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Clinical Trial Preparedness Framework
The main objectives of Work Package Five are to:
Develop a framework
Develop a framework for clinical trial preparedness.
Develop a roadmap
Develop a roadmap to a data-sharing network.
Preparedness tools and training
Generate clinical trial preparedness approaches, tools and training.
Promote functionality
Promote functionality for centralised and online training for sites & laboratories.
Pandemic preparedness
Create a pandemic preparedness plan for the conduct of clinical trials in disease outbreaks.
Description of Work
What and Why
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Design a clinical trial and pandemic preparedness framework along with the relevant capacity development activities in order to conduct clinical trials in Africa with efficiency, effectiveness, and quality.
Goals
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Develop a framework for clinical trial preparedness.
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Develop a roadmap to a data-sharing network.
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Generate clinical trial preparedness approaches, tools and training.
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Promote functionality for centralised and online training for sites & laboratories.
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Create a pandemic preparedness plan for the conduct of clinical trials in disease outbreaks.
Activities
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Task 5.1: Define critical capabilities for clinical trial preparedness and related capacity development activities.
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Task 5.2: Create a module in CTC for the clinical trial preparedness framework of sites and laboratories.
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Task 5.3: Implement and populate the system supporting the clinical trial preparedness framework with CD resources.
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Task 5.4: Create a pandemic preparedness plan for the conduct of clinical trials in disease outbreaks.
Expected Outcomes
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Designed a quality management framework for a clinical site/lab.
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Identified training sources and resources.
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CTC platform module created and resources available.
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Designed framework for clinical trials to be conducted during an outbreak.
Freedoms
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Other partners can be involved in the creation of CTC content, but it should be adapted to the local context when needed.
Constraints
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CTC is only applicable for the African continent and infectious disease area.
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Budget.
Responsible Consortium Partners
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