The Barnett approach is a unique combination of strategy development and practical, hands-on implementation. This eLearning course answers the questions of why, when and how to complete the FDA 1572 to make everyone’s jobs easier. Master your understanding of protocol deviations, one of the most common problems identified in FDA inspections and the main reason for the rejection of data from a site or study. 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. This website uses cookies so that we can provide you with the best user experience possible. Clinical Research is one of the most knowledge-intensive industries. 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. 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. 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. Fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals. Getting the necessary educational background is a critical step on the pathway to a successful career in clinical research. Webinar replay expires May 8, 2020. 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. 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 eLearning course is an excellent starting point for anyone wanting to begin work in clinical research and a great refresher for those who have been in the role for some time. This session is a two-part “master series” program. As a research professional and industry leader it is imperative to be proactive in combating these market forces. 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. 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. This webinar will discuss their experience. Turn off the lights? They will discuss a suite of initiatives that, using innovative digital efforts, has to potential to transform the end-to-end clinical trial experience. In this session, the rationale for surgical placebo-controlled trials will be reviewed. This means that every time you visit this website you will need to enable or disable cookies again. ACRP 2021 kicks off in January! 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. Focus on your core business and take advantage of our standardized, competence-based training solutions for organizations. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach? This session will provide an overview of the reorganization of the FDA’s Center for Devices and Radiological Health (CDRH). 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. Explore the ethical considerations facing clinical research professionals and learn to put the rules into practice to ensure human subject safety and well-being. Looking to become a clinical research associate (CRA)? Webinar Replay: Expressing Gratitude & Returning Aggregate Study Results to Participants—It’s the Right Thing to Do! It will also highlight ethical and privacy concerns, reviewing recent big data consent guidelines and how to clinically integrate RWD. Familiarize yourself with the exam format, gain valuable strategies for preparing for an ACRP exam, tackle sample exam questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP certification. Receive guidance on how to analyze the professional development resources available and how to create an action plan to customize your own path for growth and advancement. This session takes a practical approach to risk-based monitoring. 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. The Office of Clinical Research has the responsibility for courses which provide clinical research training for the spectrum of investigators and others involved in clinical research. In the past 12 months, three gene therapy products received approval from FDA. This session will provide tools and define efforts to create and operationalize a comprehensive, competency based, systematic Clinical Research Workforce Development program. This eLearning course will teach site personnel assess current site performance and readiness for action, and to implement appropriate metric measurement and monitoring. Panic? Webinar Replay expires on June 12, 2020. It is complete biography of drug from its inception in the lab to its introduction to the consumer market and beyond. Webinar Replay expires on June 26, 2020. Understand the current regulations and guidance related to vulnerable subjects while learning methods for practical application in your daily activities. 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. Developing protocols that either meet the needs of both regulatory and marketing, or setting up post market studies that answer these questions, requires both detective and analytic capabilities. Leave with a strong understanding of the considerations and configurations that need to be made for a successful EMR/CTMS integration. SOCRA offers a robust portfolio of live conferences, workshops, and courses to keep you at the forefront of the industry and support your continuing educational goals. The clinical research courses are delivered through an effective online portal and are conceptually designed to meet the needs of the clinical research industry." 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. Currently, there is often confusion or lack of understanding regarding the roles of the CRC and CRA. The Master of Health Sciences in Clinical Research program awarded by the Duke University School of Medicine provides academic training in the quantitative and methodological principles of clinical research. I hope to share my experience to help others who deal with patients every day. NEW—Take the Certification Exam from Home. A hiring manager will naturally have a different perspective than the site staff being monitored. 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. If you’re prepared, it should be an exercise to ensure your systems are working the way you designed them. Clinical Research is one of the most knowledge-intensive industries. Learn strategies to ensure your company’s long term survival and growth in our industry’s competitive environment. For the course “Introduction to the Principles and Practice of Clinical Research”, it says above that “Both the course and registration for the 2018-2019 course year are now open through June 30, 2019.”, but when I got to the IPPCR website, it says that the registration is closed. 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. Research excellence and networks. 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. ACRP Executive Director Jim Kremidas will deliver welcome remarks and provide an overview of the state of the association. Certified Clinical Research Professionals Society Corp. (CCRPS) is a not-for-profit 501 (c)(3) professional society providing accredited certification and training for entry-level and mid-level clinical research professionals. “Coming together is a beginning. Safety, Regulation & Guidance. Overcome challenges in subject recruitment and retention by learning how to leverage the metrics critical to success. Scheduled to begin mid-2018, this significant restructuring will combine the CDRH Office of Compliance, Office of Surveillance and Biometrics and the Office of Device Evaluation into a “super-office,” designed to increase efficiency and effectiveness and to focus on the total product life cycle of medical devices. Apply to earn your certification online, on-demand, 24/7. The second session will employ hands-on activities to create corrective and preventive action plans utilizing root cause analysis procedures to address FDA citations in warning letters and 483s. Aligned to our goal of enhancing the sites’ experience when working with IQVIA, we have developed online training for … Speakers will pay special attention to effective source documentation review to assess if it meets ALCOA and the process for securing compliance. The Quality Management Institute and ACRP have partnered in a program of education for individual professionalism and the quality management of clinical research sites. The speaker will highlight methods for best presenting the knowledge and capabilities of your staff and facility, and for communicating effectively with CRO/sponsor personnel. Our techniques are easy to implement and include quality assurance checks, office guidelines, checklists and lessons learned. Learn about the Duke University School of Medicine’s experience with a competency-based framework for career advancement. You’re in the right place! Come play “Research Jeopardy!” Test your knowledge and skills by participating on one of three teams during this interactive session for novices and experts alike. 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. The CTSI offers several training courses through UF’s MyTraining platform. Come explore how sites might find themselves in such a circumstance, ways to identify what is and is not working, taking corrective actions, and solidifying those actions into a research program focused on quality. 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. Learn the basics of what makes a corrective and preventative action (CAPA) plan. The minimum eligibility for admission in which is a 55% score in graduation in the Medical science courses (MBBS, BDS etc.) 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. Explore the individual dynamics of technology, process, and workforce on the industry and their effect on each other. 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. Some simplifying the work load, others seemingly making it more complex. Are you a current CRA wondering how the position is rapidly changing and how you can stay current? Reasons for committing fraud will be explored. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and open forum for discussion provided. 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. Courses Online training for research professionals | Clinical and Translational Science Institute - University of Minnesota 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. Learn how to avoid under budgeting, review generic clinical trial protocols and issues within them that might affect your final budget, and leave with the tools needed to ensure your budget supports successful trial conduct. or Degree in Science, Pharmacology, Pharmacy, Life Sciences, Biotechnology etc. Attendees will learn about the Core Competence Framework for Clinical Trial Monitoring and hear a case study on its use in AstraZeneca’s initiative to internalize its monitoring program. Come hear case studies of cloud-based monitoring and a conversation about how different stakeholders can cooperate to increase research effectiveness. Planning to earn your ACRP Certification? Thus, it is incumbent on all of us to have our own personal career map or career development plan in order to get the most out of our careers. Webinar Replay: Designing, Operationalizing and Maintaining a Comprehensive Assessment Driven Clinical Research Orientation, Ethics and Human Subject Protection: A Refresher Course, Webinar Replay: ResearchMatch.org: Empowering the Researcher/Serving the Participant, Webinar Replay: Single IRB: Getting Ahead of the Curve at a Non-Traditional Academic Medical Institution. 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. Enjoy a paneled discussion on the future of our industry with perspectives from the FDA, CRO, Site and TransCelerate. 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 session will be beneficial for all clinical research professionals working in pediatric trials or those with an interest in the topic. Speakers will outline how they have approached local context review and study site activation under the SMART reliance agreement for multi-center trials, among other topics. 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. Diploma in Clinical Research is a 1-year full-time course. pursued from a recognized university. Part 2 will consist of a workshop using hypothetical cases to determine iRECIST responses.