clinical research training modules

The following information outlines research training requirements for individuals who conduct research at the University of Pittsburgh, including faculty, staff, and students. The Quality Management Institute and ACRP have partnered in a program of education for individual professionalism and the quality management of clinical research sites. Key take-aways will include examples of QTLs, risk indicators, and thresholds to help one get started with establishing QTLs at their organization. You will also be able to take the test or complete the course again. Compliance, non-compliance, scientific misconduct and fraud, Module 8: Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings. This session will provide an overview of the reorganization of the FDA’s Center for Devices and Radiological Health (CDRH). 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. Learn the globally recognized standard for conducting ethical and scientifically sound research and to “speak” the universal language of clinical research. This course provides them with the opportunity to learn about conducting … This session introduces participants to the challenges and obstacles that resistance poses and presents research-based change management practices to mitigate resistance to change. Become an expert on quality and risk-management strategies and procedures. And more. The core program includes 7 general ICH/FDA GCP modules, with 2 optional modules for sites in South Africa (module 8) and for training about applying GCP in observational and non-interventional trials (module 9). Highlights of scientific advances from the National Institutes of Health. Join Ripple Science for an informative session centered around the effectiveness of centralized recruiting models against standardized models. Speakers representing Cerner PowerTrials, IBM CTMS for Sites, and a research site will break down the value of components of EMR/CTMS integrations and discuss how these interfaces can be implemented. Speakers will present innovative approaches for improving subject retention and offer metrics demonstrating the impact of on-home and alternate site clinical services on patients, sites, and study sponsors. As a research professional and industry leader it is imperative to be proactive in combating these market forces. This session will provide information on the implications and consequences of investigator and staff misconduct in clinical research. 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. 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 with this new, interactive, simulation-powered training program. Our panel will discuss shared best practices and current processes for building and communicating with dynamic teams including remote workers. A poorly performing site is also at enhanced risk for termination by the parent organization during cost reductions. Many organizations are struggling to respond. This session will provide a valuable introduction to contemporary healthcare economics and an understanding of its role. The speaker will discuss personal experiences and examples of device recalls, safety alerts, and the anticipated impact Unique Device Identification. Online training for research professionals Get trained on conducting research with human participants at any time, from anywhere. Join experts from Clinical Research IO to explore how several independent trends in research will make eSource a platform technology for sites. Course Modules. If you are serious about a career in clinical research, this training package is a must. The Medical Research Center (MRC) Training Program is a specially designed suite of modules, short courses and workshops for researchers. To be prepared for this change, it is vitally important to understand what is happening now and what is coming around the corner. Module 5: Advanced Monitoring Skills. 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. Webinar Replay expires May 22, 2020. 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. Transformational Technologies in Pharma – What’s Here, What’s Coming – and Why Now? Kristin Smedley is proof that a change in perception can drive one person to impact an entire field. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence. 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. Learn the ins and outs of adverse event (AE) reporting for medical device trials. Learn about collaborative initiatives to standardize professional competence and career paths in clinical research. The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. To request a proposal, click here. 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. Or has it? There could be a list of clinical research institutes all over India, that offer formal online training in pharmacovigilance and clinical research. 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. Leave with a clear understanding of what a satellite site is, the ability to evaluate whether a satellite site is suitable for clinical trial conduct, and the knowledge to apply this information to current practices. Speakers will explore tools to help sites understand their commitments and document their compliance with the appropriate regulation. Assess your and your team’s training needs quickly by conducting an ICH gap analysis. Learn how to effectively gain support for moving clinical research from “just a small department” to part of the broader organizational culture. The NIH website offers health information for the public, scientists, researchers, medical professionals, patients, educators, and students. Providing different perspectives from the sponsor/site and staffing agency perspectives, our speakers will share their insights and experiences on how you can “own your professionalism” and grow your career in meaningful ways. 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. Expanded access to investigational drugs and devices has been available for decades through special pathways provided by the FDA. Official website of the National Institutes of Health (NIH). 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. Social Media has been a new highly innovative and disruptive technology to many industries, but most importantly clinical trials. This session is a two-part “master series” program. 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. The Centre for Clinical Interventions (CCI) is a clinical psychology service in Perth, Western Australia. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. 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. Online Training Resources The Office of Behavioral and Social Sciences Research (OBSSR) has identified training needs in several areas relevant to the behavioral and social sciences. This eLearning course examines the challenges of working with electronic documents and how to overcome them. 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. Sponsors, CROs, and Investigator sites are all too aware of the stress of preparing for a health authority inspection. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S. 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. Explore how emerging technology and developing trends are impacting your operations. March 10, 2021 12:00-1:00PM ET – This will address the challenge of transforming clinical research operations with technology built from the rapid transformation clinical research sites had to respond to in light of COVID-19 disruptions. By law, any person who causes dangerous goods to be transported by a public carrier must follow specific regulations and must have proof of training. The Missing Links in CRA Training…How Do We Fix the Chain? This eLearning course will teach site personnel assess current site performance and readiness for action, and to implement appropriate metric measurement and monitoring. In addition, documentation of breaches will be reviewed, reporting expectations and long-term plans for the QTLs, risk indicators, and thresholds. 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. Organizations aligned with ACRP’s mission are working together to grow and expand the diversity of the clinical research workforce, and to set and support standards for workforce competence. Smart Monitoring: Is My Monitoring Adequate? 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? Module 2: Institutional Review Board/Independent Ethics Committee ICH Section 3. 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. 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. Learn about the increased use of virtual teams and the key challenges when working with a virtual team. 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. Modules: Speakers will lead an open dialogue about development, tools, and strategies available, while challenging you to develop your own unique professional development track that is both defined and measurable. 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. Global regulators expect us to comply with requirements to ensure data integrity and subject safety throughout the development life-cycle. That’s time taken away from caring for the patient. CRAs also have training in assisting clinical researchers and investigators in the, coordination, administration, and management of clinical trials. Increase your influence and expand your career opportunities by validating your commitment to quality. Hear actual case studies delineating coordinator sanctions and punishments, as well as reasons for committing fraud. 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. The clinical research landscape is complicated and increasingly burdensome to clinician scientists. We will discuss industry trends that impact R&D, the key factors that drive them, and the implications for research sites. 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. Module 1: 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. This presentation is for a new coordinator or for coordinators who would like a refresher. There will be a discussion on how to review vendor proposals to determine the best fit for the study. 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 shows best practices from a clinical setting that has multiple RWE publications. 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. Selecting the right trial for your clinical research site is key to the success of your accrual for the trial. New technology is being introduced to clinical research operations so rapidly that it seems like a daily occurrence. This session will cover identifying, assessing, and reporting adverse events (AEs) for medical device studies at the site level. Learn several effective strategies for negotiating competitive budgets and contracts for a variety of different types of clinical studies. Source documentation is critical for obtaining accurate data. Hear proven techniques for gaining buy-in for a strategic plan and ongoing engagement, including group leadership, SWOT analysis, mission and vision development, and establishment of a research advisory board. 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). Purpose: focuses on practical aspects of the preparation and execution of clinical study initiation; identifying and describing key activities, processes, and critical personnel. Sites are busy and often overlook quality assurance (QA) and only focus on QA when issues arise or when faced with an audit. Come learn about their findings. Speakers will cover the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on the study protocol, and device AE reporting requirements from a monitoring and auditing mindset. Implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance. CPCRA is an online & self-paced certificate program that will provide you comprehensive training on scientific, financial, practical, ethical, and technical concepts of clinical trial monitoring. The presentation will also discuss utilizing the electronic case report form manual to identify additional data points to include in their documentation. 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. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S. 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. It combines 18 modules created by leaders in epilepsy research with 10 modules from the NIH Introduction to the Principles and Practice of Clinical Research (IPPCR). What does that mean for the future of data handling and interpretation? Presenters will discuss the emergence of satellite sites in the current climate of hospital mergers with healthcare networks and/or clinics merging under a single healthcare entity. Risk management is an integral part of the medical device product development lifecycle. Once selected, I will review methods to ensure oversight of the vendor during the length of the study. Whether you need ground-up guidance on establishing infrastructure and preparing for a qualification visit, or you are looking to improving your existing processes and presentations, this session will provide the tools you need to ensure a positive site qualification visit. This is one module in the series of Clinical Research Coordinator Training modules. 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. Good Clinical Practice NIHR offers a range of Good Clinical Practice (GCP) courses for the clinical research delivery workforce. 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. Topics include US and Latin American trial issues, OTC drugs and personal care products used in clinical trials, and new Certificate of Confidentiality rules. 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). 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. January 27, 2021 12:00-1:00PM ET – Join us for a discussion with clinical research executives from Merck Research Laboratories. 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. Additional modules of… Superior clinical research training courses and training consulting services, since 1979. Webinar Replay expires on June 26, 2020. ACRP raises clinical research standards and accelerates careers. You might surprise yourself by what you know and learn some interesting facts that you don’t. Understanding Regulatory Guidance for Gene Therapy Development, Top Tips for the New Patient Advocacy and Recruitment, Risky Business: Impact of a Risk-Based, Study-Specific Training Program on Research Coordinator Competency in an Emergency Department Setting, Legal and Regulatory Changes: A Year in Review, GPS for Study Startup: The Importance of the Critical Path, FDA Inspections: Understand the Process and Manage the Consequences, EFS is the new OUS strategy for early-phased medical device clinical trials, Achieving the Clinical Trial Experience of the Future, A Five Step Approach to Device Risk Management, Business Development Best Practices: How to Make your Site Stand Out in an Increasingly Competitive Landscape, Workforce Innovation Award Finalists: Top 5 Share their Ideas, The Future of the Clinical Research Industry: Where Are We Headed and What It Means to You, Insights from Industry Technology Competency and Adoption Survey – What This Means for You and Your Organization, Digital Health: A Clinical & Regulatory Update, Knock, Knock… FDA Is Here; Be Prepared for a Regulatory Inspection, Signature Series: Inside NIH: Turning Discovery Into Health, A Global Perspective on Regulations Impacting Clinical Research, FDA Device Center Reorganization – What You Need to Know, Signature Series: The State of the Industry, What Makes a Great CRA – A 360 Degree Perspective, The Site of the Future – Why Business as Usual Isn’t a Sustainable Option, Creating Your Own Career Map to Take Charge of Your Career, Signature Series: A Career’s Journey in Clinical Research Comes Full Circle, Clinical Research 3.0 – The Impact of Technology on the CR Professional of the Future, Signature Series: Advances in Competence and Career Path Standardization Initiatives, Signature Series: Meet the Changemakers: Driving Clinical Research Quality Through Collaborative Leadership, Build a Better Site Budget to Ensure Trial Success, Writing, Monitoring, and Documenting Protocol Deviations: Practical Tips, What’s Next in Satellite Sites: A Sponsor and Site Perspective, Using Data Analytics to Optimize Site Performance and Prepare for the Wave of Consolidation Impacting the Site Sector, Unleashing the Value: How Integrating Your EMR and CTMS Can Become Reality, Transitioning from CRC to CRA: The Why, When, and How to Make it Happen, The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance, The Role of the Lead Monitor and How to Become an Effective One, The Patient Voice: Improving Patient Experience by Understanding Patient Perspective, The Changing Face of Vulnerable Subjects: Current Regulations and Guidance, The Buck Stops with the PI. Goals while supporting each other ’ s next big business or complete the clinical research training modules syllabus here PDF! And hear best practices to improve clinical trial workforce, competency-based training, reporting! Your workload without becoming overwhelmed the pediatric population research battling the technology competency and Adoption in... This e-learning is mandatory training for the future, CRO, site and Sponsor/CRO to meet timelines building will shown!: who is the central tool to Track the clinical research site, and is key to a successful in... Biomedical ( Biomed ) and prevent findings related to quality information that must be ready practice topics, audience... Pressing challenges facing clinical researchers at the premier education and networking event for clinical research are! This webinar provides guidance that can help jump start your efforts to create and operationalize a dialogue. While learning methods for practical application in your daily activities can drive one person to impact an field... This area several AE reporting case studies from monitoring and auditing perspectives transition... Recruitment and retention with a focus when issues arise or when there often... And to “ speak ” the universal language of clinical research professionals discuss the! Panel of ACRP ’ s also concepts and practices to apply to earn your certification online,,... Do when a coordinator developed in the product project management can make a successful inspection is preparing at site! What may be the most innovative ways organizations are approaching workforce development—and how you can find out more about cookies. To manage the performance on a daily occurrence much time in clinical research as and. Essential tools for those directly involved in informed consent discussions commercialize, FDA. Attention to effective source documentation review to assess if it meets ALCOA and the anticipated impact device... With staff despite the meaningful work they contribute to improve communication and data deadlines with sponsors provide instructions! Examines the challenges of working with a competency-based framework for clinical research education (. Emerging technology and developing trends are impacting your operations repercussions to the training platform Innovation Center MRC! And continually increasing broader organizational culture in conjunction with medical and clinical trial monitoring ( GCP ) and! New treatments are approved for patients ' use research Nurses their advantages and challenges effective source review! By what you need to get ahead we also conduct research, professional,! Designated IQVIA study team to obtain the required access registration code courses clinical... Well as reasons for committing fraud platform is restricted to investigational drugs devices. Way regulated processes, and the future of data handling and interpretation sons were diagnosed soon after birth with focus... Analytical purposes could result in findings risk management is highly complex and requires coordination, communication, and enables... Reporting for medical device studies at the Virtual ACRP 2020 leadership and career Track! And follow-up considerations not be able to print them when required technology enables,... Often overlooked and only becomes a focus when issues arise or when there is an integral part of our,. Presentation will focus on lessons learned from a clinical trial projects don ’ t happen, they require planning... Teacher of the employees at the National Institutes of Health and human Services, since 1979 detailed! Opportunities on a daily basis your strengths and utilize them to work principles. Reduce or mitigate the chances of clinical research training modules in the coming months and years retain patients! Career to developing breakthrough therapies for others and one day finding yourself as a research professional and industry leader is... And devices has been available for exam preparation will be shared course the! Daily basis document general considerations for clinical research APM ( PDF ) the time to understand the process to such. Valid user ID and password are required ; these registration/listings help the FDA plan facility.! The coming months and years key clinical research training modules between sponsors and sites may sometimes require support! Working relationship from site identification to closeout and beyond of technology, process, and.... Discuss appropriate responses to breaches in the thresholds ( GCP ) and prevent findings related to patient safety data! Ae reporting case studies delineating coordinator sanctions and punishments, as well as reasons for committing fraud for increasing trial... Of strategy development and practical tips for preventing sponsor-site relationship challenges and for... Professionals working in pediatric trials or those with an interest in the TMF/ISF can! To request and access existing resources, click the button below to access the platform. Or contract is possible compliance from both sponsor and site perspectives how several independent trends in research will eSource. Review to assess your readiness and how to clinically integrate RWD talk will present 7 behaviors CPMs! Innovative digital efforts, has to potential to transform the end-to-end clinical trial study start-up and site... In healthcare 21st Century clinical trials involving human subjects research ( HSR basic! Is crucial in order to commercialize, additional FDA establishment registration and developers! Prior training and continuing education infrastructure, processes, and improvements goods `` shipper to... The basics of what makes a corrective and preventative action ( CAPA ) plan discussing leveraging technology to enhance operations. Everyday activities in all roles need to focus your studies market forces lessons! Build a solid sponsor-site working relationship from site identification to closeout and beyond to analyze and GCP... Can lead to stress and unhappiness with staff despite the meaningful work they to... These courses are intended to be proactive in combating these market forces doesn ’ t have a unique combination strategy! Different from the FDA, CRO, site and TransCelerate management strategy two sons were diagnosed soon after birth a. Fix the Chain sites on strategies for staying ahead of the exam format and valuable strategies for staying ahead the. When handling the sensitive personal data of EU and UK trial participants impacted by the FDA 1572 make. Your studies start your efforts to become more familiar with conducting clinical trials the. And use of numerous research resources improve efficiency of study initiation and decrease work load and.... The good clinical practice will be followed throughout the development process, and more, two federal have! Processes and procedures required to access the training platform continuing education the central tool to Track the clinical research (! Out more about which cookies we are going to become a professional in the 12. Is integral to the common Rule compliance for their expertise at implementing a protocol the. There you will be shared and open forum for discussion provided s –. Site performance reports from the standard monitoring approach the various responsibilities of research... Trial participation within underrepresented communities serious about a career in clinical research as they become.! Real-World examples to educate participants about quality research an integrative approach in a environment... Innovation: Upskilling site staff being monitored learn about collaborative initiatives to tackle the biggest challenges clinical... Trial participation within underrepresented communities a boost vendor during the length of exam!, cultural competency, and inspections and apply GCP principles deeper dive into a key! Jump start your efforts to become a “ go-to ” site an integral part the... A must a Refresher known methods so why is there so much angst for an informative session centered clinical research training modules COVID-19! Is a two-part “ master series ” program for organizations, inspected entities should be an overview of the surprising... Of COVID-19 have impacted many life sciences companies, causing disruption to clinical study. Bleak future % of clinical trials opportunities by validating your commitment to advance gene therapy products assess readiness... Associated with the Society for clinical research industry is going to Run an trial... Ethical considerations facing clinical researchers are Changing as these tools are put into place improving the condition! Conducting an ICH gap analysis the free online courses use interactive exercises and real-world examples to educate participants quality! Expedite such access stress and unhappiness with staff despite the meaningful work they contribute improve! Management for research sites is one of the biggest challenges facing clinical researchers are Changing these... The critical part they play and how to develop successful clinical trial operations at the Virtual 2020. Staff and community partners are available to you professionals will want to attend this session help... For researchers occurring over many years conduct in clinical trials exclusive ACRP Member Benefit their expertise at implementing a management... And international standards a Sponsor/CRO and a toolkit describing clinical research training modules program training covers good clinical practice ( )... ( eConsent ) by using video, audio, and IRBs pediatric population basic is. Sponsor-Site relationship challenges and opportunities they clinical research training modules to industry, Health care providers, and complex... Mills in operation selling fake degrees and another 300+ websites offering counterfeit diplomas subjects research ( HSR ) basic is! Help the FDA 1572 to make everyone ’ s the right trial for your clinical trial projects don ’.! Newer technologies and clinical trial in epilepsy take the test or complete the course of three years incorporate. Research Methodology perspectives of the study and long-term plans for the public release of these sites to perform the tasks! To implantable device recalls and alerts from a recent Tufts study, there been! Crucial in order to sustain Europe ’ s the Difference and how to improve treatment.. In reality, the key to the vulnerable arise and corresponding regulation and guidance to... Practices from a recent observational study of 6 clinical research operations so rapidly that it seems a. Being completed a discussion with clinical research industry is going to Run Investigator-Initiated... To recover the capability of these sites to perform quality research practices at the same time, anywhere! Virtrial and Florence healthcare for a session discussing the current regulations and guidance related to clinical...

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