Good Clinical Practice For Clinical Research Professionals
MP4 | Video: h264, 1280×720 | Audio: AAC, 44.1 KHz
Language: English | Size: 702.63 MB | Duration: 2h 51m
A complete, certified ICH-GCP(R2) course for Investigators, Study Coordinators, Sponsors, Monitors and other Study staff
What you’ll learn
Identify and understand the ICH-GCP requirements throughout the conduct of clinical trials
Learn the 13 core principles of ICH-GCP and how to implement them in practice
Define the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and Investigators
Understand the purpose of the essential documents and the best practice for filing in the TMF
Identify common ICH-GCP inspection findings and how to avoid them
Understand the essential requirements and contents of the Investigator’s Brochure and the Protocol
Requirements
No prior working experience or knowledge in clinical research is required to attend this course
This course is dedicated to beginners as wells as to more advanced professionals willing to refresh their knowledge
Description
Welcome to the complete edition of the ICH-GCP (R2) course!This course offers the first, on-line Professional, complete, fundamental ICH-GCP (R2) 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 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. It provides full lifetime access to GCP Revison 2, and all subsequent Revisions of the GCP by the ICH. The course is updated on regular intervals to present the most up-to-date relevant information.My name is Dr. Vincent Baeyens PhD, I have more than 20 years of experience in running Clinical Trials (phase 1 to 4) 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.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.This course will provide you with a strong foundation to prepare for successful regulatory ICH-GCP inspections and audits.To do so, I will lead you step-by-step through the ICH-GCP E6, and you will be able to 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 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 and how to avoid themI 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!Several Quiz are proposed to test your knowledge along your journey. A final Quiz at the ens 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
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