OVERVIEW OF THE OFFICE OF
CLINICAL RESEARCH (OCR)
Maha Dutt, MS, CCRC
Clinical Research Navigator
Office of Clinical Research (OCR)
OCR Office of Clinical Research
OCR Structure and Support Services Senior Associate Dean and Chief Clinical
Research Officer Emma A. Meagher, MD
Executive Director OCR Alyson Hettenbach
Clinical Research Monitoring Manager
Melissa Byrn
Clinical Research Compliance
Clinical Research Operations Manager
Laura Fluharty
Clinical Research Operations & Education
Research Finance Manager Michael Johnston
Kiran Matsko J.D. Associate Director.
Monica Sabnis, JD Associate Director
Clinical Trial Contracting Unit, OCR
Clinical Trial Contracting Unit Director
Kathryn Steinbugler, JD
IND-IDE Support Unit Director
Shelly Fehr
Research Finance
OCR Office of Clinical Research
Training and Education
OCR Auditing Program
FDA Audit Assistance
IND and IDE Consultation
Early Review & Consultation of Protocol and Study-Related Documents
Study Monitoring
Navigator or Research Consultative Services
Research Billing
Negotiating and concluding corporate-sponsored
clinical trial contracts
OCR Core Services
OCR Office of Clinical Research
OCR Core Services- Operations, Education and Training
• CRC Training and Certification- 2 half day course & assessment
• PI Training one on one, Protocol & Study-Related Document Development
• Site Based Consultation- Unit or Issue Specific
• Website Development and Management
• Penn Clinical Research Manual
OCR Office of Clinical Research
OCR Core Services- Clinical Research Compliance
• Routine and Non-Routine Surveillance for Quality Assurance
• FDA & External Audit Assistance and Supervision
• Research Consultative Services
• Study Auditing
• Development of Monitoring Plans
• Vendor Consultation
OCR Office of Clinical Research
OCR Core Services- IND/IDE Unit- Sponsor Support Unit
• Determine IND/IDE exemptions
• Partner with sites during FDA discussions,
meetings and audits
• Training and support for sponsors
• Potentially hold IND/IDE for study team
• Provide guidance on current FDA regulations
and sponsor responsibilities
OCR Office of Clinical Research
OCR Core Services- Clinical Research Finance
• Research Billing
• Prospective Reimbursement Analysis
• EPIC APM
• Bill Processing
• Consultative research finance services:
• Feasibility
• Budget preparation
OCR Office of Clinical Research
Negotiation of clinical trial and related agreements
for pharmaceutical sponsored trials
Serving as a liaison with sponsors and faculty/staff
while making contractual decisions
Pre-populated list of master agreements will allow
streamlining of individual contracts
Pre-made contract templates as starting points for
investigators
OCR Core Services- Clinical Trial Contracting Unit
OCR Office of Clinical Research
OCR Resources on Website
OCR website: http://www.med.upenn.edu/ocr/
OCR Office of Clinical Research
OCR Resources on Website
OCR website: http://www.med.upenn.edu/ocr/
OCR Office of Clinical Research
iConnect-Penn Medicine’s new free clinical trials recruitment registry
OCR Office of Clinical Research
Thank you!
In case of questions contact :
OR
Maha Dutt, MS, CCRC
Clinical Research Navigator
Phone: 215-662-4629
Penn Medicine Data Liberation A view from the journey
March 16, 2015
Brian Wells, MBA, FHIMSS Associate Vice President Health Technology and Academic Computing
2
Why Is This So Hard? Healthcare data may be more complex than any other industry
• Data variable and dynamic • Majority is unstructured
– Text – Images
• Medicine is subjective • Timing of events is critical
No historical incentives to standardize • Data format and content • Clinical rule sets • Vendor competition with no clear leader (until Epic) • No single unique patient identifier
Security and privacy must be enforced
Long retention periods
3
From best of breed to single vendor
2009 2011 2010 2012 2013 2014 2015
Epic EMR
Allscripts CPOE
Cerner Lab
GE Radiology
Cardiology – Vendor(s)
Epic EMR
Allscripts CPOE
Allscripts SRX
Cerner Lab
GE Radiology
Cardiology – Vendor(s)
Allscripts KBC
Epic EMR
Epic Practice Mgmt.
Allscripts SRX
Allscripts CPOE
Cerner Lab
GE Radiology
Cardiology – Vendor(s)
Epic EMR
Allscripts KBC
Epic Practice Mgmt.
Allscripts SRX
Epic Optime
Allscripts CPOE
GE Radiology
Cerner Lab
Cardiology – Vendor(s)
Epic EMR
Allscripts KBC
Epic Practice Mgmt.
Epic OpTime
Allscripts CPOE
GE Radiology
Allscripts SRX
Cerner Lab
Cardiology – Vendor(s)
2016 2017
McKesson RxS
Visicu ICU
IDX Practice Mgmt.
McKesson HSM
Emtrac ED
Siemens Hosp. Billing
McKesson RxS
Visicu ICU
IDX Practice Mgmt.
McKesson HSM
Emtrac ED
Siemens Hosp. Billing
Visicu ICU
IDX Practice Mgmt.
McKesson HSM
Emtrac ED
Siemens Hosp. Billing
McKesson HSM
Emtrac ED
Siemens Hosp. Billing
Siemens Hosp. Billing
Emtrac ED
Siemens Hosp. Billing
Siemens Hosp. Billing
Emtrac ED
Siemens Hosp. Billing
Allscripts ePD
Epic EMR
Epic Practice Mgmt.
Allscripts KBC
Epic OpTime
Epic ASAP ED
Allscripts CPOE
GE Radiology
Allscripts SRX
Cerner Lab
Cardiology – Vendor(s)
Allscripts ePD
Epic EMR
Epic Practice Mgmt.
Allscripts KBC
Epic OpTime
Epic ASAP ED
Allscripts CPOE
Allscripts SRX
Cerner Lab
Cardiology – Vendor(s)
Allscripts ePD
Epic EMR
Epic Practice Mgmt.
Allscripts KBC
Epic OpTime
Epic ASAP ED
Allscripts CPOE
Allscripts SRX
Cerner Lab
Cardiology – Vendor(s)
Allscripts ePD
Epic Practice Mgmt.
Epic ClinDoc
Epic OpTime
Epic ASAP ED
Epic CPOE
Epic RxS
Cerner Lab
Cardiology – Vendor(s)
Epic ePD
Epic EMR
Epic Hosp. Billing & ADT
Siemens Hosp. Billing
Epic Radiant Epic Radiant
Epic Radiant
All clinicians on Epic
Ambulatory
4
Which method, which tool? Tool Real-
Time Identified Structured Unstructured
Penn Data Store (PDS) • Clinical
warehouse
No Yes Yes No
PennOmics • Research
warehouse
No No Yes No
PennSeek • Text mining • Some PDS
No Yes Limited Yes
MedView • web services
Yes Yes Yes
HPM • Financial
warehouse
No Yes Yes
Patient 4 million
Encounter 40 million
Dx & Proc
Orders & Results
400 million
Inpatient Infection
50 thousand
UPHS Source Systems
Penn Data Store
Nightly Extract Process Monthly Extract Process
HPM
SDS QDM
Patient 3 Million
Encounter 47 million
Dx & Proc
AA
Penn Data Store
Bio-banks
Clinical Trial Management System
Tumor Registry
Cancer Registries
Oracle Health Sciences Network
Trial Protocol
Electronic Health Record
Industry
Penn Researchers
and Clinicians
Cohort Counts Only
Search /Analytics “Cohort Explorer”
Tumors Treatment
‘Omics Protocols
Consents Studies
Phenotype
Center for Personalized Diagnostics
Research Sequencing
Translational Centers of Excellence
Subjects / Patients
Samples
Outcomes
External Genetic References
Point of care recruiting
PennOmics
PennOmics
De-Identified
PennOmics Content Data Release 1
Q2 FY14 Release 2 Q2 FY15
Patients (2005, 2.1 million) X
Encounters (2005, 67 million) X
Diagnosis (2005, 41.2 million) X
Procedures (2005, 10.8 million) X
Labs (2008, 201.6 million) X +
Medication (2005, 49 million) X
Vital Signs (2011, 66 million X
Tumor Registry (2010, 51,000) X +
Velos Studies (2001, 2,000) X
Clinical Genetic/Genomics (CPD) X +
Research Genetic/Genomics (Contributing Labs)
X +
Samples X +
Research Registries ?
Combining Diverse Information - PennSeek
Structured Data in PDS • Diagnoses • Labs • Meds • Demographics • Location
Unstructured Text Any Source
Medical Terminology
Unstructured Records in PennSeek
Un + Structured Records in PennSeek
Epic Clarity Encounters 16,278,086 16,278,086 RIS Radiology Accession Reports 11,225,396 11,225,396 PDS Pathology & Demographics 739,637 5,355,664 Horizon Cardiology—ECHO 233,032 233,032 Epic Clarity My Penn Med Msgs 104,266 104,266 Epic Clarity In-Clinic Meds 1,220,409 Epic Clarity Prescriptions 51,623,315
10
HIPAA and HITECH Privacy and Security Protected Health Information (PHI)
• Health status, provision of care, payment • Identifiers, dates, locations that link to a person • Fifty years after death
Can be disclosed for treatment, payment or operations without consent
Minimum necessary Business Associates are now included in
addition to Covered Entities • Cloud vendors, etc.
Breach notification and stiff penalties • Fines and imprisonment
De-identification for research • Remove identifiers, dates, locations • Cannot reliably de-identify unstructured data in an automated way
Risk of re-identification
Navigating the IRB at Penn
© 2008 University of Pennsylvania School of Medicine 1
Tracy Ziolek, MS, CIP
Director, Human Research
Protections Director, IRB
© 2008 University of Pennsylvania School of Medicine 3
What does the IRB do?
♦ Oversees all UPenn research on human participants
~INCLUDING~
Federally funded research [Department of Health and Human Services (DHHS)]
Industry sponsored research through the Food and Drug Administration (FDA)
Investigator-initiated research (whether funded or not)
Penn IRB Organization Chart
Vice Provost for Research
Director , Human Research Protections
Director, IRB
Associate Director, IRB
Assistant Director, IRB
Senior IRB Administrators/Analysts
IRB Administrative Coordinators/Assistants
IRB Administrators/Analysts
Regulatory Records Specialist
Technical Systems Support Specialist
Penn IRB Structure ♦ 9 IRBs
• 1 Social/behavioral science IRB • 4 General Medical IRBs • 3 High risk/oncology/early phase IRBs • 1 Executive IRB (meets on an ad hoc basis)
♦ Each IRB is staffed by an Administrator and Admin Coordinator/Assistant
♦ Each IRB meets once per month (except the Executive IRB)
♦ Submissions are assigned according to:
• Date of receipt • Type of research • Need for expertise for review
© 2008 University of Pennsylvania School of Medicine 5
© 2008 University of Pennsylvania School of Medicine 6
How does the IRB review research?
♦Reviews are divided into categories • Administrative acknowledgment
–not human subjects/research/or both
• Exempt
• Expedited
• Convened IRB (reviewed by IRB committee)
Submission Process
♦ Electronic submissions via HS-ERA (online IRB application)
• Initial screening questions help to designate level of review and type of application
• Last page of application allows for uploads of any documents needed to supplement the review
• Personnel page tracks completion of human subject training via CITI
• Notification system for other review entities/research support offices
© 2008 University of Pennsylvania School of Medicine 7
© 2008 University of Pennsylvania School of Medicine 8
Protocol Review Requirements
For the IRB to approve a proposed protocol, the following requirements must be satisfied:
Risks to subjects are minimized
Risks to subjects are reasonable in relation to
anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonable be expected to result
© 2008 University of Pennsylvania School of Medicine 9
Protocol Review Requirements
Selection of subjects is equitable
Informed consent will be sought from each prospective subject or the subject’s legally authorized representative (unless waived)
Informed consent will be properly documented
(unless waived)
© 2008 University of Pennsylvania School of Medicine 10
Protocol Review Requirements
IF APPLICABLE
Research plan makes adequate provision for monitoring the data collected to ensure safety of subjects (for greater than minimal risk studies)
Providing adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data
Additional safeguards in place when subjects are likely to be vulnerable to coercion or undue influence
IRB Committee Review Process
♦ Penn IRB uses a dual-review system for initial reviews • Primary Reviewer (protocol content, regulations) • Secondary Reviewer (focus on consent form)
♦ Continuing reviews, modifications and reportable events have one reviewer
♦ Each Committee member is provided documentation regarding each agenda action item and 1-2 Committee members lead the discussion, with input from the IRB Chair
© 2008 University of Pennsylvania School of Medicine 11
© 2008 University of Pennsylvania School of Medicine 12
Ongoing Reviews
♦ Continuing review (at least annually)
♦ Modifications
♦ Reportable Events
♦ Exceptions
♦ Deviations
♦ Any additional information that might impact IRB review/approval
IRB Decision Matrix – Continuing Reviews, Modifications & Reportable Events
♦ Approval
♦ Withheld Approval (decision by the convened IRB when the modification requires specific changes for approval)
♦ Tabled (decision by the convened IRB when the modification requires substantive changes to address IRB concerns, these are not always directive stipulations)
♦ Disapproved (decision by the convened IRB when the modification is not approvable in its current form, currently approved study may continue)
♦ Conditional Re-Approval (continuing reviews only, new enrollment is put on hold until response received, other study activity may continue)
♦ Accepted (decision by convened IRB for reportable events and potential unanticipated problems)
Need Assistance? ♦ Monday through Friday from 9am-5pm
♦ All staff have direct emails and phone lines
♦ IRB Staff listing is available on the IRB website
♦ IRB website contains guidance for several common research topics and for submitting to the IRB
♦ IRB forms page has consent form templates, authorization forms and any other supplemental documents you may need for your submission
♦ http://www.upenn.edu/IRB/
♦ Go to www.upenn.edu and search “IRB”
© 2008 University of Pennsylvania School of Medicine 14
Top Related