OVERVIEW OF THE OFFICE OF CLINICAL RESEARCH (OCR)

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


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 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 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 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 Core Services- Clinical Research Finance

• Research Billing

• Prospective Reimbursement Analysis

• EPIC APM

• Bill Processing

• Consultative research finance services:

• Feasibility

• Budget preparation


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 Resources on Website

OCR website: http://www.med.upenn.edu/ocr/

http://www.med.upenn.edu/ocr/

http://www.med.upenn.edu/ocr/


iConnect-Penn Medicine’s new free clinical trials recruitment registry


Thank you!

In case of questions contact :

[email protected]

OR

Maha Dutt, MS, CCRC

Clinical Research Navigator

[email protected]

Phone: 215-662-4629

mailto:[email protected]

mailto:[email protected]

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


Allscripts KBC

Epic EMR

Epic Practice Mgmt.

Allscripts SRX

Allscripts CPOE

Cerner Lab

GE Radiology


Epic EMR

Allscripts KBC

Epic Practice Mgmt.

Allscripts SRX

Epic Optime

Allscripts CPOE

GE Radiology

Cerner Lab


Epic EMR

Allscripts KBC

Epic Practice Mgmt.

Epic OpTime

Allscripts CPOE

GE Radiology

Allscripts SRX

Cerner Lab


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


Visicu ICU

IDX Practice Mgmt.

McKesson HSM

Emtrac ED


McKesson HSM

Emtrac ED



Emtrac ED



Emtrac ED


Allscripts ePD

Epic EMR

Epic Practice Mgmt.

Allscripts KBC

Epic OpTime

Epic ASAP ED

Allscripts CPOE

GE Radiology

Allscripts SRX

Cerner Lab


Allscripts ePD

Epic EMR

Epic Practice Mgmt.

Allscripts KBC

Epic OpTime

Epic ASAP ED

Allscripts CPOE

Allscripts SRX

Cerner Lab


Allscripts ePD

Epic EMR

Epic Practice Mgmt.

Allscripts KBC

Epic OpTime

Epic ASAP ED

Allscripts CPOE

Allscripts SRX

Cerner Lab


Allscripts ePD

Epic Practice Mgmt.

Epic ClinDoc

Epic OpTime

Epic ASAP ED

Epic CPOE

Epic RxS

Cerner Lab


Epic ePD

Epic EMR

Epic Hosp. Billing & ADT


Epic Radiant Epic Radiant

Epic Radiant

All clinicians on Epic

Ambulatory

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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

6

Penn Data Store Data Model

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

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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

11

www.med.upenn.edu/dac

https://www.med.upenn.edu/dac/data-request.html

Navigating the IRB at Penn

© 2008 University of Pennsylvania School of Medicine 1

Tracy Ziolek, MS, CIP

Director, Human Research

Protections Director, IRB


What is the IRB?


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



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



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



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)



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



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”


http://www.upenn.edu/IRB/

http://www.upenn.edu/

Need Assistance?


OVERVIEW OF THE OFFICE OF CLINICAL RESEARCH (OCR)

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