Good Clinical Practice Iso 14155 Of Medical Devices

Complete ISO GCP Course of Clinical Investigations with Medical Devices for Clinical Research Professionals

What you'll learn

What is a medical device, scope and regulatory framework of ISO 14155

Understand essential Safety and Clinical Definitions in ISO 14155

Identify and understand the ISO 14155 GCP requirements throughout the planning and conduct of clinical investigations with medical devices

Learn the core principles of ISO 14155 GCP

Define the roles and responsibilities of each involved key stakeholder: Ethics Committees, Sponsors and Investigators

Review the main findings at the sites and sponsors of audits and inspections of clinical investigations

Reflect upon ISO 14155 GCP deviations as a Sponsor and/or Investigator

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 this complete edition of the ISO 14155 GCP course of Clinical Investigations with Medical Device!This course offers the first professional, 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 with Medical Devices. This GCP course is maintained up-to-date with upcoming revisions as they become available.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 ISO GCP requirements to plan, conduct,  clinical trials with Medical Devices in humans. We will review the role and responsibilities of the key stakeholders.To facilitate the learning of beginner students, the course has been broken up on purpose in several small lectures.This course will provide you with a strong support to prepare for successful regulatory GCP inspections and audits.I will lead you step-by-step through the ISO 14155 GCP, and you will learn & understand:What is a Medical DeviceRegulatory framework of ISO 14155Common ISO GCP audit and inspection findings in clinical investigations (sponsor/investigator)Scope of ISO 14155ISO 14155 Good Clinical Practice principlesThe responsibilities of ethics committees,  principle investigators and sponsorHow to effectively plan a Clinical InvestigationWhat are the key steps to conduct a Clinical InvestigationWhat to focus upon in order to be audit and inspection-readyReflect upon potential deviations to ISO 14155 GCPs and  possible action planPlease note that, for copyright reasons, I am not allowed to share the copy of the ISO 14155 norm. 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!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 a Medical Device?

Lecture 2 Regulatory Framework of ISO 14155

Lecture 3 Most Common ISO 14155 Inspection Findings

Section 2: Scope

Lecture 4 Scope and Domains of Application of ISO 14155

Section 3: Definitions of Key Terms in ISO 14155

Lecture 5 Safety Definitions

Lecture 6 Clinical Definitions

Section 4: Summary of Good Clinical Practice Principles with Medical Devices

Lecture 7 The 13 Principles of Good Clinical Practice

Section 5: Ethical Considerations

Lecture 8 General Ethical Principles

Lecture 9 Responsibilities of the Ethics Committee

Lecture 10 Protection of Study Participants and Informed Consent Process

Section 6: Clinical Investigation Planning

Lecture 11 Overview of Clinical Investigation Planning

Lecture 12 Risk Management Cycle and Areas

Lecture 13 Investigator’s Brochure (IB) and Clinical Investigation Plan (CIP)

Lecture 14 Case Report Forms (CRFs) and Data Monitoring Committee (DMC)

Lecture 15 Monitoring Plan • Investigator Selection • Agreements • Labelling

Section 7: Clinical Investigation Conduct

Lecture 16 Submission

Lecture 17 Sites Initiation

Lecture 18 Sites Monitoring Activities

Lecture 19 Close-out and Reporting

Section 8: Responsibilities of the Sponsor

Lecture 20 Clinical Quality Management

Lecture 21 Risk Management

Lecture 22 Clinical Investigation Planning and Conduct

Lecture 23 Outsourcing Duties and Functions

Lecture 24 Communication with Regulatory Authorities

Section 9: Responsibilities of the Principal Investigator

Lecture 25 Qualification of the Principal Investigator and the Site

Lecture 26 Communication with the Ethics Committee

Lecture 27 Informed Consent Process

Lecture 28 Compliance with the Clinical Investigation Plan (CIP)

Lecture 29 Medical Care of Subjects

Lecture 30 Safety Reporting

Section 10: Audit and Inspection Readiness

Lecture 31 Content of the Audit of a Sponsor

Lecture 32 Content of the Audit of an Investigation Site

Section 11: Conclusion

Lecture 33 Conclusion

This course is intended to all professionals involved in clinical research, such as clinical project manager, investigator, study nurse, study coordinator willing to comply with ISO 14155 GCP