Webinar Replay—Communication Strategies for Conflict Resolution in Clinical Research Teams

Replay expires August 25, 2024 — Join us to examine how specific communication behaviors can foster effective conflict resolution that facilitates team growth.

Webinar Replay—Career Paths in Clinical Research: Sharing the Journey and Providing Insight

Replay expires August 18, 2024 — Join our panel of clinical research professionals as they discuss their career paths into and through the clinical research industry, how they see the future of their roles, and what advice they would give to those wanting to join the industry.

techXpo—Research Ready: Leveraging Technology in the New Research Landscape

September 30, 2021, 1:30-2:30 PM ET — Join Advarra to learn how implementing eRegulatory & eConsent systems can improve compliance and productivity, and reduce cost.

Webinar—Best Practices for Communicating Benefit, Risk and Uncertainty in Medical Device Clinical Trials

October 6, 2021, 12:00-1:00 PM ET — Join us to learn the evidence-based practices for communicating the benefits, risks, and uncertainty regarding medical technology to patients and providers.

Webinar Replay—Let’s Talk Patient Recruitment: Strategies, Tools, Communication

Replay expires July 14, 2024 — Join ACRP Editor-in-Chief, Michael Causey, as he reviews two recruitment strategies with our guests that have helped increase efficiencies and increase patient recruitment into trials.

Webinar—2021 ACRP/Academy Annual Membership Meeting

October 20, 2021, 12:00-1:00 PM ET — Join ACRP/Academy leadership to explore highlights of ACRP’s year, learn what’s planned for 2022, and participate in a live Q&A session.

Webinar Replay—Clinical Trial Diversity: Strategies to Support Patients, Sites, and Sponsors

Join executives from Merck Research Laboratories to explore practical strategies for engaging and enrolling diverse patients in clinical trials.

• Entry Level, Intermediate

ACRP Certification Exam Live Study Session

Prepare for your upcoming ACRP Certification exam with a two-hour, live study session hosted by an ACRP Certified instruction. The study session will cover the Detailed Content Outlines for the exams as well as content from the ICH Guidelines and the Declaration of Helsinki. A question and answer session with the instructor will be included.

Webinar Replay—Monitoring Investigator-Initiated Trials

Explore the processes and procedures needed to design and implement a monitoring program for investigator-initiated research studies, with a specific focus on sponsor-investigator studies that involve an Investigational New Drug or Investigational Device Exemption.

Webinar Replay—Improving Technology Proficiency in Clinical Research

Join Veeva Systems to explore what a competency-based approach to technology looks like in clinical research.

techXpo Replay—How to Build Advanced Workflows with an Integrated Technology Environment

Join Florence Healthcare to learn how to harness the power of best-in-class software while avoiding digital fatigue, duplication, and wasted time.

techXpo Replay—Quality Improvements as a Result of Paperless Site-Based Systems

Join RealTime CTMS to examine how paperless sites and site networks are driving quality and improved timelines for the clinical research industry.

techXpo Replay—Exit the Feature Battle: How to Think Long Term and Prepare Your Site for the Future of Technology in Clinical Research

Join Veeva Systems to explore the key qualities and features sites need to look for in their technology partners to increase their connectivity with sponsors and patients.

Webinar Replay—Research and Expanded Access in Pandemic Times

Explore the mechanisms allowing experimental COVID-19 therapies and diagnostics to patients and how that has affected researchers’ ability to generate substantial evidence of product effectiveness.

Good Clinical Practice (GCP) Simulation

The New Standard in GCP Training. Now Free with ACRP Membership! This interactive simulation-powered training course helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).

techXpo Replay—COVID Catch 22 – Don’t Get Burned Out by Dependency on Technology

Ready to simplify your technology footprint for 2021? Join Exostar to explore how to streamline technology access and create a better user experience.

techXpo Replay—eSource: Why This is the Platform of the Future

Join experts from Clinical Research IO to explore how several independent trends in research will make eSource a platform technology for sites.

techXpo Replay—The Impact of Brexit and COVID-19 on Clinical Research Data Processing in the EU/UK

Join The DPO Centre for this exploration of data protection challenges relating to the handling of sensitive personal data of EU and UK trial participants and how COVID-19 has bought data protection to the forefront of people’s minds.

Webinar Replay—Session I: Continuing Organizational SOP Needs to Maintain Compliance

Join us for part one of the Webinar series ‘Adaptive Operational Optimization through Transformative SOPs’ and learn to transform operational effectiveness by drafting your clinical research SOPs to be specific, meaningful, and productive for your unique organization.

Webinar Replay—Session II: Transforming SOP Infrastructure for COVID Times

Join us for part two of the Webinar series ‘Adaptive Operational Optimization through Transformative SOPs’ and explore the stages of the SOP life cycle beyond merely drafting to include training and enforcement as well.

Virtual ACRP 2020, Part II – Workforce Development – (Part 2) Track Replay

Workforce development takes center stage at Virtual ACRP 2020, Part II. With so much great insight and intelligence, we’re offering this track in two parts!

Virtual ACRP 2020, Part II – Workforce Development – (Part 1) Track Replay

Examine ways to build a vibrant, diverse workforce, improve competent communication in clinical research teams, establish training pathways, and much more.

Virtual ACRP 2020, Part II – Study Management & Conduct (Part 2) Track Replay

Get the insight, practical tips, and best practices needed to improve every facet of clinical trial operations. Don’t miss the expert advice and candid discussion on creative recruiting, ethical issues, and more.

Virtual ACRP 2020, Part II – Study Management & Conduct (Part 1) Track Replay

Tackle the biggest challenges facing clinical researchers at the Virtual ACRP 2020, Part II Study Management and Conduct Track.

Virtual ACRP 2020, Part II – Technology & Future Trends Track Replay

Explore how emerging technology and developing trends are impacting your operations. From remote trial innovation prompted by a pandemic, to the impact of emerging tech on the clinical research workforce, get the expert insight you need to prepare for the future and thrive in the rapidly-changing world of clinical research.

Virtual ACRP 2020, Part II – Leadership & Career Growth Track Replay

Get expert insight into advancing the clinical trial workforce, competency-based training, leadership skills and more.

Virtual ACRP 2020, Part II – Full Program Replay

Experience 24 expert-led sessions across six educational tracks exploring late-breaking trends and developments in conducting clinical research.

Virtual ACRP 2020, Part I – Workforce Development Track Replay

Examine ways to build a vibrant, diverse workforce, and how we can get on the same page and improve relationships, communications, and expectations with the Workforce Development Track, part of Virtual ACRP 2020, Part I.

Virtual ACRP 2020, Part I – Leadership & Career Growth Track Replay

Make this the year you develop your leadership skills and give your career a boost! The Virtual ACRP 2020 Leadership and Career Growth Track will deliver the tools, inspiration, and expert advice you need to get ahead.

Virtual ACRP 2020, Part I – Study Management & Conduct (Part 2) Track Replay

Tackle the biggest challenges facing clinical researchers at the Virtual ACRP 2020 Study Management and Conduct Track. We’ve lined up so much content with insight, practical tips, and best practices, we’re offering this track in two parts!

Virtual ACRP 2020, Part I – Study Management & Conduct (Part 1) Track Replay

Tackle the biggest challenges facing clinical researchers at the Virtual ACRP 2020 Study Management and Conduct Track. We’ve lined up so much content with insight, practical tips, and best practices, we’re offering this track in two parts!

Virtual ACRP 2020, Part I – Technology & Future Trends Track Replay

Explore how emerging technology and developing trends are impacting your operations. From AI to SaaS (Software as a Service), Digital Twins and more, get the expert insight you need to prepare for the future and thrive in the rapidly-changing world of clinical research.

Virtual ACRP 2020, Part I – Regulatory Trends & Compliance Track Replay

Get expert insight into enforcement trends, compliance tips, and more from regulatory and compliance specialists — including three speakers from the U.S. Food and Drug Administration.

Virtual ACRP 2020, Part I – Full Program Replay

Learn best practices to improve clinical trial operations at the premier education and networking event for clinical research professionals.

Webinar Replay—ACRP/Academy Annual Membership Meeting

Join ACRP/Academy leadership to explore highlights of ACRP’s year, COVID-19’s impact on the association, and what’s planned for 2021. Speakers will also deliver an update on ACRP/Academy finances and attendees will be able to submit questions to ACRP/Academy leadership for a Q&A session.

Webinar Replay—ACRP/SCRS SARS-Cov-2, the Law and You

This ACRP / SCRS webinar replay discussed how COVID-19 laws and regulations affect small clinical research sites.

Webinar Replay—COVID-19 Technology Mad-Dash, What Worked and What Didn’t?

This Webinar will address the challenge of transforming clinical research operations with technology built from the rapid transformation clinical research sites had to undergo in light of COVID-19 disruptions.

Webinar Replay—Merck Journeys: Opportunities to Invent for Life – Clinical Trial Operations

Explore how a career with Merck within our Global Clinical Trials Operations team will allow you to Invent, Impact, and Inspire.

Webinar Replay—Innovative Approach of Using EHR Data to Improve the Speed, Efficiency, Quality and Costs of Conducting Clinical Trials

Learn how a research site’s electronic health record (EHR) data can be used to precisely identify potential subjects from their patient population, reducing the recruitment and screening effort and accelerating the time to completion of enrollment.

Webinar Replay—Practical Tips for Career Development

Learn to build a successful career for yourself all while developing a strong team, by understanding different personality types and how to communicate with them.

Webinar Replay—Building Relationships With Healthcare Professionals and Community Groups to Increase Enrollment

Join us as we explore best practices for building and maintaining relationships with healthcare professionals and community groups in order to increase study enrollment, especially among diverse populations.

Webinar Replay—Fresh Ideas in Workforce Innovation

Learn some of the most innovative ways organizations are approaching workforce development—and how you can put them to work for you.

techXpo Replay—GDPR for Clinical Research Professionals: Handling EU and UK Medical Data in a Post Brexit World

Join The DPO Centre to explore data protection challenges and solutions when handling the sensitive personal data of EU and UK trial participants.

techXpo Replay—Increase Efficiency and Accelerate Trial Timelines with eISF and SSO, presented by Exostar & Cognizant SIP

Join Exostar and Cognizant for an informative session on improving trial efficiency through SSO and eISF.

techXpo Replay—Going Digital: How Sites are Moving Research Forward During a Pandemic

Join Veeva Systems to learn how COVID-19 has resulted in greater need to keep existing clinical trials on track by enabling digital processes and remote access for study monitors.

techXpo Replay—Knowing is Half the Battle: How Site Performance Reports Can Optimize Clinical Trial Outcomes and Strengthen Partnerships

Join Merck & Co. for a session examining the benefits of site performance reports from the perspective of both a Sponsor/CRO and a site.

Webinar Replay—Diversity of Research Personnel: Knowing Who We Are to Know Who We Serve

Evaluating recruitment efforts to increase diversity among subjects to make research findings more generalizable and applicable to all populations.

techXpo Replay—Dismantling the Status Quo of Monitoring: Moving Towards a Technology-Enabled Approach to Trial Oversight

Join Remarque for a session discussing leveraging technology to allow for more efficient monitoring.

techXpo Replay—Disrupting the Clinical Research Market: Leveraging Innovative Approaches and Technologies from Other Industries

Join Schlesinger Clinical Research as they share best practices that will improve your studies.

Virtual Replay: ACRP – Avoca Quality Congress: Adding Electricity to Patient Centricity: Energizing Solutions

Join leaders from sites, sponsors, CROS and tech providers in exploring how to strategically align stakeholders in the use of patient-centric tools and technology, and develop action plans for ensuring appropriate implementation of specially-developed patient centricity tools.

techXpo Replay: Virtual Site Monitoring: The Evolution of Remote Site Monitoring

Join VirTrial and Florence Healthcare for a session discussing the current and future state of clinical trial monitoring.

techXpo Replay: A Two-Step Approach to Improving Patient Recruitment

Join Ripple Science for an informative session centered around the effectiveness of centralized recruiting models against standardized models.

Webinar Replay: Investigator Initiated Trial (IIT) Database Integrity

Join us for the second part of our presentation on building databases for an Investigator Initiated Trial (IIT).

Webinar Replay: Investigator Initiated Trial (IIT) Database Design and Build

Join us for the first session in a two-part session to learn how to turn your protocol into a fully functional database, translate study objectives into data points that make it easier to manage and analyze your data, and clean and monitor data points throughout the course of the study.

Entry-Level Training Package

Getting the necessary educational background is a critical step on the pathway to a successful career in clinical research. If you are serious about a career in clinical research, this training package is a must.

Webinar Replay: Strategic Planning and Creating a Roadmap for the Changing Site Landscape

This webinar will discuss the key components of creating a strategic plan; how to implement it and when and how to pivot to achieve sustainability in the competitive environment of clinical research.

Webinar Replay: Recharging the Site Business for the Future

This webinar will cover the potential evolution of the traditional site business model in how home health, telemedicine, traditional business practices, and patient visits will adapt and change.

Informed Consent Simulation

This interactive, simulation-powered training program helps ensure informed consent is obtained by the right subject, with the right forms, by the right people, through the right process, at the right time, and with the right documentation.

Webinar Replay: Strategic Planning and Operational Efficiency: There’s a Difference But It Seems We’re Losing Sight of That

Learn strategies to ensure your company’s long term survival and growth in our industry’s competitive environment.

Virtual Leadership Workshop Replay—Virtually Perfect Leadership: Thriving in the New Normal

Join us for a three-part, live, online workshop series providing tools that will empower you to present a Virtually Perfect Presence, become a Virtually Perfect Communicator, and manage a Virtually Perfect Team in the new normal of conducting business during and after the COVID-19 pandemic.

Webinar Replay: ACRP Certification: Why, What, and How Should You Prepare

This webinar will walk through some of the benefits of certification, eligibility requirements and resources available for exam preparation.

Webinar Replay: R3: Research Recovery & Ramp-Up

Explore the considerations, processes, and procedures for research recovery and ramp-up related to COVID-19 and the impact it has had on research operation and administration.

techXpo Replay—Is Your Site Ready for the “New Normal”? One Site’s Journey to Implementing New Technology for Remote Work and Increased Efficiency

Join Clinical.ly for an informative session centered around the COVID-19 paradigm shift as clinical research sites turn towards new technology to enhance their operations.

techXpo Replay—Partnering with Sponsors to Solve the Enrollment Problem

In this session, you will learn exactly how sponsors can operationalize strong partnerships with their sites and eliminate the traditional site/sponsor communication burden that plagues both sides.

techXpo Replay—The Future of Clinical Research Work Post COVID-19: How to Adapt Your Workforce in a Changing Environment

The effects of COVID-19 have impacted many life sciences companies, causing disruption to clinical research work. Join us to gain expert recommendations on creating a staffing strategy that gets business moving forward again and puts employees back to work.

techXpo Replay—Navigating Your Clinical Trial During COVID-19

Join VirTrial and learn how to navigate the frequently changing guidelines set by the FDA and other regulatory authorities, ways in which technology can support your clinical trials, and how to take advantage of home health and other direct to patient services during these challenging times.

techXpo Replay—Paperless Systems and Remote Monitoring: Keeping Trials Moving through COVID-19 and Beyond

This session will provide insights into how sites, sponsors, and CROs are rapidly adopting online systems to maintain an efficient and compliant process for data monitoring.

techXpo Replay—Remote Monitoring: Connecting Sites, Sponsors, and CROs to Drive Quality

Join this event to discover how Veeva is putting sites, sponsors, and CROs in a dramatically stronger position to respond to this crisis and improve clinical trials in the long term.

Webinar Replay: Creating a Diverse and Sustainable Clinical Research Workforce: Expert Insights and Industry Initiatives

This panel discussion, featuring ACRP’s Partners in Workforce Advancement (PWA) Executive Steering Council members will provide insights from leading experts on how to create a diverse and sustainable clinical research workforce.

techXpo Replay—Managing a Remote Workforce: Tips & Tricks During COVID-19

Join us for an informative session where we will discuss strategies to better manage your remote teams, while helping ensure efficient and effective clinical trial operations. We will share best practices on how to collaborate and implement new remote processes utilizing electronic resources from start-up to closeout.

techXpo Replay—Complion eRegulatory: Your Partner in Success

In this session, you will learn how partnering with Complion provides the top of the line technological tools and one-on-one advisory services you need to succeed. 

techXpo Replay—Remote Monitoring 101: Learn How Research Sites Are Turning on Remote Monitoring Today and Get a Glimpse of the Future

Learn how leading research centers are enabling remote monitoring for their studies today, and how you can get set up in three weeks or less for regulatory and source remote monitoring and remote access.

Entry-Level Knowledge Assessment

Whether you’re an emerging professional looking to demonstrate your foundational knowledge to prospective employers or an organizational leader looking for an efficient, effective way to vet new hires, ACRP’s new Entry-Level Knowledge Assessment (ELKA) is for you.

Webinar Replay: Impact of COVID-19 Pandemic in Clinical Trials: Considerations and Tools

Join us to review how clinical trial implementation is changing for research that was ongoing before the COVID-19 pandemic, and how sites and sponsors must prepare to face these challenging times.

Webinar Replay: FAQs for Sites During COVID-19

Join us for an FAQ session on how sites can ensure compliance through COVID-19 led by David Vulcano, Vice President, Research Compliance & Integrity for HCA Healthcare.

Webinar Replay: Part 2: iRECIST Workshop

iRECIST guidelines have been developed to capture this new response pattern. This presentation, Part 2 of the series, will consist of a workshop using hypothetical cases to determine iRECIST responses.

Webinar Replay: Harnessing the Power of Digital and Social Media to Drive Patient Recruitment

Learn about current trends in online marketing that can impact the ROI from your campaigns. Obtain a better understanding of the requirements needed to maximize your campaigns effectiveness.

Webinar Replay: Blueprint for Effective Communication & Best Practices Towards Clinical Trial Success: A Project Manager’s Guide

Managing a clinical trial requires deep understanding, a sharp vision, ability to adapt, disciplined effort, and unrelenting focus on achieving project goals. Implementation of best practices and effective communication techniques throughout the life of a study, as presented in this webinar, are key components to the success of your clinical project.

Webinar Replay: It’s in the Science: The Key Components to Building a Clinical Research Team

Join us for an interactive video webinar on the key components of building a clinical research team. Our panel will discuss shared best practices and current processes for building and communicating with dynamic teams including remote workers.

Webinar Replay: Part 1: iRECIST: New Guidelines for Oncology Tumor Assessment

iRECIST guidelines have been developed to capture this new response pattern. This presentation, Part 1 of 2 presentations, will introduce you to the history of the iRECIST guidelines, the iRECIST process and how iRECIST is being used in oncology clinical trials. Part 2 will consist of a workshop using hypothetical cases to determine iRECIST responses.

Webinar Replay: Multi-Center Investigator-Initiated Trial Guidance: The Best Practices of an Actual Multi-Center IIT

This presentation will focus on lessons learned from a recent observational study of 6 clinical research sites over the course of three years.

Webinar Replay: New Laws and Technology Standards That Will Transform Medical Research

New technology, laws, and consumer expectations are driving changes in Health IT that will impact every patient, health care provider, and researcher in the US. To be prepared for this change, it is vitally important to understand what is happening now and what is coming around the corner.

Certified Quality Manager Training

Increase your influence and expand your career opportunities by validating your commitment to quality. The Quality Management Institute and ACRP have partnered in a program of education for individual professionalism and the quality management of clinical research sites.

• CRC, CRN, DMCTO, Investigator, MCRA, PR, PMs, RM, RTA

Webinar Replay: Finding the Right Recruitment Approach: A Discussion of One Organization’s Approach

Join us for a discussion on one of the most difficult tasks within clinical research. ACRP’s Editor-in-Chief, Michael Causey, will chat with Chris Gantz, Senior Director at Sidney Kimmel Cancer Center, about an approach that has been successful for him and his team.

Webinar Replay: Best of ACRP 2019 – Building Relationships & Collaboration: Sponsors and Sites

We invite all CRCs, CRAs, Project Managers, Regulatory Liaisons, and other study personnel to join this webinar for a review of our responsibilities and a discussion of these relationship. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and open forum for discussion provided.

Webinar Replay: Best of ACRP 2019 – EFS is the new OUS strategy for early-phased medical device clinical trials

This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions.

• Entry Level, Intermediate, Senior
• BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer

Risk-Based Monitoring: The Essentials

Become an expert on quality and risk-management strategies and procedures. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?

Webinar Replay: Best of ACRP 2019 – Identifying, Documenting, and Implementing Corrective Action Plans to Improve Site Compliance from a CRO Perspective

This session will provide an overview on how to appropriately identify, document and address compliance issues noted at sites, from monitoring and Sponsor perspectives. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.

Webinar Replay: Best of ACRP 2019 – Inspection Readiness – Beginning with the End in Mind

The key to a successful inspection is preparing at the start of the study. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings

Webinar Replay: Best of ACRP 2019 – Effective Project Management to Streamline your Clinical Trial Workload

Providing clear and effective project management can make a successful clinical trial. Project planning and management are a part of achieving quality clinical data. This session will provide new and current Project Managers with useful tools to streamline their workload and hopefully decrease some of the common stress of the role.

Webinar Replay: Drug Development Process: A Review of ICH E8

Learn to describe internationally accepted principles and practices for the conduct of clinical trials and overall development strategy, facilitate the evaluation and acceptance of international trial data, and present an overview of ICH E8 other ICH guidelines pertinent to clinical trials.

Webinar Replay: Expressing Gratitude & Returning Aggregate Study Results to Participants—It’s the Right Thing to Do!

Thanking and returning results to study participants honors research volunteers, helps build trust in the clinical research process, and is simply the right thing to do! Join us for an engaging discussion on the benefits, methodology, and resources available to develop thank you cards and lay summaries of aggregate results in a language and format that is understandable and easy to read.

Webinar Replay: Best of ACRP 2019 – How to Create a Culture of Quality at a Research Site

Sites are so busy that quality assurance is often overlooked and only becomes a focus when issues arise or when there is an audit. We will describe our experience creating a culture of quality using an integrative approach in a team environment.

Webinar Replay: Identifying, Training and Retaining Investigators

How can we identify investigators, train them and all the while keep them engaged?

Webinar Replay: Defying Clinical Inertia and Improving Workflow with Measurement-Based Care Tool

Join co-Investigators as they share their experiences in conducting a pilot study on the role of Measurement Based Care (MBC) in improving mental health outcomes, its role in defying clinical inertia (the failure to change treatment plans despite the lack of improvement in symptom severity), and significance of a novel technology in the current healthcare system.

Webinar Replay: Establishing a High Quality Human Research Protection Program (HRPP) the AAHRPP Model

This presentation will look at opportunities for flexibility in human research protection programs that can facilitate research, including the notion that the resources devoted to the evaluation and management of research should be calibrated appropriately according to the risks posed by the research. In addition, the presentation will briefly consider some changes to the Common Rule and impacts on HRPPs.

Webinar Replay: A Beginner’s Guide to Implementing Competency Guidelines: Do’s and Don’ts to Set Your Institution Up for Success – Part One

ACRP and Huron Consulting Group joint two-part webinar replay, where we will discuss the theoretical aspects of a competency-based clinical research program, along with tactical considerations for implementation.

• Intermediate

The Impact of Disruptive Change in the Clinical Trials Industry on Research Sites

As we head towards the end of the second decade of the twenty-first century a great deal has changed about the way research is done at the site level particularly as it relates to the many disruptive technology driven changes that have evolved. Or has it? After 13 years managing sites and taking the investigator view followed by 13 years in the CRO industry taking the sponsor view, the author will look at what has changed in over a quarter of century and the future holds for clinical research sites. In particular he will look at the site landscape through the lens of four, supposedly major, disruptive changes.

• Senior

“You Want Me to Do WHAT?”: Building Lasting Sponsor/Site Relationships Part Deux

“Coming together is a beginning. Keeping together is progress. Working together is success.” – Henry Ford. How do you build a solid sponsor-site working relationship from site identification to closeout and beyond? This session was provided at ACRP 2018 and was requested to be brought back as it was a so insightful. The speakers for this session represent the sponsor and site perspective and will engage the attendees with an interactive session designed for all site and sponsor representatives to build on their effective communication strategies.

• Entry Level

Write Like an 8th Grader! Improving Readability in Clinical Research

How do you ensure that your clinical research materials are readable for the audiences you want to reach? This session will help you learn how to measure and improve the readability of your clinical research communications to a participant and public-facing audience. We will discuss the importance of readability and explore the pros and cons of tools you can use. Case examples from the Duke Clinical Research Institute including informed consent forms, recruitment materials, and lay summaries will highlight how to use free and existing resources to improve your communication.

• Intermediate

With Great Power Comes Great Responsibility: What to Consider in Conducting the Physician-Sponsored IDE

Physician-Sponsored IDE (PS-IDE) offers an ability for the physicians to design the study to treat patients with the unapproved medical devices without the industry support or oversight. The unapproved devices may be born out of physician’s innovation (new devices) or innovative practice such as using the commercially available devices for unapproved indication (i.e., off-label use) or customizing/modifying the approved devices (altered device is considered a new device). Although there is a lot of freedom for the physician to design and conduct his or her own PS-IDE study, it is important to understand the regulatory requirements in every aspect of the trial that you will be personally responsible for. The study site will also have a unique challenge as it must incorporate sponsor obligations into their practices.

• Intermediate

Who’s on First: Developing the Best Inspection Team

We are participants in the development process, impacting the lives of patients and improving the human condition. Global regulators expect us to comply with requirements to ensure data integrity and subject safety throughout the development life-cycle. When they come to review the processes, paper and people involved we must be ready. This visit is expected with known methods so why is there so much angst for an inspection? Taking a team approach, identify the strengths of your resources and aligning those to an inspection “game plan” brings confidence to any inspection team.

• Senior

Vendor Management- Selecting, Budgeting, and Managing

This presentation will focus on selecting the best vendors for a specific study, including vendor costs in the study budget, and how to successfully collaborate with the vendors from startup to close out. (This session will not cover qualification of vendors.) I will review the most common types of vendors needed for clinical research studies, what information each type will request from the study sponsor, and how to develop vendor budgets. There will be a discussion on how to review vendor proposals to determine the best fit for the study. Once selected, I will review methods to ensure oversight of the vendor during the length of the study.

• Intermediate

US FDA Submission Process for Medical Devices

Regulatory submissions are a result of teamwork, often occurring over many years. Each person involved in the testing, organization, or clinical studies is integral to the success of the submission. This session will take a step by step approach to walk attendees though what is required in the 510(k) and PMA submission process; and how you can best support the process. In order to commercialize, additional FDA establishment registration and device listings are required; these registration/listings help the FDA plan facility inspections. Participants of this session will get a broad appreciation of the submission process and some best practices to support your team in the regulatory submission process.

• Entry Level

Updates on Fraud, Waste, and Abuse in Clinical Research and the False Claims Act

Whistleblower Acts play an important role in detecting fraud, waste and abuse. A person who “knows” of fraud being committed against the government can file a lawsuit and, in some cases, receive a reward for bringing original information about a violation to the government’s attention. Because of the importance of the False Claims Acts in clinical research, this presentation will provide a primer on the Acts, address fraud enforcement trends and the various “hot button” issues in clinical research. It will also discuss how non-compliance compromises not only the financial and operational viability of current trials, but may result in a loss of funding, a risk of fines and penalties imposed by oversight agencies, settlement costs and/or damages arising from actions, and diminution of the organization’s reputation.

• Entry Level

Unveiling the Mystery of Quality Tolerance Limits

This session focuses on answering the questions of what quality tolerance limits (QTLs), risk indicators, and thresholds are by defining them and discussing how to establish them. We will look at examples of QTLs, risk indicators, and thresholds and discuss appropriate responses to breaches in the thresholds. In addition, documentation of breaches will be reviewed, reporting expectations and long-term plans for the QTLs, risk indicators, and thresholds. Key take-aways will include examples of QTLs, risk indicators, and thresholds to help one get started with establishing QTLs at their organization.

• Intermediate

Tools for Advancing Patient-Centered Medical Device Clinical Trials

Industry, FDA and patient groups recognize the importance and value of patient input in the ideation, design, testing and approval of new medical device technologies, but often struggle to elicit and incorporate patient input in a meaningful way. Patients can identify outcomes that are meaningful, risks that they would be willing to tolerate, and practices that can decrease the burden of participation in clinical trials. MDIC is developing a suite of tools to help medical device companies solicit input from patients and patient groups on clinical trial design elements that are aligned with patients’ real-world priorities. Panel attendees will learn about the development of these tools that they can implement in their own clinical trials to develop clinical trials that measure what matters to patients and that patients can complete.

• Intermediate

The Path of Least Resistance – Managing Opposition to Change

One of the biggest challenges to implementing change in an organization is employee resistance to change. This session introduces participants to the challenges and obstacles that resistance poses and presents research-based change management practices to mitigate resistance to change. A real-world case study will be used to demonstrate the principles and will be followed throughout the session. Through structured and guided exercises and small group discussion, participants will have the opportunity to apply the learning to a change they are experiencing in their own organization.

• Intermediate

The Missing Links in CRA Training…How Do We Fix the Chain?

This session will examine the most frequent errors witnessed at a study site due to lack of/poor training on the part of the Clinical Research Associate. Training tips and remediation ideas along with a comprehensive dialogue on how to improve training will be presented. Session participants will be asked to share their viewpoints and experiences as to what they have seen and implemented at their study sites.

• Entry Level

Risk Management, the Crash Course

Are you prepared for the risk management requirements in ICH GCP E6 (R2)? This session will provide a high-level walk through of quality risk management, the key components of a risk management program, and how to conduct a risk assessment at the system and protocol level. We will review the key steps of the process: risk identification, assessment, control, review, reporting, management, and communication. Having an effective risk management program not only ensures compliance with the ICH GCP E6 R2 requirements, but also ensures continuous improvement strategies for your clinical trials. Practical take-aways will be shared along with sample tools.

• Intermediate

Regulatory and Legal Changes, the Common Rule, and GDPR: How They Can Impact Study Data Flow Based on Real and Perceived Changes to the Privacy of Information

The session will allow the audience to identify and anticipate compliance issues associated with the privacy concerns around the revised Common Rule. It will help the audience understand the reasons why institutions may require steps to help ensure privacy that will no longer be legally required by the revised Common Rule but may be required by research institutions because of ethical concerns. It will also provide the audience with information on the privacy concerns to anticipate when research involves or could involve data covered by the GDPR.

• Intermediate

Project Review- A Transformational Change in Project Delivery

It is critical to manage the performance on a project through key operational indicator metrics. Those metrics measure the current operational and financial health of the project that allow the project team to ensure the project deliverables based on the contract and statement of work are met. In this session attendees will learn, through this ongoing review process using key operational indicators, how to proactively identify risks and develop specific and actionable plans. The project manager is able to share this data with the Sponsor to ensure clear visibility and accountability on the project. The goal is to achieve flawless execution on a project by managing to the scope of work and providing quality deliverables within the required timeline.

• Entry Level

Practical Aspects of Study Initiation

Purpose: focuses on practical aspects of the preparation and execution of clinical study initiation; identifying and describing key activities, processes, and critical personnel.
Methods: provides a practical overview of the significant processes in starting research at a site and a clear understanding of the main components of study initiation: document management, logistics, and people management. Guidance, tools, and resources help the primary investigator and coordinator perform efficiently and understand how their responsibilities tie together with the tasks and duties of others.
Conclusions: Organization and adequate time for the initiation process are critical to successful studies. Multiple activities must be orchestrated and performed concurrently, requiring use of study tools and efficient processes. Identification and use of numerous research resources improve efficiency of study initiation and decrease work load and frustration.

• Intermediate

Post-ICH GCP E6 R2: Institution/Investigator Qualification and Oversight of External Parties in Clinical Trials

Since the publication and global implementation of ICH GCP E6 R2, Institutions and Investigators are grappling with the appropriate and adequate approaches for qualifying external parties (e.g., testing facilities [clinical laboratories, radiology centers, medical specialists [ophthalmologist]) and implementing oversight of delegated trial-related duties, functions, activities and tasks. This session reviews the requirements and includes a panel discussion with experts in institutional research administration, operations and compliance, GCP compliance and a clinical investigator on how to implement the requirements, and how the sponsor/CRO Study Managers and Site Monitors are to monitor and manage the investigator/site.

• Intermediate

Pediatric Research: FDA’s 2017 Adopted Version of ICH E11 Resulting in E11(R1)

The ICH E11 guideline changed the environment of drug development for the pediatric population. In this session the speaker will provide a basic overview of pediatric clinical research to include the specifics written in the ICH E11 guideline and the rationale for the revision based on the FDA’s input. The session will be beneficial for all clinical research professionals working in pediatric trials or those with an interest in the topic.

• Entry Level

Leveraging Technology at the Site: Putting the Humanity back in Clinical Trials

We spend too much time in Clinical Research battling the technology that is supposed to be there to help us. That’s time taken away from caring for the patient. By utilizing available solutions that are designed to align current technologies across silos, we can ease the burden on the research staff, so that Investigators and staff can get back to the disciplines that drew them to the healing arts in the first place. This session will address the technology options available to sites, and participants should walk away empowered, knowing that it’s not an “either-or”, but an “and”; that they can support the patient and still not be shackled by the technology involved.

• Intermediate

Leading Clinical Research Workforce Transformation

The clinical research landscape is complicated and increasingly burdensome to clinician scientists. To better handle the evolution of the research, the role of the clinical research professional has become even more important; employing a top-notch clinical research workforce is critical. In this session attendees will learn how an AMC prioritized the role of the workforce by using the competency-based framework developed by the Joint Taskforce for Clinical Trial Competency (JTF), to implement many initiatives. These institution-wide strategic initiatives include 1) overhaul job classifications, 2) create advancement through a tiering process, 3) establish a professionals network, 4) align competencies with on-boarding and training, 5) create pipelines for clinical research positions, and ) centralize a hiring service.

• Intermediate

Integrating Quality into Investigator-Initiated Clinical Trials

There are many steps that must be taken to assess risk and integrate quality when developing, initiating and conducting a clinical trial. These steps are crucial for every type of clinical trial. This session will describe how to apply those principles to investigator-initiated clinical trials utilizing tips, tools and templates available to help along the way.

• Intermediate

Inspection Readiness – Beginning with the End in Mind

Sponsors, CROs, and Investigator sites are all too aware of the stress of preparing for a health authority inspection. The challenge is that most organizations begin preparing for an inspection when a drug is filed for approval or they receive notification of an inspection. The key to a successful inspection is preparing at the start of the study. Ensuring that your Investigator Site File (ISF) and Trial Master File (TMF) are built in a way that the complete documentation tells the story of the study, will ensure that you are ready come inspection day. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings.

• Intermediate

Implementing a Competency Based Onboarding Program for Clinical Research Nurses and Coordinators

This presentation will provide an overview of the key concepts a clinical research nurse or coordinator should know prior to independently managing their own clinical research project and how they should be incorporated into a clinical research training program. Identifying the right tactics to engage adult learners is often a trial and error process and this presentation will explore multiple methods to provide learners with the content they need to know and the pros and cons of each. Attendees will receive checklists, competency scales and week by week guides used in the onboarding program being utilized at Nationwide Children’s Hospital.

• Intermediate

Identifying, Documenting, and Implementing Corrective Action Plans to Improve Site Compliance from a CRO Perspective

This session will provide an overview on how to appropriately identify, document, and address compliance issues noted at sites, from monitoring and Sponsor perspectives. There will be an overview of common monitor findings and a discussion about appropriate next steps for developing effective CAPAs. The escalation of issues to the Sponsor will be discussed along with how to adequately document compliance issues in monitoring reports and follow-up letters. Possible ways in which the Sponsor can handle noncompliances will be addressed, as well as the consequences and risks to the Sponsor and study if compliance issues are not addressed. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.

• Entry Level

How to Create a Culture of Quality at a Research Site

Sites are busy and often overlook quality assurance (QA) and only focus on QA when issues arise or when faced with an audit. This presentation will describe our experience creating a culture of quality using an integrative approach in a team environment. Our techniques are easy to implement and include quality assurance checks, office guidelines, checklists and lessons learned. We will discuss the challenges of implementing a quality management system and how to overcome setbacks.

• Intermediate

Getting Multicenter Studies Under Control with Technology

You’ve just been handed a project: An investigator-initiated study with 20 sites on a tight deadline, and here’s the kicker: It’s up to your small team to manage it on top of all your other work. The three panelists before you have all faced this situation… and triumphed. In this session, learn how they did it. Topics explored include: • Strategic approaches to spread work equitably across study teams • Tips for the most critical phases of your study: Startup, monitoring/QC, ongoing communications and closeout In house tools that give you the leverage to “build it once, use it lots” • Purpose-built tools that enable secure collaboration of documents and tasks • What I’d do differently next time: Learn from our mistakes.

• Senior

Expanded Access vs. “Right to Try”; Navigating Disparate Pathways for Desperate Patients

Expanded access to investigational drugs and devices has been available for decades through special pathways provided by the FDA. More recently, two federal actions have widened this access. 1. A federal law allowing for the “right to try” these same unapproved products has been enacted by US Lawmakers. 2. The previous rules governing expanded access have been modified to streamline the process to expedite such access. How do they differ? How should regulatory and research professional advise and/or assist patients faced with these choices? This session will provide a current and complete description of the two pathways, their advantages and challenges.

• Intermediate

Effective Project Management to Streamline your Clinical Trial Workload

In clinical trials, studies are complex, time-intensive and leave little to no room for error. Particularly when conducting concurrent studies with limited resources, it can be difficult to ensure quality and timely data collection and entry on every study. This can lead to stress and unhappiness with staff despite the meaningful work they contribute to improve treatment options. Clear and effective project management can make or break the success of a clinical trial, and project planning and management are a key part of achieving quality clinical data.

• Senior

Compliant Clinical Trial Contracting- Sponsor and Site Perspectives

Emily Pauli, PHRMD, Director of Research at Clearview Cancer Institute (in Huntsville, AL) and Amy Schmidt, DBA, MBA, CCRC, Compliance Manager, AbbVie (Mettawa, IL) will provide the perspective of both the Sponsor and the Site regarding FMV, SOC and Subject/Travel Reimbursement in clinical study budgets. There are two vantage points to contracting and this session will allow the audience to hear from both regarding their processes and how they mirror and possibly conflict….and suggestions how to have a positive outcome for both parties.

• Intermediate

Combating Increasing Complexity of Clinical Trial Data with Expanded Skill Sets and More Teamwork

The number of data sources in clinical trials is increasing and the data coming from those sources are more complex than ever. According to a recent Tufts study, there has been a 20% reduction in EDC as the single source of clinical trials data. What does that mean for the future of data handling and interpretation? It is a broad problem that touches many more areas than just traditional clinical data management. This session will address how skill sets across multiple clinical research disciplines including bioinformatics, statistics, project management and clinical operations will need to broaden, and discuss why greater teamwork, cross-functional collaboration, and minimization of organizational silos are needed.

• Senior

Clinical Research Management Transformation: Infrastructure, Process, and Technology

Clinical research program management is highly complex and requires coordination, communication and cooperation among multiple stakeholders, departments, and teams. Improving research management workflows is a priority for research programs. Reviewing organizational capabilities and streamlining multiple systems and workflows throughout the research program infrastructure expedites performance. Transforming research management infrastructure, processes, and technology enables efficiencies, and is key to improving cycle times and reducing redundancies. Identifying and effectively communicating with key stakeholders fosters champions for change and eliminates roadblocks for implementation success. Participants in this Master Session will learn practical, step-by-step transformational strategies and tools, and have the opportunity for hands-on practice using these tools through case studies.

• Intermediate

Clinical Research Site Culture & the Impact on Adverse Event Reporting

Site culture is a significant, yet under-addressed factor on the impact of timely and complete adverse event (AE) reporting; a large component of patient safety and execution of quality clinical trials. AE collecting, documenting and reporting seems straightforward process that can be covered with a standard operating procedure. In reality, the process itself is impacted by the site culture and effective communication among all of the employees at the site. Quality sites also have a culture that recognizes that clinical trials and their participants are complex, thus requiring checks and balances between the team. This presentation will define the negative impact of strained site cultures on adverse event reporting, identify internal and external pressures, and strategies for improving culture, communication, and adverse event reporting.

• Intermediate

Clinical Project Schedule Management: Successful Start-Up Planning

Successful clinical trial projects don’t happen, they require effective planning and processes at both the site and sponsor/CRO to meet timelines. The use of a project management tool, a Work Breakdown Structure (WBS) to define clinical trial start-up tasks, timelines, and assignments is an effective method to improve project success. Instruction on how to implement a WBS for clinical trial start-up planning will be mapped out along with best practices to ensure successful communication between the investigative site departments responsible for timely deliverables to the sponsor/CRO.

• Senior

Clinical Misconduct: Examples and Implications for your Clinical Staff

The Buck Stops with the PI… or Does It? Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. This session will provide information on the implications and consequences of investigator and staff misconduct in clinical research. Using case studies and actual findings, participants will learn about clinical trials compliance, what kinds of misconduct have occurred in the past and the consequences of a finding of misconduct. Reasons for committing fraud will be explored.

• Entry Level

Careers in Clinical Research: Charting a Path for CRO Professionals

A career in clinical research as a CRO professional has many advantages – plentiful demand, good compensation, and the ability to make a positive impact – but investigating and exploring these career opportunities can be difficult for those unfamiliar with contract research organizations. In this presentation, we’ll look at a number of different career path options available at CROs, identify how to get started on these paths, and discuss the skills and knowledge you’ll need to progress along those paths. The presentation will include real world examples including those who start their professional careers at a CRO, those who transition from other jobs and industries, some common career paths, and some not so common ones.

• Intermediate

Building Relationships & Collaboration: Sponsors and Sites

Currently, there is often confusion or lack of understanding regarding the roles of the CRC and CRA. we need to take the time to understand each other’s backgrounds and expertise, and then align these competencies in effective collaboration. Taking the time to do this by the CRC and CRA would make the best use of our limited time together promoting a quality and timely work product. We have often heard from CRCs that they look to CRAs as their first point of Sponsor contact, a guide and support, not just a someone to verify data against source documents. CRAs look to CRCs for their expertise at implementing a protocol at the site. How can we maximize our roles to effectively reach our individual goals while supporting each other?

• Intermediate

Big Data, RWD & RWE – What’s the Difference and How is it Changing the Research Landscape?

Real world data (RWD) involves data collected outside of clinical trials, and produces real world evidence (RWE), becoming actionable when powered by analytics, machine learning & artificial intelligence (AI). RWE provides insight beyond traditional clinical trial data, adding potential to link data from different sources; improve trial efficiency; identify new indications, and a real-world perspective of risks/benefits to make informed decisions beyond traditional clinical trials. This session reviews RWE regulatory and market impact including the updated FDA guidelines requiring RWE use in regulatory decisions and how AI and information exchange can be securely managed. It will also highlight ethical and privacy concerns, reviewing recent big data consent guidelines and how to clinically integrate RWD. This session shows best practices from a clinical setting that has multiple RWE publications.

• Entry Level

Applying Six-Sigma Tools and Concepts to Your Clinical Research Activities

Six Sigma is a certification that can be achieved but it’s also concepts and practices to apply to everyday activities. The way regulated processes, documents and work practices are handled and executed offer opportunities on a daily basis.

• Entry Level

ALCOA-C Redefined: Writing Effective Site Monitoring Visit Reports

Detailed and accurate documentation, source or otherwise, is crucial in clinical research and yet the site monitoring visit report is often perceived as a “B-list” celebrity when compared with the superstar, source documentation. This session will shine the spotlight on the site monitoring visit report and provide guidance to CRAs on how to not only document observations at the site but also to communicate key information to the trial team in an effective manner.

• Intermediate

7 Breakthrough Behaviors For Clinical Research Project Managers

Clinical Project Managers (CPMs) can spend a considerable amount of time “firefighting”. This talk will present 7 behaviors that CPMs can internalize and demonstrate to prevent firefighting. The discussion will also include real-world examples and tried-and-true techniques that will help avoid some of the pitfalls, along with the hefty benefits garnered when the behaviors are embraced.

• Intermediate

Innovative Solutions. Best Practices. Excellence in Cancer Research

Dr. Skip Burris will present some of the challenges in Oncology research and some of the innovative solutions that he and his team at Sarah Cannon Research Institute have implemented to overcome these challenges. He will share some best practices and resources that can be utilized by other institutions and most of all he will share his key takeaway in clinical research that you won’t want to miss.

• Intermediate

Office of Regulatory Affairs (ORA) Update

This session will focus on an overview of the Office of Regulatory Affairs “Program Alignment” initiative including new divisions, what the initiative will mean for your next (or first) inspection, and who to contact with concerns. This session will also provide a review of current metrics associated with the Bioresearch Monitoring (BIMO) program, including common regulatory violations. Finally, recently released guidance documents and regulations changes related to good clinical practice will be discussed.

• Entry Level

Set Extraordinary Expectations

Kristin Smedley is proof that a change in perception can drive one person to impact an entire field. Eighteen years ago Kristin was on course to achieve her dream: Teacher of the Year. However, fate had an unanticipated outcome for her destiny. Her two sons were diagnosed soon after birth with a rare blindness. Although Kristin was initially paralyzed with fear, she launched an extraordinary mission to change their bleak future. Kristin will demonstrate how the power of perceptions and expectations drives your outcomes and discuss components necessary to ignite your own extraordinary journey through her (often hilarious) real life stories and examples.

• Intermediate

Evolution of the Clinical Research Workforce for the Future

TBD

• Intermediate

Advancing Medical Device Innovation and Safety: An FDA Perspective

CDRH’s vision is that patients in the US have access to high quality, safe and effective medical devices of public health importance first in the world. Ten years ago, the medical device regulatory landscape was perceived to have limited options for bringing new therapies and devices to patients in a timely manner. Today, however, that outlook has changed due in part to the significant efforts that FDA has taken to advance medical device innovation and safety by focusing on our vision. This presentation will provide an overview of multiple CDRH initiatives across the total product lifecycle ranging from streamlined regulatory approaches for clinical studies to new programs for expediting review of devices which address unmet medical needs, and increased opportunity for using real world evidence to support regulatory submissions.

• Intermediate

Thinking Ahead – Enterprise-Wide Implementation of a Clinical Research Management System

Duke invested in a new clinical research management system (CRMS) to improve quality and support reworked business processes that create administrative simplicity and operational excellence. The CRMS is the central tool to track the clinical research operations portfolio. Its integration with the electronic IRB system (a 1:1 match on protocols, including exemptions) is critical to understanding the diverse clinical research activities across the institution. This required Duke to: implement system-wide workflows, create pathways for heavy and infrequent users, and develop tools for monitoring non-compliance and data completeness. The CRMS has been integral in helping study teams use standardize workflows. Nearly a year post-go live, this presentation will review key success factors, decision points, challenges and successes of an enterprise-wide adoption of Forte’s CRMS, OnCore.

• Intermediate

Transformational Technologies in Pharma – What’s Here, What’s Coming – and Why Now?

Technology is changing at light speed and the automobile, retail, airline, finance and many other industries have made a concerted effort to adapt to such. The pharmaceutical industry has been a lager in adapting to newer technologies and clinical trial processes have evolved very little in two decades. However, the regulatory authorities are embracing an effort to transform clinical trials and change is now inevitable for sponsors, CROs, clinical sites and patients. How are/will wearables, digital therapeutics, digital medicine, real world data, machine learning, artificial intelligence and telemedicine impacting the future of clinical trials; are we all ready for it – is the real question. All clinical research professionals will want to attend this session to assess your readiness and how you may want to prepare.

• Entry Level

Cybersecurity: Is Your Clinical Research Data Protected?

Maintaining the confidentiality, integrity and availability of data and systems is critical in healthcare. A cyber-security incident could result in the compromise of critical information or systems, disruption of operations, and even harm to patients. For these reasons, multiple layers of security defenses are needed to protect our people, data, devices, systems, and networks. People in all roles need to understand the critical part they play and how to utilize processes and technology to protect our ecosystem.

• Intermediate

CDER BIMO Compliance and Enforcement: What You Need to Know

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.

• Entry Level

ACRP ICH Gap Analysis: Are You Ready for the Certification Exam?

This interactive 4 hour session will navigate you through the main ICH guidelines (E2a, E6 R2, E8, E9, E11) and the Declaration of Helsinki which are noted on the ACRP certification exams. The session will help you create an analysis of where you may need to focus your studies. A discussion of the exam format and valuable strategies for exam preparation will be discussed. This session is not intended for those that are preparing to take the exam in the Spring cycle as this is merely a gap analysis to help prepare you for the format of the exams and where you may want to focus in preparation for any of the ACRP main certification exams (CCRA, CCRC, CPI, ACRP-CP).

• Entry Level

Working Smarter, Not Longer

Looking to find new ways to organize and increase your workload without becoming overwhelmed? This session will break down how you can better understand your strengths and utilize them to improve productivity. We will cover how this can be applied in the patient setting to provide the best care for your patients before, during and after the visit. We will also cover how you can use these skills to improve communication and data deadlines with sponsors. Lastly, this session will cover tips and examples where organization and multitasking can improve the amount of work being completed.

• Intermediate

Why Do Surgical Placebo Controlled Trials?

In this session, the rationale for surgical placebo-controlled trials will be reviewed. One example of such a trial is the world first randomized placebo-controlled trial to evaluate the efficacy and cost-effectiveness of decompressive surgery for lumbar spinal stenosis, which is currently being conducted in Australia. A variety of techniques have been used to address ethical and safety considerations including the unusual step of recruiting a consumer and ethicist to act in advisory roles to provide input on the practicalities of the study design. This session will provide attendees with a high level overview of the trial together with highlighting key learnings about protocol design, consent form drafting and collection of consent, recruitment of surgeons, working with private healthcare providers, and other relevant site level activities.

• Intermediate

Understanding Regulatory Guidance for Gene Therapy Development

It has been a big year for gene therapy. In the past 12 months, three gene therapy products received approval from FDA. In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. In this presentation, Dr. Vaughn will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for clinical development of new gene therapy products.

• Entry Level

Top Tips for the New Patient Advocacy and Recruitment

Social Media has been a new highly innovative and disruptive technology to many industries, but most importantly clinical trials. Our latest talk on social media breaks down, step-by-step, the latest techniques for patient recruitment, retention and advocacy across the new and old platforms including: Snapchat, Instagram and Facebook.

• Entry Level

The Evolution of Source Documents

This presentation is for a new coordinator or for coordinators who would like a refresher. The presentation will address the creation of comprehensive source documents and how to incorporate source documents within the electronic medical record system without creating more work. Source documentation is critical for obtaining accurate data. The number one cause of FDA 483s reported is that sites are not following the protocol. Therefore, developing well written source documents will provide detailed instructions on the information that must be collected. The presentation will also discuss utilizing the electronic case report form manual to identify additional data points to include in their documentation. Source documents should be organized in such a way that anyone is able to complete a visit without missing essential data points.

• Intermediate

Scope- What Is It and Why Should I Care

While most of us intuitively understand the concept of scope, many do not firmly understand how project managers use the terms “scope”, “scope creep”, and “scope change”. After defining these terms, we will review parameters that most commonly define the scope of a project from both a sponsor, CRO, and site perspective. The importance of tracking scope changes and monitoring for scope creep will be shown using examples of how these could impact on studies.

• Intermediate

Risky Business: Impact of a Risk-Based, Study-Specific Training Program on Research Coordinator Competency in an Emergency Department Setting

This session will describe three important steps to assure RC competency in study procedures at the beginning of a trial: risk assessment, development of a competency based training program, and implementation of that program. Participants will gain an understanding of how to conduct a risk assessment for a clinical trial. They will also learn how to develop and implement this type of program for their studies in order to help increase study procedure awareness and CRC competence. Take-aways will include a training checklist template that can be applied to clinical trial study start-up and a toolkit describing our program.

• Intermediate

Legal and Regulatory Changes: A Year in Review

A lot has happened this year! Get up to speed with this overview session designed to bring you the highlights and breaking news since last year’s ACRP Conference. How are recent legal and regulatory changes fundamentally affecting research? What should research sites and institutions be ready for in the coming months and years? Get answers to these questions and more through this session’s issue-spotting exploration and analysis of changes in laws, regulations, and standards promulgated by FDA, DHHS, the NIH, and ICH.

• Senior

GPS for Study Startup: The Importance of the Critical Path

Site activation cycle times within the industry are now worse than they were over a decade ago by an average of 4 to 6 weeks. Large, global organizations and small ones alike struggle more than ever to manage the complexities of today’s trials and activities on the critical path to activation are always changing. This session will provide practical information on how technologies, best practices, and KPIs can proactively lead life-science organizations towards an entirely different approach to managing study startup.

• Intermediate

FDA Inspections: Understand the Process and Manage the Consequences

This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. Part 2 will employ hands-on activities to create corrective and preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters and 483s.

• Intermediate

EFS is the new OUS strategy for early-phased medical device clinical trials

This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue fo regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.

• Entry Level

Achieving the Clinical Trial Experience of the Future

During this interactive session, leaders from TransCelerate Member Companies will candidly share their experiences collaborating to create solutions that will bring about innovative change, and address some of our industry’s greatest challenges. They will discuss a suite of initiatives that, using innovative digital efforts, has to potential to transform the end-to-end clinical trial experience. TransCelerate has been developing solutions to allow patients to easily find trials, understand studies and provide consent, participate in trial information exchange, utilize electronic medicine labels, provide feedback on their experiences, and ultimately own their digital medical records. The audience will learn how the use of patient technologies, The Registry of the Future, eConsent, eLabels, and electronic health records can advance clinical research and create the patient experience of the future.

• Senior

A Five Step Approach to Device Risk Management

Companies are faced with challenges to make medical devices safe for human use. Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. In this session participants will look at a five step approach to risk management. In this interactive session participants will gain knowledge into the identification, assessment, evaluation, reduction, control and monitoring of risk that are essential to device risk management. Speakers will provide tools, guidance, and some tips on developing a risk management strategy.

• Senior

2019 Regulatory Update

Join us for a stimulating presentation that offers a high level overview of the recent changes to laws, regulations, policies and trends that affect our industry. Many of these are from FRDA and OHRP buy many are intended mostly for healthcare operations that are unintentionally (or intentionally) bleeding over into research operations.

• Entry Level

Business Development Best Practices: How to Make your Site Stand Out in an Increasingly Competitive Landscape

With the clinical trial landscape becoming increasingly complex and competitive, it is essential that clinical research sites position themselves in a way to stand out from the “competition.” Factors such as a downturn in the volume of trials being conducted in sites’ primary indications leads to increased competition for each study and a potential downturn in the number of active trials at a site. We will discuss industry trends that impact R&D, the key factors that drive them, and the implications for research sites. We will discuss insightful strategies for staying ahead of the curve, such as therapeutic expansion and increasing patient access within existing key indications. Finally, we will discuss key tactics for developing and strengthening CRO & sponsor relationships in order to become a “go-to” site.

• Intermediate

Workforce Innovation Award Finalists: Top 5 Share their Ideas

Come see the top 5 Workforce Innovations Finalists share their innovative ideas in workforce development and have the opportunity to ask questions for your own idea creations.

• Intermediate

The Future of the Clinical Research Industry: Where Are We Headed and What It Means to You

Enjoy a paneled discussion on the future of our industry with perspectives from the FDA, CRO, Site and TransCelerate. Gain knowledge on what the future may look like in each of our panelists perspectives and how they are preparing and how you may want to prepare.

• Intermediate

Insights from Industry Technology Competency and Adoption Survey – What This Means for You and Your Organization

ACRP and Forte have recognized that there is a critical need improve tech adoption in clinical trial operations and to define and refine the technology-related skill sets and competencies. Such competencies will more effectively adapt and develop job descriptions, hiring practices, and training programs that enable a more tech-savvy and more sustainable workforce. Therefore, the two organizations collaborated to launch the Technology Competency and Adoption survey in early 2019. We will be sharing highlights from the survey results with a focus on discussing: • Barriers to competency achievement and technology adoption • How individuals can enhance their individual competency • Best practices for how organizations can foster improved adoption of clinical research technologies.

• Intermediate

A Deeper Dive: What Makes a Great CRA

Join the continued discussion from ACRP 2018 session with data from session participants to gain insights regarding skills and competencies of today contrasted to those of tomorrow for a CRA. This session included a 360 perspective and discussion of what makes a great CRA. Through the proposed session discussion and data, it is a conversation to be continued through a deeper dive into a few key areas. These areas include technology skills, regulatory knowledge and RCA competency. During this session, our team will reconvene to discuss and share specific recommendations for how to ensure CRAs, employers of CRAs and research sites engaging with CRAs are best prepared to support and optimize the performance of individuals who are undergoing a shift within a long-established role for our industry.

• Intermediate

Digital Health: A Clinical & Regulatory Update

Software as a Medical Device (SaMD) is performing a larger and more impactful role in patient care than ever before, and new technologies present new regulatory and development challenges. This presentation explores Digital Health technologies and the challenges and opportunities they present to industry, health care providers, and global regulators. After a brief review of the regulatory approaches used for Digital Health technologies across multiple international venues, the US FDA’s Digital Health Precertification Program will be explored. The underlying principles, philosophy and challenges to digital health tech development will be presented, the real and potential “value” of SaMD will be defined, and implications for research and regulatory professionals will be discussed.

• Intermediate

Knock, Knock… FDA Is Here; 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. We will briefly look at FDA Inspections and how to prepare for the inevitable knock, and discuss resources available to you.

9th Annual DPharm: Disruptive Innovations

Featuring ACRP Executive Director Jim Kremidas presenting Workforce Innovation: Upskilling Site Staff for 21st Century Clinical Trials

• Entry Level, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, , Trainer

Ethics and Human Subject Protection: A Refresher Course

When in need of a comprehensive refresher, this on-demand eLearning course provides a consolidated overview on the history and importance of ethical conduct in clinical trials involving human subjects.

• Entry Level
• Investigator,

Investigator Responsibilities

Learn the various responsibilities of clinical investigators based on FDA Regulations, ICH Guidance Documents, and international standards.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer

Save 10% on Training from Barnett International

ACRP and Barnett International’s new strategic partnership provides ACRP Members with expanded access to high-quality education and training, and an exclusive 10% discount on Barnett’s online and in-person programs for clinical research professionals.

• Senior

Improving Recruitment, Accrual, and Retention in Clinical Trials

Explore best practices to improve recruitment and retention with a focus on operational efficiency, cultural competency, and patient centricity. Included tools will help you assess how to better communicate with potential participants and begin a critical reflection of your own skills and organizational practices.

• Senior

Trial Feasibility and Selection: Their Impact on Accrual

Selecting the right trial for your clinical research site is key to the success of your accrual for the trial. This eLearning course will discuss how the menu or portfolio of studies offered at a site has an important impact on accrual and how research professionals can become part of the process.

• Entry Level

Webinar Replay: How to Enter the Clinical Research Field

There are many paths for entering and navigating clinical research careers. This webinar provides guidance that can help jump start your efforts to become a professional in the field.

• Entry Level
• CRC, CRN, Investigator, PR, RM

Implementing a Patient-Centered Informed Consent Process

Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language. This eLearning course will provide essential tools for those directly involved in informed consent discussions.

• Intermediate
• CRC, CRN, Investigator, PR, RM

Using Metrics to Improve Subject Recruitment and Retention

Overcome challenges in subject recruitment and retention by learning how to leverage the metrics critical to success. This eLearning course will teach site personnel assess current site performance and readiness for action, and to implement appropriate metric measurement and monitoring.

• Entry Level
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Introduction to Clinical Trials

Fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals. This free eLearning course details how medical products are developed, how volunteer patients are protected, and key roles in the development, research, review, and approval of medical products.

• Intermediate, Senior

Site Quality Management Tools: SOPs, Metrics and Training

Master quality-related processes and procedures required to ensure trial compliance. This eLearning course is a comprehensive training program that prepares you for the next step of setting up a quality management system– essential information for site personnel involved in quality management and improvement.

• Entry Level, Intermediate, Senior
• BCO, CDC, CRC, CRN, CRS, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

Reduce your anxiety by being prepared for clinical trial inspections. This eLearning course takes you through the full cycle of a regulatory authority GCP inspection and answers key questions including: Why, when and where are regulatory inspections performed? Who can be inspected? And more.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety

Efficiently identify and report safety events in your clinical trials. This eLearning course, appropriate for all clinical research professionals, guides you through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 Guidelines.

• Entry Level

ACRP Certification Exam Preparation eLearning Course

Prepare for an ACRP Certification with this comprehensive guide. This eLearning course will help you become familiar with the exam format, tackle example questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP Certification.

• Entry Level, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, DM, Investigator, MA, MD, MRS, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review

Expand your knowledge and skills in study protocol design and review. This e-Learning course covers the anatomy of a protocol, hypothesis development, study design, subject safety and data integrity risk considerations, protocol feasibility and protocol amendments.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Theory to Practice: Operationalize Your Clinical Study Protocol

Improve protocol interpretation and implementation by understanding trial scope, design, conduct, data analysis, and the evaluation and reporting of safety and tolerability data. This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials.

• Entry Level
• BCO, CRC, CRN, DMCTO, Executive, FA, Investigator, MCRA, PMs, RM, RTA, SSSU, Trainer

Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense

Learn the key phases of the budget process and critical components required for consideration, including preparation and study protocol review, study start-up Costs and more. This eLearning course is ideal for both site and sponsor personnel who are tasked with building site budgets and reaching agreeable terms.

• Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Key Skills for Ensuring Quality Control through Risk-Based Decision Making

Gain confidence in making risk-based decisions and implementing actions related to quality control initiatives. This eLearning course covers key aspects related to risks in clinical trials, including: identification, analysis, planning, communication, change management and much more.

• Intermediate, Senior
• CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

ICH Gap Analysis

Assess your and your team’s training needs quickly by conducting an ICH gap analysis. This eLearning course uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines.

• Entry Level, Intermediate, Senior
• Investigator, MCRA, PMs

Form FDA 1572: Get it Right the First Time

The Statement of Investigator (Form FDA 1572) doesn’t have to be complicated – let us help you get it right the first time. This eLearning course answers the questions of why, when and how to complete the FDA 1572 to make everyone’s jobs easier.

• Entry Level
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Ethics and Human Subject Protection: A Comprehensive Introduction

Explore the ethical considerations facing clinical research professionals and learn to put the rules into practice to ensure human subject safety and well-being. This eLearning course provides in-depth training on the importance of ethical conduct in clinical trials involving human subjects.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

The Drug Development Process: Improving Trial Feasibility and Exploring Your Growth Potential

Develop a better understanding of the overall drug development process and how each study fits into the “big picture” of the development life cycle. This eLearning course puts into practice the ICH E8 guidance document General Considerations for Clinical Trials.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA

Implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance. This eLearning course will teach you risk management strategies to avoid inaccurate trial data, regulatory non-compliance and more.

• Entry Level, Intermediate, Senior
• BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Trainer

eResearch: Managing Clinical Trials in an Electronic Environment

Learn how to set up and manage electronic clinical research documents in compliance with U.S. and EU regulations, and current trends from both the site and sponsor perspectives. This eLearning course examines the challenges of working with electronic documents and how to overcome them.