Imagine being able to consent a participant remotely. With today's new electronic data capture (EDC) systems, this is a reality. Come learn how to ethically and technically complete an electronic consent (eConsent) by using video, audio, and digital media. The speaker will present a live eConsent demonstration and help expand your consenting skills by empowering you to leverage your EDC system to save time and money.

Learning Objectives:

• How to design an e-consent that meets and exceeds GCP and applicable laws
• What tools can be used to enhance the consenting process
• How to integrate video, audio and digital consent into one simple process

Gain the tools you need to develop a protocol that meets regulatory and marketing needs through inquiries, surveys, and discussions. Developing device protocols that maximize impact while minimizing costs is difficult, and often does not reach the goal of generating data for both. Developing protocols that either meet the needs of both regulatory and marketing, or setting up post market studies that answer these questions, requires both detective and analytic capabilities. Speakers will shed light on the steps required to determine what data needs to be collected to answer these questions, or support the post market surveillance to do so.

Learning Objectives:

• Determine what endpoints for Regulatory can do for Marketing
• Developing strategies to collect data for marketing claims
• Minimizing Sample size to answer both Regulatory and Marketing needs

Learn about innovative CIRB workflows developed by working groups of the National Institutes of Health-funded Trial Innovation Center (TIC). Speakers will outline how they have approached local context review and study site activation under the SMART reliance agreement for multi-center trials, among other topics. Hear how these innovative workflows are paving the way for future research and playing an integral role in accelerating the translation of research to the bedside. This session is a two-part "master series" program.

Learning Objectives:

• Identify the technical issues of operationalizing a CIRB review model
• Describe early workflow models for study teams; what has worked and not worked
• Review approaches and operational principles to be in compliance with new regulations

Financial management for research sites is one of the most time-consuming and complicated aspects of the clinical research process. Learn several effective strategies for negotiating competitive budgets and contracts for a variety of different types of clinical studies. Speakers will delve into several different hurdles that sites of various setups must overcome, including unfair payment terms, coverage analysis, and claims review, among others. Explore different methods of receivable management, including how to know when renegotiating a budget or contract is possible. This session is a two-part "master series" program.

Learning Objectives:

• Effectively negotiate the most competitive study budgets and contracts
• Strategies to best manage your study receivables and know when renegotiation is appropriate
• How to conduct full coverage analysis and claims review

Learn how to effectively gain support for moving clinical research from "just a small department" to part of the broader organizational culture. Hear proven techniques for gaining buy-in for a strategic plan and ongoing engagement, including group leadership, SWOT analysis, mission and vision development, and establishment of a research advisory board. Leave with proven strategies for gaining recognition for the program and establishing yourself as a peer among business leaders within your organization.

Learning Objectives:

• Improve communication with organizational leadership through appropriate messaging and language
• Lead a group through a SWOT analysis (strengths, weaknesses, opportunities and threats) to create a viable mission and vision for research
• Create a research advisory board

Improve your understanding of adverse events (AEs) by working step-by-step through the definitions of the different types of AEs and reviewing the recording and reporting requirements of each. The speaker will provide a detailed review of AEs and requirements for assessment, documentation, recording, and reporting. Leave confident in your ability to effectively monitor AEs and ensure patient safety and data integrity.

Learning Objectives:

• Participants will be able to describe a decision-making framework that will facilitate correct adverse event recording and reporting
• Participants will be able to describe Investigator, Clinical Research Coordinator (CRC) and Sponsor responsibilities with regards to identifying, documenting and reporting AEs
• Participants will be able to discuss how the Common Terminology Criteria for Adverse Events (CTCAE) is used for assessing AEs

Learn about the role of the Lead Monitor and take away tools and tricks for meeting the expected responsibilities and deliverables. Speakers will examine the characteristics, background, and experiences required of a Lead Monitor based on survey results from decision makers in the industry. Take away a solid understanding of the importance of building relationships with monitors and the study team, and of the importance of the Lead Monitor as a liaison between various functions.

Learning Objectives:

• Participants will be able to know what characteristics makes a good lead monitor. What is senior management looking for in a monitor to take on the role of a lead monitor. Participants will learn tips on how to grow into the role of a lead monitor
• Participants will become familiar with what are the responsibilities of a lead monitor. What are your deliverables
• Participants will learn tips and techniques on how to build relationships with monitors, the study team and senior management. Speakers will share tips on creating tools on how to communicate the effectiveness of the monitoring function and how deliverables were met to the study team and senior management

Learn how to take a strategic approach to digital communications - underpinned by a metrics model - by hearing lessons learned from those managing the website and social media channels for PCORnet, the National Patient-Centered Clinical Research Network. Speakers will explore the cyclical process of data-driven communication from development through analysis, recommendations, and improvements. Explore opportunities to leverage social media channels in clinical research and hear best practices and case studies. Leave with an greater understanding of audience segmentation and engagement, and how a metrics model can be used to measure digital channel performance and inform website and social media strategy.

• Understand the purpose and benefits of data-driven communications
• Learn how to develop a digital channel metrics model to assess performance and track user engagement and interaction
• Gather recommendations to inform decision-making about the future direction of your organization’s/study’s/research program’s digital channels

Hear a firsthand account of sponsor and site perspectives on managing and conducting a large, multicenter medical device trial involving a large network of satellite sites. Presenters will discuss the emergence of satellite sites in the current climate of hospital mergers with healthcare networks and/or clinics merging under a single healthcare entity. Leave with a clear understanding of what a satellite site is, the ability to evaluate whether a satellite site is suitable for clinical trial conduct, and the knowledge to apply this information to current practices.

Learning Objectives:

• Identify satellites sites - early detection is key but identification can occur at all stages of a clinical trial
• Implement best practices: e.g. Early detection; Discussions at interest visits, site qualification visits and site initiation visits; Ongoing evaluation during study conduct; IRB oversight (Local and/or Centralized)
• Apply appropriate study conduction: e.g. Subject enrollment and tracking; Subject follow ups and assessments; Investigational device management; Housing and maintenance of study documents; Study staff at satellite locations; Monitoring, PI oversight and Safety reporting management among other topics

Join FDA personnel from the Center for Drug Evaluation and Research as they discuss key opportunities for the clinical research industry to make their FDA inspection experience a positive one. The speaker will outline recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.

Learning Objectives:

• Identify recent trends in CDER-BIMO inspections of clinical investigators, sponsors, and IRBs
• Describe key strategies for building quality into clinical trials
• Describe key strategies for responding to FORM FDA 483s and Warning Letters