Good Clinical Practice for Medical Writers from E6 to E3 GCP

Name: Good Clinical Practice for Medical Writers from E6 to E3 GCP
Rating: 3.5 (2 reviews)

How to excel in medical writing within the framework of GCP

Created byGiovanna Gelmi

Last updated 12/2023

English

What you'll learn

Understand the Foundations of GCP: Grasp the fundamental principles of Good Clinical Practice (GCP) and its significance in the context of medical writing.
Master ICH GCP E6 (R3) and E3: Explore the key concepts and requirements outlined in ICH GCP E6, focusing on how they impact the role of medical writers.
In-Depth Exploration of ICH GCP E3: Take a detailed dive into ICH GCP E3, specifically focusing on Clinical Study Reports (CSRs).
Enhance Clinical Writing Skills: Develop advanced skills in mw for clinical trials, ensuring clarity, accuracy, and adherence to regulatory guidelines.
Stay Updated on Emerging Trends: Explore emerging trends and technologies in clinical research and medical writing, ensuring that you stay ahead in this field.

Course content

5 sections • 27 lectures • 3h 19m total length

Is GCP legally binding?2:44
In this lesson you will have a Good Clinical Practice (GCP) Overview:
• GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.
• ICH-GCP E6 is a fundamental guideline, and ICH-GCP E3 focuses on the structure and content of clinical study reports (CSRs).
Moreover, there is a clarification about GCP Legal Requirements:
• GCP compliance is a legal obligation in Europe for trials of investigational medicinal products.
• In the United States, ICH GCP guidelines are recommended but not statutory.
• GCP is a unified international standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate mutual acceptance of clinical trial data.
Introduction to GCP_ Questions & Answers
GCP Timeline3:44
The Historical Background of GCP:
• GCP's origins trace back to the aftermath of World War II and the Nuremberg Trials, emphasizing the protection of human rights and ethical conduct in research.
Differences between GCP and GPP4:11
The differences between GCP and GPP will be outlined:
• GCP is internationally recognized, legally enforceable, and mandatory for clinical trials, while GPP (Good Pharmacoepidemiology Practices) is not internationally endorsed, voluntary, and provides guidance for pharmacoepidemiologic research without legal obligations.
Do not confuse GCP, GMP and GLP5:19
All those "G" can be confusing! Here is the distinction between GMP and GLP clearly expressed:
• Good Laboratory Practice (GLP) governs research processes, GCP focuses on ethical and scientific quality in clinical trials, and Good Manufacturing Practice (GMP) ensures product quality in manufacturing.
Importance of GCP for a Medical Writer1:20
GCP is crucial for medical writers involved in clinical trial documentation to ensure ethical and scientific quality, compliance, and the protection of participants' rights and safety.
Understanding and adhering to GCP is essential for maintaining research integrity, ethical conduct, and the safety of participants in clinical trials.
To sum up3:12
In this session, you have learned the following aspects of GCP:
GCP Overview: Ethical and scientific standards for clinical trials.
Legal Requirements: GCP compliance in Europe, recommendations in the U.S.
Applicability: Unified standard for global clinical trial data acceptance.
Historical Background: Origin post-WWII and Nuremberg Trials.
GCP vs. GPP: Enforceable GCP vs. voluntary GPP distinctions.
Distinction from GMP and GLP: Focus on ethical quality in clinical trials.
Importance for Medical Writers: Crucial for documentation integrity and compliance.
Great job on the session! Keep up your good work in understanding GCP nuances!
True or False ?

GCP Revision Process9:30
In today's lesson, we will explore the key changes in Good Clinical Practice (GCP) E6 from its second to third revision, emphasizing its significance for medical writers.
The revision procedure for GCP involves updating outdated content or incorporating new information, following a systematic process mirroring the Formal ICH Procedure.
The ongoing development of GCP E6 (R3) reached Step 2_b in the ICH process, with a draft released for public consultation until September 2023, focusing on interventional clinical trials in Annex 1.
Please note that this information may be subject to updates, according to GCP E6 (R3) evolution.
Q&A Session10:48
In the Q&A session, classical questions that pop up during GCP courses are answered and explained. You are not alone in this course, other people are learning with you and constantly improving the quality of the course!
Q&A
GCP E6(R3) Introduction and Principles7:31
Overview of the key aspects of I. INTRODUCTION and II. PRINCIPLES OF ICH GCP as outlined in ICH GCP E6(R3). (Rows: 1-264)
Good Clinical Practice (GCP) principles

Institutional Review Boards/Independent Ethics Committees (IRB/IEC)_Part_17:17
Overview of the key aspects of Institutional Review Boards (IRB) or Independent Ethics Committees (IEC) as outlined in ICH GCP E6(R3). (Rows: 266-437). In this lesson IRB composition and IRB responsibilities are explained.
Institutional Review Boards/Independent Ethics Committees (IRB/IEC)_Part_24:44
Overview of the key aspects of Institutional Review Boards (IRB) or Independent Ethics Committees (IEC) as outlined in ICH GCP E6(R3). (Rows: 266-437). In this lesson IRB procedures are explained.
Institutional Review Boards/Independent Ethics Committees (IRB/IEC)_Part_36:48
Overview of the key aspects of Institutional Review Boards (IRB) or Independent Ethics Committees (IEC) as outlined in ICH GCP E6(R3). (Rows: 266-437). In this lesson IRB communication and submission processes are explained.
Institutional Review Board/Independent Ethics Committee (IRB/IEC)
Investigator_Part_14:31
Overview of the key aspects of the Investigator’s Role and Responsibilities as outlined in ICH GCP E6(R3).
(Rows: 439-920). In this lesson, we will delve into the investigator's responsibilities, qualifications, and training. Communication with IRB and compliance with protocol will be analyzed here.
Investigator_Part_23:11
Overview of the key aspects of the Investigator’s Role and Responsibilities as outlined in ICH GCP E6(R3).
(Rows: 439-920). Premature termination or suspension of a trial, participant medical care and informed consent of trial participants will be discussed here.
Investigator_Part_34:27
Overview of the key aspects of the Investigator’s Role and Responsibilities as outlined in ICH GCP E6(R3).
(Rows: 439-920). A complete summary of the key takeaways of the previous lessons about the investigator is at your disposal.
Investigator
Sponsor5:49
Overview of the key aspects of Sponsor’s Role and Responsibilities as outlined in ICH GCP E6(R3).
(Rows: 922- 1812)
Q&A about Sponsor7:47
Q&A about the Sponsor and summary of the key takeaways of the Sponsor’s Role and Responsibilities as outlined in ICH GCP E6(R3).
Sponsor

Appendix A14:01
Appendix A introduces the Investigator's Brochure (IB), an essential document that compiles both clinical and nonclinical data on investigational products relevant to their study in human participants.
Multiple choice test about the investigator brochure (IB)
Exercises_IB
Appendix B19:45
Appendix B in ICH GCP E6(R3) is my favorite one as I like trial protocols and Appendix B is all about clinical trial protocol and protocol amendment(s). And you? Do you like writing trial protocols?
Translate Scientific Jargon and vice versa
Appendix_C_Part_113:48
Essential and potential records required for conducting clinical trials according to Appendix_C in ICH-GCP E6 R3.
Appendix C_Part_26:42
Why are essential records so important? Managing essential records.
Appendix_C_Part_37:55
How does a potential essential record become an essential record?
Appendix_C

How to write a Clinical Study Report ( CSR) according to ICH GCP E3_Part_112:25
This lesson will cover the Clinical Study Report from the Title Page to the Efficacy Evaluation
How to write a Clinical Study Report ( CSR) according to ICH GCP E3_Part_212:55
This lesson will cover the second part of the Clinical Study Report
How to write a Clinical Study Report ( CSR) according to ICH GCP E3_Part_312:08
This lesson will end the Clinical Study Report
How ICH GCP E3 integrates with overall GCP compliance4:24
In the context of overall Good Clinical Practice (GCP) compliance, ICH GCP E3 is just one part of a broader framework. GCP is a set of international ethical and scientific standards for designing, conducting, recording, and reporting clinical trials and E3 integrates with it at various levels, as explained in this lesson.
Summary of the key takeaways about ICH GCP E33:02
Compliance with ICH GCP E3 contributes to overall adherence to GCP principles. CSRs are, in fact, a critical component of regulatory submissions. ICH GCP E3 focuses on the structure and content of Clinical Study Reports (CSRs) for regulatory submissions.

Requirements

Knowledge of ICH GCP E6 (R2)
Familiarity with medical terminology would be beneficial
Basic understanding of clinical research
This course is designed for both beginners looking to enter the field and experienced professionals seeking to deepen their knowledge in GCP for effective medical writing.

Description

Are you a medical writer ready to enhance your skills and understanding of Good Clinical Practice (GCP)? This course is designed specifically for medical writers like you!

Elevate your clinical writing skills with this in-depth course covering from ICH GCP E6 (R3) essentials to an immersive exploration of ICH GCP E3 (Step 5).

It is based upon the principles delineated in the ICH GCP E6 (R3) framework, tailored to serve as an educational solution to the needs of medical writers seeking to acquire a comprehensive understanding of Good Clinical Practice (GCP).

Good Clinical Practice (GCP) is the ethical and scientific standard that ensures the integrity, quality, and credibility of clinical trials. As a medical writer, mastering GCP is key to effectively communicate and report clinical trial findings.

The course is crafted to provide you with a deep understanding of GCP principles, with a special focus on ICH GCP E6 (R3) for a solid introduction. We then take a detailed exploration into ICH GCP E3 (Step 5) and critical aspects of clinical trial documentation.

Of particular emphasis is the training's targeted orientation toward the specific documents that medical writers are tasked with generating in strict accordance with GCP standards. This orientation is fortified by practical models and an interactive learning approach.

Key Sessions:

· Introduction to GCP Principles E6 (R3)

· ICH GCP E6 (R3) - Key Concepts

· ICH GCP E3 - In-depth Analysis

· The Role of CSRs in Clinical Research

· CORE: stay updated with emerging trends

It is worth noting, however, that this training does not confer an official certification, which, as per regulatory stipulations, necessitates biennial renewal. Such recertification is mandatory for all individuals engaged in clinical trial activities, particularly those interfacing directly with patients, such as coordinators, site personnel, and monitors.

Furthermore, it is important to acknowledge that certain sponsors may mandate their own GCP training program, which could require participants to undertake it even if they possess a currently valid certification from another source.

Who this course is for:

Medical Writers
Aspiring Regulatory Medical Writers
Clinical Research Professionals involved in documentation
Regulatory Affairs Professionals
Individuals transitioning into medical writing roles
Anyone involved in clinical trial documentation
Anyone interested in mastering GCP principles for effective clinical writing

Good Clinical Practice for Medical Writers from E6 to E3 GCP

What you'll learn

Explore related topics

Course content

GCP General Framework6 lectures • 21min

From GCP E6 (R2) to ICH GCP E6(R3)3 lectures • 28min

GCP E6 R3 Annex 1 and its protagonists: IRBs/IEC, Investigator and Sponsor8 lectures • 45min

Appendix A, B and C5 lectures • 1hr 2min

Overview of ICH GCP E35 lectures • 45min

Requirements

Description

Who this course is for: