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Clinical Research Improvement in Systems and Processes (CRISP) Dean’s Office Quarterly Meeting September 16
Study Start-up
Study Conduct
Study Close-out
Here is a Health Sciences Human Research Study Management process:
Project scope: Health Sciences Human Research Study Start-up at UVa
Begin: Principal Investigator has an idea/study protocol
or an industry invites to participate in a study.
End: study is ready to enroll
subjects/patients.
Study Start-up component
Why are we focusing on the Study Start-up?
The survey conducted in May 2015, 85% of Full Board studies
The study start-up is taking more than 100 days, not meeting industry expectation.
The study start-up is taking more than 100 days, not meeting industry expectation.
The survey conducted in May 2015, 85% of Full Board studies
Our patient is waiting
Study Start-up
Study Conduct
Study Close-out
Value Cost
Improving the study start-up will decrease our cost and increase our value.
Why is Study Start-up taking so long?
Guggenheim Museum in Bilbao, Spain.
Here is what it feels like…
High curling walls are all around you, tall silos… All you can do is to keep moving, Forward and back, Forward and back,…
“The Matter of Time”, Richard Serra exhibition
No sense of further direction…
Limited visibility of where you are…
“The Matter of Time”, Richard Serra exhibition
Ancillary Services
IRB Protocol Builder
IRB Online Institutional Review Board
Non-IRB Regulatory
Non-IRB Regulatory • ISPRO • RSC / HIRE • PRC • Scientific Pre-Review • IBC • Medical Device • Gene Transfer • Cert. of Confidentiality • Conflict of Interest • ESCRO • FERPA / SBS • CIRB
Contract
Budget set-up
Billing Coverage Analysis
Ancillary Services • Investigational Drug
Services • Biorepository and Tissue
Research Facility (BTRF) • Radiology and Medical
Imaging • Clinical Laboratories • Ambulatory Clinic/Hospital
Nursing Unit/Cancer Center Infusion
• New Medical Device/Supply Chain Management
• Clinical Research Unit • Continuum Home Health • Therapy Services (Physical
Therapy, Occupational Therapy)
PTAO set-up
Epic set-up
Grant Pricing Request
Study Start-up Current State
“The Matter of Time”, Richard Serra exhibition
Awareness and education Visibility over steps and statuses Efficiency
IRB Protocol Builder
IRB Online Institutional Review Board Non-IRB Regulatory
Non-IRB Regulatory • ISPRO • RSC / HIRE • PRC • Scientific Pre-Review • IBC • Medical Device • Gene Transfer • Cert. of Confidentiality • Conflict of Interest • ESCRO • FERPA / SBS • CIRB Contract
Budget set-up
Billing Coverage Analysis
Ancillary Services • Investigational Drug
Services • Biorepository and Tissue
Research Facility (BTRF) • Radiology and Medical
Imaging • Clinical Laboratories • Ambulatory Clinic/Hospital
Nursing Unit/Cancer Center Infusion
• New Medical Device/Supply Chain Management
• Clinical Research Unit • Continuum Home Health • Therapy Services (Physical
Therapy, Occupational Therapy)
PTAO set-up Epic set-up
Grant Pricing Request
Workflow: Study Start-Up
Ancillary Services
Ready for Enrollment
OnCore Clinical Trials Mgmt
System
ResearchUVa
Electronic Submission and Approval System Interfaces
Study Start-up Future State
Project Launch Jan 2015
Current State Analysis
Process Improvement & Future State Creation
System/ Workflow Configuration Jan 2016
Systems Interfaces
Improved and Automated Future State Go-live 2017
It is a process improvement first of all, then automation
Thanks to Workgroup Cricket Birk, RN CCRN Clinical Research Coordinator, Department of Anesthesiology
Sandra Burks, RN, BSN, CCRC Associate Director, Surgical Therapeutic Advancement Center
Stewart P. Craig, MS Assistant Dean for Research Administration Director, Office of Grants and Contracts
Lori Elder, RN BSN CCRA Director, SOM Clinical Trials Office
Susie Hoffman, RN BSN CIP Director: IRB for Health Sciences Research
Lynn Koplin, M.A., CRCP Assistant Director of Contracts, Office of Sponsored Programs
Johanna Loomba, BS, CCRC Director, UVa Neurosurgery Clinical Research
Goga Radakovic, MD, CCRC Director, Office of Clinical Research, Cancer Center
Catherine A. Reniere, MA Cancer Informatics Program Manager
Lydia Fetcho, MS Technical Business Analyst, School of Medicine
Doug Johnson, MBA Business Analyst, School of Medicine
Chuck Morris, N.D. Webmaster and Database Administrator,
Office of VP for Research
Robert Pastor, MS Manager of Enterprise Architecture,
School of Medicine
Thanks to Project Advisory Amy P. Adams, PharmD, CCRP Coordinator, Investigational Drug Service
Chris G. Allison Manager of Billing and Collections, UPG
Lauren C. Benusa, Pharm.D. Investigational Drug Services Coordinator
Amy Camblos, BS Project Manager
Jennifer Crosby, BS, CCRP Clinical Trials Budget & Billing Coordinator
Patrick Dillon, MD Assistant Professor of Medicine
Amy C. Fansler, MPH CCRP Clinical Research Program Manager, Neurological Emergencies
Nathan B. Fountain, MD Professor of Neurology Director, FE Dreifuss Comprehensive Epilepsy Program
Leisa Gonnella, MHA, CPC Finance Administrator, Department of Anesthesiology
Dina Gould Halme, PhD Associate Director, Research Program Administration, Cancer Center
David Kaufman, MD Professor of Pediatrics, NICU Clinical Trials Group Director
Robert Meyer, MD Director, VCTRS Assc. Professor, Public Health Sciences
Jonathon Neel, MS, CISM, CISSP Information Security and Risk Management Officer, School of Medicine
Wendy M. Novicoff, Ph.D Associate Professor Department of Public Health Sciences and Orthopaedic Surgery
Kathy Richardson Clinical Trials Office Budget & Billing coordinator
Michael Salerno, MD, PhD Assistant Professor of Medicine, Radiology, and Biomedical Engineering
Angela Sherman, CRA Manager of Sponsored Projects Administration, School of Medicine
Richard D. Stevenson, M.D. Professor of Pediatrics Chief, Division of Developmental Pediatrics Medical Director, UVA Child Development and Rehabilitation Center Chair, Institutional Review Board - HSR
Paul V Targonski, MD, PhD, MPH Associate Professor of Department of Public Health Sciences and Director for Clinical Research Initiatives
Ronald B. Turner, M.D. Professor of Pediatrics
Thanks to Steering Committee Elizabeth H. Adams Assistant Vice President for Research Administration, Office of Sponsored Programs, University of Virginia James A. Amato, MBA Chief of Clinical Ancillary Services and Interim Chief Operating Officer for Hospital and Clinics Operations David J. Hudson, PhD Associate VP for Research, University of Virginia Katherine L. Peck, MBA Chief Operating Officer, School Of Medicine Margaret A. Shupnik, Ph.D. Professor of Medicine and Physiology, Division of Endocrinology and Metabolism Senior Associate Dean for Research, School of Medicine
Thanks to Stakeholders Lee Baszczewski, BA, PMP, Lean – Black Belt Director, Organizational Excellence, University of Virginia Christopher M. Kramer, MD Ruth C. Heede Professor of Cardiology Professor of Radiology Michael R. Marquardt, MBA, MPH Chief of Staff, Office of the Executive Vice President for Health Affairs
Thanks to Project Leadership Jeffrey D. Blank, MPA Assistant Vice President for Research Office of the Vice President for Research
Linda R. Duska, MD, MPH Professor of Obstetrics and Gynecology Interim Associate Dean for Clinical Research
Thea Grover-Patrick, MBA Director, Strategic Initiatives, Health System
Olga Kipnis, MS, PMP Project Manager
Thank you!
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If you want to know more, contact us or visit: https://cr.med.virginia.edu
Survey results: start-up timeline
14.53%
36.87%
21.79%
4.47%
6.15%
6.70%
9.50%
0% 5% 10% 15% 20% 25% 30% 35% 40%
<= 3 months
> 3 months, <= 6 months
> 6 months, <= 9 months
> 9 months, <= 1 year
> 1 year
Do not know
Have not set up studies using FullBoard review
Survey results: entire process of a study start –up , for studies that go through a Full Board review
