Essential Documentation within Clinical Research

Essential Documentation within Clinical Research, available at $27.99, has an average rating of 4.35, with 6 lectures, based on 106 reviews, and has 2945 subscribers.

You will learn about This course will look at the purpose of Essential Documents. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and with all applicable regulatory requirements. This course is ideal for individuals who are This course is for anyone woking with clinical research or with a keen interest. It is particularly useful for This course is for anyone woking with clinical research or with a keen interest.

Enroll now: Essential Documentation within Clinical Research

Summary

Title: Essential Documentation within Clinical Research

Price: $27.99

Average Rating: 4.35

Number of Lectures: 6

Number of Published Lectures: 6

Number of Curriculum Items: 6

Number of Published Curriculum Objects: 6

Original Price: £99.99

Quality Status: approved

Status: Live

What You Will Learn

This course will look at the purpose of Essential Documents. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and with all applicable regulatory requirements.

Who Should Attend

This course is for anyone woking with clinical research or with a keen interest.

Target Audiences

This course is for anyone woking with clinical research or with a keen interest.

This comprehensive course for Essential Documents will give you all the required information you need regarding documentation required for the conduct of a clinical trial. This course will cover

•Define Essential Documents and their purpose

•Understand what ICH GCP E6 R2 says about Essential Documents

•Investigate eTMF systems and their place in accurate storage and retrieval of Essential Documents

•Understand how to archive Essential Documents according to ICH GCP standards

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction

Chapter 2: 2) Defining and Understanding Essential Documents

Lecture 1: 2) Defining and Understanding Essential Documents

Chapter 3: 3) Clinical trial Masterfile (part 1)

Lecture 1: 3) Clinical Trial Masterfile (part 1)

Lecture 2: 3) Clinical Trial Masterfile (part 2)

Chapter 4: 5) Summary

Lecture 1: 5) Summary

Chapter 5: 6) Bonus Content

Lecture 1: 6) Bonus Contents

Instructors

Linda Hopkinson
Director at Training Online 4U

Rating Distribution

1 stars: 6 votes
2 stars: 5 votes
3 stars: 32 votes
4 stars: 34 votes
5 stars: 29 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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