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. Session participants will be asked to share their viewpoints and experiences as to what they have seen and implemented at their study sites. Join us for an interactive video webinar on the key components of building a clinical research team. 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. This course is recommended for individuals with prior training and experience with ICH GCP. Excellence in Cancer Research, Office of Regulatory Affairs (ORA) Update, Evolution of the Clinical Research Workforce for the Future, Advancing Medical Device Innovation and Safety: An FDA Perspective, Thinking Ahead – Enterprise-Wide Implementation of a Clinical Research Management System. Also, a valid user ID and password are required to access the training platform. 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. This is reality for Peter and Vicky DiBiaso. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. This eLearning course examines the challenges of working with electronic documents and how to overcome them. 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. More recently, two federal actions have widened this access. 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. Module 1: In the first session, speakers will cover important Good Clinical Practice topics, and preparation for audits and regulatory inspections. 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. Leave with an greater understanding of audience segmentation and engagement, and how a metrics model can be used to measure digital channel performance and inform website and social media strategy. CRCs Gone Wrong, Technology and Innovation: Collaboration as the Key to Industry Transformation, Tech-Driven Sites: The Why and How to Get There, Strategies for Ensuring Part 11 Compliance at Research Sites, So You Want to be a CRA. Connect with your peers, discuss issues you face day to day, and access helpful resources through this exclusive ACRP Member Benefit. This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials. We will share best practices on how to collaborate and implement new remote processes utilizing electronic resources from start-up to closeout. Perfectly tailored training modules for all medical staff. 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. Join us for the second part of our presentation on building databases for an Investigator Initiated Trial (IIT). Taking a team approach, identify the strengths of your resources and aligning those to an inspection “game plan” brings confidence to any inspection team. The Clinical Research Associate (CRA) Training Program is organized in two modules: Module 1 – CRA Training for Entry Level ; Module 2 – CRA Training for Advanced Level; The participants to Module 1 will benefit of 15% discount to Module 2. Gain specific guidance on how to develop a plan for responding to implantable device recalls and alerts from a clinical trial management perspective. The TRANSVAC2 Consortium has set up training modules at leading European centres (in collaboration with WP18 partners) that can be combined to … The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. We specialise in treating anxiety, depression, bipolar disorder, and eating disorders. Join us to gain expert recommendations on creating a staffing strategy that gets business moving forward again and puts employees back to work. 1. Drastic actions could be needed to recover the capability of these sites to perform quality research. Despite the widespread use of this training, little evidence has been collected to determine whether it provides the knowledge and skills necessary to support investigators and their delegates in the quality conduct of clinical trials. We will discuss the challenges of implementing a quality management system and how to overcome setbacks. Medical Research Initiatives. This is one module in the series of Clinical Research Coordinator Training modules. 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. 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. Speakers will provide tools, guidance, and some insider tips from the viewpoints of dedicated research sites and large, hospital-based research institutions on issues to consider during implementation. The speaker will review data showing how racial and ethnic minorities are underrepresented in clinical research while addressing the rationale behind enactment of the National Institutes of Health Revitalization Act and its effect on minority enrollment in clinical trials. This session will provide tools and define efforts to create and operationalize a comprehensive, competency based, systematic Clinical Research Workforce Development program. Smart Monitoring: Is My Monitoring Adequate? What new collaborations need to exist to defy the bounds of innovation and accelerate the prevention, diagnosis, treatment, and – ultimately – cures? This eLearning course will teach site personnel assess current site performance and readiness for action, and to implement appropriate metric measurement and monitoring. Join experts from Clinical Research IO to explore how several independent trends in research will make eSource a platform technology for sites. Learn how to effectively gain support for moving clinical research from “just a small department” to part of the broader organizational culture. If you are a returning user with a user ID and password and need to recertify, you can do so by logging in to the website using your existing login credentials. 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. Upon completion of this course, participants will be eligible to take an online self-assessment … You will also be able to take the test or complete the course again. Clinical Trial Fundamentals eLearning Program (all three modules!) 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. 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. 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. Investigator brochure and clinical trial protocol, Module 6: Overview of Community-Engaged Research The University recognizes that academic research is substantively, procedurally, and administratively complex. Project planning and management are a part of achieving quality clinical data. Leave with several takeaways to help develop or update your organization’s education program. Building on last year’s session outlining the creation of competency-based job descriptions and the process used to match incumbents to these new classifications, speakers this year will address steps taken to provide advancement opportunities using objectively-measured competency assessments. Join Exostar and Cognizant for an informative session on improving trial efficiency through SSO and eISF. Speakers will examine the characteristics, background, and experiences required of a Lead Monitor based on survey results from decision makers in the industry. This session will also provide a review of current metrics associated with the Bioresearch Monitoring (BIMO) program, including common regulatory violations. Each person involved in the testing, organization, or clinical studies is integral to the success of the submission. The pharmaceutical industry has been a lager in adapting to newer technologies and clinical trial processes have evolved very little in two decades. We are all used to hearing that the demand for quality investigative sites is outpacing the growth of sites to support the clinical research needs of the industry. 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. In order to commercialize, additional FDA establishment registration and device listings are required; these registration/listings help the FDA plan facility inspections. 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. June 9, 2021 12:00-1:00PM ET – This presentation will outline 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. Grasping the state of affairs within hours and how compliance came over me was mind boggling. ICH Section 3, Module 3: The newly-revised ACRP Certification Exam Preparation Course provides eligible candidates guidance on how to prepare for the ACRP certification exams — CCRA(R), CCRC(R) and CPI(R). 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. Good research practice. Get the full three-part ACRP 2021 program + 24 contact hours for just $299 through December 31, 2020. Or has it? 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). These modules allow site staff with less experience to become more familiar with conducting clinical research. One of the biggest challenges to implementing change in an organization is employee resistance to change. An agency of the U.S. Department of Health and Human Services, the NIH is the Federal focal point for health and medical research. In this session, learn how they did it. 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. Learn about collaborative initiatives to tackle the most pressing challenges facing clinical development. 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. Improve protocol interpretation and implementation by understanding trial scope, design, conduct, data analysis, and the evaluation and reporting of safety and tolerability data. A CRA ensures that medical devices, new drugs, and new treatments are approved for patients' use. 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 to apply for career development support The NIHR Academy supports a vibrant community of over 4,000 members with training programmes, career support, mentoring and guidance on research funding. Clinical monitors, project managers, and risk managers learn how to maximize their monitoring resources to have the greatest impact on quality and compliance. ACRP Executive Director Jim Kremidas will deliver welcome remarks and provide an overview of the state of the association. There are not only legal ramifications for someone misrepresenting educational credentials, but the repercussions to the hiring company are just as serious. Financial management for research sites is one of the most time-consuming and complicated aspects of the clinical research process. Speakers will lead an active discussion of ethical and patient safety considerations related to informed consent, inclusion and exclusion criteria rationale, the difference between clinical care and clinical research, and much more. Speakers will share their personal experiences in making the transition, including successes, lessons learned, and effective methods for getting on the monitor career path. 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. Clinical research program management is highly complex and requires coordination, communication and cooperation among multiple stakeholders, departments, and teams. Learn about a novel learning module developed and launched to address this need and an applied framework based on applied science to maximize its effectiveness. The current training available to our active investigators covers a variety of topics related to Good Clinical Practice (GCP). Speakers will shed light on the steps required to determine what data needs to be collected to answer these questions, or support the post market surveillance to do so. 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. This program is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. The key to a successful inspection is preparing at the start of the study. Eighteen years ago Kristin was on course to achieve her dream: Teacher of the Year. Training scientists in vaccine research and development is crucial in order to sustain Europe’s excellence in this field. 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