Good Clinical Practice (GCP)
3.7 (27 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.
312 students enrolled
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Good Clinical Practice (GCP)

Key features of the GCP guideline, roles and responsibilities involved and the requirements of essential documentation.
3.7 (27 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.
312 students enrolled
Last updated 1/2014
English
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Current price: $10 Original price: $30 Discount: 67% off
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Includes:
  • 1.5 hours on-demand video
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
What Will I Learn?
  • 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
View Curriculum
Requirements
  • None
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.

Who is the target audience?
  • This course introduces GCP for new professionals, but also serves as a refresher for those who feel they need it.
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Curriculum For This Course
71 Lectures
01:38:23
+
The Purpose of GCP
10 Lectures 16:19
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Global Harmonisation
13 Lectures 13:31
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
+
ICH GCP E6 Guideline
12 Lectures 13:48
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
+
Protocol
20 Lectures 33:05
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
+
Essential Documents
8 Lectures 11:04
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
+
Course Roundup
2 Lectures 02:53
Course Roundup Part 1
01:35

Course Roundup Part 2
01:18

GCP Quiz
21 questions
+
Bonus Chapter: GCP in China CFDA (formerly SFDA)
6 Lectures 07:43
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
About the Instructor
SONIC - High Quality Training for Over 20 Years
4.3 Average rating
362 Reviews
6,247 Students
51 Courses
Training Company

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.