The Purpose of GCP
- Course Overview
- The Purpose of GCP
- What Is GCP?
- Why Do We Need GCP? Disasters
- Why Do We Need GCP? Poor Research
- Why Do We Need GCP? Recognise and Minimise Negative Effects
- Why Do We Need GCP? Fraud, Ethics and Cost
- The History of GCP
- Declaration of Helsinki
- The Purpose of GCP - Summary
Global Harmonisation
- Reasons for Harmonisation
- History of Harmonisation
- What Does ICH Mean?
- Who Is ICH?
- ICH Worldwide - Market Share
- Importance of the Market
- Disease-Prevalence and Population versus Market
- ICH Worldwide - Observers
- ICH Topics
- QSEM
- ICH Guidelines
- Efficacy Guidelines
- Global Harmonisation - Summary
ICH GCP E6 Guideline
- Structure
- 13 Principles
- Make the 13 Principles Part of Your Work
- Roles and Responsibilities
- Ethics Committee
- Ethics Committee Composition
- Ethics Committee Function
- Investigators
- Sponsors
- Sponsor-Inverstigator Demarcation
- ICH GCP E6 Guideline - Summary
- ICH GCP E6 Guideline on Documentation
Protocol
- Protocol Intro
- What Is a Protocol?
- Content
- Background
- Objective and Purpose
- Design Parallel
- Design Crossover
- Design Antibiotics
- Design Migraine
- Minimising Bias Randomisation
- Minimising Bias Blinding
- Choice of Comparators
- Methodology - Patient Selection
- Methodology - Assessment
- Study Schedule
- Statistical Considerations
- Protocol - Summary Part 1
- Protocol - Summary Part 2
- Protocol Review
- Investigator Brochure
Essential Documents
- Essential Documents - Intro
- Documents for Different Study Phases
- Location
- Archiving
- Important Essential Documents
- Source Data
- CRF and Source Data
- Essential Documents - Summary
Course Roundup
- Course Roundup Part 1
- Course Roundup Part 2
- GCP Quiz
Bonus Chapter: GCP in China CFDA (formerly SFDA)
- China CFDA GCP - Intro
- CFDA Special Requirements 1
- CFDA Special Requirements 2
- CFDA Special Requirements 3
- Course Roundup
- CFDA Website
