Looking to become a clinical research associate (CRA)? Are you a current CRA wondering how the position is rapidly changing and how you can stay current? This session is for you. The speaker will give real-world perspective on how industry is changing, what it means to someone trying to break in, and what it all means for long-time CRAs. Learn about risk-based monitoring, eConsent, exciting new apps, developing technology, and how studies are changing in the way they monitor and look at data.

Learning Objectives:

• Learn about the CRA role and the skills required to be a CRA
• Learn about topics driving change for CRAs such as Risk Based Monitoring, Centralized Monitoring, increased use of technology
• Learn about how the design of studies is changing, and how this affects the CRA position

New research from the Clinical Trials Transformation Initiative may help investigative sites prepare for the potentially disruptive shift toward greater use of mobile technology to capture objective patient data in clinical research studies. Presenters will summarize key findings from a series of in-depth interviews with investigators who have conducted both traditional clinical trials and studies using mobile technology, providing insights on the advantages and disadvantages to be aware of when running a trial with mobile technology, budgetary and training needs, and other important factors for investigative site personnel to consider. Explore findings from an initial online survey of potential research participants on the use of mobile technology in clinical research, and learn potential implications for clinical research sites.

Learning Objectives:

• Understand investigator perspectives on the advantages and disadvantages of clinical trials that use mobile technology for collection of research data
• Discuss site-level budgetary, training, and other support needs necessary to adequately prepare for and implement clinical research studies using mobile technology, as identified by investigators who have conducted such studies
• Identify potential impacts of mobile technology on participant experiences in clinical trials

Review new laws and regulations passed (or pending passage) within the previous 12 months that are generally not intended to directly govern the clinical research industry but certainly will have direct or indirect impacts and intended or unintended consequences. The speaker will lead an engaging and lively discussion of the regulatory year in review at this always-popular and provocative session.

Learning Objectives:

• Recall the relevant portions of the varying laws and regulations discussed.
• Analyze the potential impact that the laws and regulations bring to the research industry.
• Interpret how the laws and accompanying regulations affect them.

Unlike clinical studies conducted by industry in which companies provide monitors to help verify data quality, studies conducted in academia often lack such oversight. These investigator-initiated studies would benefit from internal monitoring by, for example, a group of research personnel who might monitor each other’s trials. While all research professionals are frequently training on Good Clinical Practice, the tactical instructions on how to achieve positive outcomes - including approaches to proper monitoring - are lacking. Learn about a novel learning module developed and launched to address this need and an applied framework based on applied science to maximize its effectiveness. The speaker will discuss reasons and methods for developing this initiative, as well as implementation strategies, tools utilized to assess successful implementation, and findings.

Learning Objectives:

• Understand the necessity for quality initiatives in investigator-initiated clinical trials
• Understand how an implementation science framework can be used to improve the effectiveness of training initiatives
• Understand metrics used to determine the success of the training initiative and the resulting findings

Many clinical research sites are operated in organizations that are not otherwise focused on research. At times, such sites might encounter problems that threaten patient safety, study integrity, and the future of their engaging in research. Poorly performing sites can experience poor investigator and participant satisfaction, negative net revenue, and meager quality. A poorly performing site is also at enhanced risk for termination by the parent organization during cost reductions. Drastic actions could be needed to recover the capability of these sites to perform quality research. Come explore how sites might find themselves in such a circumstance, ways to identify what is and is not working, taking corrective actions, and solidifying those actions into a research program focused on quality.

Learning Objectives:

• Assess strengths and weaknesses of a clinical research site
• Implement corrective actions for site recovery
• Advance a clinical research program emphasizing quality

Gain the tools and knowledge needed for an efficient transition from study coordinator to monitor. Speakers will share their personal experiences in making the transition, including successes, lessons learned, and effective methods for getting on the monitor career path. Take away a checklist that you can use during your transition, as well as the ability to determine the right time for your career move, to evaluate your competencies and gaps in preparation, and to address your needs during the onboarding process.

Learning Objectives:

• Identify the why and how of this career change, including the certifications and education desired by sponsors and CROs
• Understand a day in the life of a new CRA, such as travel responsibilities and working remotely
• Recognize the new company expectations as well as your professional development and training needs

While beauty may be in the eye of the beholder, views of CRA competency and proficiency also rest in the eyes of different stakeholders. A hiring manager will naturally have a different perspective than the site staff being monitored. And while the industry struggles with the age-old myth that to be a "good" CRA (or be hired as a CRA) you need to have at least two years of experience as a CRA, the situation is becoming even more complex as the traditional role of the CRA is ever evolving. In this dynamic panel discussion, four industry experts will share their observations on the critical knowledge, skills and abilities essential for a great CRA, how these can be developed and assessed and why it is important to consider a holistic view of CRA performance from different perspectives.

Learning Objectives:

• Describe some key elements that different stakeholders (site, CRO, sponsor) hold most critical for a successful CRA
• List some ways that sponsors and CROs groom and grow CRAs ensure they are competent and successful
• Discuss ways in which the site’s view of CRA performance can be a valuable way to enhance the quality of the CRA workforce

Get the tools you need to reap the benefits of an electronic medical records (EMR) / clinical trial management system (CTMS) integration. Speakers representing Cerner PowerTrials, IBM CTMS for Sites, and a research site will break down the value of components of EMR/CTMS integrations and discuss how these interfaces can be implemented. Leave with a strong understanding of the considerations and configurations that need to be made for a successful EMR/CTMS integration.

Learning Objectives:

• Understand the value and the components of an interface between Electronic Medical Record (EMR) and Clinical Trial Management System (CTMS)
• Understand how interfaces between EMR and CTMS systems can be implemented at research sites
• Understand considerations and configurations required to successfully implement an interface between an EMR and CTMS

With the proliferation of electronic regulatory document management systems in clinical research, investigative sites are at risk of compliance findings if they do not have strategies in place to ensure sites comply with 21 CFR 11 regulations. Learn the various aspects and best practice for helping sites build an appropriate risk based approach to Part 11 compliance for their electronic records. Speakers will explore tools to help sites understand their commitments and document their compliance with the appropriate regulation.

Learning Objectives:

• Understand FDA expectations for investigative sites under Part 11
• Review implications of draft guidance identify best practices for building a risk-based approach to Part 11 compliance
• Active programs and systems to maintain Part 11 inspection readiness

We are all used to hearing that the demand for quality investigative sites is outpacing the growth of sites to support the clinical research needs of the industry. And, we all know the various methods that have been tried and tested over the years with SMO and site network models which, depending on your perspectives have been more or less successful. What’s different now is that we have new technologies that open up a whole new range of possibilities to creating site models that are more sustainable and provide more patients with the opportunity to participate. In this interactive panel discussion, our industry experts will share more about their visions as well as the practical realities and progress reports for what the site of the future looks like and how this is changing the clinical research site landscape.

Learning Objectives:

• Discuss the need to think more creatively about what it means to be a research site
• Describe different site models that are evolving to meet the growing demand for quality research sites
• List some operational, ethical and regulatory considerations and concerns that must be addressed to realize the vision of different site models in the future