Good Clinical Practice (GCP)

临床试验药物管理规范的准则是为世界各地的临床试验行为提供法律依据。最初它是欧盟,日本和美国开发的统一标准,同时也成为了其它国家,包括中国,印度,韩国和巴西等国家的基础模式。
4.5 (4 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.
60 students enrolled
$30
Take This Course
  • Lectures 66
  • Contents Video: 1.5 hours
  • Skill Level All Levels
  • Languages Traditional Chinese
  • Includes Lifetime access
    30 day money back guarantee!
    Available on iOS and Android
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 Traditional Chinese

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.

What are the requirements?

  • None

What am I going to get from this course?

  • 了解全球标准,以及在特定国家的重点差异(如中国)
  • 随时随刻可以灵活在网上了解你想要得到的信息
  • 使用更有效的视频教学
  • 选择中英对照的讲座
  • 内容涵盖 ICH 和 SFDA
  • 得到“混合教学“,导师在线支持
  • 融合了企业学习管理系统,SCORM

What is the target audience?

  • nurses
  • doctors
  • students

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
The Purpose of GCP
Preview
02:09
What Is GCP?
Preview
00:18
Why Do We Need GCP? Disasters
Preview
02:29
Why Do We Need GCP? Poor Research
Preview
00:56
Why Do We Need GCP? Recognise and Minimise Negative Effects
Preview
01:19
Why Do We Need GCP? Fraud, Ethics and Cost
Preview
02:07
The History of GCP
Preview
00:44
Declaration of Helsinki
02:33
The Purpose of GCP - Summary
00:32
Section 2: Global Harmonisation
Reasons for Harmonisation
01:55
History of Harmonisation
00:35
What Does ICH Mean?
01:00
Who Is ICH?
00:45
ICH Worldwide - Market Share
00:41
Importance of the Market
02:07
ICH Worldwide - Observers
00:30
ICH Topics
02:15
QSEM
00:51
ICH Guidelines
01:05
Efficacy Guidelines
00:49
Global Harmonisation - Summary
00:36
Section 3: ICH GCP E6 Guideline
ICH GCP E6 Guideline Intro
00:34
Structure
00:45
13 Principles
00:22
13 Principles Exercise
01:16
Roles and Responsibilities
00:34
Ethics Committee
03:01
Ethics Committee Composition
01:10
Ethics Committee Function
01:11
Investigators
02:36
Sponsors
01:59
Sponsor-Inverstigator Demarcation
00:56
ICH GCP E6 Guideline - Summary
01:43
ICH GCP E6 Guideline on Documentation
00:24
Section 4: Protocol
Protocol Intro
00:20
What Is a Protocol?
00:54
Content
03:15
Background
01:24
Objective and Purpose
01:42
Design Parallel
01:15
Design Crossover
00:12
Design Antibiotics
01:45
Design Migraine
01:33
Minimising Bias Randomisation
02:11
Minimising Bias Blinding
01:34
Choice of Comparators
00:59
Methodology - Patient Selection
03:49
Methodology - Assessment
06:53
Study Schedule
01:55
Statistical Considerations
01:43
Protocol - Summary Part 1
00:49
Protocol - Summary Part 2
01:40
Protocol Review
01:53
Section 5: Investigator Brochure
Investigator Brochure - Summary
01:02
Other Essential Documents
00:45
Section 6: Essential Documents
Documents for Different Study Phases
02:06
Source Data
01:48
CRF and Source Data
01:03
Essential Documents - Summary
00:17
Section 7: Course Roundup
Course Roundup Part 1
01:55
Course Roundup Part 2
02:15
Section 8: China SFDA GCP
SFDA Special Requirements 1
02:33
SFDA Special Requirements 2
01:05
SFDA Special Requirements 3
01:22
Course Roundup
00:22
SFDA Website
00:37

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