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2016 IACRN 8th Annual Conference Clinical : Embodying Team Science for Participant-Focused Care

October 25-26, 2016 Pre-Conference Sessions October 24, 2016 Wyndham Lake Buena Vista Lake Buena Vista, Florida, USA (Approximately 18 CNE credits expected to be offered for Conference and Pre-conference)

This activity will be submitted to the Society for approval to award contact hours. ONS is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center’s COA.

Dear Colleagues,

On behalf of the International Association of Clinical Research Nurses, I am pleased and honored to invite you to our 8th An- nual Conference entitled “Clinical Research Nursing: Embodying Team Science for Participant-Focused Care.” The con- ference will be held at the Wyndham Lake Buena Vista in Lake Buena Vista, Florida from October 25-26, 2016 with pre- conference sessions being offered on October 24. It’s an exciting time for clinical research nursing as we continue to grow on an international scale, while remaining adaptable, motivated and responsive to opportunities for development of our specialty nursing practice. As part of that landscape, IACRN has recently submitted its “Scope and Standards of Clinical Research Nursing” document to the ANA for recognition of our specialty practice.

Following through on this commitment, this year’s conference highlights both the individual and collective impact that clinical research nurses have on maintaining the equilibrium between the care of the research participant and fidelity to the research protocol. During our conference you can expect to gain knowledge, strategies and tools for adapting your professional practice within a changing global clinical research landscape while keeping focus on what is most important to the art and science of nursing practice, the nurse-client relationship.

Our conference objectives for 2016 are:

 Build an evidence base for addressing ethical considerations, interdisciplinary leadership teams and professional development for the profession of clinical research nursing

 Identify best practices that ensure quality community/participant focused input and care for clinical research planning and study management

 Identify and expand innovative strategies for managing regulatory affairs, site and study management in domestic and international research settings

I hope that each of you see the exceptional value in attending our conference, designed specifically around your needs and your specialty practice and in bringing your expertise to our gathering. You have the vision, the knowledge, and the experience to help us pave our way into the future. You are truly the greatest asset to our organization and we could not accomplish what we do without your support and leadership.

Sincerely,

Margaret McCabe, PhD, RN, PNP President, International Association of Clinical Research Nurses

“Enhancing clinical research quality and safety through specialized nursing practice.” Registration Online Registration and Payment is Available at www.iacrn.org. Early Registration Deadline: 5:00pm ET Wednesday, August 31, 2016

Register early! It helps us plan better and keeps your Once you register, you will receive a costs down. Take advantage of the early registration confirmation letter from IACRN. If you do not discount by registering on or before 5:00pm ET receive a letter confirming receipt of your Wednesday, August 31, 2016. The discounted rates are registration, please call us at 412-343-2235 to made available in order to facilitate the administrative check your registration status, or contact us via planning which is required prior to the conference. email at [email protected].

**This activity will be submitted to the Oncology Nursing Society for approval to award contact hours. ONS is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center's COA.**

IACRN Event Registration Refund Policy — Pre-conference/Conference

*All cancellations or refund requests must be in writing via: Email: [email protected]—or—Fax: IACRN, Attn: Helaine 412-344-0559 *Cancellations or refund requests received before 14 business days from the start of the pre-conference/conference will be fully refunded minus a $50 administration fee. *Cancellations or refund requests received within 14 business days leading into the pre-conference/conference or after close of the conference will not receive a refund. *Conference registration is transferable to another person at no additional charge. Notify IACRN at [email protected] with name of original registrant and new registrant. Cancelled registrations are non-transferable.

Sponsors & Exhibitors

IACRN is a professional nursing organization founded in 2008 to increase awareness of this specialty practice in keeping with the changing international research landscape. Its purpose is to define, validate and advance clinical research nursing as a specialty practice and to support the professional development of registered nurses who directly or indirectly impact the care of clinical research participants. Our vision is reflected in our statement: “Enhancing clinical research quality and safety through specialized nursing practice.”

Exhibitors and sponsors for this meeting will have access to a large group of Clinical Research Nurses and to the organizations that they serve. IACRN will include sponsor and exhibitor names on the conference website and conference printed materials broadening the opportunity to bring your message to our membership and visitors to our website.

The passion of our members ensures the continued development and recognition of this specialty practice. IACRN is on schedule to release the Scope and Standards of Practice for Clinical Research Nursing this summer. We need your help to continue to elevate the specialty practice of Clinical Research Nursing. To learn more about our organization and the work we are doing, I encourage you to visit our website at www.iacrn.org.

There are a number of different opportunities for sponsorship and exhibiting at the Conference. For more information and a full Sponsor/Exhibitor Prospectus, click here.

Hotel Information Wyndham Lake Buena Vista Resort 1850 Hotel Plaza Boulevard Lake Buena Vista, Florida 32830-2202

In the middle of Walt Disney World®, Wyndham Lake Buena Vista overlooks all of Disney’s Florida empire, including Disney Springs®, right across the street. If access to days of unforgettable fun is important to you, there’s no better place to stay on a family getaway or Florida business trip. We even offer a continuous shuttle to and from every Disney® Theme Park, none further than 7 miles away. These shuttles begin running one hour before the theme parks open and run every 30 minutes up until two hours after the parks normal park operating hours.

All our rooms are fully furnished with classically contemporary amenities, including refrigerators with icemakers and high-speed wireless Internet. Some have exterior entrances for easy access, while others have towering views of Walt Disney World®, Lake Buena Vista, and our own beautiful Lake Buena Vista Resort.

There are two ways to book your reservation: By Phone: Hotel direct: Guests can call the hotel directly to book their rooms. Simply call (800) 624-4109, ask for reservations and give the group name—International Association of Clinical Research Nurses/IACRN.

Room Rate: $129.00 (single/double) plus taxes if reserved by 9/30/2016 or until the IACRN room block is filled. After 9/30/2016, reservations will be accepted on a space and rate availability basis only.

Online Reservations: Guests can book online via the hotel website, www.wyndhamlakebuenavista.com > click on reservations link > enter in arrival date/departure date > click add special rate code > enter in GROUP CODE - CRN

Transportation

Orlando International Airport (MCO) MCO is only 17 miles from the Wyndham Lake Buena Vista Resort. Transportation is available near the baggage claim area. If you choose to rent a car, the hotel parking fee is $8.00 per night per vehicle and includes unlimited use throughout the day.

Ground Transportation: Mears Transportation offers a round trip shuttle from MCO Airport to the Wyndham Lake Buena Vista for $37 round trip. You may go to their website at www.mearstransportation.com or call them at +1 407-423-5566 to book your space once your flight reservation is made.

Taxi service costs approximately $55 one way.

Want a luggage free last day? Bags Inc. Remote Airline Check-in Service offers a complimentary service to get your boarding passes delivered to your room and your baggage checked in for your flight home from our resort lobby. To enroll visit www.maketraveleasier.com/wyndhamlbv. Participating airlines include: American, AirTran, Alaska, Delta, JetBlue, Southwest, United, and US Airways—all applicable airline baggage fees still apply.

“Clinical Research Nursing: Embodying Team Science for Participant-Focused Care” PRELIMINARY AGENDA

Monday, October 24, 2016

7:30 AM - 4:00 PM EARLY REGISTRATION

9:00 AM - 12:00 PM MORNING PRECONFERENCE SESSIONS

PRECONFERENCE SESSION I:

How to Develop and Deliver a Successful Webinar Patricia Eckardt, PhD Director, Heilbrunn Family Center for Research Nursing Rockefeller University, USA Liza Behrens, MSN, RN, CCRC Project Coordinator Pennsylvania State University, USA Rosemarie DeLucca, BSN, RN, CCRC Clinical Research Coordinator Geisinger Health Systems, USA

Workshop Description: Webinars are increasingly being used to deliv- er professional development education due to their accessibility, affordability, and ability to be archived. Best practices in webinar development and delivery are available that can guide webinar content creators and presenters. The objectives of this preconference workshop are to: describe a webinar; discuss types of webi- nars for professional development; describe the key elements of a webinar; demon- strate steps in developing and preparing a webinar; apply resources for webinar development and best practices. This professional development module is intended for any nurse who is interested in learning how to create or present a webinar.

PRECONFERENCE SESSION II:

How to Use the UK Clinical Research Facilities Network ‘Study Intensi- ty Tool’ to Improve Workforce Planning Lisa Berry, BSc (Hons) Clinical Practice, Diploma Adult Nursing , Research & Development University Southampton NHS Foundation Trust, UK

Workshop Description: The three-hour workshop ‘How To Use The UK Clin- ical Research Facilities Network ‘Study Intensity Tool’ To Improve Workforce Plan- ning’ will involve a verbal and powerpoint presentation to introduce the tool to attendees. This will be followed with a practical session where attendees have the opportunity to use the tool to calculate the intensity of study visits and the staffing requirements for a test protocol. Attendees will be given practical support from presenters and will be given electronic copies of presentation, SIT handbook and version 12 of the tool. Pre and post training impact questionnaires will be complet- ed by attendees.

12:00 PM - 1:30 PM LUNCH – On Your Own

1:30 PM - 4:30 PM AFTERNOON PRECONFERENCE SESSIONS

PRECONFERENCE SESSION III:

Developing New Approaches to Patient Involvement and Engagement Susan Hamer, RGN, BA, MA, DED Director of Nursing, Learning and Organisational Development NIHR Clinical Research Network, UK Fiona O’Neill, RGN, RMN, BA (Hons), PhD Head of Workforce and Learning NIHR Clinical Research Network, UK

Workshop Description: This highly interactive session will provide the opportunity to consider a range of innovative approaches to patient involvement and engagement. Using a number of international case studies participants will hear about different approaches to improve public literacy about taking part in clinical studies and the different ways we can improve authentic collaboration with patient led organisations and charities. The session will also examine how the in- crease in consumer voice and confidence and technological innovation is changing how we need to think about and connect with our key communities.

“Clinical Research Nursing: Embodying Team Science for Participant-Focused Care” PRELIMINARY AGENDA

PRECONFERENCE SESSION IV:

Generating Clinical Research Nurse Priorities Consistent with IACRN’s Mission, Vision, and Strategic Plan Using Nominal Group Technique Carolynn Jones, DNP, MSPH, RN Lead Instructor, Master of Applied Clinical and Preclinical Research Ohio State University, USA Cheryl Fisher, EdD, RN Senior Nurse Consultant National Institutes of Health Clinical Center, USA Catherine Griffith, PhD, RN Clinical Research Nurse Massachusetts General Hospital, USA

Workshop Description: This first aim of this preconference is to bring together expert CRNs to generate research priorities using Nominal Group Tech- nique (NGT). The second is to provide an energizing learning experience for at- tendees resulting in highly motivated CRNs who will use NGT in solving research practice issues within their home environments. Of the available research methods suitable to group processes, NGT will be used at this preconference. NGT is a semi -quantitative/qualitative evaluative methodology grounded in social-psychology designed to promote group participation in the decision-making process and can be used by small groups to reach consensus on the identification of key issues.

Tuesday, October 25, 2016

7:30 AM - 8:30 AM REGISTRATION AND COFFEE

8:30 AM - 7:30 PM EXHIBIT HALL OPEN - NETWORKING - POSTER VIEWING

8:30 AM - 8:45 AM 2016 IACRN ANNUAL CONFERENCE WELCOME Margaret McCabe, PhD, RN, PNP President, IACRN 8:45 AM – 10:00 AM KEYNOTE ADDRESS

Stephen M. Fiore, PhD Director, Cognitive Sciences Laboratory and Faculty University of Central Florida Cognitive Sciences Program, USA

10:00 AM-10:15 AM Break – Tweet/Refreshments/Visit Exhibitors/Posters

10:15 AM-11:15 AM BREAKOUT SESSION 1 (Choose either session A, B, or C) Session A:

Creating a Research Nurse Orientation Curriculum Kristen Johnson, JD, RN, OCN Director of Research Nursing Dana-Farber Cancer Institute, USA

Clinical Research Nurses Preceptor Programs: A Review of the Litera- ture and Pilot Program Allison Settler, MSN, FNP-BC Clinical Research Molecular Immunology Lab The Rockefeller University, USA

Session B:

Standardized Subjects Self-management in Hematological Phase I Clin- ical Trials Guimin Zhang, Undergraduate Head Nurse Tianjin Hospital, China

The Effects of Trans-resveratrol on Inflammation, Insulin Resistance and the Metabolic Syndrome: A Placebo Controlled, Double-Blind Study Jeanne Walker, MS, ANP Clinical Research Nurse Practitioner The Rockefeller University, USA

“Clinical Research Nursing: Embodying Team Science for Participant-Focused Care” PRELIMINARY AGENDA

Session C:

Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Marjorie Good, RN, MPH, OCN Nurse Consultant/Program Director National Cancer Institute, USA

Lack of Evidence for Financial Burden of Clinical Trials Nurses Research Amanda Copeland, MSN, RN, CNS Director, Clinical Trials Nursing Memorial Sloan Kettering Cancer Center, USA

11:15 AM-12:15 PM BREAKOUT SESSION 2 (Choose either session A, B, or C) Session A:

Skill Mix and Staff Mix Within Multi-disciplinary Teams: Developing an Integrated National Workforce Framework for Clinical Research Deliv- ery Fiona O’Neill, PhD, BA (Hons), RMN, RGN Head of Workforce and Learning NIHR Clinical Research Network, UK Susan Hamer, DEd, MA, BA, RGN Director of Learning and Organisational Development NIHR Clinical Research Network, UK

Development Of A New Educational Programme For Clinical Trials Assistants: Developing Our Workforce To Meet the Challenges of the Future Marie Nelson, MSc, BA (Hons), RN Matron, Research and Development University Hospital Southampton NHS Foundation Trust, UK

Session B:

Modern Technology in Research: Paper Consents Gone Digital Education Ilana Logvinov, MSN, RN, CCRP Advanced RN CCRC Mayo Clinic, USA

Exploring the Informed Consent Process in Cancer Clinical Trials in Taiwan Chi-Yin Kao, PhD, RN Assistant Professor National Cheng Kung University, Taiwan

Session C:

Research Timepoint Indicators: Using Benchmarks to Improve Perfor- mance Tamara Kempken Mehring, MSN, RN, CCRC CNS University of Wisconsin, USA Marianne Hines, MS, APNP, NP-C Nurse Practitioner University of Wisconsin, USA Ann Wieben, BSN, RN, RN-BC Nurse Clinician University of Wisconsin, USA

Impact Of Professional Nursing Practice Environment And Psychologi- cal Empowerment On Nurses’ Work Engagement: Test Of Structural Equation Modeling Shanshan Wang, MD, PhD School of Nursing Zhengzhou University, China

12:15 AM-1:45 PM LUNCH AND BUSINESS MEETING “Clinical Research Nursing: Embodying Team Science for Participant-Focused Care” PRELIMINARY AGENDA

1:45 PM-2:45 PM BREAKOUT SESSION 3 (Choose either session A, B, or C) Session A:

5 different round tables in the General Session Room Session B:

1 or 2 skillset sessions Session C:

1 or 2 skillset sessions 2:45 PM-3:45 PM PLENARY SPEAKER

3:45 PM-4:15 PM Break – Tweet/Refreshments/Visit Exhibitors/Posters

4:15 PM-5:30 PM PANEL DISCUSSION

5:30 PM-7:00 PM POSTER SESSION/SOCIAL NETWORKING/RECEPTION

Wednesday, October 26, 2016

7:30 AM - 8:30 AM REGISTRATION AND COFFEE COMMITTEE AND SPECIAL INTEREST GROUPS MEETINGS Chapter Governance Committee Conference Planning Committee Education Committee Membership, Marketing, & Communications Committee Nominations Committee Research Committee Scopes & Standards of Practice Committee 7:30 AM - 3:00 PM EXHIBIT HALL OPEN - NETWORKING - POSTER VIEWING

8:30 AM - 8:45 AM DAY 2 INTRODUCTIONS AND ANNOUNCEMENTS Margaret McCabe, PhD, RN, PNP President, IACRN 8:45 AM – 9:45 AM PLENARY SPEAKER 9:45 AM-10:00 AM Break – Tweet/Refreshments/Visit Exhibitors/Posters 10:00 AM-11:00 AM BREAKOUT SESSION 1 (Choose either session A, B, or C) Session A:

Evolution of the Oncology Clinical Trials Nurse (OCTN) Competencies to Reflect Changing Practice Barbara Lubejko, MS, RN Oncology Clinical Specialist Oncology Nursing Society, USA

Expanding the Description of the Clinical Research Nursing Domain of Practice: An International Survey Approach Research Cheryl Fisher, EdD, RN Senior Nurse Consultant National Institutes of Health, USA Catherine Griffith, PhD, RN Clinical Research Nurse Massachusetts General Hospital, USA

Session B:

Changing the Inpatient Unit Culture in a Research Environment: A Pro- cess to Enhance Interdisciplinary Collaboration during Daily Patient Rounds Amanda Bray, BSN, RN, OCN National Research Coordinator National University of Ireland Galway, Ireland

Team Science Continuum: The Journey of the Georgetown University Clinical Research Unit Marie Therese Jeffs, BSN, RN Clinical Research Nurse Georgetown University Clinical Research Unit Shaunagh Browning, MSN, RN, FNP-BC Nurse Manager Georgetown University Clinical Research Unit

“Clinical Research Nursing: Embodying Team Science for Participant-Focused Care” PRELIMINARY AGENDA

Session C:

Managing Clinical Research Nurses - The Edinburgh Experience Jean Bruce, PG Cert, BSc, RGN Clinical Research Nurse Manager NHS Lothian, UK

Creating ePortfolios to Illustrate Leadership Planning and Clinical Re- search Competency: A Clinical Research Nurses Guide Caroynn Jones, DNP, MSPH, RN Assistant Professor The Ohio State University, USA

The Clinical Research Nurse Margaret McCabe, PhD, RN Director, Nursing Research Boston Children’s Hospital

11:00 AM-12:00 PM BREAKOUT SESSION 2 (Choose either session A, B, or C) Session A:

Establishing an International Chapter Gordon Hill, MSc, PGCE, BA, RGN Senior Lecturer Glasgow Caledonian University, UK

IACRN Fundamentals of Clinical Research Nursing Course in China Xiaokun Liang, PhD Project Manager Global MD, China

Session B:

Breaking Down the Delegation of Authority Log Research Shaunagh Browning, MSN, RN, FNP-BC Nurse Manager Georgetown University Clinical Research Unit

A Retrospective, Blinded Pilot Study Comparing Staffing Influence on Protocol Deviation Rates: A Report on Study Methods and Preparation Penelope Jester, MPH, RN Director University of Alabama at Birmingham, USA

Session C:

Nurse Scientists’ Educational Preparation, Efficacy, and Knowledge in Clinical Research Nursing Patricia Eckardt, PhD, RN Director Heilbrunn Center The Rockefeller University, USA

Use OSCE Teaching Model to Develop, Build and Test the Nursing Cur- riculum of Capacity Index for Clinical Research Nurse Wen-Yu Hu, PhD Professor, Department of Nursing National Taiwan University College of Medicine, Taiwan

12:00 PM – 12:30 PM LUNCH 12:30 PM-1:15 PM 2016 Distinguished Clinical Research Nurse Award Recipient

Shaunagh Browning, MSN, RN, RNP-BC Nurse Manager, Clinical Research Unit Georgetown University, USA

1:15 PM-2:15 PM ENDNOTE SPEAKER

Regina Cunningham, PhD, RN, AOCN, FAAN Chief Nursing Executive and Associate Executive Director Hospital of the University of Pennsylvania

2:15 PM-2:30 PM 2016 Conference Closing Remarks Margaret McCabe, PhD, RN, PNP President, IACRN