Published 6/2022
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
Overview
Section 1: Introduction
Lecture 1 Welcome and Objectives
Lecture 2 What is ICH-GCP (Revision 2) and what problems does it solve?
Lecture 3 The Declaration of Helsinki
Lecture 4 The future: ICH-GCP (Revision 3)
Section 2: Definitions of key terms used in GCP
Lecture 5 GCP and Clinical Study
Lecture 6 Key stakeholders in a Clinical Study
Lecture 7 Key Processes in a Clinical Study
Lecture 8 Key Essential Documents
Lecture 9 Investigational Products (IPs)
Section 3: The 13 Principles of ICH-GCP (R2)
Lecture 10 Principles of GCPs and Practical Advices
Section 4: Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
Lecture 11 Responsibilities of Ethics Committees
Lecture 12 Responsibilities of the Investigators towards the IRB/IEC
Lecture 13 Composition, Function and Operating Criteria of Ethics Committees
Lecture 14 Procedures and Records
Section 5: Responsibilities of the Investigator
Lecture 15 Qualifications and Agreements
Lecture 16 Adequate Resources (ADDENDUM R2)
Lecture 17 Medical Care of Trial Subjects
Lecture 18 Communication with IRB / IEC
Lecture 19 Compliance with Protocol
Lecture 20 Investigational Product(s), Randomization Procedures and Unblinding
Lecture 21 Informed Consent of Trial Subjects
Lecture 22 Records and Reports (ADDENDUM R2)
Lecture 23 Progress Report and Safety Reporting
Lecture 24 Premature Termination or Suspension of a Trial and Final Report by Investigator
Section 6: Responsibilities of the Sponsor
Lecture 25 Quality Management (ADDENDUM R2)
Lecture 26 Quality Assurance and Quality Control
Lecture 27 Contract Research Organization (CRO)
Lecture 28 Medical Expertise and Trial Design
Lecture 29 Trial Management, Data Handling, and Record Keeping
Lecture 30 Investigator Selection
Lecture 31 Allocation of Responsibilities, Compensation, Financing
Lecture 32 Notification/Submission to Regulatory Authority, Confirmation of Review by ECs
Lecture 33 Information and Manufacturing of IPs
Lecture 34 Supplying / Handling IPs, Record Access, Safety Information, ADR Reporting
Lecture 35 Monitoring (ADDENDUM R2)
Lecture 36 Audit
Lecture 37 Non Compliance (ADDENDUM R2)
Lecture 38 Premature Termination / Suspension of a Trial, Clinical Trial/Study Reports
Lecture 39 Multicentre Trials
Section 7: Clinical Trial Protocol and Protocol Amendments
Lecture 40 General Administrative Information
Lecture 41 Background Information, Trial Objectives and Purpose
Lecture 42 Trial Design
Lecture 43 Selection and Withdrawal Criteria, Treatment of Subjects, Assessments
Lecture 44 Statisitics, and other Key Sections
Section 8: Investigator’s Brochure (IB)
Lecture 45 Introduction
Lecture 46 General Considerations
Lecture 47 Contents of the IB
Section 9: Essential Documents
Lecture 48 Introduction: Definition, and Purpose (ADDENDUM R2)
Lecture 49 Essential Documents Filing Before the Clinical Phase of the Trial commences
Lecture 50 Essential Documents Filing During the Clinical Conduct of the Trial
Lecture 51 Essential Documents After Completion or Termination of the Trial
Section 10: Conclusion and Final Quiz
Lecture 52 Conclusion
This course is intended to all professional involved in clinical research, such as clinical project manager, investigator, study nurse, study coordinator willing to comply with ICH-GCP
Homepage
https://www.udemy.com/course/good-clinical-practice-for-clinical-research-professionals/
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