Courses

Our course series on ICH Good Clinical Practice equips trial investigators and clinical researchers with the essential knowledge required to conduct reliable and ethical clinical trials. Whether you are new to the field or an experienced professional, this course series provides the background needed to ensure participant safety, data integrity, and compliance with international regulations.

Complete, Certified ICH GCP E6 (R3) Course for Investigators, Study Coordinators, Sponsors, Monitors and Study staff What you'll learn: Identify and understand the ICH-GCP requirements throughout the conduct of clinical trialsLearn the core principles of ICH-GCP R3 and how to implement them in practiceDefine the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and InvestigatorsUnderstand the purpose of the essential documents and the best practice for filing in the TMFUnderstand the essential requirements and contents of the Investigator's Brochure and the ProtocolPractice on real cases: Identify common ICH-GCP inspection findings (FDA warning letters) and how to avoid themPractice on real cases: Conduct a gap analysis in your organization based on a real MHRA inspection report Welcome to the only up-to-date, complete edition of the ICH GCP course!This course meets the Minimum Criteria for ICH E6 GCP Investigator and Site Personnel Training that TransCelerate has identified as necessary to enable mutual recognition of GCP training.This course offers the first professional, fundamental on-line ICH GCP detailed course for Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials.My name is Dr. Vincent Baeyens PhD, Ihave more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma, and Biotech settings. I have worked with most of the Global as well as several niche CROs andI am also an expert inCRO Management and Oversight, budgeting and Risk Management. In this course, you will be able to understand based on my experience the key ICH GCPrequirements to design, conduct, record and report clinical trials in humans from A to Z. We will review the role and responsibilities of the key stakeholders and the structure of the essentials documents.To facilitate the learning of beginner students, the course has been broken up on purpose in several small lectures.Note: If you are a more advanced student, you can increase the speed of lecture to learn the course at your own pace.This course will provide you with a strong support to prepare for successful regulatory ICH GCP inspections and audits.I will lead you step-by-step through the ICH GCPE6, and you will learn & understand: What is GCP and why GCP is important in clinical researchThe link between the Declaration of Helsinki and current GCPThe definition of the key definitions of terms and concepts used in clinical research, including stakeholders involved and essential documentsThe ICH GCP Principles of Revision 2 and Revision 3 and practical advices to apply them in your clinical trialsThe responsibilities of ethics committees, its composition, function, operational aspects and obligationsThe detailed responsibilities of the Investigator throughout the trial, including his/her qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reportingHow to write an adequate Protocol / protocol amendment and rationale for its structureThe What, the Why and the How for an effective writing of the Investigator's BrochureThe purpose of Essential Documents in clinical research: How and Where to file them in the Trial Master File (TMF)The common ICH GCP audit and inspection findings in clinical trials with practical exercises (FDA, MHRA) Iwill illustrate the GCP concepts with several practical tips & tricks , so that you will be able to apply ICH GCP to your daily practice from Day 1!Quizzes are proposed to test your knowledge along your journey. A final Quiz at the end of the course will consolidate your knowledge.Feel free to look at the content of the course to know more and contact me any time if you have any questions!After the course, spend 1 hour with the EXPERT to answer ALLthe questions that you would have!! All you have to do is to send me an e-mail with your questions and contact details, and I will set up a call with you.I am of course available personally during the course as well to answer your questions or comments! I am looking forward to seeing you inside the course! Sincerely, Vincent---Updates:July 2025: Updated with ICH-GCP(R3)guidelineJune 2024: Added ICH-GCP(R3) Annex 2concept paperJanuary 2024: Updated Bonus section; added the ICH-GCP(R3) Overview of comments received on Step 2. Comments will now be sent to the ICH E6 (R3) Expert Working Group for consideration in the context of Step 3 of the ICH process.September 2023: Updated section of ICHGCPR3Draft Principles and added resource documentationAugust 2023: Added list of Acronyms and Abbreviations used in the course (section 1)June 2023: Added DRAFTICH GCP(R3) Annexe 1 (interventional clinical trials), its summary of changes and explanatory video in the resources. This version is made available by the ICH for public consultation until September 2023 (step 2 of the ICH process)May 2023: Added link to ICH E8 (R1) in resources of quality managementFebruary 2023: Added awareness of the most common GCP findings (lecture 4)January 2023: Edited English subtitles, adding French subtitlesDecember 2022: Added assignment: Practical risk assessment based on UK MHRA inspection report (section 11)October 2022: Added assignment: Practical exercises from real FDA inspection cases (section 10)September 2022: Added updates on ongoing development of Revision 3 of ICH-GCP (section 12)

Certification on ICH GCP E6 R2 Good Clinical Practice for Clinical Research The Only Complete Course You Can Find Online What you'll learn: What Good Clinical Practices Are?Guidelines of What An Ethical And Safe Trail Is?The Rights And Importance Of Consent Of The Trial SubjectsThe Duties Of The Sponsor And Investigator Of The TrialWhat Is International Council For Harmonization?Aims Of ICHHow Was ICH Established?The Importance Of ICHGroups Working Within ICHICH GCP E6 R2 Efficacy GuidelinesLink Between ICH And GCPAll About The Institutional Review Board, Investigators, Sponsors, Clinical Trial Protocol And Protocol Amendment, Investigator’s Brochure, Essential Documents ***Why this course is considered as a TOP RATED and BEST SELLING course for the ICH GCP category on Udemy?***See what students are talking about in this course:5***** Star RatingI’m very glad I enrolled in this class! There’s so much information to be absorbed and she did a great job in presenting everything in as much detail as possible, but at the same time simplifying it to make your learning experience a lot smoother. This is a great course if you’re just starting out and want to know the fundamentals of GCP. This master class has it all! ---Devon Roman5***** Star RatingShe is a great instructor, very transparent, cuts out all the BS getting straight to the meat and potatoes of the subject at hand, exactly how I like to learn.I am happy about investing in this course. The videos are over the shoulder at the right pace explaining the process of understanding the clauses.The course has left me feeling confident that I can achieve my goals, plus I had so much fun learning.If you create any more courses, you have a repeat customer in me.--- Rebecca5***** Star RatingVery well constructed course covering all the topics I was interested in. Really liked the step-by-step approach and tasks broken into manageable chunks, allowing me to absorb the information. The tutor was great, the notes were very helpful and I made a lot of use of the Quizzes and Assignments section.Highly recommend the course for either a beginner or someone with some experience but a bit rusty (such as me).--- Reshma 5***** Star RatingShe is an amazing teacher, the best I could find so far. She is knowledgeable, explains very well, has a nice and soothing voice, and has a great sense of presentation.The course is also more hands-on than a lot of other courses where you practically just watch guys read. She explains clauses practically who ICH GCP E6 document.If you want to learn and understand GCP or clinical research in general, this is a great place to start.--- Varun P5***** Star RatingThis is an excellent, cost-effective, and comprehensive course and I'm so glad to enroll in the class. Plus, I've learned so much from the basics that have been taught. I'm so grateful to have the instructor spending time to develop this course and share knowledge. Again, thanks, and this course is highly recommended!--- Dennis Clayton5***** Star RatingThe content was helpful and this was a nice quick review.--- Ayesha A. Rizvi, Ed.D.5***** Star RatingThe information is explained in a detailed manner--- Monique Brown5***** Star RatingBravo--- Tshering JAMTSHO--------------------------------------------------------------------------------------------COMPLETE COURSE DESCRIPTION:Welcome to the complete ICH Good Clinical Practices E6 R2 course.In this course, we will learn what Good clinical practices are, guidelines of what an ethical and safe trial is, the rights and importance of consent of the trial subjects, the duties of the sponsor and investigator of the trial, and much more. Basically, I will walk you through the entire GCP guidelines document step by step.My name is Warda Naz, and I will be leading you through this course.Here at Magine Solutions highly experienced instructors, engineers, and doctors with more than 10 years of experience in the industry will guide you through very high-quality online courses.At the end of the course, you will be able to understandWhat is International Council for harmonization?Aims of ICHHow was ICH established?The importance of ICH.Groups working within ICHEfficacy GuidelinesWhat are Good clinical Practices (GCP)?The link between ICH and GCPAll about the Institutional review board, investigators, sponsors, clinical trial protocol and protocol amendment, investigator’s brochure, essential documents for the conduct of a clinical trial, and much more.We will also learn to understand these concepts by looking at case studies to strengthen the theoretical concepts.The ideal student for this course is anyone who wants to learn about the ICH GCP E6 document or an existing professional who wants to expand on their current skills. There are no requirements necessary to enroll. I only ask to come open-minded and ready to learn.Feel free to take a look at the course description and I look forward to seeing you inside. Thank you!!--------------------------------------------------------------------------------------------

Learn how to manage your manager. In this course, adapted from the podcast How to Be Awesome at Your Job, Mary Abbajay explains how to build a good relationship with your boss.

Explore the critical role of forensic medicine in clinical practice through this 25-minute video lecture by Prof. (Dr.) Mohammed Nasimul Islam. Gain valuable insights into crime scene investigation, post-mortem procedures, and providing medical aid to the court of law. Delve into various aspects of forensic medicine, including types of injuries, antimatter, color analysis, non-accidental injuries, and sexual assault cases. Learn about the importance of chain of custody, informed consent, and proper medical history documentation. Discover techniques for preventing contamination, conducting standardized clinical examinations, and handling sterilized items and hair evidence. Enhance your understanding of forensic medicine's application in rendering justice through medical knowledge and ethics.

Welcome to 'Introduction to Good Clinical Practice'! This course is designed to introduce you to the basic principles and practices of Good Clinical Practice (GCP), which are essential for conducting clinical trials and ensuring the safety and well-being of human subjects. Whether you are new to the field or seeking to refresh your knowledge, this course and its sequel courses covering the fundamentals of Good Clinical Practice will equip you with the necessary skills and understanding to begin to navigate the complex world of clinical research. Developed by industry experts, the course offers an introduction to the key concepts, guidelines, and regulatory requirements outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP guidelines. During this course, you will explore the essential elements of Good Clinical Practice and gain insights into its significance in the global clinical research arena. By the end of the course, you will have a solid understanding of the principles of GCP and its role in ensuring the integrity and reliability of clinical trial data. The course is divided into several modules, each covering specific aspects of GCP. The modules include video lectures and interactive quizzes to reinforce your learning. You can progress through the course at your own pace, allowing you to fit your studies around your existing commitments and responsibilities. We are excited to embark on this learning journey with you as we delve into the world of Good Clinical Practice. Enroll now and start building a strong foundation in clinical research ethics and regulations!

Learn how to create and manage apps with SCCM and prepare for Microsoft certification exam 70-703. See how to deploy apps using PowerShell scripts, and deploy App-V virtual apps.

The preventive aspect and importance of nutrition are well-known for both deficiency and chronic diseases. The importance of nutrition on global health is demonstrated in the Sustainable Development Goals for 2030 as set by the United Nations General Assembly, as nutrition is considered a cornerstone for 12 out of 17 of these goals. Nutrition has a positive effect on health as well as on economic growth. Clinical nutrition described as the basic interdisciplinary and applied science that deals with the prevention, diagnosis and management of nutritional and metabolic changes related to acute and chronic diseases for both patients in healthcare institutions or those who receive care periodically as outpatients, is an old concept but the importance is hardly recognized. Aiming to emphasize the importance of clinical nutrition, this course equips you with evidence-based insights and practical know-how on nutrition-related solutions. By providing you with this information, the course broadens your conceptual knowledge towards the context & background-independent application of nutrition-related issues due to chronic and infectious disorders. Our evidence-based practice approach will allow you as a decision-maker to identify the relevant evidence for practice while taking into account the sociocultural background and wishes of a patient. This evidence-based practice approach will eliminate the ‘trial & error’ approach in favor of better health outcomes and originates from North and South countries. This course is taught by instructors with decades of experience in clinical nutrition, dietetics, endocrinology, and gastroenterology. The instructors are teachers/lecturers and researchers in these fields at universities in Europe (KU Leuven, Department of Chronic Diseases and Metabolism) and in Africa (Stellenbosh University, Division of Human Nutrition; University of Ghana, Department of Nutrition and Dietetics; University of Rwanda, School of Public Health, and University of Zimbabwe, Institute of Food and Nutrition) which is the uniqueness of this course. By being able to apply the evidence-based practice of clinical nutrition in different situations you will be able to function as a linking pin between research and practice with experience from North & South countries. Such profiles align strongly with the future outlook of nutrition-related needs as reported by organizations like the World Food Programme, World Health Organization, United Nations Children's Fund, and International Committee of the Red Cross. This MOOC was created with the support of the KU Leuven Faculty of Medicine

This course teaches you the fundamentals of transforming clinical practice using predictive models. This course examines specific challenges and methods of clinical implementation, that clinical data scientists must be aware of when developing their predictive models.

Explore aminoglycoside use in clinical practice with safe and effective methods Aminoglycosides are a powerful class of antibiotics commonly used to treat severe infections. On this three-week course, build your foundational understanding of how these antimicrobials work, when and how to use them, and how to monitor patients effectively. Explore how aminoglycosides work and when to use them Begin by investigating the mechanisms of aminoglycosides and the bacterial infections they are designed to treat. You’ll review clinical indications, including empirical therapy, monotherapy, and prophylactic use, as well as risks and potential adverse effects. Through case studies and real-world applications, you’ll contextualise their clinical relevance. Master dosing, pharmacokinetics, and therapeutic monitoring Take a deeper dive into pharmacokinetics and pharmacodynamics, focusing on effective dosing strategies and therapeutic drug monitoring (TDM). You’ll explore how gentamicin and other aminoglycosides are administered and adjusted in real clinical settings, ensuring both efficacy and safety. Apply aminoglycoside strategies in special patient groups The final week focuses on optimising aminoglycoside use across diverse patient populations, including those with renal impairment, neonates, older adults, pregnant patients, and those with extreme body weight. You’ll also consider resistance mechanisms and stewardship strategies to ensure responsible antimicrobial use. This course is aimed at healthcare professionals interested in the clinical application of aminoglycosides, including dosing, monitoring, and stewardship.

This test prep course is designed to help you review information that you need to know for the Association of Social Work Boards (ASWB) Clinical licensing exam. Consult this course's engaging lessons and practice quizzes to make sure you've mastered all the concepts that appear on the test.

Learn about the transformative potential of artificial intelligence in ECG interpretation through a comprehensive presentation by Senior Data Scientist Manolis Kargiantoulakis from GE HealthCare's Diagnostic Cardiology division. Explore current applications and future developments of AI technology in clinical ECG analysis, understanding how machine learning algorithms can enhance diagnostic accuracy and streamline cardiac care workflows. Gain insights into the practical implementation of AI-ECG systems in healthcare settings and discover the evolving landscape of cardiac diagnostics powered by artificial intelligence.

This section includes Security Identity Manager best practices and troubleshooting topics.

Great leadership doesn't happen by chance—it happens by design. This course helps you create and evolve a personalized leadership checklist that keeps you focused on what matters most. You'll learn the core components of an effective checklist, from daily practices to strategic responsibilities, and how to structure them for clarity and action. Through practical tools, case examples, and hands-on activities, you'll build a Version 1 of your leadership checklist, test it against real challenges, and refine it as your role evolves.

Build sustainable practices in modern healthcare Healthcare systems are under increasing pressure to become more environmentally and economically sustainable. As climate change and resource scarcity intensify, healthcare professionals must adapt their practices to protect both patients and the planet. This course offers a practical, forward-thinking approach to sustainable healthcare, empowering you to make changes that matter. Understand sustainability in the healthcare ecosystem Begin by exploring the broader ecosystem of sustainable healthcare. Learn about key stakeholders, regulatory frameworks, and global health trends driving the shift toward greener clinical practices. You’ll examine how issues like waste, emissions, and chemical use affect hospital operations, patient outcomes, and community health. Apply sustainable solutions to healthcare operations Next, you’ll discover actionable strategies to implement sustainable practices in your day-to-day work. From optimising resource use and improving waste management to reducing transportation emissions and energy consumption, you’ll gain practical tools that enhance clinical efficiency while minimising environmental impact. Lead change with strategy and collaboration Explore how hospitals and clinics can foster a culture of sustainability. You’ll delve into examples of successful initiatives, analyse real-world case studies, and engage with your peers to design a sustainability strategy tailored to your healthcare environment. This collaborative, hands-on approach ensures you’re ready to lead change in your workplace. This course is for healthcare professionals – nurses, doctors, and hospital staff – who want to integrate sustainability into daily clinical practice and operations.

This course is designed to teach you about Extended Reality (XR) and how it's used in healthcare education and clinical practice. Using lessons from experts in the field and different case studies, this course shows you how to use this innovative technology in a way that creates sustainable, accessible real-world applications. The course considers Extended Reality (XR) from a number of perspectives. First of all, you will learn about the hardware and software considerations, then focus on education structures and frameworks and how Extended Reality is applied appropriately within this context. The final two weeks demonstrate how XR has been applied in real-world clinical practice and how you can best make use of the technology by understanding the impact of interdisciplinary expertise in the field. Overall, this course will help you to advance your use of Extended Reality, whatever your background, in clinical training and technologically-enhanced healthcare education contexts. You will also have the optional pathway of developing a business case alongside fellow learners. The business case can be the first step in promoting your XR idea or project to different stakeholders.

Looking for a consistent and reliable way to install Windows applications? Learn about the Chocolatey package manager.

Learn how to interpret medical literature to make guided patient care decisions On this course, you will learn how to apply the key principles of evidence-based medicine in practice. You will explore the basic applications of p-values, power and statistical tests that are typically found in medical literature. You will discover how to interpret number-needed-to-treat, number-needed-to-harm and noninferiority studies through medical literature examples. You will also understand and review the pros and cons of clinical practice guidelines and decipher the appropriate application of these guidelines in practice. This course is for professionals or students looking to build their clinical pharmacokinetic knowledge. You might be an undergraduate pharmacy student, a postgraduate pharmacy student or a pharmacist in clinical practice.

Welcome to 'Fundamentals of Good Clinical Practice: Recruitment and Trial'! This is the third course in the Clinical Trial GCP series. It is designed to introduce you to the processes, procedures and documentation needed prior, during and after a clinical trial according to Good Clinical Practice (GCP). In Courses One and Two, we explored the foundations of clinical research, including the preparations and documentation needed to begin a trial as well as the role of the investigator, site staff and the IRB/IEC. We conclude our GCP studies with this final course. The course is divided into several modules, each covering specific stages of a clinical trial. The modules include a variety of videos, a fictional case study and interactive quizzes to reinforce your learning. Enroll now and start building a strong foundation in the conduct of clinical research!

Use this engaging test prep course to help you prepare for the UK Clinical Aptitude Test (UKCAT). Our short video lessons and self-assessment quizzes can help build your confidence ahead of the exam so you can do your best on test day.