operationalizing research it governance...operationalizing research it governance laura fluharty,...
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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
Disclaimer
The following speakers have no relevant financial relationships to disclose:
Jessica Chen, MBA, CPHIMS, SHIMSS
Laura Fluharty, MPH
Emma Meagher, MD
Kash Patel
Penn Medicine Overview
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.
Previous State of Clinical Research Informatics
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
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
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
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
Clinical Research IS Plan