Good Clinical Practice (GCP)

Key features of the GCP guideline, roles and responsibilities involved and the requirements of essential documentation.
3.8 (14 ratings) Instead of using a simple lifetime average, Udemy calculates a
course's star rating by considering a number of different factors
such as the number of ratings, the age of ratings, and the
likelihood of fraudulent ratings.
276 students enrolled
$19
$30
37% off
Take This Course
  • Lectures 71
  • Length 1.5 hours
  • Skill Level All Levels
  • Languages English
  • Includes Lifetime access
    30 day money back guarantee!
    Available on iOS and Android
    Certificate of Completion
Wishlisted Wishlist

How taking a course works

Discover

Find online courses made by experts from around the world.

Learn

Take your courses with you and learn anywhere, anytime.

Master

Learn and practice real-world skills and achieve your goals.

About This Course

Published 10/2013 English

Course Description

The principles of Good Clinical Practice (GCP) underpin the legal requirements for the conduct of clinical trials around the world. Originally developed as a unified standard by the European Union (EU), Japan and the United States (US), it also forms the basis of national regulation in many other countries, including China, India, Korea and Brazil.

A strong understanding of GCP is a fundamental requirement for anyone intending to develop a career in any aspect of clinical research, whether in industry, healthcare provision or academia.

This course introduces GCP for new professionals, but also serves as a refresher for those who feel they need it. The programme is clear and simple in design and gives full instructions for use.

Multi user pricing options are available. Contact us for more information.

What are the requirements?

  • None

What am I going to get from this course?

  • Understand the global standard, and key variations in specific countries (eg, China)
  • Learn when and where you want, with the flexibility of online learning
  • Learn more effectively with video lecture capture
  • Choose between lectures delivered in English or Chinese
  • The topics cover ICH and SFDA standards
  • Integrate with corporate learning management systems via SCORM compliance

What is the target audience?

  • This course introduces GCP for new professionals, but also serves as a refresher for those who feel they need it.

What you get with this course?

Not for you? No problem.
30 day money back guarantee.

Forever yours.
Lifetime access.

Learn on the go.
Desktop, iOS and Android.

Get rewarded.
Certificate of completion.

Curriculum

Section 1: The Purpose of GCP
00:58

You can download the ICH GCP Guidelines from the link below.

The Purpose of GCP
Preview
01:06
What Is GCP?
Preview
00:27
Why Do We Need GCP? Disasters
Preview
02:44
Why Do We Need GCP? Poor Research
Preview
01:27
Why Do We Need GCP? Recognise and Minimise Negative Effects
Preview
01:17
Why Do We Need GCP? Fraud, Ethics and Cost
Preview
03:13
The History of GCP
00:47
Declaration of Helsinki
03:50
The Purpose of GCP - Summary
00:30
Section 2: Global Harmonisation
Reasons for Harmonisation
00:39
History of Harmonisation
00:43
What Does ICH Mean?
01:12
Who Is ICH?
01:03
ICH Worldwide - Market Share
00:32
Importance of the Market
01:31
Disease-Prevalence and Population versus Market
00:43
ICH Worldwide - Observers
00:34
ICH Topics
02:13
QSEM
01:02
ICH Guidelines
02:05
Efficacy Guidelines
00:47
Global Harmonisation - Summary
00:27
Section 3: ICH GCP E6 Guideline
Structure
00:42
13 Principles
00:30
Make the 13 Principles Part of Your Work
01:18
Roles and Responsibilities
00:34
Ethics Committee
02:40
Ethics Committee Composition
00:41
Ethics Committee Function
01:41
Investigators
01:00
Sponsors
01:23
Sponsor-Inverstigator Demarcation
01:16
ICH GCP E6 Guideline - Summary
01:41
ICH GCP E6 Guideline on Documentation
00:22
Section 4: Protocol
Protocol Intro
00:13
What Is a Protocol?
00:37
Content
03:32
Background
01:17
Objective and Purpose
01:38
Design Parallel
01:11
Design Crossover
00:09
Design Antibiotics
01:48
Design Migraine
01:36
Minimising Bias Randomisation
02:16
Minimising Bias Blinding
01:32
Choice of Comparators
00:56
Methodology - Patient Selection
02:40
Methodology - Assessment
04:47
Study Schedule
01:44
Statistical Considerations
01:39
Protocol - Summary Part 1
00:47
Protocol - Summary Part 2
00:46
Protocol Review
01:38
Investigator Brochure
02:19
Section 5: Essential Documents
Essential Documents - Intro
01:34
Documents for Different Study Phases
00:35
Location
02:54
Archiving
03:06
Important Essential Documents
00:51
Source Data
01:14
CRF and Source Data
00:31
Essential Documents - Summary
00:19
Section 6: Course Roundup
Course Roundup Part 1
01:35
Course Roundup Part 2
01:18
GCP Quiz
21 questions
Section 7: Bonus Chapter: GCP in China CFDA (formerly SFDA)
China CFDA GCP - Intro
01:01
CFDA Special Requirements 1
03:42
CFDA Special Requirements 2
00:53
CFDA Special Requirements 3
01:30
Course Roundup
00:18
CFDA Website
00:19

Students Who Viewed This Course Also Viewed

  • Loading
  • Loading
  • Loading

Instructor Biography

SONIC Performance Support is a leading provider of e-learning and performance support solutions. We proudly serve individuals, government agencies, schools and businesses of all sizes. SONIC Performance Support provides high-quality video training, that is used by well-known domestic and foreign companies. With video based training, you have a personal coach explaining and demonstrating the task at hand. You can stop the video, perform the task in the application, and rewind if you want to review.

Ready to start learning?
Take This Course