Announcements

The Minnesota Chapter of the Association of Clinical Research Professionals presents SHARE FAIR II October 13, 2016 Au Fait & International Conference Rooms at Fairview Southdale Hospital 6401 France Avenue South, Edina 2.0 ACRP/CME/Nursing Contact Hours (applied for through ACRP) It’s back due to popular demand! The format of the SHARE FAIR is similar to a school science fair, with 15-minute mini-presentations on diverse topics directly related to issues encountered daily in the practice of clinical research. SHARE FAIR II fosters an environment that allows research professionals to exchange knowledge and garner insight into best practices developed by others. The relevant target audience for this presentation is all clinical research professionals. Upon completion of attendance at these SHARE FAIR II presentations, participants should be able to: 1. Describe aspects of clinical research practice that exemplify a broad range of contemporary concerns presented at SHARE FAIR II 2. Review differing approaches to the clinical research collaborative process, from the viewpoints of Sponsors and of clinical facilities 3. Determine whether a technique applied by colleagues to a specific clinical research issue pertains to your research process Please come and invite your colleagues to join the casual, fun atmosphere! 5:30 – 6:30 Registration, Buffet Supper, & Brief Chapter Business Meeting 6:30 – 8:30 Presentations & Q&A—See Below for Session Break-Outs All sessions are 15-minutes long, with the last 2 minutes of each session reserved for Q & A: 6:30 – 6:45 Recruitment: We all need to do it. How do we do it with a limited staff? Presented by: Beth Jorgenson One of the significant challenges to a successful clinical trial is patient recruitment. This presentation covers concepts to consider when developing recruitment plans for your site and your trials. Upon completion of this session, participants should be able to: 1. Describe three forms of contacts to recruit patients 2. Identify barriers to database queries in searching for potential patients 3. Identify at least one tool that can be used to train their team for improved recruiting success 6:45 – 7:00 Changing Perspectives: Inside the CRC and CRA Mind Presented by: Jill Wass, Kelly Sullivan This presentation spotlights key clinical study topics from both the CRA’s and the CRC’s perspective—and primarily discusses risk-based monitoring and the importance of good documentation. Upon completion of this session, participants should be able to: 1. Describe the purpose of risk based monitoring and what it means for sites 2. Identify and apply good documentation: AE/SAE and Source 3. Demonstrate effective communication between a CRA/Sponsor with a CRC/Site 7:00 – 7:15 Entering the Clinical Research Field—A Student’s Perspective Presented by: Zaakir Merchant Page 2 of 3 Medical device companies have noticed a gap in knowledge and experience for employees involved in Clinical Research, as most working professionals stumble upon these careers without formal training. It may be necessary for those who are already in Clinical Research to obtain more education. Moreover, many people are not aware of Clinical Research as a career path. How can awareness spread of the career opportunities that exist? Upon completion of this session, participants should be able to: 1. Evaluate common barriers involved in entering the Clinical Research field 2. Describe a student’s perspective in entering the Clinical Research field 3. Validate Clinical Research career paths 4. Compare experiences involved in entering the Clinical Research field 7:15 – 7:30 Learn to Excel in Clinical Research: Excel Formula Basics Presented by: Erich Berg Spreadsheets can simplify work and increase efficiency. This interactive presentation is designed with coordinators and research managers in mind, aiming to teach the basic principles of Excel formulas to allow for immediate application of these formulas to simplify coordination of a research study. Attendees are encouraged, but not required, to bring a laptop with the Excel program. Upon completion of this session, participants should be able to: 1. Identify areas in a spreadsheet where Excel formulas can assist in the coordination of a research study 2. Apply Excel formulas to the research spreadsheet 3. Compose formulas to assist in subject recruitment, follow-up, and data organization within a study 7:30 – 7:45 Successful transition from being a nurse to working in industry Presented by: Susan Petersen-Stejskal Examine the career transition from working as a professional health care provider or technician in the clinical medical setting to working in industry as a professional member of a clinical research project team. Desirable attributes and skill sets, along with potential jobs, will be discussed. Upon completion of this session, participants should be able to: 1. Describe at least three potential jobs within industry that may be appropriate for a professional working within the healthcare area. 2. Specify at least two professional attributes that are essential for a successful transition into industry 3. Summarize at least four areas of focus that require expertise /or formal education in the clinical research area within industry 7:45 – 8:00 Clinical Trial Reporting: Will Better Compliance Lead to Greater Transparency? Presented by: Shelley Johnson Just last month, the Final Rule regarding Clinical Trial Transparency was issued by the FDA, and NIH published a complementary policy statement. The goal is for timely registration of clinical trials and of their results at ClinicalTrials.gov. Will companies and academic institutions be ready by next January’s effective date? Upon completion of this session, participants should be able to: 1. Describe the registration information requirements and the type of data provided in result summaries for applicable clinical trials 2. Discuss proponent and opponent views to full transparency 3. Recognize the possible consequences of non-compliance with registration and posting of summary results in accordance with the Final Rule Page 3 of 3 8:00 – 8:15 Benefits of Professional Certification Presented by: Minnesota ACRP Chapter Board Members Holding a certification credential in clinical research demonstrates competency, recognizes achievement, and promotes efficient and ethical study conduct. Are you ready to take the plunge? Upon completion of this session, participants should be able to: 1. Name at least three benefits of clinical research certification 2. Identify the three clinical research credentials sponsored by the Association of Clinical Research Professionals (ACRP) 3. Explain the steps to become a CCRA, CCRC, or CPI 8:15 – 8:30 General Q & A Every clinical research professional benefits by connecting with others in the profession to share ideas, tips, and opportunities to grow and develop. This ultimate goal of Share Fair II will conclude the evening in a general session where no question or comment is too insignificant and discussion of alternative opinions is encouraged and supported. We invite all attendees to join us for the buffet supper that precedes the mini-presentations. This meeting and the associated contact hours are free-of-charge to members of the Minnesota Chapter of ACRP. Non-members are welcome and encouraged to attend. Fees for attendance and contact hour transcripts for non-members are listed below. Attendance with: Contact Hours No Contact Hours Minnesota ACRP Chapter Member $ 0 $ 0 ACRP Member (not MN chapter member) $25 $10 Not ACRP or MN Chapter Member $40 $20 Contact hours (2.0) for attending this educational activity have been applied for through ACRP’s Academy. Membership is not required for online registration/application of contact hours. To receive contact hours, sign in at the registration desk and attend the program. Go to the “Learning Portal” on the ACRP website within 30 days following this event to complete an evaluation and obtain the online certificate. To help us plan for the buffet supper, it is helpful if you can RSVP by October 12, 2016 at http://www.acrpnet.org/GetInfoFor/USChapters/Minnesota.aspx. If you miss this deadline, feel free to come and register on-site. Please attend and share your viewpoints! You must register to receive contact hours. If you need to cancel your pre-registration, we will refund your money—please notify us as soon as possible. Contact the Programming Committee (link at the above-cited website) with any questions. The Minnesota ACRP Chapter is funding this event. Fairview Health Services is donating the facility, with no influence on the presentations’ contents.