Research - HCCA's Official Site45 – Lisa Murtha, ... A Case Study –s ... Research Year in Review...

TWO CONFERENCES FOR THE PRICE OF ONEComplimentary access to SCCE’s Higher Education Compliance Conference is included with your registration.

Join us for the primary education and networking event for research compliance professionals. Increase the effectiveness of your compliance program, discuss emerging risks, share best practices, and build valuable relationships.

June 4–7, 2017 | Baltimore, MD

ResearchCompliance Conference

hcca-info.org/researchquestions? catherine.stollenwerk@ corporatecompliance.org

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Agenda Research Compliance Conference | June 4–7, 2017 | Baltimore, MD

* Advanced Discussions are interactive sessions geared toward more experienced compliance and ethics professionals. They are limited to 50 attendees and open on a first-come, first-served basis. No pre-registration is available.

SUNDAY, JUNE 4: PRE-CONFERENCE12:30 – 5:30 pm Registration Open

1:00 – 2:30 pm BReAKout sessions pRe-ConFeRenCe

P1 The Most Challenging Provisions in CTAs – Michael C. Roach, Managing Director, Aegis Compliance & Ethics Center, LLP

P2 Investigator Initiated Trials: Common Startup Struggles and Oversights – David B. Russell, Director, Site Strategy, PFS Clinical; Liz Christianson, Senior Clinical Research Analyst, PFS Clinical

2:30 – 2:45 pm Networking Break

2:45 – 4:15 pm BReAKout sessions pRe-ConFeRenCe

P3 Enterprise Solutions for Implementing Effective Corrective Action and Prevention Plans (CAPA) Following Internal Audits of Clinical Research Trials – Deepika Bhatia, Assist. Director - Research & Academics Compliance, UT Southwestern; Trissi S. Gray, Assistant Director, Health System Compliance, UT Southwestern Med Center

P4 How Research Risks Affect Compliance – Sarah Fowler-Dixon, Education Specialist, Human Research Protection Office, Washington University School of Medicine

4:15 – 5:30 pm Welcome Reception

MONDAY, JUNE 5: CONFERENCE7:30 Am – 6:30 pm Registration Open

7:30 – 8:30 Am Breakfast (provided)

8:30 – 8:45 Am Opening Remarks

8:45 – 9:45 Am General Session 1: Research Year in Review – Lisa Murtha, Senior Managing Director, FTI Consulting

9:45 – 10:15 Am Networking Break

10:15 – 11:15 Am BReAKout sessions

101 Against Tradeoffs: Improving Compliance and Researcher Satisfaction – Matthew W. Staman, Managing Director, Huron Consulting Group; Marisa Zuskar, Director, Huron Consulting Group; Anne Pifer, Senior Director, Huron Consulting Group

102 Compliance Implications for the Commercialization of Federally Funded Research – Bethany H. Loftin, Chief Operating Officer, TreMonti Consulting LLC; Ann Hammersla, Dir., Div of Extramural Invent. and Tech Resources, National Institutes of Health

11:15 Am – 12:15 pm Networking Lunch (provided)

12:15 – 1:15 pm BReAKout sessions

201 The Intersection Between Medicare Coverage Analysis, IRB Review, and Informed Consent – Linn Defensor, Sr. MCA Analyst, Cedars-Sinai Medical Center; Keren Dunn, Manager, Research Compliance & QI, Cedars-Sinai Medical Ctr

202 Managing Preclinical Risk to Protect Data Integrity, Animal Welfare, and Human Subject Safety – Stephen A. Frattini, Preclinical Research Compliance Manager, Northwell Health; Alison Powell, Research Compliance Manager, Northwell Health



301 Want to Participate in Research? There’s An App for That: Security and Privacy Issues with the Increased Use of Connected Devices, Apps and Social Media In Research – Marti Arvin, Vice President, Audit Strategy, CynergisTek, Inc; David Mata, Senior Associate, Aegis Compliance and Ethics Center

302 Managing Research Compliance Utilizing an Electronic Compliance Database System – Mike Jensen, Intermountain Healthcare

ADVANCED DISCUSSION*

303AD Good Clinical Practice: Interactive Discussion On Maintaining GCP in a Compliant Driven World – Kelly Willenberg, Owner, Kelly Willenberg and Associates


3:15 – 4:15 pm 401 Where Is the Data? Risks of Data Location, Storage and Protection of Sensitive Protected Health Information (PHI) – Margaret M. Groves, Associate Compliance Officer, HSRC, Duke University Office of Audit, Risk and Compliance; Holly B. Benton, Director, Privacy Compliance, Duke University Office of Audit, Risk and Compliance

402 Finding Flexibility in the IRB Regulations: How to Reduce Burden – Mariette Marsh, Director, Human Subjects Protection Program, The University of Arizona


4:30 – 5:30 pm General Session 2: Update on the Revisions to the Common Rule – Laura Odwazny, Senior Attorney, Public Health Division, Office of the General Counsel, U.S. Department of Health and Human Services

5:30 – 6:30 pm Networking Reception

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TUESDAY, JUNE 6: CONFERENCE7:30 Am – 4:45 pm Registration Open

7:30 – 8:30 Am Breakfast (provided)

8:30 – 9:30 AM General Session 3: Cause and Effect: False Science = False Claim – Margaret (Peg) Hutchinson, Chief, Civil Division, U.S. Attorney’s Office for the Eastern District of Pennsylvania


10:00 – 11:00 Am BReAKout sessions

501 Creating Infrastructure Support for Investigator-Initiated Research – Karen A. Hartman, Administrator - Research Compliance, Mayo Clinic

502 Defining and Streamlining Review of Reportable Events – Emily Smotherman, Research Comp Mgr, Children’s Healthcare of Atlanta; Sarah Marie Huban, IRB Manager, Children’s Healthcare of Atlanta


503AD Interactive Coverage Analysis Workshopping: Three Case Scenarios – Ryan Meade, CHRC, CHC-F, Director of Regulatory Compliance Studies, Loyola University Chicago, School of Law


11:15 Am – 12:15 pm 601 Effectively Managing and Monitoring Controlled Substances in Research – Emmelyn Kim, AVP, Research Compliance & Privacy Officer, Northwell Health; Ji-Eun Kim, Research Pharmacist, Northwell Health

602 The Federal What…? Using the FSG as Organizing Principles for a Research Compliance Office – Robert S. Bienkowski, Director of Research Compliance, Central Michigan University

12:15 – 1:15 pm Networking Lunch (provided)


701 Navigating Animal Research Compliance and Managing Risks – Denise Ancharski-Stutler, Assistant Director, Post-Approval Monitoring, Children’s Hospital of Philadelphia

702 Sharing Is Caring: HHS Final Rule on Clinical Trials Registration and Results Information Submission – Anne Ruff, Attorney, Hall, Render, Killian, Heath & Lyman, PC



801 ClinicalTrials.gov: The Push for More Transparency, and How Your Institution Can Keep Up with the Expanded Requirements, Tackle Systematic Changes, and Prepare for Enforcement – Diane Wilson, Compliance Specialist, Lead, University of Michigan Med School; Emily Ouellette, QI Program Assistant Director, FDA and Regulatory Support, Partners HealthCare

802 Re-Organize the Research Program to Minimize Legal Risk and Maximize Compliance: A Case Study – Emma A Meagher, MD, Vice Dean for Clinical Research & Chief Clinical Research Officer, Perelman School of Medicine, University of Pennsylvania


3:45 – 4:45 pm General Session 4: Progression of the Profession: Formal Education Trends In Developing and Recruiting Compliance Professionals – Moderator: Ryan Meade, CHRC, CHC-F, Director of Regulatory Compliance Studies, Loyola University Chicago, School of Law; Melanie R. Kay, Director, Daniels Fund Ethics Initiative, University of Colorado Law School; Alice M. BrightSky, Senior Director, Compliance Programs, Fordham Law School; Colleen Dorsey, Esq., Director, Organizational Ethics & Compliance, University of St. Thomas

WEDNESDAY, JUNE 7: POST-CONFERENCE8:00 – 11:45 Am Registration Open

8:30 – 10:00 Am BReAKout sessionspost-ConFeRenCe

W1 Understanding and Applying the Guidance in Part 6: Internal Controls of the OMB Compliance Supplement – Matthew W. Staman, Managing Director, Huron Consulting Group; Marisa Zuskar, Director, Huron Consulting Group

W2 A Primer on Human Subject Protection Regulations for the Compliance Professional – Scott Lipkin, DPM, CIP, Managing Director, Research & Compliance, FTI Consulting


10:15 – 11:45 Am BReAKout sessionspost-ConFeRenCe

W3 Research Compliance Structures and Quality Systems – Johanna J. Stamates, Executive Director, University of Miami

W4 Research Compliance Programs: Always a Work in Progress – Dwight Claustre, Director, Aegis Compliance & Ethics Center, LLP; Karen Mottola, Research Compliance Officer, Sutter Health

12:30 pm CHRC Exam Check-in

1:00 – 3:30 pm Certified in Healthcare Research Compliance (CHRC)® exam (optional)

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SUNDAY, JUNE 4PRE-CONFERENCE

12:30 – 5:30 pm Registration Open

1:00 – 2:30 pm BREAKOUT SESSIONS

P1 The Most Challenging Provisions in CTAs

Michael C. Roach, Managing Director, Aegis Compliance & Ethics Center, LLP

xx This session will discuss the most challenging provisions in sponsor template clinical trial agreements

xx The speakers will provide alternative language that institutions might consider using that are designed to protect both parties to the agreement

xx Participants will be encouraged to discuss approaches they use to negotiate these provisions

P2 Investigator Initiated Trials: Common Startup Struggles and Oversights

David B. Russell, Director, Site Strategy, PFS Clinical

Liz Christianson, Senior Clinical Research Analyst, PFS Clinical

xx The administrative responsibilities involved in IIT startup are unfamiliar as they are normally taken on by industry sponsors and outside agencies. Mistakes made during the initial development and start up stages can cause compliance and financial issues

xx Provide a walkthrough of how to define and portray the intent of the objectives (interventional vs observational) and qualifying status of study in order to determine compliant billing strategy, precisely assess financial feasibility and maximize profit

xx We will also provide suggestions on how to educate PIs about coverage analysis billing designations and on their startup responsibilities as study Sponsors in order to streamline processes

2:30 – 2:45 pm

Networking Break


P3 Enterprise Solutions for Implementing Effective Corrective Action and Prevention Plans (CAPA) Following Internal Audits of Clinical Research Trials

Deepika Bhatia, MSBME, CCRP, CHRC, Assist. Director - Research & Academics Compliance, UT Southwestern

Trissi S. Gray, MBA, CHRC, Assistant Director, Health System Compliance, UT Southwestern Med Center

xx Review Internal Audit Debriefing Steps for Clinical Trial PIs and Study Team Members

xx Describe the Use of Self-Monitoring, Content Experts, Peer Mentors, Institutional Leaders and Novel Educational Platforms for Engaging PIs/ Study Teams in the Corrective Action Process

xx Discuss Strategies for Evaluating the Organizational Effectiveness of Corrective Action Planning

P4 How Research Risks Affect Compliance

Sarah Fowler-Dixon, Education Specialist, Human Research Protection Office, Washington University School of Medicine

xx Research risks “need to know” for compliance officers

xx Reducing research risks using preliminary risk assessments

xx Effects of research risks on approvals, consent, indemnifications, and risk management

4:15 – 5:30 pm Welcome Reception

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MONDAY, JUNE 5CONFERENCE

7:30 am – 6:30 pm Registration Open

7:30 – 8:30 am

Breakfast (provided)

8:30 – 8:45 am

Opening Remarks

8:45 – 9:45 am

General Session 1: Research Year in Review

Lisa Murtha, Senior Managing Director, FTI Consulting

9:45 – 10:15 am

Networking Break

10:15 – 11:15 am BREAKOUT SESSIONS

101 Against Tradeoffs: Improving Compliance and Researcher Satisfaction

Matthew W. Staman, Managing Director, Huron Consulting Group

Marisa Zuskar, Director, Huron Consulting Group

Anne Pifer, Senior Director, Huron Consulting Group

xx Research compliance is often characterized by the need to accept trade-offs between compliance and researcher satisfaction. This session will focus on opportunities to improve both

xx Excessive compliance requirements (or those perceived as such) can actually increase compliance risk given a human tendency to find ways around barriers to success

xx Some compliance requirements, sometimes even the most painful ones, cannot and should not be removed. But there are ways to reduce researcher burden

102 Compliance Implications for the Commercialization of Federally Funded Research

Bethany H. Loftin, Chief Operating Officer, TreMonti Consulting LLC

Ann Hammersla, Dir., Div of Extramural Invent. and Tech Resources, National Institutes of Health

xx The Bayh-Dole Act imposes several policy and compliance obligations on universities and institutions receiving federal funding for research, particularly when research results in an invention

xx Many Compliance Officers are unaware of these obligations. Failure to meet all compliance requirements may result in a loss of rights or federal funding support

xx This presentation will discuss institutions’ Bayh-Dole obligations and how to implement policy and procedures to ensure that your university is and remains compliant

11:15 am – 12:15 pm

Networking Lunch (provided)


201 The Intersection Between Medicare Coverage Analysis, IRB Review, and Informed Consent

Linn Defensor, Sr. MCA Analyst, Cedars-Sinai Medical Center

Keren Dunn, Manager, Research Compliance & QI, Cedars-Sinai Medical Ctr

xx Review the Medicare Clinical Trial Policy and FDA/HHS regulations governing IRB review and the protection of human research subjects, highlighting the intersections between them

xx Describe one institution’s approach to integration of the Medicare Coverage Analysis (MCA), IRB review and creation of the consent form

xx Present a process where risks of the study and financial obligations are integrated into the consent form based on the MCA

202 Managing Preclinical Risk to Protect Data Integrity, Animal Welfare, and Human Subject Safety

Stephen A. Frattini, DVM, Preclinical Research Compliance Manager, Northwell Health

Alison Powell, Research Compliance Manager, Northwell Health

xx Understand the laboratory development of biomedical technology from the bench to the bedside

xx Understand how compliance oversight, and risk management can help lead to quality, reproducible data, increased animal welfare, and safe foundational knowledge for early phase clinical trials

xx Review and discuss relevant cases that exemplify researcher and subject risk, and how they affect bench research, animal studies, and early phase clinical trials

1:15 – 1:45 pm

Networking Break


301 Want to Participate in Research? There’s An App for That: Security and Privacy Issues with the Increased Use of Connected Devices, Apps and Social Media In Research

Marti Arvin, Vice President, Audit Strategy, CynergisTek, Inc

David Mata, Senior Associate, Aegis Compliance and Ethics Center

xx What are the ways apps, medical devices, and social media are being used in research?

xx What are the privacy and information security issues around this?

xx How can you help researchers minimize the risk?

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302 Managing Research Compliance Utilizing an Electronic Compliance Database System

Mike Jensen, Intermountain Healthcare

xx The use of an electronic compliance database manager we developed provides a real-time method for coordinating managing, and documenting aspects of compliance for research related activities in the health-care setting

xx The electronic compliance database manager provides the tool to organize individual research related activities of compliance, tailored to the demands required based on the research project being conducted

xx The use of an electronic compliance database manager provides the compliance specialist to ability to organize, validate, audit, report, trend, and assess all research compliance requirements, in an effort to ensure compliance to research conducted


303AD Good Clinical Practice: Interactive Discussion On Maintaining GCP in a Compliant Driven World

Kelly Willenberg, Owner, Kelly Willenberg and Associates

2:45 – 3:15 pm

Networking Break

3:15 – 4:15 pm

BREAKOUT SESSIONS

401 Where Is the Data? Risks of Data Location, Storage and Protection of Sensitive Protected Health Information (PHI)

Margaret M. Groves, Associate Compliance Officer, HSRC, Duke University Office of Audit, Risk and Compliance

Holly B. Benton, Director, Privacy Compliance, Duke University Office of Audit, Risk and Compliance

xx This session focuses on locating sensitive data and PHI and tips for safeguarding the institution when these types of data both enter and exit the institution

xx What is a Research Data Security Plan and how can sensitive paper, electronic data and PHI be monitored across an institution?

xx As faculty come and go, what considerations should be discussed with regard to the transfer of data between institutions?

402 Finding Flexibility in the IRB Regulations: How to Reduce Burden

Mariette Marsh, Director, Human Subjects Protection Program, The University of Arizona

xx Flexible IRB review allows for greater efficiency while maintaining legal requirements. Learn how to identify where you can be flexible in your review

xx Hands on flexible policies will be presented to showcase how institutions have chosen to apply the federal rules

xx A discussion of HIPAA and single IRB of record will occur and how to implement this at your institution

4:15 – 4:30 pm

Networking Break

4:30 – 5:30 pm

General Session 2: Update on the Revisions to the Common Rule

Laura Odwazny, Senior Attorney, Public Health Division, Office of the General Counsel, U.S. Department of Health and Human Services

xx Provide an overview of the final rule, published January 20, 2017, revising the U.S. Federal human subjects protection regulations (the “Common Rule”)

xx Discuss the planned effective date of the final rule provisions and implementation considerations for research institutions

xx Address how the revised Common Rule intersects with requirements of the 21st Century Cures Act

5:30 – 6:30 pm

Networking Reception

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TUESDAY, JUNE 6CONFERENCE

7:30 am – 4:45 pm

Registration Open

7:30 – 8:30 am

Breakfast (provided)

8:30 – 9:30 am

General Session 3: Cause and Effect: False Science = False Claim

Margaret (Peg) Hutchinson, Chief, Civil Division, U.S. Attorney’s Office for the Eastern District of Pennsylvania

xx Discussion of the amendments to the False Claims Act that pertain to the research arena

xx Examples of False Claims Act liability in the research arena

xx Lessons learned from False Claims Act research cases

9:30 – 10:00 am

Networking Break


501 Creating Infrastructure Support for Investigator-Initiated Research

Karen A. Hartman, Administrator - Research Compliance, Mayo Clinic

xx Share best practices in providing support to investigators and study teams for investigator-initiated, FDA regulated studies

xx Discuss support activities including tools and templates for FDA submissions, creation of a database for tracking FDA submissions, resources for ClinicalTrials.gov reporting, and monitoring activities

xx Describe models of support using a case example approach from one Academic Medical Center

502 Defining and Streamlining Review of Reportable Events

Emily Smotherman, Research Comp Mgr, Children’s Healthcare of Atlanta

Sarah Marie Huban, IRB Manager, Children’s Healthcare of Atlanta

xx Review regulatory requirements for IRB review of important events in research (AEs, UPs, NC)

xx Share best practices to streamline investigator reporting to IRBs and IRB review

xx Discuss work flow to promote efficiency of IRB review and consistency of IRB determinations


503AD Interactive Coverage Analysis Workshopping: Three Case Scenarios

Ryan Meade, CHRC, CHC-F, Director of Regulatory Compliance Studies, Loyola University Chicago, School of Law

11:00 – 11:15 am

Networking Break

11:15 am – 12:15 pm

BREAKOUT SESSIONS

601 Effectively Managing and Monitoring Controlled Substances in Research

Emmelyn Kim, AVP, Research Compliance & Privacy Officer, Northwell Health

Ji-Eun Kim, Research Pharmacist, Northwell Health

xx Key regulatory and policy considerations for laboratory, animal and clinical research programs

xx Working effectively with environmental health and safety, researchers, security, pharmacy and administration on controlled substance management in research

xx How to integrate controlled substance reviews into your compliance program

602 The Federal What…? Using the FSG as Organizing Principles for a Research Compliance Office

Robert S. Bienkowski, Director of Research Compliance, Central Michigan University

xx Propose a modified version of the FSG as organizing principles for an Office of Research Compliance

xx Illustrate how the standards of the major research compliance accrediting bodies (AAHRPP and AAALAC) map onto the FSG.

xx Illustrate how the FSG can be used to develop standards for other research compliance areas such as the IBC and Export Control

12:15 – 1:15 pm

Networking Lunch (provided)

1:15 – 2:15 pm

BREAKOUT SESSIONS

701 Navigating Animal Research Compliance and Managing Risks

Denise Ancharski-Stutler, Assistant Director, Post-Approval Monitoring, Children’s Hospital of Philadelphia

xx Describe trends and challenges of Post-Approval Monitoring Programs (PAM)

xx Identify risks affecting animal research and discuss strategies to implement corrective and preventative actions

xx Discuss strategies for minimizing and mitigating risks

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702 Sharing Is Caring: HHS Final Rule on Clinical Trials Registration and Results Information Submission

Anne Ruff, Attorney, Hall, Render, Killian, Heath & Lyman, PC

xx Provide an overview of the HHS Final Rule’s new requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov

xx Discuss the complementary policy issued by NIH on registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded trials

xx Consider how the Final Rule and the NIH policy will impact various organizations and entities performing research

2:15 – 2:30 pm

Networking Break

2:30 – 3:30 pm

BREAKOUT SESSIONS

801 ClinicalTrials.gov: The Push for More Transparency, and How Your Institution Can Keep Up with the Expanded Requirements, Tackle Systematic Changes, and Prepare for Enforcement

Diane Wilson, Compliance Specialist, Lead, University of Michigan Med School

Emily Ouellette, QI Program Assistant Director, FDA and Regulatory Support, Partners HealthCare

xx The Federal Regulatory Landscape under FDAAA: 42 CFRÂ§11. With new Clinicaltrials.gov deadlines, results reporting requirements, protocol uploads, enforcement, and PRS system changes, what do regulatory specialists and investigators need to know?

xx The new NIH policy and clinical trials definition: What trials are covered? What additional obligations apply?

xx What Are Your Pain Points? Building on attendees’ shared areas of concern, presenters will share solutions and best practices gleaned from scores of hours with top clinicaltrials.gov administrators around the country and Clinicaltrials.gov staff

802 Re-Organize the Research Program to Minimize Legal Risk and Maximize Compliance: A Case Study

Emma A. Meagher, MD, Vice Dean for Clinical Research & Chief Clinical Research Officer, Perelman School of Medicine, University of Pennsylvania

xx The current state of clinical research and where risks are present

xx The research strategy/re-organization plan

xx Optimizing and growing the clinical research portfolio while managing change

3:30 – 3:45 pm

Networking Break

3:45 – 4:45 pm

General Session 4: Progression of the Profession: Formal Education Trends In Developing and Recruiting Compliance Professionals

Moderator: Ryan Meade, CHRC, CHC-F, Director of Regulatory Compliance Studies, Loyola University Chicago, School of Law

Melanie R. Kay, Director, Daniels Fund Ethics Initiative, University of Colorado Law School

Alice M. BrightSky, Senior Director, Compliance Programs, Fordham Law School

Colleen Dorsey, Esq., Director, Organizational Ethics & Compliance, University of St. Thomas

xx Learn about new programs and methods for developing the next generation of compliance professionals

xx Discuss benefits and challenges in hiring new graduates

xx Review approaches for recruiting new talent

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WEDNESDAY, JUNE 7POST-CONFERENCE

8:00 – 11:45 am

Registration Open


W1 Understanding and Applying the Guidance in Part 6: Internal Controls of the OMB Compliance Supplement

Matthew W. Staman, Managing Director, Huron Consulting Group

Marisa Zuskar, Director, Huron Consulting Group

xx During this training session, we will be discussing the Office of Management and Budget (OMB) 2 CFR 200, Subpart F – Compliance Supplement. The session will incorporate an overview of Compliance Supplement, including important updates to Part 6 – Internal Controls.

xx We will break down Part 6, including answering questions such as:

x– How is Part 6 different from its predecessors?

x– How can your institution evaluate its internal control structure?

x– What should your institution consider when developing or supplementing the control environment?

xx Participants will gain insight on the application of Part 6 to the Single Audit, the role of internal controls in the compliance environment and specific strategies to evaluate the sufficiency of internal controls in light of Part 6.

W2 A Primer on Human Subject Protection Regulations for the Compliance Professional

Scott Lipkin, DPM, CIP, Managing Director, Research & Compliance, FTI Consulting

xx Review the regulatory framework applicable to human research protections

xx Describe the responsibilities and requirements of the human research protection program

xx Identify common and high risk compliance areas related to human research protections

10:00 – 10:15 am

Networking Break


W3 Research Compliance Structures and Quality Systems

Johanna J. Stamates, Executive Director, University of Miami

xx The constantly evolving field of clinical research—changes in regulations, guidance documents, increased oversight by regulatory agencies, and the increasing sophistication of research subjects—require us to pause and rethink current practices

xx The current climate requires awareness, implementation of a robust compliance structure, use of quality systems, and risk management approaches in short, a proactive rather than a reactive approach

xx Examples of positive changes, heightened awareness, and strategies for the implementation of new and strengthening of existing compliance structures and quality systems will be discussed and that compliance professionals should be seen as change agents

W4 Research Compliance Programs: Always a Work in Progress

Dwight Claustre, Director, Aegis Compliance & Ethics Center, LLP

Karen Mottola, Research Compliance Officer, Sutter Health

xx Assess current state and evaluate opportunities for improvement

xx Identify the desirable enhancements and potential obstacles

xx Re-engineer the existing program and launch the new

12:30 pm

CHRC Exam Check-in

1:00 – 2:30 pm

Certified in Healthcare Research Compliance (CHRC)® exam (optional)

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CEUs Research Compliance Conference | June 4–7, 2017 | Baltimore, MD

HCCA is in the process of applying for additional credits. Should overall number of education hours decrease or increase, the maximum number of CEUs available will be changed accordingly. If you do not see information on your specific accreditation and would like to make a request, please contact us at 952-988-0141 or 888-580-8373 or email [email protected]. Visit HCCA’s website, hcca-info.org, for up-to-date information.

ACHE: The Health Care Compliance Association is authorized to award 17 hours of pre-approved ACHE Qualified Education credit (non-ACHE) for this program toward advancement, or recertification in the American College of Healthcare Executives. Participants in this program wishing to have the continuing education hours applied toward ACHE Qualified Education credit should indicate their attendance when submitting and application to the American College of Healthcare Executives for advancement or recertification.

Compliance Certification Board (CCB): CCB has awarded a maximum of 21.6 CEUs for these certifications: Certified in Healthcare Compliance (CHC)®, Certified in Healthcare Compliance– Fellow (CHC-F)®, Certified in Healthcare Privacy Compliance (CHPC®), Certified in Healthcare Research Compliance (CHRC)®, Certified Compliance & Ethics Professional (CCEP)®, Certified Compliance & Ethics Professional–Fellow (CCEP-F)®, Certified Compliance & Ethics Professional–International (CCEP-I)®.

CLE: The Health Care Compliance Association is a State Bar of California Approved MCLE provider, a Pennsylvania Accredited Provider, and is an accredited sponsor, approved by the State Bar of Texas, Committee on MCLE. HCCA will be submitting this course to additional states for consideration. An approximate maximum of 17.0 clock hours of CLE credit will be available to attendees of this conference. All CLE credits will be awarded based on individual attendance.

NASBA/CPE: The Health Care Compliance Association is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE sponsors, Sponsor Identification No: 105638. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.learningmarket. org. A recommended maximum of 21.5 credits based on a 50-minute hour will be granted for this activity. This program addresses topics that are of a current concern in the compliance environment and is a group-live activity in the recommended field of study of Specialized Knowledge and Application. For more information regarding administrative policies such as complaints or refunds, call (888) 580-8373 or (952) 988-0141.

Nursing Credit: The Health Care Compliance Association is preapproved by the California Board of Registered Nursing, Provider Number CEP 14593, for a maximum of 21.6 contact hour(s). The following states will not accept CA Board of Nursing contact hours: Delaware, Florida, New Jersey and Utah. Massachusetts and Mississippi nurses may submit CA Board of Nursing contact hours to their state board, but approval will depend on review by the board. Please contact the Accreditation Department at [email protected] with any questions you may have. Oncology Nurses who are certified by ONCC may request CA Nursing Credit (check box or indicate “Nursing” on the CEU form).

RACC: Attendees seeking CRA credits through the Research Administrators Certification Council (RACC) may request a certificate of attendance from HCCA by completing an Application for Continuing Education and indicating RACC/CRA as the credit type sought. HCCA will issue a certificate of attendance that details your completed continuing education hours. Those sections of the conference which match sections of the

CRA Body of Knowledge will be able to count toward contact hours for recertification of your CRA. If proof of participation is requested by RACC, your certificate will serve as proof that you completed the coursework as described. The Research Administrators Certification Council (RACC) promotes the concept of voluntary certification by examination for all research and sponsored programs administrators. Certification in research and sponsored programs administration is highly valued and provides formal recognition of basic knowledge in the field.

SoCRA: The Society of Clinical Research Associates (SoCRA - www.SoCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 18 hours of CE credit. SoCRA’s requirements for recertification Continuing Education credit are quite general, as they pertain to clinical research regulations, operations and management, and to the therapeutic area of the clinical research in which the candidate participates. We therefore leave it to the candidate to determine whether a course or program would be acceptable for SoCRA’s CE requirement. SoCRA does not “validate” individual training courses/ workshops.

PRIM&R: Some portions of this program may meet the requirements for CPIA continuing education. The CPIA Council accepts documentation of continuing education hours when the topics fall within the CPIA Body of Knowledge. If you are unsure about whether a specific session meets these requirements you should consult with PRIM&R. Some portions of this program may meet the requirements for CIP continuing education. CCIP accepts documentation of continuing education hours when the topics fall within the CIP Body of Knowledge and the education is intended to be beyond initial, basic or fundamental level education. If you are unsure about whether a specific session meets these requirements you should consult with PRIM&R.

Certified in Healthcare Research Compliance (CHRC)®

Learn more about the CHRC certification at compliancecertification.org/chrc

EARN YOUR CERTIFICATION

Take the CHRC Certification Exam on-site after the conferenceWednesday, June 7 | 12:30 pm

$250 HCCA MEMBERS OR $350 NON-MEMBERS

You must be pre-registered to sit for the exam. To apply, download the CHRC exam application from hcca-info.org. Questions? Email [email protected]. Twenty CCB CEUS are required to sit for the exam. For Research Compliance Conference sessions, one clock hour equals 1.2 CCB/CHRC hours. Attending the entire Research Compliance Conference will provide 21.6 CCB CEUs, which will provide sufficient CEUs to qualify to sit for the exam.

Certified in Healthcare Compliance

(CHC)®

Certified in Healthcare Privacy

Compliance (CHPC®)

Certified in Healthcare Research

Compliance (CHRC)®

Certified in Healthcare

Compliance-Fellow (CHC-F)®

Showcase your healthcare compliance

knowledge and experience

A few letters after your name can make a big diff erenceWhy do people add JD, MBA, or CPA after their name? They know those initials add credibility.

Become Certified in Healthcare Compliance (CHC)®, Certified in Healthcare Privacy Compliance (CHPC®), Certified in Healthcare Research Compliance (CHRC)® or a Certified in Healthcare Compliance-Fellow (CHC-F)®.

Applying to become certifi ed is easy.To learn what it takes to earn the CHC, CHRC, CHPC, or CHC-F designation, visit compliancecertification.org.

Become Certifi ed

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50+ conferences a year to choose from, all with special members-only rates.

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Register Research Compliance Conference | June 4–7, 2017 | Baltimore, MD

Full name please type or print

Sharing your demographic information with HCCA will help us create better networking opportunities for you. Thank you for taking a moment to fill out the following information.

What is your functional job title? Please select one.

List others not listed here:

Academic/Professor

Administration

Asst Compliance Officer

Attorney (In-House Counsel)

Attorney (Outside Counsel)

Audit Analyst

Audit Manager/Officer

Billing Manager/Officer

Charger Master

Chief Compliance Officer

CEO/President

Chief Financial Officer

Chief Information Officer

Chief Medical Officer

Chief Operating Officer

Clinical

Coder

Compliance Analyst

Compliance Coordinator

Compliance Director

Compliance Fraud Examiner

Compliance Officer

Compliance Specialist

Consultant

Controller

Ethics Officer

Executive Director

General Counsel

HIM Professional

HIPAA/Privacy Officer

Human Resources

Medical Director

Nurse

Nurse Manager

Patient Safety Officer

Pharmacy Director

Physician

Quality Assurance/ Quality of Care

Regulatory Officer

Reimbursement Coordinator

Research Analyst

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Other (please list below)

What is your primary health care entity?


What credentials do you hold? Select all that apply.


Academic

Ambulance/Transportation

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Home Care/Hospice

Hospital

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Integrated Delivery System

Integrated Health System

Laboratory

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Payor/Insurance

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Other (please list below)

BA BBA BS BSN CCEP CEM CCS CCS-P CFE CHC

CHE CHP CHPC CHRC CIA CPA CPC CPHQ DDS ESQ

FHFMA JD LLM MA MBA MHA MPA MPH MS MSHA

MSN MT NHA PhD RHIA RHIT RN

Are you a first-time attendee of the Research Compliance Conference?

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REGISTRATION CONTINUES ON NEXT PAGE (OVER)

1 Demographic Information

14 hcca-info.org

Register Research Compliance Conference | June 4–7, 2017 | Baltimore, MD

Health Care Compliance Association®

6500 Barrie Road, Suite 250Minneapolis, MN 55435-2358p 888-580-8373 | f 952-988-0146helpteam @ hcca-info.org | hcca-info.org

3 Registration Options SCCE Members: MONDAY & TUESDAY ........................................$799

Non-Members: MONDAY & TUESDAY ..........................................$949

New Membership & Registration: MON/TUE ...............................$999 New members only. Dues regularly $295 annually.

Pre-Conference: SUNDAY ...........................................................$125

Post-Conference: WEDNESDAY ...................................................$125

Discount for 5 or more from same organization ........................... ($50)

Discount for 10 or more from same organization ....................... ($100)

TOTAL $ Registration fees are as listed and considered net of any local withholding taxes applicable in your country of residence.

2 Contact Information Mr Mrs Ms Dr

Member ID (if applicable)

First Name MI

Last Name

Credentials (CHC, CCEP, etc.)

Job Title

Name of Employer

Street Address

City/Town

State/Province Zip/Postal Code

Country

Phone Fax

Email (required for registration confirmation and conference info)

4 Payment Options Check enclosed (payable to HCCA)

Invoice me

I authorize HCCA to charge my credit card (choose card below):

CREDIT CARD: American Express Discover MasterCard Visa

Due to PCI Compliance, please do not provide any credit card information via email. You may email this form to [email protected] (without credit card information) and call HCCA at 888-580-8373 or 952-988-0141 with your credit card information.

Credit Card Account Number

Credit Card Expiration Date

Cardholder’s Name

Cardholder’s SignatureRC0617

WAYS TO REGISTERMAIL Include registration form & check payable to: HCCA, 6500 Barrie Road, Suite 250, Minneapolis, MN 55435

ONLINE hcca-info.org/research

FAX 952-988-0146 (include billing info)

EMAIL [email protected] (do not email credit card details)

QUESTIONS? Call 888-580-8373 or email helpteam @ hcca-info.org

SPECIAL REQUESTDIETARY NEEDS

Gluten Free

Kosher-Style (no shellfish, pork, or meat/dairy mixed)

Kosher (Hechsher certified)

Vegetarian

Vegan

Other (write below)

By submitting this registration form you agree to the Terms and Conditions as stated on page 15.

Registering for HCCA’s Research Compliance Conference automatically registers you for SCCE’s Higher Education Compliance Conference at no additional cost.

5 Session SelectionPlease select your sessions to assist us in room planning. Select only ONE session per time slot. Advanced Discussions are limited to the first 50 attendees and open on a first-come, first-served basis —no pre-registration is available.

MON, JUNE 5 BREAKOUTS

10:15 – 11:15 am

101

102

12:15 – 1:15 pm

201

202

1:45 – 2:45 pm

301

302

* 303AD

3:15 – 4:15 pm

401

402

TUE, JUNE 6 BREAKOUTS

10:00 – 11:00 am

501

502

* 503AD

11:15 am – 12:15 pm

601

602

1:15 – 2:15 pm

701

702

2:30 – 3:30 pm

801

802

WED, JUNE 7 POST-CONFERENCE

+$125

8:30 – 10:00 am

W1

W2

10:15 – 11:45 am

W3

W4

SUN, JUNE 4 PRE-CONFERENCE

+$125

1:00 – 2:30 pm

P1

P2

2:45 – 4:15 pm

P3

P4

I’m interested in selecting sessions from SCCE’s Higher Education Compliance Conference. Please send me more information.

hcca-info.org 15

Details Research Compliance Conference | June 4–7, 2017 | Baltimore, MD

TERMS AND CONDITIONS

Registration Payment Terms. Checks are payable to HCCA. Credit cards accepted: American Express, MasterCard, Visa, or Discover. HCCA will charge your credit card the correct amount should your total be miscalculated. If you wish to pay using wire transfer funds, please email [email protected] for instructions.

Cancellations/Substitutions. You may send a substitute in your place or request a conference credit. Refunds will not be issued. Conference credits are issued in the full amount of the registration fees paid, and will expire 12 months from the date of the original, cancelled event. Conference credits may be used toward any HCCA service or product, except The Health Care Compliance Professional’s Manual. If a credit is applied toward an event, the event must take place prior to the credit’s expiration date. If you need to cancel your participation, notification is required by email, sent to [email protected], prior to the start date of the event. Please note that if you are sending a substitute, an additional fee may apply.such purposes.

Group Discounts. Discounts take effect the day a group reaches the discount number of registrants. Please send registration forms together to ensure that the discount is applied. A separate registration form is required for each registrant. The group discount is NOT available through online registration. Note that discounts will NOT be applied retroactively if more registrants are added at a later date, but new registrants will receive the group discount.

5 or more: $50 discount/each registrant10 or more: $100 discount/each registrant

Use of Information. Your information may be received by exhibitors at a conference as well as our affiliates and partners who we may share it with for marketing purposes. Please note that only postal address information is shared. If you wish to opt-out, please follow the process set out in our Privacy Statement (online at hcca-info.org/privacy.aspx).

Agreements & Acknowledgements. I agree and acknowledge that I am undertaking participation in HCCA events and activities as my own free and intentional act, and I am fully aware that possible physical injury might occur to me as a result of my participation in these events. I give this acknowledgement freely and knowingly and assert that I am, as a result, able to participate in HCCA events, and I do hereby assume responsibility for my own well-being. I agree and acknowledge that HCCA plans to take photographs and/or video at the Research Compliance Conference and reproduce them in HCCA educational, news, or promotional material, whether in print, electronic, or other media, including the HCCA website. By participating in the Research Compliance Conference, I grant HCCA the right to use my name, photograph, video, and biography for such purposes. As a participant of this event, your name, job title, organization, city, state, and country will be listed on the attendee list that will be distributed to attendees, speakers, and exhibitors of this event.

Special Needs/Concerns. Prior to your arrival, please call HCCA at 888-580-8373 if you have a special need and require accommodation to participate.

Dress Code. Business casual dress is appropriate.

Recording. No unauthorized audio or video recording of HCCA Conferences is allowed.

Continuing Education Units. HCCA is in the process of applying for credits. See page 10 for more. Visit the website, hcca-info.org/research, for up-to-date information.

HOTEL & CONFERENCE LOCATIONMarriott Baltimore Waterfront 700 Aliceanna Street Baltimore, MD 21202 p 410-385-3000 baltimoremarriottwaterfront.com

PHONE RESERVATIONS: Call the hotel directly at 410-385-3000 and ask for the HCCA Research Compliance Conference rate.

ONLINE RESERVATIONS: https://aws.passkey.com/event/15793724/owner/3649/landing

A reduced rate of $242 per night for single/double occupancy plus applicable taxes has been arranged for this conference. This rate is good through May 12, 2017, or until the group room block is full, whichever comes first. All reservations must be accompanied by a first-night room deposit or guaranteed with a major credit card.

Please visit hcca-info.org/research for updated hotel reservation information.

PLEASE NOTE: Neither HCCA nor any hotel it is affiliated with will ever contact you to make a hotel reservation. If you receive a call soliciting reservations on behalf of HCCA or the event, it is likely from a room poacher and may be fraudulent. We recommend you make reservations directly with the hotel using the phone number or web link provided by HCCA. If you have concerns or questions, please contact 888-580-8373.

HCCA THANKS OUR 2017 PLATINUM SPONSOR

6500 Barrie Road, Suite 250Minneapolis, MN 55435hcca-info.org

Register today and enjoy the flexibility of two conferences for the price of one!Complimentary access to SCCE’s Higher Education Compliance Conference is included with your registration. The parallel schedule gives you the freedom to attend sessions at either conference—two for the price of one.hcca-info.org/research

Join your peers at the primary networking and educational event for compliance professionals working in research compliance





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Research - HCCA's Official Site45 – Lisa Murtha, ... A Case Study –s ... Research Year in Review...

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