- Basic
-
Provides some background knowledge and basic definitions
Basic Protocol
Basic Management
Basic Ethics and Laws
Basic Documents
Basic Safety
Basic Data Management
Basic Statistic Methodology
Basic Quality and Risk
Basic Monitoring
Basic Drug or Device
Basic Biobanking
- Concept
-
Starts with a study idea
Ends after having assessed and evaluated study feasibility
Concept Protocol
Concept Management
Concept Ethics and Laws
Concept Documents
Concept Safety
Concept Data Management
Concept Statistic Methodology
Concept Quality and Risk
Concept Monitoring
Concept Drug or Device
Concept Biobanking
- Development
-
Starts with confidence that the study is feasible
Ends after having received ethics and regulatory approval
Development Protocol
Development Management
Development Ethics and Laws
Development Documents
Development Safety
Development Data Management
Development Statistic Methodology
Development Quality and Risk
Development Monitoring
Development Drug or Device
Development Biobanking
- Set-Up
-
Starts with ethics and regulatory approval
Ends after successful study initiation
Set-Up Protocol
Set-Up Management
Set-Up Ethics and Laws
Set-Up Documents
Set-Up Safety
Set-Up Data Management
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Monitoring
Set-Up Drug or Device
Set-Up Biobanking
- Conduct
-
Starts with participant recruitment
Ends after the last participant has completed the last study visit
Conduct Protocol
Conduct Management
Conduct Ethics and Laws
Conduct Documents
Conduct Safety
Conduct Data Management
Conduct Statistic Methodology
Conduct Quality and Risk
Conduct Monitoring
Conduct Drug or Device
Conduct Biobanking
- Completion
-
Starts with last study visit completed
Ends after study publication and archiving
Completion Protocol
Completion Management
Completion Ethics and Laws
Completion Documents
Completion Safety
Completion Data Management
Completion Statistic Methodology
Completion Quality and Risk
Completion Monitoring
Completion Drug or Device
Completion Biobanking