Make sure you know HIPAA Privacy and Security Rules, and the implications of federal and state laws on privacy and information security, as they related to clinical research. The speaker will identify key challenges and common areas of non-compliance, and the different approaches Institutional Review Boards take to meeting regulatory obligations in this arena and their implications on the research team. Take away an understanding of why the structure of an organization – and the status of the researcher as it relates to the clinical component of the organization – can have implications for how compliance is achieved. This session is a two-part "master series" program.

Learning Objectives:

• Understand the interplay between the Common Rule, the HIPAA privacy and security regulations and other regulations impacting clinical research
• Identify key areas of concern and non-compliance regarding privacy and information security in a clinical research project
• Work effectively with the compliance team of their organization to resolve privacy and information security concerns in research

Review the use of a standard system and tools to compliment the risk-based monitoring strategy. Speakers will pay special attention to effective source documentation review to assess if it meets ALCOA and the process for securing compliance. Learn about key verification points of consent, deviations, and safety while participating in practice exercises intended to identify, investigate, and resolve real-world site compliance issues. This session is a two-part "master series" program.

Learning Objectives:

• Discuss monitoring and risk based indicators
• Recognize the use of monitoring tools as part of the RBM strategy
• Discuss the strategies of securing compliance for common issues identified

GCP training has become the industry standard for meeting sponsors' responsibility to ensure qualified investigators. Despite the widespread use of this training, little evidence has been collected to determine whether it provides the knowledge and skills necessary to support investigators and their delegates in the quality conduct of clinical trials. In addition, the burden of training that is redundant or of little value, often required before each clinical trial, could make it untenable for investigators to participate in future trials. Rather than accepting GCP training as the default solution for qualifying investigators, the Clinical Trials Transformation Initiative's multi-stakeholder project team has worked to gain a broader, evidence-based perspective to inform the efficient and effective qualification of site investigators for the quality conduct of clinical trials. Come learn about their findings.

Learning Objectives:

• Describe the characteristics that define the quality conduct of clinical trials
• Identify gaps and redundancies in the current training of investigators in preparation for the conduct of clinical trials
• Discuss key learning objectives for training to qualify investigators for the quality conduct of clinical trials

Learn the different models by which investigators can be compensated, the basics of the Anti-Kickback Statute, the False Claims Act, the Stark Law, and how they govern investigator payment, and the average per-patient investigator compensation by trial type. Speakers will share one hospital’s experience successfully compensating physicians based on the various types of medical groups and hospital physicians they contract with. Take away tips for successful physician payment negotiations.

Learning Objectives:

• Understand the laws that govern investigator payments
• Explain different models for Investigator Compensation
• Successfully negotiate physician payments with investigators

As a nurse and compliance professional, my recent experience dealing with my husband's sudden death brought home to me all that I work with every day. The reality of when it is "you" on the receiving end is overwhelming. I want to relate how understanding compliance from both sides helped me to give his organs and tissue for research. Grasping the state of affairs within hours and how compliance came over me was mind boggling. I hope to share my experience to help others who deal with patients every day

Learning Objectives:

1. Verbalize the need for HIPAA
2. Analyze a hospital's responsibility to a patient when they are an "employee"
3. Create a culture that promotes research

Gain a framework for identifying what research tasks to automate and how to prioritize them among different technology modules, and understand the key elements of an implementation plan. The speaker will discuss the wide and growing array of technology available to assist research sites with recruiting, financial administration, regulatory compliance, source data collection, lab routing, patient stipends, communications, business development, and more. Take away implementation tools such as a vendor qualification checklist, an ROI calculator, a compliance checklist, and a sample SOP, among others.

Learning Objectives:

•  Identify what parts of your clinical trial operations to tech-enable
• Prioritize your technology initiatives
• Develop an implementation plan

According to Wikipedia there are 400+ Diploma Mills in operation selling fake degrees and another 300+ websites offering counterfeit diplomas. The number of individuals "owning" a fake degree or diploma is hard to estimate, however Allen Ezel and John Bear boldly state in "Degree Mills: The Billion-Dollar industry that has Sold Over a Million Fake Diplomas" that more than 50% of the individuals claiming to have earned a PhD actually have a fake degree. There are not only legal ramifications for someone misrepresenting educational credentials, but the repercussions to the hiring company are just as serious. In this session, the speaker will provide resources to help identify Diploma Mills and Falsified Educational Credentials and discuss alternative solutions to the "Degree Requirement" in place at many companies.

Learning Objectives:

• Describe the breadth and depth of the extensive issue of individuals representing Bogus Degrees
• Use available resources to identify Diploma Mills and/or Falsified Educational Credentials
• Understand the legal ramifications of misrepresenting educational credentials as well as the significant repercussions to Hiring Organization

Showcase your site in the most positive light by learning the critical steps in preparing for site qualification visits. The speaker will highlight methods for best presenting the knowledge and capabilities of your staff and facility, and for communicating effectively with CRO/sponsor personnel. Whether you need ground-up guidance on establishing infrastructure and preparing for a qualification visit, or you are looking to improve your existing processes and presentations, this session will provide the tools you need to ensure a positive site qualification visit.

Learning Objectives:

• How to best prepare the investigational site/staff and ancillary facilities for the site qualification visit tour and staff/equipment assessment by the sponsor/CRO
• Compile and provide the appropriate recruitment, site information and staff experience data to present to sponsor/CRO staff at the site qualification visit
• Identify key investigational site staff to attend/conduct the site qualification visit with the sponsor/CRO

Learn about the Duke University School of Medicine's experience with a competency-based framework for career advancement. Building on last year?s session outlining the creation of competency-based job descriptions and the process used to match incumbents to these new classifications, speakers this year will address steps taken to provide advancement opportunities using objectively-measured competency assessments. Hear results of the initial tier advancement cycles, lessons learned, and how this tier advancement process is providing clearer career paths for staff while attracting and retaining a valuable workforce.

Learning Objectives:

• Describe the benefits of a workforce initiative, built upon clinical research competencies
• Detail the process and components of competency-based tier advancement for clinical research professionals
• Describe the results of the tier advancement process for the clinical research workforce at an academic medical center

Come hear case studies of cloud-based monitoring and a conversation about how different stakeholders can cooperate to increase research effectiveness. Speakers will explore remote monitoring from the perspectives of the contract research organization, research site, and technology vendor. Learn about the impact of HIPAA-compliant, cloud-based subject binders, associate regulatory issues such as Certified Copy, and best practices for implementation.

Learning Objectives:

• Facilitate regulatory compliant remote monitoring
• Explain the role and importance of Certified Copy under FDA guidance and ICH-GCP E6 R2
• Discuss best practices for handling cloud-based source and regulatory documents