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Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical Research & Chief Clinical Research Officer Kash Patel AVP, Chief Digital Technologist

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Page 1: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

Operationalizing Research IT GovernanceLaura Fluharty, MPH

Sr. Director, Clinical Research OperationsEmma Meagher, MD

Vice Dean for Clinical Research & Chief Clinical Research Officer

Kash PatelAVP, Chief Digital Technologist

Page 2: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

Disclaimer

The following speakers have no relevant financial relationships to disclose:

Jessica Chen, MBA, CPHIMS, SHIMSS

Laura Fluharty, MPH

Emma Meagher, MD

Kash Patel

Page 3: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

Penn Medicine Overview

Page 4: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical
Page 5: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

Clinical Research at Penn Medicine

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Type of Studies

Novel Trials with Penn technology or innovation irrespective if funding

Commercialization of a Penn technology or investigator initiated protocol/Penn lead site

Industry or federally sponsored clinical trial

Tissue or biospecimen research, registry studies, prospective cohorts, etc.

Page 6: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

Previous State of Clinical Research Informatics

Page 7: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

PennChart IS and Research Governance

Clinical Research Leadership Council

Clinical Research Operations Committee

Clinical Research Informatics Leadership

CTMS Operations Committee

PennChart Research Operations Committee

DMS Leadership

CTMS Project Team

DMS Project Team

PennChart Research Project Team

PennChart IT Governance

Revenue Cycle Oversight Committee

Clinical Oversight Committee

Rev Cyle Project Teams

Clinical Project Teams

Page 8: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

PSOM IT Council

Application Operations Committees

Clinical Research Informatics

Quality & Manufacturi

ng Operations

ClinicalOperations

Revenue Cycle

Operations

MES, PennCTMS, eTMF, SiteDocs, QualityDocs, LIMS, HPC, RedCap, PennChart Research

Penn Medicine Research IT Governance

Page 9: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

Penn Medicine Research IS Environment

Clinical Trial Management System (CTMS)

Velos

Document Management System (DMS)

Veeva eTMF, VeevaSiteVault, Veeva Quality

Electronic Medical Record System (EMR)

PennChart (EPIC)

Electronic Data Capture System (EDC)

Velos, RedCap, Veeva EDC

Recruitment IT Platforms iConnect, Emerging Med,

Epic MyChart

Feasibility/Cohort Identification Tools

PennSeek, PennOmics, Penn DataStore, Oracle

HSN, TriNetX

Administrative/Financial Tools

CRSPR, RBA, RBS, HSERA, PennERA

Page 10: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

Large and decentralized institution it can be challenging to raise awareness and adoption of tools that support research

• OCR serve in navigation and outreach role to departments

• ISSAC team creation by clinical research IS

Resourcing volume of requests

• Development of more self service tools with training and policies

Different IS departments managing applications that all support research

• Leads to resourcing and prioritization issues but the faculty and staff don’t see the distinction just see applications as all in support of research Example : University IRB system vs. Epic health system application vs. CTMS PSOM system

Challenges and Opportunities

Page 11: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical

Clinical Research IS Plan

Page 12: Operationalizing Research IT Governance...Operationalizing Research IT Governance Laura Fluharty, MPH Sr. Director, Clinical Research Operations Emma Meagher, MD Vice Dean for Clinical