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Learn more at www.hcca-info.org/events June 1–4, 2014 | Austin, TX AT&T Executive Education Conference Center Research Compliance Conference 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. Join your peers at the primary networking and educational event for compliance & ethics professionals working in research compliance Questions: [email protected] LAST CHANCE TO REGISTER

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Page 1: LAST CHANCE TO REGISTER Research...402 Human Gene Transfer, Institutional Biosafety Committees, and Biological Materials Oversight: Past, Present and Future for Clinical Research –

Learn more at www.hcca-info.org/events

June 1–4, 2014 | Austin, TXAT&T Executive Education Conference Center

ResearchCompliance Conference

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.

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

Questions: jodi.ericksonhernandez @ hcca-info.org

LAST CHANCE TO REGISTER

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Program at a Glance

SUNDAY, JUNE 1: PRE-CONFERENCE12:00 – 5:30 pm Registration Open

1:00 – 2:30 pm BREAKOUT SESSIONS pRE-CONFERENCE 1

P1 Human Research Protections 101 – Jeffrey A. Cooper, MD, MMM, Vice President Global Consulting WIRB-Copernicus Group; Tina R. Tyson, JD, Chief Ethics and Compliance Officer, Duke University; Scott J. Lipkin, DPM, Chief, Network Office of Research & Innovation, Lehigh Valley Health Network

P2 Technology Solutions for Managing Research Compliance – Srini Kalluri, CEO, Forte Research Systems, Inc.; Rhonda A. Hoffman, CCRP, System Director, Norton Healthcare Office of Research Administration (NHORA)

2:30 – 3:00 pm Networking Break

3:00 – 5:00 pm BREAKOUT SESSIONS pRE-CONFERENCE 2

P3 Reality vs. Perception: What a Site Really Needs to Do to Be GCP – Liz Wool, President & CEO, QD-Quality and Training Solutions, Inc

P4 The Basics for Achieving Compliance in Clinical Research Billing – Shanley J. Curran, RN, Esq., CHRC, CHC, CCRP, Manager, Clinical Research Billing Compliance, Office of Compliance Services for UCLA Health System & DGSOM

5:00 – 6:00 pm Welcome Reception in Exhibit Hall

MONDAY, JUNE 2: CONFERENCE7:00 Am – 5:30 pm Registration Open

7:00 – 8:15 Am Continental Breakfast in Exhibit Hall

8:15 – 8:30 Am Opening Remarks

8:30 – 9:30 Am General Session 1: International Research – Mark Barnes, Partner, Ropes & Gray LLP, Faculty Co-Chair, Multi-Regional Clinical Trials Center, Harvard University

9:30 – 10:00 Am Networking Break

10:00 – 11:30 Am BREAKOUT SESSIONS

101 The False Claims Act and Its Impact on Federally Sponsored Research – Jeff Seo, Director of Research Compliance, Harvard Medical School

102 Regulations and Ethics on using EHR Data for Research – David Vulcano, AVP Clinical Research, HCA

103 Fair Market Value Issues with Research Physicians – Ryan D. Meade, CHRC, Director of Regulatory Compliance Studies, Loyola University Chicago School of Law

11:30 Am – 12:30 pm Networking Lunch (provided)

12:45 – 2:15 pm BREAKOUT SESSIONS

201 Practical Tools for Handling Conflict of Interest Requirements – Gustavo A. Fernandez, Research Compliance Monitor, Univ of Connecticut Health Ctr; Julia M. Campbell, Director, Conflict of Interest, Northwestern University

202 Lessons Learned in Building a Research Compliance Program – Chartley McMaster Bondurant, Associate Director, Office of Research Compliance, Indiana University; Marcia N. Gonzales, Chief Compliance Officer, Indiana University

203 Human Research Protection Program (HRPP) Inspections: What To Expect, What To Do & What Not To Do – Lisa Rooney, Director, Aegis/Meade Roach & Annulis; Susan C. Buskirk, MS, Assistant Vice President, Human Research Integrity and Compliance, Office of Academic Affairs-Research Compliance

2:15 – 2:45 pm Networking Break in Exhibit Hall

2:45 – 4:15 pm BREAKOUT SESSIONS

301 Preserving Integrity in Billing: Affording Fraud and Abuse – Kelly M. Willenberg, Owner, Kelly Willenberg, LLC; Cindy C. Parman, Principal, Coding Strategies Inc

302 Risk Based Monitoring for Pediatric Research – Kele K. Piper, Research Compliance Officer, Children’s Hospital Colorado

303 The Importance and Impact of Effective Clinical Trial Feasibility Assessment – Kevin R. Eskew, MBA, CHC, Managing Director, Dentons US LLP

4:15 – 4:30 pm Networking Break in Exhibit Hall

4:30 – 5:30 pm General Session 2: Research Year in Review – Lisa Murtha, CHC, CHRC, Senior Managing Director, FTI Consulting

5:30 – 6:30 pm Networking Reception in Exhibit Hall

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Program at a Glance

TUESDAY, JUNE 3: CONFERENCE7:30 Am – 4:30 pm Registration Open

7:30 – 8:30 Am Continental Breakfast in Exhibit Hall

8:15 – 8:30 Am Opening Remarks

8:30 – 10:00 AM General Session 3: Ethics and Compliance Transformation: Establishing a New Model at Penn State – Regis Becker, Director, Office of Ethics and Compliance, The Pennsylvania State University; Julie Del Giorno, Athletics Integrity Officer, The Pennsylvania State University; Sandy Weaver, Youth Programs Compliance Specialist, The Pennsylvania State University

10:00 – 10:30 Am Networking Break in Exhibit Hall

10:30 Am – 12:00 pm BREAKOUT SESSIONS

401 ICD-10 Readiness & Clinical Research Is Your Research Compliance Program Ready for the Transition? – Erika Stevens, Senior Manager, Ernst & Young, LLP; Mary Rydman, MPA, CIP, Director HRPO, Dignity Health

402 Human Gene Transfer, Institutional Biosafety Committees, and Biological Materials Oversight: Past, Present and Future for Clinical Research – Chris Jenkins, PhD, MPH, RBP, Senior Director of IBC Services and Director of Biosafety Consulting, WIRB-Copernicus Group

403 A New Flexibility for Researchers Under the Final Omnibus Rule: Understanding the Law, Practical Considerations and Recent Case Studies – Andrew W. Mahler, JD, Privacy Officer, The University of Arizona; Gregory J. Ehardt, JD, Assistant Compliance Officer (Office of General Counsel), Assistant Professor in Health Care, Idaho State University

12:00 – 1:00 pm Networking Lunch (provided)

1:15 – 2:45 pm BREAKOUT SESSIONS

501 Preparing and Responding to an FDA Inspection – Frank Estala, Research Compliance Mgr, UT-Health Science Center at San Antonio (moderator); Anna Taranova, MD, MS, CCRP, Senior Research Director, University Health System, San Antonio; Kathleen D. James, Asst Compliance Officer, UT Health Science Center At SA; Clara Vorpahl, Sr. Research Compliance Specialist, UT-Health Science Center at San Antonio

502 They Do the Crime, You Do the Time – Kristin H. West, JD, M.S. Pharm., CHRC, Associate Vice President and Director of the Office of Research Compliance, Emory University

503 Research Misconduct: The Most Vexing Challenge for the Research Compliance Professional – Juliann Tenney, JD, CHRC, Institutional Research Compliance & Privacy Officer; Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill

2:45 – 3:00 pm Networking Break

3:00 – 4:00 pm General Session 4: Medicare Billing & Cancer Cooperative Group Studies – Kelly Willenberg, MBA, BSN, RN, CHC, CHRC, President, Kelly Willenberg, LLC; Nathan Eriksen, Chief of Administration, SWOG Group Chair’s Office

WEDNESDAY, JUNE 4: POST-CONFERENCE8:00 – 11:30 Am Registration Open

8:00 – 8:30 Am Continental Breakfast

8:30 – 11:30 Am BREAKOUT SESSIONSpOST-CONFERENCE (INClUdES 15-mIN BREAK)

W1 Federal Grants Compliance 101 – Matthew Staman, Managing Director, Huron Consulting Group; Marisa Zuskar, Director, Huron Consulting Group

W2 Healthcare Reform and The Clinical Research Industry – David Vulcano, AVP Clinical Research, HCA

11:30 Am – 12:30 pm Lunch (on own)

12:30 – 1:00 pm CHRC Exam Check-In

1:00 – 3:00 pm Certified in Healthcare Research Compliance (CHRC)® Exam

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Agenda

SUNDAY, JUNE 112:00 – 5:30 pm Registration Open

1:00 – 2:30 pm PRE-CONFERENCE 1: BREAKOUT SESSIONS

P1 Human Research Protections 101 Jeffrey A. Cooper, MD, MMM, Vice President Global Consulting, WIRB-Copernicus Group

Tina R. Tyson, JD, Chief Ethics and Compliance Officer, Duke University

Scott J. Lipkin, DPM, Chief, Network Office of Research & Innovation, Lehigh Valley Health Network

P2 Technology Solutions for Managing Research Compliance

Srini Kalluri, CEO, Forte Research Systems, Inc.

Rhonda A. Hoffman, CCRP, System Director, Norton Healthcare Office of Research Administration (NHORA)

2:30 – 3:00 pm Networking Break

3:00 – 5:00 pm PRE-CONFERENCE 2: BREAKOUT SESSIONS

P3 Reality vs. Perception: What a Site Really Needs to Do to Be GCP

Liz Wool, President & CEO, QD-Quality and Training Solutions, Inc

xx Understand that clinical trial execution requirements in 2014 is more than being compliant—it is about the prospective cycle of quality

xx Distinguish attributes of patient care-health care standards-clinical care and scope of practice that apply to the execution of clinical trials

xx Translate regulatory agency expectations regarding Clinical Investigator supervision, oversight and control of the clinical investigation

P4 The Basics for Achieving Compliance in Clinical Research Billing

Shanley J. Curran, RN, Esq., CHRC, CHC, CCRP, Manager, Clinical Research Billing Compliance, Office of Compliance Services for UCLA Health System & DGSOM

xx CRB compliance program and the CRB compliance risks

xx CRB operations

xx Basic issues and workflow challenges

5:00 – 6:00 pm Welcome Reception in Exhibit Hall

MONDAY, JUNE 2 7:00 am – 5:30 pm Registration Open

7:00 – 8:15 am Continental Breakfast in Exhibit Hall

8:15 – 8:30 am Opening Remarks

8:30 – 9:30 am

General Session 1: International ResearchMark Barnes, Partner, Ropes & Gray LLP, Faculty Co-Chair, Multi-Regional Clinical Trials Center, Harvard University

xx Identifying and managing financial, compliance and logistical risks in international projects

xx Special risks in health services and health research projects

xx Foreign Corrupt Practices Act and UK Bribery Act

9:30 – 10:00 am Networking Break in Exhibit Hall

10:00 – 11:30 am CONCURRENT BREAKOUT SESSIONS

101 The False Claims Act and Its Impact on Federally Sponsored Research

Jeff Seo, Director of Research Compliance, Harvard Medical School

xx Historical look at how the FCA evolved and its use as a federal enforcement tool to combat fraud, waste and abuse

xx Examination of the FCA’s application against academic research institutions

xx Lessons learned from the trends in federal enfocement actions

102 Regulations and Ethics on using EHR Data for Research

David Vulcano, AVP Clinical Research, HCA

xx Analyzes research regulations and how they pertain to using EHR data for research

xx Analyzes privacy regulations and how they pertain to using EHR data for research

xx Analyzes key business and ethical decisions pertaining to using EHR data for research

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Agenda

103 Fair Market Value Issues with Research Physicians

Ryan D. Meade, CHRC, Director of Regulatory Compliance Studies, Loyola University Chicago School of Law

xx Fraud and abuse laws that apply to research compensation arrangements

xx How to construct compliant compensation arrangements with research physicians

xx Recent cases and settlements

11:30 am – 12:30 pm Networking Lunch

12:45 – 2:15 pm CONCURRENT BREAKOUT SESSIONS

201 Practical Tools for Handling Conflict of Interest Requirements

Gustavo A. Fernandez, Research Compliance Monitor, University of Connecticut Health Center

Julia M. Campbell, Director, Conflict of Interest, Northwestern University

xx Take full advantage of your training tools (classroom, computer or web-based trainings) to educate your community relative to conflict of interest

xx Establish standards and procedures for collecting, reviewing, and managing conflicts of interest

xx Maximize your resources to achieve compliance with all aspects of conflict of interest regulations

202 Lessons Learned in Building a Research Compliance Program

Chartley McMaster Bondurant, Associate Director, Office of Research Compliance, Indiana University

Marcia N. Gonzales, Chief Compliance Officer, Indiana University

xx Building a Research Compliance Program to address the evolving needs across multi-disciplinary areas with current resources

xx What worked? What didn’t? There are lots of lessons to be learned while building a program from the ground up

xx Adapting and evolving a Research Compliance Program to meet the compliance needs of researchers while protecting the institution

203 Human Research Protection Program (HRPP) Inspections: What To Expect, What To Do & What Not To Do

Lisa Rooney, Director, Aegis/Meade Roach & Annulis

Susan C. Buskirk, MS, Assistant Vice President, Human Research Integrity and Compliance, Office of Academic Affairs-Research Compliance

xx Provide information on what to expect during a HRPP inspection

xx Tips on how to prepare for a HRPP inspection

xx Discuss what to do and not do before, during and after HRPP Inspection

2:15 – 2:45 pm Networking Break in Exhibit Hall

2:45 – 4:15 pm CONCURRENT BREAKOUT SESSIONS

301 Preserving Integrity in Billing: Affording Fraud and Abuse

Kelly M. Willenberg, Owner, Kelly Willenberg, LLC

Cindy C. Parman, Principal, Coding Strategies Inc

xx Challenges in billing for clinical trials—the best practice model

xx Federal government’s focus on fraud and abuse

xx Complete your scorecard for the complexities in billing

302 Risk Based Monitoring for Pediatric ResearchKele K. Piper, Research Compliance Officer, Children’s Hospital Colorado

xx Risk-based monitoring—not a one-size-fits all approach

xx Describe key components of the FDA guidance for industry, review of oversight of clinical investigations—a risk-based approach to monitoring

xx Compare and contrast the industries response to FDA guidance

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Agenda

303 The Importance and Impact of Effective Clinical Trial Feasibility Assessment

Kevin R. Eskew, MBA, CHC, Managing Director, Dentons US LLP

xx Before initiating clinical research, Investigators, research coordinators, and leading institutional stakeholders must define the institutional breadth and depth of commitment

xx Among other factors, this group must realistically assess the feasibility of your accrual goals, financial viability, and logistical implications

xx Session will illuminate the common pitfalls that can be avoided when one considers the disparities between feasibility assessment and the reality of trial conduct

4:15 – 4:30 pm Networking Break in Exhibit Hall

4:30 – 5:30pm

General Session 2: Research Year in Review Lisa Murtha, CHC, CHRC, Senior Managing Director, FTI Consulting

5:30 – 6:30 pm Networking Reception in Exhibit Hall

TUESDAY, JUNE 3, 2014 7:30 am – 4:30 pm Registration Open

7:30 – 8:30 am Continental Breakfast in Exhibit Hall

8:15 – 8:30 am Opening Remarks

8:30 - 10:00 am

General Session 3: Ethics and Compliance Transformation: Establishing a New Model at Penn State

Regis Becker, Director, Office of Ethics and Compliance, The Pennsylvania State University

Julie Del Giorno, Athletics Integrity Officer, The Pennsylvania State University

Sandy Weaver, Youth Programs Compliance Specialist, The Pennsylvania State University

10:00 – 10:30 am Networking Break in Exhibit Hall

10:30 am – 12:00 pm CONCURRENT BREAKOUT SESSIONS

401 ICD-10 Readiness & Clinical Research Is Your Research Compliance Program Ready for the Transition?

Erika Stevens, Senior Manager, Ernst & Young, LLP

Mary Rydman, MPA, CIP, Director HRPO, Dignity Health

xx Describe research compliance issues impacted by IDC-10 conversion

xx Analyze key processes for mitigating research compliance risks resulting from ICD-10

xx Evaluate a large health system’s approach to readiness for ICD-10 conversion and its impact on the clinical research enterprise

402 Human Gene Transfer, Institutional Biosafety Committees, and Biological Materials Oversight: Past, Present and Future for Clinical Research

Chris Jenkins, PhD, MPH, RBP, Senior Director of IBC Services and Director of Biosafety Consulting, WIRB-Copernicus Group

xx Provide an overview on the past, present, and future state of research and regulatory requirements with regards to human gene therapy in clinical research environments

xx Outline the requirements and best practices of Institutional Biosafety Committee risk assessment review of a human gene therapy protocol under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids

xx Present and highlight the results of a National Institutes of Health, Office of Biotechnology Activities (NIH-OBA) survey on institutional life sciences research oversight utilizing biological materials and implications for research medical centers

403 A New Flexibility for Researchers Under the Final Omnibus Rule: Understanding the Law, Practical Considerations and Recent Case Studies

Andrew W. Mahler, JD, Privacy Officer, The University of Arizona

Gregory J. Ehardt, JD, Assistant Compliance Officer (Office of General Counsel), Assistant Professor in Health Care, Idaho State University

xx Understand implications for research under the HIPAA Final Omnibus Rule and receive practical guidance and materials for professionals working in a clinical research setting

xx “Beauty in Breaches:” outline a research institution’s journey from breach to settlement, specifically elaborating on the “do’s” and “don’ts” when being investigated by OCR

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Agenda12:00 – 1:00 pm Networking Lunch

1:15 – 2:45 pm CONCURRENT BREAKOUT SESSIONS

501 Preparing and Responding to an FDA Inspection

Frank Estala, Research Compliance Mgr, UT-Health Science Center at San Antonio (moderator)

Anna Taranova, MD, MS, CCRP, Senior Research Director, University Health System, San Antonio

Kathleen D. James, Asst Compliance Officer, UT Health Science Center At SA

Clara Vorpahl, Sr. Research Compliance Specialist, UT-Health Science Center at San Antonio

502 They Do the Crime, You Do the TimeKristin H. West, JD, M.S. Pharm., CHRC, Associate Vice President and Director of the Office of Research Compliance, Emory University

503 Research Misconduct: The Most Vexing Challenge for the Research Compliance Professional

Juliann Tenney, JD, CHRC, Institutional Research Compliance & Privacy Officer; Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill

xx Identifying research and scientific misconduct

xx Managing the process from allegation to appeal—a project management approach

xx Governing regulations and authorities

2:45 – 3:00 pm Networking Break

3:00 – 4:00 pm General Session 4: Medicare Billing & Cancer Cooperative Group Studies

Kelly Willenberg, MBA, BSN, RN, CHC, CHRC, President, Kelly Willenberg, LLC

Nathan Eriksen, Chief of Administration, SWOG Group Chair’s Office

WEDNESDAY, JUNE 4 8:00 – 11:30 am Registration Open

8:00 – 8:30 am Continental Breakfast

8:30 – 11:30 am POST-CONFERENCE BREAKOUT SESSIONS (INCLUDES A 15-MINUTE BREAK)

W1 Federal Grants Compliance 101 Matthew Staman, Managing Director, Huron Consulting Group

Marisa Zuskar, Director, Huron Consulting Group

W2 Healthcare Reform and The Clinical Research Industry

David Vulcano, AVP Clinical Research, HCA

xx Reviewing the Provisions of the Patient Protection and Affordable Care Act on the research industry

xx Impact of other healthcare legislation on the research industry

xx Impact of other healthcare initiatives on the research industry

1:00 – 3:00 pm Certified in Healthcare Research Compliance (CHRC)® Certification Exam (optional)You must be pre-registered to sit for the exam. To apply, download the CHRC exam application from www.hcca-info.org.

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HCCA is in the process of applying for additional credits. 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. Visit HCCA’s website, www.hcca-info.org for up-to-date information.

Compliance Certification Board (CCB): 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): CCB has awarded a maximum of 21.9 CEUs for these accreditations.

CLE: The Health Care Compliance Association is a State Bar of California Approved MCLE provider, Pennsylvania Accredited Provider, and Texas Accredited Sponsor. This course has been approved by the Supreme Court of Ohio Commission on Continuing Legal Education for 16.5 total CLE hours instruction. An approximate maximum of 18.25 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 and may not accept one-half credits. Complaints regarding registered sponsors may be addressed 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 the entire learning activity. This program addresses topics that are of a current concern in the compliance environment. This is an update, group-live activity. Advanced Preparation: None. For more information regarding administrative policies such as complaints or refunds, call HCCA at 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 12990, for a maximum of 21.9 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).

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.

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 on the form. A certificate of attendance along with a complete brochure should be submitted to RACC at the end of each individual’s RACC renewal period. 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 18.25 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.

Continuing Education UnitsPLATINUM SPONSOR

HCCA would like to thank the 2014 Conference Co-ChairsLisa Murtha, CHC, CHRC, Senior Managing Director, FTI Consulting

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

MEET THESE EXHIBITORS

ACUA

Amber Road

Baker McKenzie

BRANY

CaseWare

HCCS

Meditract

Navex

WeComply

EXHIBIT HALLThe HCCA Research Compliance Conference and the SCCE Higher Education Compliance Conference have teamed up to provide a combined exhibit hall for your convenience. Discover new products and services provided by companies in the compliance profession. The Internet Café, continental breakfast (Monday and Tuesday only), and networking breaks will be located in the exhibit area throughout the conference. Open hours are listed below.

Exhibit Viewing Hours

Sunday, June 1 ............... 5:00 – 6:00 pm

Monday, June 2 .......... 7:15 am – 6:30 pm

Tuesday, June 3 .......... 7:15 am – 1:15 pm

Take the CHRC Certification Exam

Wednesday, June 4 | 1:00–3:00 pm $250 HCCA Members | $350 Non-Members

You must be pre-registered to sit for the exam. To apply, download the CHRC exam application from www.hcca-info.org. Questions? E-mail [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 a maximum of 21.9 CEUs to qualify to sit for the exam.

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Registration Research Compliance Conference | June 1–4, 2014 | Austin, TX

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.

REGISTRATION CONTINUES ON NEXT PAGE (OVER)

What is your functional job title? Please select one.

List others not listed here:

Academic/Professor

Administration

Asst Compliance Officer

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CEO/President

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Other (please list below)

What is your primary health care entity?

List others not listed here:

What certifications do you hold? Select all that apply.

List others not listed here:

Academic

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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

Please tell us if you are a first-time attendee of the Research Compliance Conference:

This is my first Research Compliance Conference

DEMOGRAPHIC INFORMATION

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Registration Research Compliance Conference | June 1–4, 2014 | Austin, TX

HEALTH CARE COMPLIANCE ASSOCIATION 6500 Barrie Road, Suite 250, Minneapolis, MN 55435phone 888-580-8373 | fax 952-988-0146www.hcca-info.org | helpteam @ hcca-info.org

SESSION SELECTIONPlease select your sessions to assist us in room planning. Select only ONE session per time slot.

SUN, JUNE 1 PRE-CONFERENCE 1

1:00 – 2:30 pm

P1

P2 PRE-CONFERENCE 2

3:00 – 5:00 pm

P3

P4

MON, JUNE 2 BREAKOUTS

10:00 –11:30 am

101

102

103

12:45 –2:15 pm

201

202

203

2:45 –4:15 pm

301

302

303

TUE, JUNE 3 BREAKOUTS

10:30 am–12:00 pm

401

402

403

1:15 –2:45 pm

501

502

503

WED, JUNE 4 POST-CONFERENCE

8:30 – 11:30 am

W1

W2

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

CONTACT INFORMATION Mr Mrs Ms Dr

HCCA Member ID (if applicable)

First Name MI

Last Name

Credentials (CHRC, CHC, etc.)

Job Title

Name of Employer

Street Address

City/Town State/Province

Country Zip/Postal Code

Phone

Email (required for registration confirmation & conference information)

REGISTRATION OPTIONS

HCCA/SCCE Members ......................................................... $649

Non-Members ......................................................................$749

Membership Renewal & Registration .................................. $944

New Membership & Registration .........................................$849 NEw mEmBERS ONly / dUES REgUlARly $295 ANNUAlly

Pre-Conference Registration 1 ............................................ $125

Pre-Conference Registration 2 ............................................ $125

Post-Conference Registration (FREE wITh FUll CONFERENCE REgISTRATION ONly)

Group Discount: subtract $ from my total (SEE dETAIlS AT lEFT)

Exhibit Hall Guest Badge ....................................................... $50

TOTAL $

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

PAYMENT OPTIONSMail check to: HCCA, 6500 Barrie Road, Suite 250, Minneapolis, MN 55435

Fax to: 952-988-0146

Invoice me

Check enclosed (payable to HCCA)

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

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

Credit Card: American Express MasterCard Visa

Credit Card Account Number

Credit Card Expiration Date

Cardholder’s Name

Cardholder’s Signature

RC0614

Please fax your completed registration form with payment information to 952-988-0146, or register online at www.hcca-info.org/events

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Hotel & Conference Location: AT&T Executive Education Conference Center The University of Texas at Austin 1900 University Avenue, Austin, Texas 78705

SLEEPING ROOM BLOCK IS SOLD OUT

Hotel Reservations: https://resweb.passkey.com/go/SCCEHA0614

Phone Reservations: 877-744-8822 and mention identification code SCCEHA0614

A special rate of $179/night plus tax (for standard rooms) has been arranged for this conference. Please make your reservations directly with the hotel via phone or online by following the instructions below. Reservations will be accepted at the group rate until May 14, 2014, or until the group block is sold out, whichever comes first. Reservations received after this date, or after the block is filled, will be accepted based on space and rate availability. Individual reservations may be cancelled up to 48 hours prior to arrival without charge. Cancellations after this time will result in room rate and applicable taxes being charged one night room rate and applicable taxes to the credit card on file of the party that made the reservation. This hotel offers free high-speed wireless internet at any location in the hotel.

Overflow hotel optionsDoubleTree Suites by Hilton–Austin 303 W. 15th Street, Austin, Texas 512-478-7000

MENTION GROUP CODE: HEA

When making online reservations, you will need to select “Add special rate codes” and enter in HEA in order to get the $189 rate: www.austinsuites.doubletree.com/

A group rate of $189 has been arranged for conference attendees. Please make your reservations directly with the hotel via phone or online link above. Reservations will be accepted at the group rate until May 16, 2014. Cancellations must be made 72 hours in advance of arrival date.

Hampton Inn & Suites 1701 Lavaca Street Austin, TX 78701 512-499-8881

http://hamptoninn.hilton.com/en/hp/groups/personalized/ A/AUSUAHX-SCH-20140531/index.jhtml?WT.mc_id=POG

A LIMITED NUMBER OF ROOMS IS AVAILABLE

A group rate of $179 plus tax has been arranged for conference attendees. Please make your reservations directly with the hotel via phone or online link above. If reserving over the phone, please identify that you are with the SCCE/HCCA group. Individual reservations may be cancelled up to 72 hours prior to scheduled arrival. Any reservations canceled after this time will be subject to charge of one nights room and tax. Reservations will be accepted at the group rate until May 10, 2014, or until the group block is sold out, whichever comes first. Reservations received after this date, or after the block is filled, will be accepted based on space and rate availability.

Registration Terms & Conditions: Please make your check payable to HCCA, enclose payment with your registration, and return it to the HCCA office, or fax your credit card payment to 952-988-0146. If your total is miscalculated, HCCA will charge your card the correct amount. All expenses incurred to maintain or improve skills in your profession may be tax deductible, including tuition, travel, lodging, and meals. Please consult your tax advisor.

Cancellations/Substitutions: You may send a substitute in your place or request a conference credit. Conference credits are issued in the full amount of the registration fees paid and are good for 12 months from the date of the cancelled event. Conference credits may be used towards any HCCA service. If you need to cancel your participation, notify us prior to the start date of the event by email at helpteam @ hcca-info.org or by fax at 952-988-0146. Please note that if you are sending a substitute, an additional fee may apply.

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. 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 for each registrant 10 or more: $100 discount for each registrant

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

Dress Code: Business casual dress is appropriate.

Recording: No unathorized audio or video recording of HCCA conferences is allowed.

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 at the HCCA 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 HCCA Research Compliance Conference, I grant HCCA the right to use my name, photograph, and biography for such purposes.

Certified in Healthcare Research Compliance (CHRC)® Exam: The CHRC exam will be held on Wednesday, June 4. You must register in advance to sit for the exam. The cost of the exam is not included in the conference registration fee. To register for the exam, complete the date-specific exam application and mail or fax as directed on the application. For a link to the exam application, visit www.hcca-info.org/research.

Details

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.

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

learn more at www.hcca-info.org/research

June 1–4, 2014 | Austin, TXAT&T Executive Education Conference Center

ResearchCompliance Conference

June 1–4, 2014 | Austin, TXAT&T Executive Education Conference Center

ResearchCompliance Conference

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.

LAST CHANCEREGISTER

NOW

LAST CHANCEREGISTER

NOW