Clinical Trials Management Certificate This five-course certificate is designed for pharmaceutical and healthcare professionals who are interested or already participate in all aspects of clinical trials. We are a Virginia-based 501(c)(3) not-for-profit professional organization serving all people involved in clinical trials from volunteers to professionals. The Certificate in Pharmaceutical and Clinical Trials Management is open to candidates from the pharmaceutical and biotech industries, as well as graduate students in the sciences and engineering. It provides the tools and information needed to design, conduct and audit clinical trials of pharmaceuticals. The University of Delaware’s Clinical Trials Management Online Certificate Program is an approved Lower Level Health Science elective (3 credits) for Wilmington University’s Bachelor of Science degree in Health Sciences. For exam details, including eligibility requirements, visit Association of Clinical Research Professionals. Prior to her career in the pharmaceutical industry, she practiced as an RN in various clinical agencies and taught nursing in academia. By running a fully integrated course covering all key aspects of clinical trials, students will acquire a good understanding of the theoretical underpinning as well as the practical aspects of randomised clinical trials and have an in-depth training in trials methodology. This course trains participants on how to effectively and safely conduct clinical research.Topics covered in the course include: study design, measurement, statistics, ethical, legal, monitoring, and regulatory considerations, preparing and implementing clinical studies, additional study designs and more. This course is intended as an introduction to clinical trials for site staff who are new to clinical research and those from a non-clinical background. Students are expected to complete the program in 1 year (see schedule below). The curriculum of the Clinical Trials Management Online Certificate covers core concepts consistent with the Association of Clinical Research Professionals (ACRP) certification exams, a valuable credentialing opportunity for clinical research professionals. Courses for the Clinical Research Program are completed through continuing education on a course by course basis. This module provides an overview of the clinical and pre-clinical processes involved in setting up clinical trials, and the roles and responsibilities of those conducting and administering these processes. With this certificate, you will master the practical aspects of running and managing a clinical trial, including trial design and phases, good clinical practices, the drug discovery and development process, and quality control and assurance. Evaluation by the sponsor or agency regarding site and sponsor performance, Audits surrounding an NDA (New Drug Application) filing, random and for-cause, Introducing a product to health-care practitioners and consumers: market research, advertising principles, governmental rules and regulations, product branding, Effectively reporting the outcome of clinical trials, including unbiased reporting to potential consumers regarding the results, limitations, and availability of the new product, Required: a PC or Mac, laptop or desktop computer must be used to complete course activities like tests, quizzes, homework, or chats. Get answers to your questions regarding the online course immediately by chatting with our team online. It is perfect for retaining the material, making connections to other disciplines or already known information as well as inspiring thought and further research.”, “I feel passionate about the clinical trial path, and I believe the knowledge I’m gaining will further my goal of pursuing opportunities to enter this field.”, Common Productivity Challenges and How to Solve Them, Virtual Meeting Etiquette: Best Practices and Protocols for Productivity, Improving Your Personal Information Security and Awareness, Cultural Awareness and Diversity in the Workplace. Clinical Trials Management can be taken either full-time (one year) or part-time (two years). It is the first such course in Ireland and is provided by the HRB Clinical Research Facility at UCC, a world-class centre of excellence, with experts in clinical trial design and analysis. The Clinical Trials Management Online Certificate is offered 100% online and provides a broad overview of key competencies necessary for a successful understanding and conduct of the new product development process in today’s environment. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition. LOCATION: ONLINE — This is a self-paced online course with some scheduled requirements. All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. It is also ideal for staff who need a grounding in the clinical trials process without the need for a full ICH GCP course. This course is supported by grant number R25HS023214 from the Agency for Healthcare Research and Quality. This course is aimed at non-statisticians who work in clinical research and provides an introduction to the statistical methods used for the design, conduct and analysis of clinical trials. We recommend that team members leading and delivering research complete, as a minimum, the Introduction to Good Clinical Practice (GCP) course (online or face-to-face). 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. In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential. This course focuses on the theoretical underpinnings of clinical research and the practical aspects of conducting clinical trials: the rationale for design features of Phase I, II, and III trials, recruitment of participants, techniques for randomization, data collection and endpoints, interim monitoring, and results reporting. To receive the certificate, students must complete the course requirements listed below. This course focuses on the theoretical underpinnings of clinical research and the practical aspects of conducting clinical trials: the rationale for design features of Phase I, II, and III trials, recruitment of participants, techniques for randomization, data collection and endpoints, interim monitoring, and results reporting. Understand the use of statistics in designing clinical trials and analysis of results. The field of clinical research is focused on developing cost-effective ways to treat disease and increase quality of life through successful development and launch of new biologics, devices, and pharmaceuticals and by incorporating the science of genomics or personalized genetic prescribing. The course emphasises the application of statistical concepts to clinical research; aiming to demystify the subject and equipping delegates with the knowledge to read, understand, interpret and communicate data & statistics. By learning key concepts of clinical research, guidelines, regulations, and best practices for clinical studies, participants gain the skills needed to become part of an active clinical research workforce. By the end of the course, students should have the knowledge and skills required to design and undertake a clinical trial. The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. The certificate provides the fundamental knowledge to enter the field of clinical research. The course is self-paced and takes approximately six hours to complete. Of course, there are many other programs and courses available, and we urge you to do your own research as well before committing … A comprehensive guide to the practical application of International ICH-GCP. The purpose of this course is to introduce you to the process and procedures of monitoring a clinical trial as a clinical research associate working for a pharmaceutical or device manufacturer (known as the sponsor). ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. [The instructor] is very knowledgeable, and delivers the information as if she is having an informative informal conversation with you. Her recent work (with Diana Elbourne) focuses on issues around bereavement for parents, clinicians and trial teams in the context of neonatal intensive care trials. The research team collaborates across several business units, starting with the sponsor of the investigative new product, to the clinical site that collects ongoing data from subjects receiving the product, to the sponsor or designee who monitors the quality of the data being collected. What you'll learn Skip What you'll learn. The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. It is expected that students pursuing the Clinical Trials Management Certificate will have a strong science and/or health-care related background. 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