The top 4 Clinical Practice courses you need to take

1. Good Clinical Practice for Clinical Research Professionals

4.5

(537)

Updates: September 2023: Updated section of ICH GCP R3 Draft Principles and added resource documentationAugust 2023: Added list of Acronyms and Abbreviations used in the course (section 1)June 2023: Added DRAFT ICH 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)-Welcome to the only up-to-date, complete edition of the ICH GCP  course! This course meets the Minimum Criteria for ICH E6 (R2) 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 (R2) 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. This ICH-GCP course also presents elements of ICH GCP E6 (R3) as they become available currently under revision by ICH. My name is Dr. Vincent Baeyens PhD, I have 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 and I am also an expert in CRO Management and Oversight, budgeting and Risk Management.  In this course, you will be able to understand based on my experience the key ICH GCP requirements 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 GCP E6, 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)I will 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 ALL the 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...

2. Good Clinical Practice (GCP)

4.2

(313)

The principles of Good Clinical Practice (GCP) underpin the legal requirements for the conduct of clinical trials around the world. Originally developed as a unified standard by the European Union (EU), Japan and the United States (US), it also forms the basis of national regulation in many other countries, including China, India, Korea and Brazil. A strong understanding of GCP is a fundamental requirement for anyone intending to develop a career in any aspect of clinical research, whether in industry, healthcare provision or academia. This course introduces GCP for new professionals, but also serves as a refresher for those who feel they need it. The programme is clear and simple in design and gives full instructions for use. Multi user pricing options are available. Contact us for more information...

3. Good Clinical Practice ICH GCP for Clinical Research

4.5

(710)

***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!!----------------------------------------------...