Good Clinical Practice Ich-Gcp For Clinical Investigators

A complete, certified ICH-GCP E6 (R2) course for Investigators, Study Coordinators and Site Clinical Research 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 Investigators
Identify common ICH-GCP inspection findings and how to avoid them
Define the roles and responsibilities of each involved key stakeholder, and key processes in clinical research
Requirements
No prior working experience or knowledge in clinical research is required to attend this course
his course is dedicated to beginners as wells as to more advanced Investigators or Site staff willing to refresh their knowledge
Description
Welcome to the complete edition of the ICH-GCP (R2) course!This course offers the a fundamental ICH-GCP (R2) course for Investigators, Co-investigators, Study Coordinators,  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 Investigators.This course will provide you with a strong foundation to prepare for successful site 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 and key processes involved The ICH-GCP Principles and practical advices to apply them in your clinical trialsThe detailed responsibilities of the Investigator throughout the trial, including qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reportingThe 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!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

Overview

Section 1: Introduction

Lecture 1 What is ICH-GCP (Revision 2)

Lecture 2 The Declaration of Helsinki

Lecture 3 The future of ICH-GCP

Section 2: Definitions of terms

Lecture 4 GCP and Clinical Study

Lecture 5 Key stakeholders in a Clinical Study

Lecture 6 Key Processes in a Clinical Study

Lecture 7 Key Essential Documents

Lecture 8 Investigational Products (IPs)

Section 3: The 13 Principles of ICH-GCP R2

Lecture 9 Principles of GCP

Section 4: Responsibilities of the Investigator

Lecture 10 Qualifications and Agreements

Lecture 11 Adequate Resources (ADDENDUM R2)

Lecture 12 Medical Care of Trial Subjects

Lecture 13 Communication with IRB / IEC

Lecture 14 Compliance with Protocol

Lecture 15 IPs, Randomization Procedures and Unblinding

Lecture 16 Informed Consent of Trial Subjects

Lecture 17 Records and Reports (ADDENDUM R2)

Lecture 18 Progress Report and Safety Reporting

Lecture 19 Premature Termination or Suspension of a Trial and Final Report by Investigator

This course is intended to Investigator, study nurse, study coordinator or other study site personal willing to comply with ICH-GCP