratio Number of SAEs to invoice Milestone for visit invoice Invoicing reminders

Invoice able items Milestones and Pass Through Items Withholding applied? Protocol related items as they occur

Invoices

Financial tracking

Virtual Biobank Integrations with RedCap and OnCore Fall 2017 All new biobanks in OnCore April 2017 All biobanks in OnCore Collect clinical data not in EMR in RedCap Use Compass for reporting

Researcher Biobank Staff Other Patient Data Sources Enterprise Research Systems UCDenver | Anschutz Medical Campus May 26, 2017 Non-Epic / Non-Compass Study Data (Manual Entry) REDCap Research Data Entry & Reporting TICR Bioinformatics & Computational Analysis Analytical Results Study Data Listings Researcher Variant Calls Patient Records Patient Records Researcher Health Data Compass Clinical & Omics Data Warehouse OnCore Study & Biospecimen Management Study Management / Biospecimen Data (Manual Entry) Consent Data / Biospecimen Metadata Reports and Query Results Researcher Biobank Staff Updates from Sarah on this slide Patient Study Status Patient Demographics Patient Records Patient Records Billing Records Patient Records UCHealth Epic CHCO Epic UPI Centricity Other Patient Data Sources

Integrations Current Integrations EPIC Demographic InfoEd Review Information Future Integrations EPIC Sept 2017: EPIC Protocol and Subject Information: Will assist in associating in EPIC June 2018: EPIC EMR Protocol Billing: All calendars and financials must be built Dec 2018: Full Integration with EPIC BioBank Compass integration Fall 2017

TRinetx Coming Fall 2017

For local investigators: TriNetX interface provides a customer friendly interface for access to i2b2 queries and better analytics for describing cohorts User friendly access to Compass data from the researchers laptop Aim is to reduce the support personnel needed to enable local researchers to do cohort queries, prepatory-to-research analysis for feasibility Important data for grant or foundation applications as well as industry Identifying studies that can recruit early in design process Addresses HIPAA issues as facilitates access to de-identified data