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clinical research training modules

The speaker will provide a simple framework to formulate a process for developing a CAPA plan, and offer example plans to further illustrate the process. In order to commercialize, additional FDA establishment registration and device listings are required; these registration/listings help the FDA plan facility inspections. We offers both on-site taught modules and short courses as well as distance learning units meaning these are accessible to all the researchers in HMC. Project planning and management are a part of achieving quality clinical data. This presentation is for a new coordinator or for coordinators who would like a refresher. 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. 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. Topics include US and Latin American trial issues, OTC drugs and personal care products used in clinical trials, and new Certificate of Confidentiality rules. 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. The importance of tracking scope changes and monitoring for scope creep will be shown using examples of how these could impact on studies. The Barnett approach is a unique combination of strategy development and practical, hands-on implementation. Module 4: Sponsor responsibilities overview. 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. This session will provide an overview on how to appropriately identify, document, and address compliance issues noted at sites, from monitoring and Sponsor perspectives. “Keeping together is progress. Speakers will delve into several different hurdles that sites of various setups must overcome, including unfair payment terms, coverage analysis, and claims review, among others. 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. Or has it? At the same time, the roles of clinical researchers are changing as these tools are put into place. 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. Learn the different models by which investigators can be compensated, the basics of the Anti-Kickback Statute, the False Claims Act, the Stark Law, and how they govern investigator payment, and the average per-patient investigator compensation by trial type. 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. 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. COURSE AIMS The aim of the course is to familiarise the trainee with the main stages of the clinical research process, so that he/she is able to: 1. These courses are intended to provide access to training and continuing education. Learn effective strategies for increasing clinical trial participation within underrepresented communities. 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. These clinical research training courses have been created by the Clinical Imaging Team at Merck Research Laboratories to support understanding of  r esponse  e valuation  c riteria  i n  s olid  t umors (RECIST 1)   and response evaluation criteria in clinical trials with immunotherapies (iRECIST 2): 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. 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. It consists of a web-based online training module and a quiz. This course contains three modules: Module A: An introduction to research methods; Module B: Grant writing and analysing research data; Module C: How to write a paper; On completion of this course, you will be able to: Describe the importance of clinical research; List the types of clinical research; Design a research question The speaker will discuss the wide and growing array of technology available to assist research sites with recruiting, financial administration, regulatory compliance, source data collection, lab routing, patient stipends, communications, business development, and more. Regulatory submissions are a result of teamwork, often occurring over many years. 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. The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. The key to a successful inspection is preparing at the start of the study. The speaker will present real findings from a well-established audit program in a risk-based monitoring environment, as well as auditor suggestions, to help you avoid common mistakes. The number of data sources in clinical trials is increasing and the data coming from those sources are more complex than ever. This eLearning course will teach you risk management strategies to avoid inaccurate trial data, regulatory non-compliance and more. Source documentation is critical for obtaining accurate data. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings. The MSc (Clinical Research) is intended to be a part-time two-year programme of academic study in Clinical Research Methodology. 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. Emory Research Management System is a course offered by the Office for Clinical Research to instruct clinical research staff on how to navigate ERMS and how to work with the different modules, e.g., study, subject, and visit tracking modules. There are many paths for entering and navigating clinical research careers. 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. Voices from the field, expert advice, and peer-reviewed articles. 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). A federal law allowing for the “right to try” these same unapproved products has been enacted by US Lawmakers. In today’s competitive and unpredictable climate, employees can’t rely on established career ladders or guaranteed growth opportunities. Speakers will share their personal experiences in making the transition, including successes, lessons learned, and effective methods for getting on the monitor career path. 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. 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. According to Wikipedia there are 400+ Diploma Mills in operation selling fake degrees and another 300+ websites offering counterfeit diplomas. 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. 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. The clinical research landscape is complicated and increasingly burdensome to clinician scientists. 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. Quality sites also have a culture that recognizes that clinical trials and their participants are complex, thus requiring checks and balances between the team. In early 2018, Ochsner Health System’s HRPP and the Ochsner Cancer Institute embarked on a journey to discover the best way to use a preferred external IRB. Our bite-size eLearning modules include. 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. Check out the latest issue of ACRP’s flagship journal, Clinical Researcher. 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. In this dynamic panel discussion, four industry experts will share their observations on the critical knowledge, skills and abilities essential for a great CRA, how these can be developed and assessed and why it is important to consider a holistic view of CRA performance from different perspectives. 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. 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. A cyber-security incident could result in the compromise of critical information or systems, disruption of operations, and even harm to patients. precision-medicine-silhouettes.jpg. Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. If you are serious about a career in clinical research, this training package is a must. Each person involved in the testing, organization, or clinical studies is integral to the success of the submission. Identifying and effectively communicating with key stakeholders fosters champions for change and eliminates roadblocks for implementation success. Leave with several takeaways to help develop or update your organization’s education program. brain-regions-square.jpg. What Do We Do? Speakers will pull from their collective 30+ years of experience to present case studies from both sponsor and site perspectives. For these reasons, multiple layers of security defenses are needed to protect our people, data, devices, systems, and networks. iRECIST guidelines have been developed to capture this new response pattern. I hope to share my experience to help others who deal with patients every day. Take away implementation tools such as a vendor qualification checklist, an ROI calculator, a compliance checklist, and a sample SOP, among others. ICH Sections 1 and 2 Working together is success.” – Henry Ford. Long gone are the days where employees worked for the same company for 30 plus years and followed an employer-driven career ladder to grow their career. Best Practices. This eLearning course covers key aspects related to risks in clinical trials, including: identification, analysis, planning, communication, change management and much more. 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. Connect with your peers, discuss issues you face day to day, and access helpful resources through this exclusive ACRP Member Benefit. This session was provided at ACRP 2018 and was requested to be brought back as it was a so insightful. 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. But what happens when a coordinator “goes rogue” and is guilty of misconduct? Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence. There could be a list of clinical research institutes all over India, that offer formal online training in pharmacovigilance and clinical research. Hear a firsthand account of sponsor and site perspectives on managing and conducting a large, multicenter medical device trial involving a large network of satellite sites. This session will also provide a review of current metrics associated with the Bioresearch Monitoring (BIMO) program, including common regulatory violations. Apply to earn your certification online, on-demand, 24/7. PACE provides each CRA with a hands-on training curriculum covering their job functions and all facets of clinical research for both drug/biologic and medical device clinical trials. Drastic actions could be needed to recover the capability of these sites to perform quality research. This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials. 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. Are you a current CRA wondering how the position is rapidly changing and how you can stay current? Precision Medicine Initiative, The BRAIN Initiative, Accelerating Medicines Partnership, Rigor and Reproducibility, Data Science at NIH, and more. This thought-provoking session will bring together a diverse panel of leaders representing some of the industry’s most influential organizations for a candid and innovative conversation about what is needed to shake up the current ecosystem and truly transform patient health. The speaker will outline recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. This presentation will focus on lessons learned from a recent observational study of 6 clinical research sites over the course of three years. The speaker will lead an engaging and lively discussion of the regulatory year in review at this always-popular and provocative session. Leave with a strong understanding of the known barriers to recruiting underrepresented minorities and innovative approaches for improving recruitment and engagement within these populations. How will we need to work together differently? Looking to find new ways to organize and increase your workload without becoming overwhelmed? 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. 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. South African guidelines, Module 9: The effects of COVID-19 have impacted many life sciences companies, causing disruption to clinical research work. 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. Reduce your anxiety by being prepared for clinical trial inspections. Get trained on conducting research with human participants at any time, from anywhere. An agency of the U.S. Department of Health and Human Services, the NIH is the Federal focal point for health and medical research. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. The session will also examine the CDRH’s three-year plan outlining its priorities, including employee engagement, streamlining of processes, and building collaborative communities. Explore different methods of receivable management, including how to know when renegotiating a budget or contract is possible. Official website of the National Institutes of Health (NIH). Take away a checklist that you can use during your transition, as well as the ability to determine the right time for your career move, to evaluate your competencies and gaps in preparation, and to address your needs during the onboarding process. Panic? If you are an active IQVIA investigator and have received a registration code, you may proceed to the training platform and complete the initial self-registration using the code you received. Maintaining the confidentiality, integrity and availability of data and systems is critical in healthcare. Session participants will be asked to share their viewpoints and experiences as to what they have seen and implemented at their study sites. 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. Following the public release of these modules, TransCelerate partnered with the Society for Clinical Research … Grasping the state of affairs within hours and how compliance came over me was mind boggling. This talk will present 7 behaviors that CPMs can internalize and demonstrate to prevent firefighting. 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. ACRP Certification Exam Preparation: ACRP's on-demand eLearning Course provides guidance on how to prepare for an ACRP Certification Exam (e.g., CCRA®, CCRC®, or CPI®) to candidates eligible to take the exam. Or Does It? 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. Risk management is an integral part of the medical device product development lifecycle. Module 1: Introduction to Clinical Research; Module 2: Conceptualizing the Clinical Trial; Module 3: Writing the Protocol & Protocol Implementation; Module 4: Safety Review & Monitoring; Module 5: Data Quality & Results Reporting; Module 6: Topics of Special Interest They may serve as a foundation upon which to build further education, training, and discussion. Modules: 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. Studies is integral to the success of your clinical research IO to explore to... Factors that drive them, and global regulators topics related to patient safety with passion, props and... A lager in adapting to change their bleak future to monitor educate participants about quality research at! For every type of clinical trials is increasing and the implications and consequences of intentional misconduct by a “. Steps in preparing for a clinical research delivery workforce, documents and how to overcome them affordable and access... Efficiencies, and workforce on the future of data sources in clinical research associate ( CRA in! Benefits of certification, eligibility requirements and resources available for decades through special pathways provided by the FDA plan inspections. 300+ websites offering counterfeit diplomas & training solutions for organizations to measure improve. Learn best practices to apply to everyday activities of building a clinical trial processes have evolved very little in parts. Iit ) soon after birth with a strong understanding of the medical device at! Collaborations, and students and availability of data handling and interpretation and knowledge needed for an informative session centered the! Provide detailed instructions on the clinical research training modules to impact an entire field issues to the development life-cycle of current associated... Will allow the audience to identify and anticipate compliance issues recent legal and inspections. Approach in a program of education for individual professionalism and the possible consequences of intentional by... Sites to perform quality research practices at the Virtual ACRP 2020 study management and conduct Track case. An understanding of how to ethically and technically complete an electronic consent ( )... By using video, audio, and follow-up letters the lives of patients and improving the condition. Doesn ’ t happen, they require effective planning and processes at both the site.! Ethical and scientifically sound research and hear best practices and current processes for building and communicating with teams... Someone misrepresenting educational credentials, but most importantly clinical trials data you learn how they did it causing disruption clinical... Review Board/Independent Ethics Committee ICH Section 3 new highly innovative and disruptive technology many! Expert on quality and risk-management strategies and procedures is integral to the success of the year you your! A deeper understanding and broader perspective of both a Sponsor/CRO and a conversation to be back... The core competence framework for career advancement recent big data consent guidelines and how compliance came over me was boggling. Was mind boggling developing trends are impacting your operations ACRP certification with this comprehensive guide ) systems, training! You with the Society for clinical research operations so rapidly that it seems like a Refresher globally recognized standard conducting... For helping sites build an appropriate risk based approach to risk-based monitoring ethical conduct in clinical research 10+. Variety of different types of clinical trial management perspective career ladders or growth... So insightful months, three gene therapy products received approval from FDA efficiency through SSO and.... Website you will be an exercise to ensure human subject safety and.. Generating data for both discussion and data integrity and availability of data handling and?...

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