The Association of Clinical Research Professionals

Virtual ACRP 2020, Part I – Full Program Replay

This package is a replay of the ACRP 2020 Virtual, Part I Program.  It includes the following sessions:

  • Knock, Knock…FDA is Here AGAIN; Be Prepared for a Regulatory Inspection

What do you do when a regulatory agency knocks on the door? Turn off the lights? Panic? If you’re prepared, it should be an exercise to ensure your systems are working the way you designed them. Examine FDA Inspections and how to prepare for the inevitable knock, discuss available resources, and review responses received from 483s. Speaker: Eric Pittman, Program Division Director, FDA, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs

  • FDA/ORA BIMO: Continuing Education and New Industry Metrics

Learn about the FDA BIMO Curriculum Committee and training initiatives, as well as existing BIMO industry metrics shared by FDA. Speaker: Eric Pittman, Program Division Director, FDA, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs

  • The FDA’s CPGM BIMO: What You Need to Know As A Clinical Research Professional

The FDA uses the Compliance Program Guidance Manuals (CPGM) to direct its field personnel on the conduct of inspectional and investigational activities. The CPGM’s form the basis of FDA’s Bioresearch Monitoring Program. The purpose of each program is to ensure the protection of research subjects and the integrity of data submitted to the agency in support of a marketing application. In this session two of the CPGM BIMO documents will be discussed and address why every research professional should be familiar with the following documents: CPGM for Clinical Investigators; CPGM for Sponsors, Contract Research Organizations, and Monitors. Speaker: Elizabeth “Beth” Nelson, MPH, President and Senior Consultant, Regulatory Risk Management

  • CDER BIMO Compliance and Enforcement – What You Need to Know!

Explore key opportunities for the clinical research industry to make the FDA inspection experience a positive one.  Hear inspections’ impact on applications 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. Speaker: David Burrow, Pharm.D., J.D. Director, Office of Scientific Investigations, Office of Compliance Center for Drug Evaluation and Research, FDA

  • Assessing Today’s Drug Development Operating Environment: Time to Hit the Reset Button?

This session examines major trends impacting the operating environment for new drug development including evolving pipelines, players and executional models.  The session will also explore the anticipated long term effects of global change and response to the coronavirus pandemic. Note: Contact hours are not provided for this session.  Speaker:  Kenneth A. Getz, Deputy Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine; Founder and Board Chair, CISCRP

  • Using SaaS (Software as a Solution) Methods in Research Operations Systems Implementation

At Dartmouth-Hitchcock Health we have worked to integrate technology and systems across research operations across multiple states and regional of our health system utilizing change management strategies and techniques for innovation implementation. We have implemented multiple systems for integration and interoperability. Systems within grants and contracts, HRPP, finance, human resources and our new CTMS. We have the utilized the SaaS (Software as a Solution) model very successfully and have gained substantial agility with very little customization required and out of the box and cloud based support. We have seen outcome measures that have reduced activation time by 39 days in one year, increased our grant portfolio and have seen our trial enrollments increase. Speaker: Leigh Burgess, MHA, MEd, MA, Vice President Research Operations, Dartmouth-Hitchcock Health

  • Intersection of AI, Patient-Centricity and Ethical Considerations

The core competency challenges addressed here are leadership and ethical and safety considerations when using AI technology in clinical research. Our organization is part of a statewide Clinical and Translational Science Alliance (CTSA network). We review and collaborate on research trials with four major academic institutions, several independent healthcare systems and multiple academic-health systems inside/outside of Georgia. As part of the research knowledge and support (RKS) team we interface regularly regarding research ethics. A growing emphasis is harnessing AI potential while continuing to protect patient’s data and rights. To do this we need a diverse research team, versed in research competencies, technology, leadership, ethics and patient safety. We will briefly explain AI in a business environment, the progression into healthcare and clinical research with emphasis on continued, safe-ethical research conduct. Speaker: Karen Lindsley, DNP, RN, CCRC, CDE, Manager, Georgia Clinical and Translational Science Alliance (CTSA), Emory University; School of Medicine

  • Digital Twins in Clinical Trials: The Insight, Ethics and Opportunities

Digital twins enable pharma/medical devices companies to run faster, more efficient, and more powerful clinical trials. Get an overview of what digital twins are and how they are shaping clinical trials now and for the future. Speaker: Charles Fisher, PhD, Founder and CEO, Unlearn AI

  • Clinical Trials and the Future of Evidence Generation: CTTI’s Vision for 2030

From real-world data to mobile technologies and beyond, the clinical trials landscape is changing rapidly. Regulators are encouraging the use of innovative methodologies; data and tech companies are providing new platforms and tools; and with increasing access to new data sources, everything from recruitment to endpoints is evolving. In this session led by the multi-stakeholder Clinical Trials Transformation Initiative, join a conversation about the future of evidence generation, and the unique opportunities and challenges of the next ten years. Speakers: Leanne Madre, JD, MHA, Director of Strategy, Clinical Trials Transformation Initiative

  • Implementation of a Feasibility Vetting Committee at the Department Level: Selecting the Right Trials

The field of clinical research is evolving at an exponential pace and sites need to be ready to take on trials they are able to handle, conduct compliantly, and successfully recruit into. At the forefront of any clinical trial is the betterment of the patient by offering life-saving or life-prolonging therapies. In addition to patient impact sites also understand academic impact and aligning projects with their scientific mission and vision. Behind the scenes of any trial is the clinical research operations team who must assess if the project is doable given the time and resources required. This session will look at the employment of a vetting feasibility tool within a formal research committee review process and outline whether or not this tool was predictive of successful participation in clinical trials. Speaker: Alyssa Stucke, Senior Clinical Research Coordinator, MedStar Georgetown Transplant Institute

  • Study Startup Innovation

Study Startup Innovation for any research organization that includes: – Startup models that allow for quick activation upon patient identification – Technology approaches that solve for visibility of the startup process – Best practices that eliminate operational barriers to opening a trial. Speaker: Noelle Gaskill, MBA, ACRP-CP, VP, Research Operations, SignalPath

  • Investigator Site File’s (ISF) – Developing, Implementing, and Maintaining a Site Standard

This presentation includes the importance of quality file management at the site level via Investigator Site File (ISF) standards. The importance of this presentation is to illustrate standardization in large site file management practices as well as assurance for regulatory compliance. The audience will walk away with practical knowledge on the importance of a solid ISF standardization process as well as how to implement into their sites or improve current state of ISF management. The presentation will include a case observation from of a newly implemented ISF process at Children’s Mercy Hospital. Speaker: Trevor Cole, BHS, MBA-HCM, CCRC, Research Quality Monitoring Program Manager, Children’s Mercy Hospital

  • Leveraging Data to Drive Decision Making – Financial Focus

Data is a powerful analytical tool that can be analyzed to drive decision-making and utilized to improve performance. Organizations with clinical research portfolios should leverage data and recognize the importance of harnessing the power of data analytics. These organizations should learn to leverage today’s smart informatic technology and effectively use data analytics to create discovery platforms, which are used to make academic content more readily available through electronic systems so it can be shared with organizations and their collaborating partners. This allows information to become more transparent and, in turn, fosters a culture of innovation. This session will focus on guiding attendees through key data analytics like metrics and key performance indicators and leveraging them at their organizations. Speaker: Mary Veazie, MBA,CPA, CHC, CHRC, Executive Director, Clinical Research Finance, The University of Texas MD Anderson Cancer Center

  • Writing Effective SOPs: A Step-by-Step Informational Session

Writing effective SOPs in the research environment, particularly at the site-level, is critical to compliance, operations, and interacting successfully with research teams and external stakeholders, such as sponsors. This process requires organization, subject matter expertise, and teamwork. Often, operations personnel require an educated starting point for such overwhelming tasks, and this session will provide just that. In addition to a step-by-step analysis of the importance of effective SOPs, the session will address tedious details and global models alike to leave the audience with a toolkit they can easily take home and operationalize at their organization. Speaker: Edye Edens, JD, MA, CIP, CCRP, Senior Research Compliance Consultant, First Class Solutions

  • Do You Have Competency Assessments? Tools for Developing Your Team

Despite great headway in the professionalization of clinical research, for most, entry to the clinical research profession continues to be indirect. In addition to journeying from novice to expert in a variety of clinical research professional roles, one aspect of the job that remains challenging is developing methods to evaluate competence and performance by staff and to evaluate programs. Often training for this role generally focuses on clinical research operations and leadership, but not necessarily on teaching and evaluation methods for staff development and assessment. We will discuss current issues in assessment and evaluations in the clinical research enterprise. We will also describe a clinical research manager persona to identify assessment skills needs. Finally, we will present a step-wise approach and specific tips for assessment development and evaluation. Speaker: Carolynn Jones, DNP, MSPH, RN, FAAN, Associate Professor- Clinical, The Ohio State University

  • How to (Better) Attract and Retain Talent

Many key industry verticals rely on a steady supply of qualified clinical and scientific professionals to remain competitive, including the pharmaceutical and biotechnology sectors. We take a new perspective on this talent segment to get inside the mind of those key candidates, and help our audience to find and retain them more effectively. Many candidates lack practical work experience and contingent staffing providers help to bridge that gap. Attendees will discover the latest trends, changes, issues and will gain a new, candidate-focused perspective on life sciences talent. We’ll cover nine distinctive talent segments with very clear goals and motivations, identifying: What talent do you need? What do they want? And how can you connect with them in a smarter way? Speaker: Brad Sibbald, National Director of Sales, Kelly Science and Clinical

  • The Two Most Important R’s in Research: Recruitment and Retention from a Site’s Perspective

The recruitment and retention of study participants is central to a successful clinical trial. Yet these basic requirements remain challenges within and across study sites. Unmet goals increase costs, deplete resources, and prolong the time to market. Lost to follow up subjects compromise the power of results and can result in missed signals. Why is this central element also one of the most difficult to execute? There are numerous challenges to recruiting patients to and keeping them in trials. While sites might not have much control over many of these, we certainly do when it comes to the tools used to recruit and engage patients at the local and site level. Takeaways: Techniques for improved enrollment planning, ideas and tools for more effective patient recruitment tactics, and strategies for retention. Speaker: Gwen Jacobs, CCRC, MS, RN, Senior Clinical Research Nurse, Uptown Research Institute

  • Risk Management in Clinical Trials Project

Risk management is an ongoing process that continues through the life of a project. It includes processes for risk management planning, identification, analysis, monitoring, and control. Many of these processes are updated throughout the project lifecycle as new risks can be identified at any time. It’s the objective of risk management to decrease the probability and impact of events adverse to the project. On the other hand, any event that could have a positive impact should be exploited. Speaker: Walaaeldin Ahmed, PMP, PBA-PMI, RMP-PMI, BCMAS, CCPM, CM, APDPHR, Managing Director, KAUMED Clinical Research Organization

  • Using Data Analytics in Quality Processes

Clinical Quality Assurance can benefit from the use of advanced analytics. These can enable faster and holistic detection of quality issues through the use of descriptive and predictive analytics, ensure efficient use of QA resources, and aid resolution of quality issues. Learn applications of analytics in quality processes, including an overview of data analytics concepts, basic data analytics techniques, how to develop simple analytics using common software, such as EXCEL. Gain insight into how analytics may be applied throughout the development lifecycle of a molecule and learn how analytics may be used in the planning and conduct of audits. Speaker: Richard Bowling, Team Lead, Quality Data Operations, Genentech

  • Safety Reporting Reference Model: Optimizing

Driven by ethical obligations to protect patients and pressure to conduct trials more cost effectively, while also adhering to regulatory requirements, pharmaceutical companies and CROs are using more innovative approaches to distribute safety reports to investigators, ethics committees and regulatory authorities worldwide. In this presentation, we will describe a process by which a sponsor or CRO can examine their global safety distribution and move towards a harmonized business model with the right safety information being distributed to the right person at the right time using the latest rules-based, workflow technologies. We will suggest an operational model that enables safety distribution and receipt to be performed more efficiently at Sponsor, CRO, Site, and Ethics Committees. Speaker: Steven Beales, SVP, Scientific and Regulatory, WCG

  • ‘Could You Repeat That?’ Effective Communication in an Age of Distraction

We think communication should be easy, but we perpetually find that it isn’t. We think we’ve done it well, only to find misunderstandings and misinformation abound and we ask, “why is this so hard?” The risks of miscommunication range from frustration and team conflict, to expensive delays and rework, to threats to scientific integrity and even patient safety. Effective communication is a journey without a destination – we can always make progress and improve, but we never fully arrive. For that reason, it is worth regularly visiting this topic and asking how we can do it better, both individually and corporately. In this session, we will explore common communication challenges and then supply practical steps to develop and deliver more effective communications at the interpersonal and organizational level. Speaker: Ryan Bailey, MA, Senior Learning & Performance Specialist II, Rho

  • We’re All in This Together – Communications Strategies for Getting What You Need

Interpersonal communication is more important than ever, and is critical to getting what we need from others to do our job. There are more and more ways to communicate, but with these come new barriers to effective communication. This course will help identify and overcome common communication barriers, develop good communication practices, and provide do’s and don’ts for effective communication. Real-life examples will be used to demonstrate communication techniques for difficult situations and removing communication barriers. Building good relationships is the key to influencing others – you don’t have to be the boss to get what you need! This course will provide strategies that can be implemented immediately to get what you need from others. Speaker: Suzanne Kincaid, CCRA, ACRP-PM, COO, Aperio Clinical Outcomes

  • Research is as Research Does: Does Drug or Device Experience Really Matter?

This session will explore the difficulty clinical research professionals face when either presented with an opportunity to cross over from drug to device studies and vice versa, or a sponsor takes the leap of faith and hires a professional to a device (or drug) company when they have several years of drug (or device) experience and no years of device (or drug) experience. As a result of this continued practice, we are creating unnecessary barriers to grow our teams and our careers. The regulations may be different, but our skill sets and strengths are all the same. Speaker: Lisa Haney, BS, CCRC, Director of Research, Nura Research Institute

  • Competencies: The Foundation for Everything

Competency is more than a buzzword. Understand how effective implementation of competency standards can improve workforce development initiatives, drive research quality, and improve internal audit outcomes. Speaker: Bree Burks, RN, MSN, Vice President of Strategy, Site Solutions, Veeva Systems

Purchase Full Program Replay

This program is a compilation of recorded sessions from Virtual ACRP 2020, Part I.