Come play "Research Jeopardy!" Test your knowledge and skills by participating on one of three teams during this interactive session for novices and experts alike. Learn about Good Clinical Practice, research terminology and methodology, human subject protection, and more with fellow attendees in a casual, fun environment. You might surprise yourself by what you know and learn some interesting facts that you don't.

Learning Objectives:

• Test their level of knowledge by answering 10 or more questions correctly
• Recognize 1 category for improvement
• List 3 new facts about clinical research

Understand the current regulations and guidance related to vulnerable subjects while learning methods for practical application in your daily activities. New threats to the vulnerable arise and corresponding regulation and guidance evolve to address them. The speaker will provide insights on the importance of maintaining a contemporary understanding of vulnerable subjects and adjusting perceptions in order to protect vulnerable subjects in clinical trials.

Learning Objectives:

• Recount the basic ethical and regulatory components that apply to protection of the vulnerable in research
• Interpret the changing regulatory landscape as it applies to the pretection of vulnerable populations and individuals
• Incorporate these into a contemporary framework that can be applied to protect the vulnerable specific to each research professional's individual role in the research enterprise

Long gone are the days where employees worked for the same company for 30 plus years and followed an employer-driven career ladder to grow their career. In today's competitive and unpredictable climate, employees can't rely on established career ladders or guaranteed growth opportunities. Thus, it is incumbent on all of us to have our own personal career map or career development plan in order to get the most out of our careers. Providing different perspectives from the sponsor/site and staffing agency perspectives, our speakers will share their insights and experiences on how you can "own your professionalism" and grow your career in meaningful ways.

Learning Objectives:

• Discuss the role and value of a personal career map to grow your professional career opportunities
• Explain how both employees and employers can leverage the value of career maps
• List the differences between career ladders, career lattices and career maps

This session will examine several regulatory issues that impact US and global trial operations from multiple perspectives. Topics include US and Latin American trial issues, OTC drugs and personal care products used in clinical trials, and new Certificate of Confidentiality rules. There will also be time set aside for Q&A with the expert panel of ACRP Regulatory Affairs Committee Members.

Learning Objectives:

• Recognize selected advantages and procedural differences when conducting clinical trials in Latin America
• Understand when a “Certificate of Confidentiality" is appropriate for your trial, what it covers, and how one is obtained
• Keep up-to-date with recent key changes to US regulations affecting clinical trials conduct and monitoring

This session will provide an overview of the reorganization of the FDA's Center for Devices and Radiological Health (CDRH). Scheduled to begin mid-2018, this significant restructuring will combine the CDRH Office of Compliance, Office of Surveillance and Biometrics and the Office of Device Evaluation into a "super-office," designed to increase efficiency and effectiveness and to focus on the total product life cycle of medical devices. The restructuring will allow CDRH to review, clear or approve pre-market medical devices and assess these products and their legal manufacturers after market in one office. The FDA's goals for this move are to enhance information sharing throughout the center, address staffing challenges, improve engagement and professional development of employees, and update IT systems. Attendees will learn how this office will impact submissions, the reporting process, and inspections. The session will also examine the CDRH's three-year plan outlining its priorities, including employee engagement, streamlining of processes, and building collaborative communities.

Learning Objectives:

• Understand how the restructuring of CDRH will impact future submissions
• Define at least 2 changes to the reporting and inspection processes resulting from the restructuring
• Describe how your organization will participate in building collaborative relationships with CDRH

Understand new initiatives underway at the National Institutes of Health (NIH) that could impact your clinical trial operations. NIH officials will highlight initiatives to enhance the accountability and transparency of clinical research and will discuss “All of Us,” an historic effort to gather data from one million or more people living in the U.S. to accelerate research and improve health. Attendees will also gain insider perspectives and practical tips for grant and funding applications, clinical study reporting requirements via ClinicalTrials.gov, and more.

ACRP Executive Director Jim Kremidas will deliver welcome remarks and provide an overview of the state of the association.

Learn about collaborative initiatives to tackle the most pressing challenges facing clinical development. Executive leadership from the organizations driving clinical research quality improvement through process and technology change initiatives will discuss initiatives ranging from investigator qualification and GCP mutual recognition to quality by design, mobile clinical trials, and more. 

Learn about collaborative initiatives to standardize professional competence and career paths in clinical research. Attendees will learn about the Core Competence Framework for Clinical Trial Monitoring and hear a case study on its use in AstraZeneca’s initiative to internalize its monitoring program. Updates on development of the Core Competence Framework for Clinical Research Coordinators will also be shared.

Imagine dedicating your career to developing breakthrough therapies for others and one day finding yourself as a study subject. This is reality for Peter and Vicky DiBiaso. After two decades of working in clinical research and championing the value and importance of participation in clinical trials, the DiBiaso’s are now engaged as study volunteers and advocates living with Parkinson’s. Come gain a deeper understanding and broader perspective of clinical research as Peter and Vicky share their candid observations and experiences.

Join Kenneth A. Getz, MBA, Director of Sponsored Research Programs & Research Associate Professor, Tufts Center for the Study of Drug Development, as he examines the forces shaping the current and future state of the clinical research industry. Explore the individual dynamics of technology, process, and workforce on the industry and their effect on each other.