research compliance conference - hcca official site...scce’s higher education compliance...

June 12–15, 2011 | Austin, TXCome to Austin, Texas, June 12–15 to learn best practices and the latest thinking on:

•Implementation of the Sunshine Act provisions to the Health Care Reform Package

•Handling the updates to the Medicare as Secondary Payer Rules and the effect on research‑related injury

•Responding to changes to CMS Clinical Research Policy (replacing the Medicare NCD for Clinical Trials)

•And much, much more

You’ll hear directly from representatives from NIH, OHRP, ORI, the FDA, the OIG, and the DOJ, and from other industry experts who can provide practical perspectives for how to handle your research compliance risks.

LeArn more And regisTer AT www.hcca-research-conference.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 Research Compliance Conference registration. The parallel schedule gives you the freedom to attend sessions at either conference—two for the price of one.

reseArchCompliance Conference

www.hcca‑research‑conference.org | 888‑580‑8373

Program at a glancesundAy, June 12: Pre-conference11:30 – 6:00 pm Registration Desk

1:00 – 3:00 pm BREAKOUT SESSIONS pRE-CONFERENCE 1

P1 FCPA Third Party Due Diligence for Health Entities – John Heldens, Director, UCSF Human Research Protection Program; Ryan Morgan AML/CA, Anti-Corruption Specialist, World Compliance, Inc.

P2 Part 1: Research Accounting: The Rules, The Right Way, The Enforcers and How to Prepare for Engagement – Juliann (Juli) Tenney, JD, CHRC, Institutional Research Compliance and HIPAA Privacy Officer, Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill; James Luther, Assistant Vice President, Cost and Reimbursement Accounting for approval per Federal regulations, Duke University

3:00 – 3:30 pm Networking Break

3:30 – 5:00 pm BREAKOUT SESSIONS pRE-CONFERENCE 2

P3 Sponsor Agreements: Perspectives of the Parties—Hospital, Sponsor and University – David Vukadinovich, Senior Counsel, Catholic Healthcare West; Angelique Dorsey, JD, CHRC, Research Compliance Director, MedStar Health; Joaquina M. Lazaro, JD, Senior Attorney, Global Clinical Trial Legal Group, Pfizer Inc.

P4 Part 2: Research Accounting: The Rules, The Right Way, The Enforcers and How to Prepare for Engagement – Juliann (Juli) Tenney, JD, CHRC, Institutional Research Compliance and HIPAA Privacy Officer, Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill; James Luther, Assistant Vice President, Cost and Reimbursement Accounting for approval per Federal Regulations, Duke University

5:00 – 6:30 pm Welcome Reception

mondAy, June 13: conference7:00 Am – 6:00 pm Registration Desk

7:00 – 8:15 Am Breakfast (provided)

8:15 – 8:30 Am General Session: Opening Remarks

8:30 – 9:30 Am General Session: Conflicts of Interest in Biomedical Research – Lewis Morris, Deputy Inspector General and Chief Counsel, Office of Inspector General, Department of Health and Human Services

9:30 – 10:00 Am Networking Break

10:00 – 11:30 Am BREAKOUT SESSIONS

101 MSP Mandatory Reporting — Implications in the Clinical Trial Context – Holley Thames Lutz, Partner, SNR Denton, LLP

102 Accounting for those Grants: Medical Schools, Federal Dollars and Patient Costs – Kelly Willenberg, CHRC, President, Synergism, LLC; Angelique Dorsey, JD, CHRC, Research Compliance Director, MedStar Health

103 Research Misconduct: The ORI and Institutional Perspectives – Jo An Rochez, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services; Debbi Gilad J.D., Executive Director of the Office of Research Compliance and Integrity, University of Pennsylvania, School of Medicine

11:30 Am – 12:45 pm Networking Lunch (provided)

12:45 – 2:15 pm BREAKOUT SESSIONS

201 The Role of Medical Affairs in Late Phase Product Development – Rick Munschauer, MD, CM, VP, Global Head, Medical Affairs, Biogen Idec

202 Conflicts of Interest: What’s new and on the Horizon? – Jeffrey Braff, Director of Human Research Protections, Kaiser Permanente; Joy Hardee, CHRC, Administrator/UHS Privacy Officer/Research Compliance, University Health Systems of Eastern Carolina

203 PI and AMC Held INDs/IDEs: Responsibilities and Resources – Kara Morgenstern, Assistant General Counsel, University of Michigan; Kay Fuller, RAC, President, Medical Device Regulatory Solutions



301 Evolution and Growth of a Research Compliance and Education Program – Luanna K. Putney, Ph.D., CHC, CCEP, Director of Research Compliance Office of Ethics, Compliance and Audit Services, University of California, Office of the President; Carol Fedor, ND, CCRC, Clinical Research Manager, Office of Research Compliance and Education, Center for Clinical Research and Technology, University Hospitals Case Medical Center

302 Data Security / FISMA –Scott Bradner, University Technology Security Officer, Office of the CIO, Harvard University

303 Discussion of 5 Scenarios of Research Billing Challenges: Law & Operations – Ryan Meade, CHRC, Attorney, Meade & Roach, LLP; Dwight Claustre, CHC, CHRC, Healthcare Compliance Professional


4:30 – 5:30 pm General Session: What Every Compliance Professional Should Know About Dealing with the FDA – Neil F. O’Flaherty, Principal, Olsson Frank Weeda Terman Bode Matz P.C.

5:30 – 6:30 pm Networking Reception

www.hcca‑research‑conference.org | 888‑580‑8373 3

Program at a glanceTuesdAy, June 14: conference7:15 Am – 4:30 pm Registration Desk

7:15 – 8:30 Am Breakfast (provided)

8:30 – 10:00 Am General Session: Research Compliance: A Year in Review – Kendra Dimond Campbell, CHRC, Research Compliance Specialist, Office of Research & Commercialization, University of Central Florida; Lisa F. Murtha, CHC, CHRC, Partner, SNR Denton US LLP

10:00 – 10:30 Am Networking Break

10:30 Am – 12:00 pm BREAKOUT SESSIONS

401 Successfully Navigating an OHRP Site Visit – Laura Odwazny, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services (Invited); Rebecca D. Armstrong, D.V.M., Ph.D., Director, Research Subject Protection, University of California at Berkeley

402 Enhancing Research Compliance through Organizational Structure – Randy Mason, Vice President, Research Operations, Institutional Official for Research, Beth Israel Deaconess Medical Center

403 An Inside Look at Clinical Trial Billing in a Multi-Institutional System – C.J.Wolf, MD, CHC, CPC, CPC-H, Assistant Systemwide Compliance Officer, The University of Texas System, Systemwide Compliance Office; Beth Belt, CHRC, Manager, Deloitte & Touche

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


501 Tissue Issues – Kristen B. Rosati, JD, Partner, Coppersmith Schermer & Brockelman PLC; David Vulcano, AVP, Clinical Research, HCA

502 Addressing the Unique Ethical Concerns Arising in Gene Transfer Research – James D. Hearn, JD, LLM, MA, General Counsel, California State University, Northridge

503 Clinical Research Enforcement Initiatives, Off-Label Use Settlements, and False Claims Act Update – Gary W. Eiland, Partner, King & Spalding LLP


3:15 – 4:30 pm General Session: Trends in Oversight of Human Research Protections – Greg Koski, PhD, MD, Associate Professor, Harvard Medical School

WednesdAy, June 15: PosT-conference7:30 – 11:30 Am Registration Desk

7:30 – 8:30 Am Networking Break (coffee service only)

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

W1 New Developments in Privacy & Research – Kristen Rosati, JD, Partner, Coppersmith Schermer & Brockelman PLC; Paula Bistak, RN, MS, CIP, CHRC, Executive Director, Human Subject Protection Program, University of Medicine and Dentistry, NJ

W2 Developing and Implementing a Research Compliance Audit Plan – Matthew Lester, MBA, MHA, Managing Director, Huron Consulting Group; Jodi S. Ogden, MBA, CRA, Executive Director, Sponsored Projects Administration, The University of Texas Health Science Center at Houston

1:00 – 3:00 pm CHRC® Exam (optional)

Top 10 Things to Do in Austin, Texas1. Completed in 1888, the pink granite TExaS STaTE CapiTol stands 302 feet

high and is 14 feet higher than our nation’s capitol.

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6. Visit the lyndon BainES JoHnSon liBRaRy and MuSEuM to see copious volumes of presidential papers, a scale replica of the Oval Office during his presidency, and a First Lady’s Gallery devoted to the work of Lady Bird Johnson.

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8. Take in all the sights on THE univERSiTy of TExaS campus, one of the largest public universities in the nation.

9. The heart of Austin is found along the lady BiRd lakE HikE and BikE TRail, a 10.1-mile path bordering the lake on its flow through downtown.

10. Head to South Congress Avenue to discover eclectic shops, trendy restaurants, unique accommodations and popular music venues.

visit www.hcca-research-conference.org for more information on these attractions.

4 www.hcca‑research‑conference.org | 888‑580‑8373

agendaSUNdAy, JUNE 12: PRE-CONFERENCE11:30 Am – 6:00 pm Registration desk

1:00 – 3:00 pm BREAKOUT SESSIONS: PRE-CONFERENCE 1

P1 FCPA Third Party due diligence for Health EntitiesJohn Heldens, Director, UCSF Human Research Protection Program; Ryan Morgan AML/CA, Anti-Corruption Specialist, World Compliance, Inc.

xx Human research protections: review differences between FDA and ICH‑GCP requirements

xx Examine strategies for domestic IRBs to evaluate local research context

xx Discuss Foreign Corrupt Practices Act: Third Party Due Diligence

P2 Part 1: Research Accounting: The Rules, The Right Way, The Enforcers and How to Prepare for EngagementJuliann (Juli) Tenney, JD, CHRC, Institutional Research Compliance and HIPAA Privacy Officer, Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill; James Luther, Assistant Vice President, Cost and Reimbursement Accounting for approval per Federal regulations, Duke University

xx Review of the applicable regulations and standards that govern federally funded research, from effort reporting to F & A

xx Building or refining your program to assure compliance

3:00 – 3:30 pm

Networking Break

3:30 – 5:00 pm BREAKOUT SESSIONS: PRE-CONFERENCE 2

P3 Sponsor Agreements: Perspectives of the Parties — Hospital, Sponsor and UniversityDavid Vukadinovich, Senior Counsel, Catholic Healthcare West; Angelique Dorsey, JD, CHRC, Research Compliance Director, MedStar Health; Joaquina M. Lazaro, JD, Senior Attorney, Global Clinical Trial Legal Group, Pfizer Inc.

xx Compliance of clinical trial agreements with Stark and anti‑kickback statutes

xx Structuring of clinical trial agreements with non‑employed physicians, with particular focus on indemnification and insurance provisions

xx Negotiating budgets

P4 Part 2: Research Accounting: The Rules, The Right Way, The Enforcers and How to Prepare for EngagementJuliann (Juli) Tenney, JD, CHRC, Institutional Research Compliance and HIPAA Privacy Officer, Director, Institutional Research Compliance Program, The University of North Carolina at Chapel Hill; James Luther, Assistant Vice President, Cost and Reimbursement Accounting for approval per Federal Regulations, Duke University

xx Enforcement and agency Updates

xx What to expect from a regulatory review or investigation

5:00 – 6:30 pm Welcome Reception

MONdAy, JUNE 13: CONFERENCE7:00 Am – 6:00 pm Registration desk

7:00 – 8:15 Am

Breakfast

8:15 – 8:30 Am

Opening Remarks

8:30 – 9:30 Am

General Session: Conflicts of Interest in Biomedical ResearchLewis Morris, Deputy Inspector General and Chief Counsel, Office of Inspector General, Department of Health and Human Services

xx OIG studies of the identification and management of conflicts of interest among federal grantees

xx NIH rules governing the grantee conflicts of interest

xx Update on regulatory requirements governing NIH grantees

9:30 – 10:00 Am

Networking Break

10:00 – 11:30 Am BREakouT SESSionS

101 MSP Mandatory Reporting — Implications in the Clinical Trial ContextHolley Thames Lutz, Partner, SNR Denton, LLP

xx Overview of the MSP laws, including a summary of the mandatory reporting requirements (and potential penalties for non‑compliance)

xx History of the issues surrounding potential application of the MSP laws to clinical trials and a summary of the recent CMS Alert

xx Options for negotiating clinical trial agreements; and special considerations in investigator‑initiated trials

102 Accounting for those Grants: Medical Schools, Federal dollars and Patient Costs Kelly Willenberg, CHRC, President, Synergism, LLC; Angelique Dorsey, JD, CHRC, Research Compliance Director, MedStar Health

xx The Ins and Outs of Grant Accounting

xx Medicare Reimbursement when you have federal dollars in the mix

xx Medical School Grants and Patient Care Costs


agenda103 Research Misconduct: The ORI and Institutional perspectives Jo An Rochez, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services; Debbi Gilad, JD, Executive Director of the Office of Research Compliance and Integrity, University of Pennsylvania, School of Medicine

xx ORI’s research misconduct oversight process

xx Nuts and bolts of shepherding an institutional research misconduct proceeding

xx Update on research misconduct cases and lessons learned

11:30 Am – 12:45 pm

lunch

12:45 – 2:15 pm BREakouT SESSionS

201 The Role of Medical Affairs in Late Phase Product developmentRick Munschauer, MD, CM, VP, Global Head, Medical Affairs, Biogen Idec

xx The role of Medical Affairs in a Biotech company and how this function serves to address the “unmet medical need”

xx How Medical Affairs operates in the context of Late Phase studies and how this function is structured to ensure ongoing compliance

xx Explore the tensions between achieving scientific goals and the development and marketing of new products

202 Conflicts of Interest: What’s New and On the Horizon?Jeffrey Braff, Director of Human Research Protections, Kaiser Permanente; Joy Hardee, CHRC, Administrator/UHS Privacy Officer/Research Compliance, University Health Systems of Eastern Carolina

xx NPRM on Financial COI for Public Health Service Funding—what this means for you and your institution (final rules hopefully will be out)

xx COI policies and how to comply with them

xx Let the sun shine in: triangulating investigator attestations with Pharma company lists

203 PI and AMC Held INds/IdEs: Responsibilities and ResourcesKara Morgenstern, Assistant General Counsel, University of Michigan; Kay Fuller, RAC, President, Medical Device Regulatory Solutions

xx Responsibilities and Risk Mitigation

xx Challenges and Lessons Learned

xx Potential Best Practices and Resources

2:15 – 2:45 pm

Networking Break


301 Evolution and Growth of a Research Compliance and Education programLuanna K. Putney, PhD, CHC, CCEP, Director of Research Compliance Office of Ethics, Compliance and Audit Services, University of California, Office of the President; Carol Fedor, ND, CCRC, Clinical Research Manager, Office of Research Compliance and Education, Center for Clinical Research and Technology, University Hospitals Case Medical Center

xx Discuss the value of building a quality improvement based research monitoring and education program

xx Outline the key steps in the evolution and growth of a research compliance and education program

xx Analyze the evolution of research compliance through quality improvement initiatives

302 data Security / FISMAScott Bradner, University Technology Security Officer, Office of the CIO, Harvard University

xx Review of Harvard’s recently adopted Harvard Research Data Security Policy (HRDSP) which covers all types of research data from public information to extremely high risk information

xx HRDSP rollout and verification, the role of the IRBs

xx The intractability of FISMA in the real world

303 discussion of 5 Scenarios of Research Billing Challenges: Law & OperationsRyan Meade, CHRC, Attorney, Meade & Roach, LLP; Dwight Claustre, CHC, CHRC, Healthcare Compliance Professional

xx Review 5 common research billing scenarios

xx Examine compliance risks for each scenario

xx Propose operational solutions to manage the compliance risk for each scenario

4:15 – 4:30 pm

Networking Break

4:30 – 5:30 pm General Session: What Every Compliance Professional Should Know About dealing with the FdA Neil F. O’Flaherty, Principal, Olsson Frank Weeda Terman Bode Matz P.C.

xx Do’s and don’ts for interacting with FDA

xx How to prepare for meetings and discussions with FDA

xx What are the various modes of interaction with FDA and when is each appropriate

xx What is new in the current FDA regulatory environment

5:30 – 6:30 pm

Networking Reception


agendaTUESdAy, JUNE 14: CONFERENCE7:15 Am – 4:30 pm

Registration desk

7:15 – 8:15 Am

Breakfast

8:30 – 10:00 Am

General Session: Research Compliance: A year in Review Kendra Dimond Campbell, CHRC, Research Compliance Specialist, Office of Research & Commercialization, University of Central Florida; Lisa F. Murtha, CHC, CHRC, Partner, SNR Denton US LLP

xx Join us to learn about the new laws, regulations and best practices related to clinical research

xx This session will also provide an overview of the most interesting investigations and settlements in the clinical research area covering HRP, research billing, conflicts of interest, accounting for research studies and much more

xx This session will address the primary focus areas for research compliance professionals for 2011 and beyond including prime training areas, risk assessment and auditing and research program design and implementation

10:00 – 10:30 Am

Networking Break

10:30 Am – 12:00 pm BREakouT SESSionS

401 Successfully Navigating an OHRP Site VisitLaura Odwazny, Senior Attorney, Office of the General Counsel, U.S. Department of Health and Human Services (Invited); Rebecca D. Armstrong, DVM, PhD, Director, Research Subject Protection, University of California at Berkeley

xx Overview of OHRP’s compliance oversight process and conduct of site visits

xx Anatomy of a site visit: the institutional perspective

xx Lessons learned from a recent OHRP site visit and recommendations as to best practices

402 Enhancing Research Compliance through Organizational StructureRandy Mason, Vice President, Research Operations, Institutional Official for Research, Beth Israel Deaconess Medical Center

xx Learn how the organizational structure of your research administration function greatly impacts compliance activities

xx Discuss how effective reporting relationships and span‑of‑control help to improve key items like effort reporting, cost transfers and FSRs

xx Learn about the roles of Vice President ‑ Research Admin, Institutional Official (IO) and Research Integrity Officer (RIO) and discuss their functions related to research compliance

403 An Inside Look at Clinical Trial Billing in a Multi-Institutional SystemC.J.Wolf, MD, CHC, CPC, CPC-H, Assistant Systemwide Compliance Officer, The University of Texas System, Systemwide Compliance Office; Beth Belt, CHRC, Manager, Deloitte & Touche

xx Complexity of regulations governing clinical trial billing

xx The University of Texas System principles and practice for clinical trial billing

xx Collaborating to develop common policies

xx Developing site‑specific procedures

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 HoursSunday, June 12 ..................... 5:00 – 6:30 pm

Monday, June 13 ............... 7:15 am – 6:30 pm

Tuesday, June 14 ................7:15 am – 3:15 pm

Hcca would like to thank the 2011 conference Planning committee:KendrA dimond cAmPbeLL, chrc, research compliance specialist, office of research & commercialization, university of central florida

AngeLique dorsey, Jd, chrc, research compliance director, medstar health

LisA f. murThA, chc, chrc, Partner, snr denton us LLP

rAcheL nosoWsKy, chrc, Principal counsel, university of california

LuAnnA K. PuTney, Ph.d., chc, cceP, director of research compliance office of ethics, compliance and Audit services, university of california, office of the President

JuLiAnn (JuLi) Tenney, Jd, chrc, institutional research compliance and hiPAA Privacy officer, director, institutional research compliance Program, The university of north carolina at chapel hill


agenda12:00 – 1:00 pm

lunch


501 Tissue issuesKristen B. Rosati, JD, Partner, Coppersmith Schermer & Brockelman PLC; David Vulcano, AVP, Clinical Research, HCA

xx Current and pending privacy rules governing research with human tissue

xx Human research protection regulations and policies

xx Landmark cases and lessons learned

xx Guidelines and best practices

502 Addressing the Unique Ethical Concerns Arising in Gene Transfer Research James D. Hearn, JD, LLM, MA, General Counsel, California State University, Northridge

xx The history of gene transfer research

xx Learning from past‑failures: costly lessons learned from the death of Jesse Gelsinger, et. al.

xx The special ethical challenges presented by such research: informed consent and conflicts of interest

503 Clinical Research Enforcement Initiatives, Off-Label Use Settlements, and False Claims Act UpdateGary W. Eiland, Partner, King & Spalding LLP

xx Recent amendments to the federal False Claims Act and other compliance and enforcement authorities addressed in the healthcare reform legislation

xx Off‑label use and other research and academic medical center related settlements

xx Federal enforcement initiatives relevant to the research and academic medical center communities including the OIG FY 2011 Work Plan, enforcement efforts relating to cost allocation, effort reporting, indirect cost rates, and Medicare secondary payor issues, and selected FDA enforcement initiatives

2:45 – 3:15 pm

Networking Break

3:15 – 4:30 pm General Session: Trends in Oversight of Human Research protections Greg Koski, PhD, MD, Associate Professor, Harvard Medical School

xx Summary of laws and regulations that cover human research protections and any updates thereto

xx Discussion of recent OHRP inquiries, investigations, findings etc. that research compliance professionals should understand

xx What types of auditing and training should research compliance professionals be doing for 2011 and beyond?

WEdNESdAy, JUNE 15: POST-CONFERENCE7:30 – 11:30 Am

Registration desk

7:30 – 8:30 Am

Networking Break

8:30 – 11:30 Am BREakouT SESSionS

W1 New developments in Privacy & ResearchKristen Rosati, JD, Partner, Coppersmith Schermer & Brockelman PLC; Paula Bistak, RN, MS, CIP, CHRC, Executive Director, Human Subject Protection Program, University of Medicine and Dentistry, NJ

xx Understanding the amendments to the HIPAA Privacy Rule, including authorizations for future research, the new prohibition on the “sale” of protected health information, and clarification on when business associate agreements are necessary in research

xx Writing “informed” consent documents for research involving genetic analysis or for future research

xx Implementing adequate security to protect health information in research and conducting breach reporting

xx Managing privacy in multi‑party research, including investigator departures and data collaborations

W2 developing and Implementing a Research Compliance Audit PlanMatthew Lester, MBA, MHA, Managing Director, Huron Consulting Group; Jodi S. Ogden, MBA, CRA, Executive Director, Sponsored Projects Administration, The University of Texas Health Science Center at Houston

xx Establishing baseline through a comprehensive risk assessment, common risk areas, and institutional priorities

xx Tips and advice with executing the plan

xx Case studies for addressing areas of indentified risks and control weakness

1:00 – 3:00 pm

CHRC® Certification Exam (optional)

conference SuPPorterS

AIS’s


continuing education creditS

take the cHrc® certification exam on-SiteWhen: Wednesday, June 15, 2011 / 1:00–3:00 pmWhere: AT&T Conference Center | Austin, TXcost: $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-research-conference.org/CEU/CHRCexamAp_042410.pdf. Questions? E‑mail ccb@hcca‑info.org. 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 22.2 CEUs to qualify to sit for the exam.

HCCA is in the process of applying for additional credits. If you do not see information on your specific accreditation, please contact us at 952-988-0141 or 888-580-8373 as we would like the opportunity to offer it. Visit HCCA’s Research Compliance Conference website, www.hcca-research-conference.org, for up-to-date information.

ACHE: The Health Care Compliance Association is authorized to award 18 hours of pre-approved Category II (non-ACHE) continuing education credit for this program toward advancement, or recertification in the America College of Healthcare Executives. Participants in this program wishing to have the continuing education hours applied toward Category II credit should indicate on their attendance when submitting application to the American College of Healthcare Executives for advancement or recertification.

CA Nursing Credit: The Health Care Compliance Association is preapproved by the California Board of Registered Nursing: Provider Number CEP 12990, for a maximum of 22.2 contact hour(s). The following states will accept CA Board of Nursing Contact Hours: Alabama, Alaska, Arkansas, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Texas, West Virginia and Wyoming. The following states do not have continuing education requirements: Arizona, Colorado, Connecticut, Georgia, Hawaii, Indiana, Maine, Missouri, Montana, New York, Oklahoma, Pennsylvania, South Dakota, Tennessee, Vermont, Virginia, Washington and Wisconsin. 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. Attendees of the Research Compliance Conference who are seeking credits to fulfill their CCRC Certification through ACRP may request a California RN certificate of participation as well as a copy of the full brochure which in turn may be submitted to ACRP for credits. On the Continuing Education Application, please check the box for RN and clearly indicate that the credits will be used for CCRC Certification.

CCIP: 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.

CLE: The Health Care Compliance Association is a State Bar of California Approved MCLE provider, a Rhode Island Accredited Provider, and a Texas Accredited Sponsor. A maximum of approximately 18.5 clock hours of CLE credit will be available to attendees. The Pennsylvania CLE Board has approved this conference for a maximum of 18.5 CLE Credits, including 4.0 Ethics credits. All CLE credits will be awarded based on individual attendance.

Compliance Certification Board (CCB): Certified in Healthcare Compliance® (CHC®), Certified in Healthcare Compliance Fellow (CHC-F), Certified Compliance & Ethics Professional® (CCEP®), Certified Compliance & Ethics Professional Fellow (CCEP-F), Certified in Healthcare Research Compliance® (CHRC®), Certified in Healthcare Privacy Compliance (CHPC): CCB has awarded a maximum of 22.2 CEUs for these accreditations in the following subject areas: Application of Management Practices for the Compliance Professional; Application of Personal and Business Ethics in Compliance; Written Compliance Policies and Procedures; Designation of Compliance Officers and Committees; Compliance Training and Education; Communication and Reporting Mechanisms in Compliance Enforcement of Compliance Standards and Discipline; Auditing and Monitoring for Compliance; Response to Compliance Violations and Corrective Actions; HIPAA Privacy Implementation and/or Complying with Government Regulations.

CPIA: 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.

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. To verify if your state board of accountancy has adopted one-half credits, please visit our website at www.hcca-info.org/accountancycredits. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN 37219-2417. Website: www.nasba.org. A recommended maximum of 22.0 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. For more information regarding administrative policies such as complaints or refunds, call the HCCA at 888-580-8373 or 952-988-0141.

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 approximately 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.


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Risk Manager

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Vice President

Other (please list below)

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regiStration research compliance conference | June 12–15, 2011 | Austin, TX

contact information mr. mrs. ms. dr.

HCCA Member ID

First Name MI Last Name

Credentials (CHC®, CHRC®, CHPC, etc.)

Title

Place of Employment

Address

City State Zip

Phone

Fax

Email (required for registration confirmation & conference information)

regiStration oPtionS AFTER 5/11/11

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 .................................................................... $100 Pre‑Conference Registration 2 .................................................................... $100 Post‑Conference Registration .......................................................................FREE

free with full conference registration only

Research Compliance Conference Binder .................................................... $45 available as a pre-sale only and for registered conference attendees only

Higher Education Compliance Conference Binder .......................................... $45 available as a pre-sale only and for registered conference attendees only

total $

By registering for the Research Compliance Conference, you will automatically be registered 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 | Purchase Order #

Check enclosed

I authorize HCCA to charge my credit card (choose below)CREDIT CARD: AmericanExpress Diners Club MasterCard Visa

Credit Card Account Number

Credit Card Expiration Date

Cardholder’s Name

Cardholder’s SignatureRC0611

heALTh cAre comPLiAnce AssociATion 6500 Barrie Road, Suite 250, Minneapolis, MN 55435888-580-8373 (p) / 952-988-0146 (f)www.hcca-info.org / [email protected]

Please fax your completed registration form with payment information to 952-988-0146, or visit www.hcca-research-conference.org to register.

SeSSion SelectionPlease select to assist in room planning. Select one session per time slot.

sundAy, June 12Pre-conf 1: 1:00 – 3:00 pm: p1 p2

Pre-conf 2: 3:30 – 5:00 pm: p3 p4

mondAy, June 13breAKouTs: 10:00 – 11:30 am: 101 102 103

breAKouTs: 12:45 – 2:15 pm: 201 202 203

breAKouTs: 2:45 – 4:15 pm: 301 302 303

TuesdAy, June 14breAKouTs: 10:30 Am – 12:00 pm: 401 402 403

breAKouTs: 1:15 – 2:45 pm: 501 502 503

WednesdAy, June 15PosT-conf: 8:30 – 11:30 am: W1 W2

i’m interested in selecting from scce’s higher education compliance conference. Please send me more information.


detailS

Hotel & conference location

AT&T Executive Education Conference CenterThe University of Texas at Austin1900 University Avenue, Austin, Texas 78705the block of hotel rooms is Sold out at the at&t conference center and the doubletree Suites by Hilton–austin (previously listed as an overflow hotel). an alternate hotel option is listed below. complimentary transportation to the at&t conference center will be provided by Hcca/Scce.oVerfloW Hotel: Sheraton Austin at the Capitol 701 East 11th Street, Austin, TX 78701 1‑888‑627‑8349 A special rate of $169/night + tax (for standard rooms) has been arranged for this conference. Please make your reservations directly with the hotel via phone at 1‑888‑627‑8349. Reference the HCCA/SCCE room block when you make the reservation. Reservations will be accepted at the group rate until June 6, 2011, 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 (24) hours prior to arrival without charge. Cancellations after this time will result in room rate and applicable taxes being charged to the credit card on file of the party that made the reservation.

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 (Federal Tax ID # 23‑2882664).

cancellationS/SubStitutionS: No refunds will be given for no‑shows or cancellations. You may send a substitute or receive a conference credit. If you have questions, please call HCCA at 888‑580‑8373. Additional charges may apply. Cancellation by telephone is NOT valid. Please fax written cancellations to 952‑988‑0146 or e‑mail helpteam@hcca‑info.org.

grouP diScount: Each individual in a group of five or more will receive $100 off his/her registration fee. Please complete a registration form for each attendee and fax or mail them in simultaneously.

dreSS code: Business casual dress is appropriate.

Hcca iS going green: Attendees will receive electronic access to the course materials prior to the program as well as an electronic version of the materials at the program. Attendees will not automatically receive the binders. If you would like to purchase the binders for $45, please check “Conference Binders” on the registration form.

attendance PrerequiSiteS: None.

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 in the Research Compliance Conference.

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.

No audio or video recordiNg of Hcca coNfereNces is allowed.

community.hcca-info.org

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

REGISTER ONLINE AT WWW.hccA-reseArch-conference.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 Research Compliance Conference registration. The parallel schedule gives you the freedom to attend sessions at either conference—two for the price of one.



June 12–15, 2011 | Austin, TX

June 12–15, 2011 | Austin, TX

research compliance conference - hcca official site...scce’s higher education compliance...

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