Join your peers at the primary networking and educational ......San Antonio Kathleen D. James, BS,...

hcca-info.org/research

May 31–June 3, 2015 | Austin, TX

ResearchCompliance Conference

TWO CONFERENCES FOR THE PRICE OF ONEComplimentary access to SCCE’s Higher Education Compliance Conference is included with your registration. Build your own schedule and attend sessions at both conferences!

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

questions? [email protected]

LAST CHANCE: REGISTER

NOW

2 hcca-info.org

PROGRAM Research Compliance Conference | May 31–June 3, 2015 | Austin, TX

SUNDAY, MAY 31: PRE-CONFERENCE12:00 – 6:00 pm Registration Open

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

P1 Auditing Clinical Research Billing: How Do You Know You Are Doing It Right? – Andrew Walton, Research Compliance Officer, UC-California; Kristina Kinard, Principal Reg Affairs Spec, UC Irvine Health

P2 Unified Compliance Framework: Establishing Risk-Based Monitoring (RBM) for Clinical Research – Anna G. Taranova, MD, MS, Senior Research Director, University Health System; Frank Estala, BA, Research Compliance Manager, UT Health Science Center at San Antonio; Kathleen D. James, BS, CHC, CHSP, Asst Compliance Officer, UT Health Science Center at San Antonio; Clara Herrera Vorpahl, BA, Senior Research Compliance Specialist, UT Health Science Center at San Antonio

2:30 – 3:00 pm Networking Break

3:00 – 5:00 pm BReAKout sessions pRe-ConFeRenCe

P3 ABCs of Human Research Protection – Scott J, Lipkin, Managing Director, FTI Consulting

P4 It’s 10 PM: Do You Know Where Your Research Data Is? – Ryan Meade, Director of Regulatory Compliance Studies, Loyola University Chicago School of Law; Marti Arvin, Chief Compliance Officer, UCLA Health System and David Geffen School of Medicine

5:00 – 6:00 pm “Wear Your School Colors” Welcome Reception

MONDAY, JUNE 1: CONFERENCE7:00 Am – 6:00 pm Registration Open

7:00 – 8:15 Am Breakfast (provided)

8:15 – 8:30 Am Opening Remarks

8:30 – 9:30 Am General Session 1: Research Year in Review – F. Lisa Murtha, Senior Managing Director, FTI Consulting

9:30 – 10:00 Am Networking Break

10:00 – 11:30 Am BReAKout sessions

101 Human Gene Transfer, Institutional Biosafety Committees, and Biological Materials Oversight: Past, Present, and Future for Clinical Research – Chris Jenkins, PhD, MPH, RBP, CHMM, Senior Vice President of Biosafety and Gene Therapy, WIRB-Copernicus Group

102 Billing and Compliance Concerns in Personalized Medicine – Paul Papagni, Executive Director of Research, Holy Cross Hospital CHE; Kelly Willenberg, Owner, Kelly Willenberg, LLC

103 Clinicaltrials.gov: Keeping Up with Evolving Clinical Trial Disclosure Requirements—Is Your Institution Prepared? – Diane L. Wilson, Compliance Specialist, University of Michigan Med School; Emily M. Ouellette, Human Research QA/QI Specialist, Partners HealthCare

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

12:30 – 2:00 pm BReAKout sessions

201 Compliance and Research Billing Considerations for Unique Clinical Research Trials – Kellie Bodeker, MSHS, CCRC, Regulatory Manager, University of Iowa Hospitals and Clinics; Bridget Adams, BA, CCRC, Senior Compliance Coordinator for Research Billing Compliance, University of Iowa Hospitals and Clinics

202 Dealing with Allegations of Non-Compliance and Scientific Misconduct: It Can Be a Minefield – Sheila Rose Garrity, JD, MPH, MBA, The George Washington University, Associate Vice President for Research Integrity, Office of the Vice President for Research

203 Creation of a Clinical Trials Business Office: Operations and Compliance Considerations, and Lessons Learned – Draco D. Forte, Manager- Health Industry Advisory, PwC; Fernando Valles, JD, Assistant Director, Clinical Trial Business Office, Boston Children’s Hospital



301 Cybersecurity of Medical Devices and Impact on Research – Ken Briggs, Attorney, Polsinelli

302 Peeling Back the Onion: Case Studies in Research Compliance – Kristin West, Assoc VP & Director, Emory University, Office of Research Compliance; F. Lisa Murtha, Senior Managing Director, FTI Consulting; Ryan Meade, Director of Regulatory Compliance Studies, Loyola University Chicago School of Law

303 Research-Related Subject Injury: Implementing and Operationalizing a Policy that Works – Keren Dunn, Manager of Research Compliance & QI, Cedars-Sinai Medical Center; Ryan Schroeder, Manager of Industry Sponsored Research Office, Cedars-Sinai Medical Center; Shanley J. Curran, CRB Compliance Manager, UC California


4:15 – 5:15 pm General Session 2: Compliance Implications for Cutting-Edge Research – Ernest D. Prentice, PhD, Associate Vice Chancellor for Academic Affairs, University of Nebraska Medical Center

5:15 – 6:30 pm Networking Reception

hcca-info.org 3

PROGRAM Research Compliance Conference | May 31–June 3, 2015 | Austin, TX

TUESDAY, JUNE 2: CONFERENCE7:30 Am – 4:00 pm Registration Open

7:30 – 8:30 Am Breakfast (provided)

8:15 – 8:30 Am Opening Remarks

8:30 – 10:00 AM General Session 3: Heed the Warnings: Using FDA Warning Letters to Stay Audit Ready – Kristin West, Assoc VP & Director, Emory University, Office of Research Compliance

10:00 – 10:30 Am Networking Break

10:30 Am – 12:00 pm BReAKout sessions

401 Embracing Quality: One Institution’s Approach to Managing Compliance Risks – Marsha C. Wallace, Asst Dir Res QA & Monitoring, Children’s Hospital of Philadelphia

402 Enterprise Research Risk – Erika Stevens, Senior Manager, Ernst & Young; Tina Noonan, Director, Research & Regulatory Affairs, St. Vincent Hospital

403 FMV, Anti-kickback, and Stark Risks in Clinical Research – Craig Holden, Chair and CEO, Ober|Kaler

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


501 Transitioning to the Uniform Guidance – Matthew Staman, Managing Director, Huron Consulting Group

502 Open Payments: Current Status and Impact – David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive for Clinical Research, Clinical Services Group, HCA

503 Process Improvement in Animal Research Compliance – Stacy L. Pritt, DVM, MS, MBA, CPIA, DACAW, Director, IACUC, UT Southwestern Medical Center; Anne R. Fisher, PhD, CPIA, Senior IACUC Coordinator, UT Southwestern Medical Center


2:45 – 4:00 pm General Session 4: The Top 10 Human Research Protection Compliance Risks – Kristina C. Borror, PhD, Director, Division of Compliance Oversight, Office for Human Research Protections, Department of Health and Human Services

WEDNESDAY, JUNE 3: POST-CONFERENCE7:30 – 11:30 Am Registration Open

8:30 – 11:30 Am BReAKout sessionspost-ConFeRenCe (inCludes 15-min BReAK)

W1 Conflict of Interest Management – Julia M. Campbell, Director, Conflict of Interest, Northwestern University; Marisa Zuskar, Director, Huron Consulting Group; Rebecca M. Scott, Clinical Research Comp Mgr, University of KY Healthcare; Andrew H. Hill, Clinical Research Charge Auditor, UK HealthCare Office of Corporate Compliance

W2 Workshop on Clinical Trial Agreements and Compliance – Michael Roach, Partner, Meade, Roach & Annulis, LLP; Brian J. Burns, Group General Counsel, DaVita Labs and DaVita Clinical Research DaVita HealthCare Partners Inc.

11:30 Am – 12:30 pm Lunch (on your own)

12:30 pm CHRC Exam Check-in

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

Certified in Healthcare Research Compliance (CHRC)®

Plan now to take the exam after the conference and earn your certification. Learn more about the CHRC certification at compliancecertification.org/chrc

See page 8 for CHRC exam registration details

BE RECOGNIZED for your experience and knowledge in healthcare research compliance

EARN YOUR CERTIFICATION

4 hcca-info.org

AGENDA Research Compliance Conference | May 31–June 3, 2015 | Austin, TX

SUNDAY, MAY 31PRE-CONFERENCE

12:00 – 6:00 pm

Registration Open

1:00 – 2:30 pm

P1 Auditing Clinical Research Billing: How Do You Know You Are Doing It Right?

Andrew Walton, Research Compliance Officer, UC-California

Kristina Kinard, Principal Reg Affairs Spec, UC Irvine Health

xx Development and implementation of a clinical research billing audit plan

xx Overcoming the barriers to implementing a clinical research billing auditing program

xx The technical tools, processes and staffing required to audit clinical research billing claims and coverage analyses

P2 Unified Compliance Framework: Establishing Risk-Based Monitoring (RBM) for Clinical Research

Anna G. Taranova, MD, MS, Senior Research Director, University Health System

Frank Estala, BA, Research Compliance Manager, UT Health Science Center at San Antonio

Kathleen D. James, BS, CHC, CHSP, Asst Compliance Officer, UT Health Science Center at San Antonio

Clara Herrera Vorpahl, BA, Senior Research Compliance Specialist, UT Health Science Center at San Antonio

xx The effectiveness of risk-based monitoring (RBM) for research oversight and quality assurance

xx FDA guidance and regulatory expectations for RBM implementation

xx Unified Compliance framework: implementation and sustainability of RBM

3:00 – 5:00 pm

P3 ABCs of Human Research Protection

Scott J, Lipkin, Managing Director, 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 Describe the compliance professional’s role when assessing adherence to human research protection regulations

xx Identify high risk compliance areas related to human research protections

P4 It’s 10 PM: Do You Know Where Your Research Data Is?

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

Marti Arvin, Chief Compliance Officer, UCLA Health System and David Geffen School of Medicine

xx Understand how researchers get access to PHI for research

xx Set out tips so that institutions don’t make and then break promises if the informed consent makes statements regarding confidentiality that the organization cannot keep

xx Review the implications of how data is stored, shared with others or used for purposes beyond the research study

5:00 – 6:00 pm

“Wear Your School Colors” Welcome Reception

MONDAY, JUNE 1

7:00 am – 6:00 pm

Registration Open

7:00 – 8:15 am

Breakfast (provided)

8:15 – 8:30 am

Opening Remarks

8:30 – 9:30 am

General Session 1: Research Year in Review

F. Lisa Murtha, Senior Managing Director, FTI Consulting

9:30 – 10:00 am Networking Break

10:00 – 11:30 am

BREAKOUT SESSIONS

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

Chris Jenkins, PhD, MPH, RBP, CHMM, Senior Vice President of Biosafety and Gene Therapy, 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

hcca-info.org 5


102 Billing and Compliance Concerns in Personalized Medicine

Paul Papagni, Executive Director of Research, Holy Cross Hospital CHE

Kelly Willenberg, Owner, Kelly Willenberg, LLC

xx Understanding New FDA guidance on LDT’s and determination of the need for an IDE

xx Review of CLIA regulations relating to the need for a CLIA certified lab when conducting Biomarker driven clinical trials

xx What is billable when utilizing genetic panels for research and/or personalized medicine and what is CMS Coverage with evidence development

103 Clinicaltrials.gov: Keeping Up with Evolving Clinical Trial Disclosure Requirements—Is Your Institution Prepared?

Diane L. Wilson, Compliance Specialist, University of Michigan Med School

Emily M. Ouellette, Human Research QA/QI Specialist, Partners HealthCare

xx Since 2000, clinical trial disclosure requirements continue to evolve. Studies must be registered on the ClinicalTrials.gov database due to requirements such as FDAAA, CMS, and ICMJE. By using cases, learn which studies must register and report results

xx Practical challenges of translating researcher’s protocol/ data into the database format abound. Inconsistent definitions for clinical trials and sponsors cause confusion. Learn how to help researchers meet their obligations

xx Each type of academic institution has unique challenges with clinical trial disclosure requirements. Benefit from lessons learned over the years at major academic medical centers and current challenges

xx Note: Proposed expanded federal requirements (NPRM & NIH Policy) will be addressed but will not be the primary focus of this presentation

11:30 am – 12:30 pm

Networking Lunch (provided)

12:30 – 2:00 pm

BREAKOUT SESSIONS

201 Compliance and Research Billing Considerations for Unique Clinical Research Trials

Kellie Bodeker, MSHS, CCRC, Regulatory Manager, University of Iowa Hospitals and Clinics

Bridget Adams, BA, CCRC, Senior Compliance Coordinator for Research Billing Compliance, University of Iowa Hospitals and Clinics

xx Review of regulatory compliance considerations for unique or unusual clinical research studies

xx Billing considerations and compliance issues for those research trials

xx Implementation of the trials once through the approval system

202 Dealing with Allegations of Non-Compliance and Scientific Misconduct: It Can Be a Minefield

Sheila Rose Garrity, JD, MPH, MBA, The George Washington University, Associate Vice President for Research Integrity, Office of the Vice President for Research

xx Investigating an allegation of non-compliance with FDA regulations using due process

xx Conducting a scientific misconduct inquiry and investigation in accordance with ORI requirements

xx Acting on findings of non-compliance and/or scientific misconduct

203 Creation of a Clinical Trials Business Office: Operations and Compliance Considerations, and Lessons Learned

Draco D. Forte, Manager-Health Industry Advisory, PwC

Fernando Valles, JD, Assistant Director, Clinical Trial Business Office, Boston Children’s Hospital

xx Determination of the scope of the office and obtaining institutional buy-in

xx Integration of technology into administrative processes

xx Mitigated and ongoing compliance considerations

2:00 – 2:30 pm

Networking Break

2:30 – 4:00 pm

BREAKOUT SESSIONS

301 Cybersecurity of Medical Devices and Impact on Research

Ken Briggs, Attorney, Polsinelli

xx Current regulatory environment of cybersecurity of medical devices

xx Trends and enforcement efforts relating to cybersecurity of medical devices

xx Best practices to minimize risks of a breach of information

302 Peeling Back the Onion: Case Studies in Research Compliance

Kristin West, Assoc VP & Director, Emory University, Office of Research Compliance

F. Lisa Murtha, Senior Managing Director, FTI Consulting

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

6 hcca-info.org


303 Research-Related Subject Injury: Implementing and Operationalizing a Policy that Works

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

Ryan Schroeder, Manager of Industry Sponsored Research Office, Cedars-Sinai Medical Center

Shanley J. Curran, CRB Compliance Manager, UC California

xx Discuss the regulatory foundation for handling research-related subject injury and challenges presented

xx Present results of a small survey about handling of research-related subject injury at academic medical centers

xx Describe process to develop and operationalize new policy on research-related subject injury and use of technology tools to support related processes at individual sites

4:00 – 4:15 pm

Networking Break

4:15 – 5:15 pm

General Session 2: Compliance Implications for Cutting-Edge Research

Ernest D. Prentice, PhD, Associate Vice Chancellor for Academic Affairs, University of Nebraska Medical Center

5:15 – 6:30 pm

Networking Reception

TUESDAY, JUNE 2

7:30 – 4:00 pm

Registration Open

7:30 – 8:30 am

Breakfast (provided)

8:15 – 8:30 am

Opening Remarks

8:30 – 10:00 am

General Session 3: Heed the Warnings: Using FDA Warning Letters to Stay Audit Ready

Kristin West, Assoc VP & Director, Emory University, Office of Research Compliance

xx Trends noted in FDA Warning Letters

xx Using information from warning letters to develop training for investigators and coordinators

xx Developing audit-ready forms and checklists

10:00 – 10:30 am

Networking Break

10:30 – 12:00 pm

BREAKOUT SESSIONS

401 Embracing Quality: One Institution’s Approach to Managing Compliance Risks

Marsha C. Wallace, Asst Dir Res QA & Monitoring, Children’s Hospital of Philadelphia

xx Describe practical considerations and approaches to developing an internal quality assurance program for human subject research

xx Identify and prioritize potential risks

xx Discuss strategies for overcoming challenges when implementing an internal audit program

402 Enterprise Research RiskErika Stevens, Senior Manager, Ernst & Young

Tina Noonan, Director, Research & Regulatory Affairs, St. Vincent Hospital

xx A major challenge associated with research risk mitigation lies in the assessment of the research enterprise and determining areas of focus

xx This session describes enterprise research risk assessment and prioritization

xx This session analyzes processes for mitigating enterprise research risk, provides tools for risk prioritization and evaluates a case study

403 FMV, Anti-kickback, and Stark Risks in Clinical Research

Craig Holden, Chair and CEO, Ober|Kaler

12:00 – 1:00 pm

Networking Lunch (provided)

1:00 – 2:30 pm

BREAKOUT SESSIONS

501 Transitioning to the Uniform Guidance

Matthew Staman, Managing Director, Huron Consulting Group

xx (Brief) Introduction and overview of the Uniform Guidance, including: background and purpose, implementation timeframe

xx Detail of critical changes and institutional approaches for implementation of major Impact areas: cost principles, effort reporting, procurement, sub recipient monitoring

xx Focus on internal controls and institutional responsibility for ensuring compliance

hcca-info.org 7


502 Open Payments: Current Status and Impact

David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive for Clinical Research, Clinical Services Group, HCA

xx A brief refresher of the Open Payments program

xx The reports: The first year out

xx Analyze tangential issues in non-research areas related to the reports

503 Process Improvement in Animal Research Compliance

Stacy L. Pritt, DVM, MS, MBA, CPIA, DACAW, Director, IACUC, UT Southwestern Medical Center

Anne R. Fisher, PhD, CPIA, Senior IACUC Coordinator, UT Southwestern Medical Center

xx Review general concepts of process improvement and apply them to animal research compliance

xx Provide examples of improved processes resulting in decreased administrative burden in animal research compliance

xx Discuss how regulatory compliance can be maintained while applying process improvement concepts

2:30 – 2:45 pm

Networking Break

2:45 – 4:00 pm

General Session 4: The Top 10 Human Research Protection Compliance Risks

Kristina C. Borror, PhD, Director, Division of Compliance Oversight, Office for Human Research Protections, Department of Health and Human Services

WEDNESDAY, JUNE 3

POST-CONFERENCE (Sessions include one 15-minute break)

7:30 – 11:30 am

Registration Open

8:30 – 11:30 am

W1 Conflict of Interest Management

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

Marisa Zuskar, Director, Huron Consulting Group

Rebecca M. Scott, Clinical Research Comp Mgr, University of KY Healthcare

Andrew H. Hill, Clinical Research Charge Auditor, UK HealthCare Office of Corporate Compliance

xx With the disclosure of outside relationships and interests and review for conflict of interest (COI) under control, how do institutions tackle establishing COI management plans?

xx What strategies are commonly and effectively utilized to manage perceived or actual individual and institutional COIs, especially within the highly-scrutinized realm of clinical research?

xx Once a COI management plan is implemented, what methods can institutions employ to regularly monitor compliance?

W2 Workshop on Clinical Trial Agreements and Compliance

Michael Roach, Partner, Meade, Roach & Annulis, LLP

Brian J. Burns, Group General Counsel, DaVita Labs and DaVita Clinical Research DaVita HealthCare Partners Inc.

xx Aspects of clinical trial agreements that pose compliance risk for sites

xx Typical starting positions of sites and sponsors on those

xx Possible CTA wording designed to mitigate compliance risk while satisfying the business concerns of both parties to the agreement

11:30 am – 12:30 pm

Lunch (on your own)

12:30 pm

CHRC Exam Check-in

1:00 – 3:30 pm

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

8 hcca-info.org

Take the CHRC Certification Exam on-site after the conferenceWednesday, June 3 | 1:00–3:30 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 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 a maximum of 22.2 CEUs to qualify to sit for the exam.

HCCA thanks our 2015 Research Compliance Conference Committee

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

F. Lisa Murtha Senior Managing Director FTI Consulting

CONTINUING EDUCATION UNITSHCCA 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 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 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.

Compliance Certification Board (CCB): Compliance Certification Board (CCB): CCB has awarded a maximum of 22.2 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)™.

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 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).

CLE: The Health Care Compliance Association is a State Bar of California Approved MCLE provider, a Pennsylvania Accredited Provider, and a Texas Accredited Sponsor. An approximate maximum of 18.5 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, 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 (888) 580-8373 or (952) 988-0141.

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 18.5 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.

hcca-info.org 9

REGISTER Research Compliance Conference | May 31–June 3, 2015 | Austin, TX

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

Risk Manager

Trainer/Educator

Vice President

Other (please list below)

What is your primary health care entity?


What certifications do you hold? Select all that apply.


Academic

Ambulance/Transportation

Behavioral Health

Consulting Firm

Durable Medical Equipment

Government Provider

Health System

Health System/Teaching

Home Care/Hospice

Hospital

Hospital/Teaching

Integrated Delivery System

Integrated Health System

Laboratory

Law Firm

Long-Term Care

Managed Care

Medical Device Manufacturer

Medical/Clinical Research

Nursing

Other Provider of Services/Products to Health Care Entities

Payor/Insurance

Pharmaceutical Manufacturer

Physician Practice

Rehabilitation

Retail Pharmacy

Third-Party Billing

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

REGISTRATION CONTINUES ON NEXT PAGE (OVER)

DEMOGRAPHIC INFORMATION

10 hcca-info.org

REGISTER Research Compliance Conference | May 31–June 3, 2015 | Austin, TX

REGISTRATION OPTIONS (Registration fees are as listed and considered net of any local withholding taxes applicable in your country of residence.)

HCCA/SCCE Members .............................................................................$799

Non-Members ........................................................................................ $899

HCCA/SCCE Membership & Registration ............................................... $999 new memBeRs only / dues RegulARly $295 AnnuAlly

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

Post-Conference Registration..................................................................$125

Group Discount: subtract $ from my total (see detAils on pAge 11)

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

Special Request for Dietary Accommodation

Gluten Free Kosher Vegetarian Vegan Other

PAYMENT OPTIONS

Invoice me

Check enclosed (payable to HCCA)

I authorize HCCA to charge my credit card (choose 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 Signature

HE0615

WAYS TO REGISTER

MAIL to HCCA, 6500 Barrie Road, Suite 250, Minneapolis, MN 55435

ONLINE at hcca-info.org/research

FAX to 952-988-0146 (include completed form with payment)

EMAIL [email protected] (without credit card information)

CONTACT INFORMATION Mr Mrs Ms Dr

HCCA Member ID (if applicable)

First Name MI

Last Name

Credentials (CHC, CCEP, etc.)

Job Title

Name of Employer

Street Address

City/Town State/Province

Country Zip/Postal Code

Phone

Email (required for registration confirmation & conference information)

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

SUN, MAY 31 PRE-CONFERENCE

1:00 – 2:30 PM

P1

P2

3:00 – 5:00 PM

P3

P4

MON, JUNE 1 BREAKOUTS

10:00 – 11:30 aM

101

102

103

12:30 – 2:00 PM

201

202

203

2:30 – 4:00 PM

301

302

303

TUE, JUNE 2 BREAKOUTS

10:30 aM – 12 PM

401

402

403

1:00 – 2:30 PM

501

502

503

WED, JUNE 3 POST-CONFERENCE

8:30 – 11:30 aM

W1

W2

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

hcca-info.org 11

DETAILS Research Compliance Conference | May 31–June 3, 2015 | Austin, TX

Hotel & conference location:

Austin Renaissance 9721 Arboretum Blvd Austin, TX 78759

A rate of $179 (single/double) plus applicable state & local taxes (currently 15%) has been arranged for this program. To make your reservation, please call the hotel reservations department (800 468 3571) and request the rate for the HCCA/SCCE Compliance Conference, or visit the booking website: https://resweb.passkey.com/Resweb.do?mode=welcome_ei_new&eventID=12480814 (under ‘guest type’, select ATTENDEE). This rate is good through Monday, May 18, or when the group block is full, whichever comes first. The rate includes complimentary parking and complimentary entry to the health/fitness club over the meeting period. HCCA recommends booking early to ensure you receive the group rate.

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 toward 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 registrant10 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 to participate.

Dress Code: Business casual dress is appropriate.

Recording: No unauthorized 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.

HEALTH CARE COMPLIANCE ASSOCIATION6500 Barrie Road, Suite 250, Minneapolis, MN 55435p 888-580-8373 oR 952-988-0141 | F 952-988-0146hcca-info.org | helpteam @ hcca-info.org

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

LAST CHANCE: REGISTER

NOW

Join your peers at the primary networking and educational ......San Antonio Kathleen D. James, BS,...

Documents

Transcript of Join your peers at the primary networking and educational ......San Antonio Kathleen D. James, BS,...