1: Introduction
Drug development process
Guidelines and regulations
Guidelines
Directive
Regulations
Management
Sponsor (GLP)
Test facility management
Test site management
Study director
Principal investigator
Quality assurance
Investigator
Overview of GLP
Objective of the guidelines
Who does GLP affect?
Financial implications
Setting up a laboratory facility to comply with GLP
Maintaining the laboratory
2: What is Good Laboratory Practice?
Responsibilities
Standard operating procedures
Study plans and reports
Data
Equipment
Computers
Test system
Test substance
Archives
Other standards
Enforcement
The inspectorate
Cost
Time
People involved
Legal implications
Pitfalls and benefits
3: What is good clinical practice?
Current status, directive/inspectorate
Declaration of Helsinki, ethics committees and institutional review boards
Main players
Cost implications
Standard operating procedures (SOPs)
Staff
Collaboration
Investigational product production
Paperwork
Lead product, time to approval and failure
Types of study
Major cost implications for sponsor companies
Investigational product production
The monitor and financial outlay
Site/CRO
Quality assurance
Central laboratories
Other laboratories
Patient costs
Insurance
Data handling and data management
Serious adverse events and adverse events
Reporting and expert reports
Conclusion
4: Case studies to be resolved by study management
Case study 4.1: Amendments and deviations
Introduction
Problems
Questions
Case study 4.2: Observations and data recording
Introduction
Problems
Questions
Suggested responses to case studies
Case study 4.1
Case study 4.2
Bibliography
References
Further reading
Useful Internet sites
List of Tables
Table 2.1: Test facility management responsibilities
Table 2.2: Study director responsibilities
Table 3.1: Sponsor responsibilities in GCP
List of Figures
Figure 1.1: Typical drug development schedule in Europe
Figure 1.2: Clinical studies project management in Europe
