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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

  • 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

  • Develop a framework for clinical trial preparedness.

  • Develop a roadmap to a data-sharing network.

  • Generate clinical trial preparedness approaches, tools and training.

  • Promote functionality for centralised and online training for sites & laboratories.

  • Create a pandemic preparedness plan for the conduct of clinical trials in disease outbreaks.

 
Activities

  • Task 5.1: Define critical capabilities for clinical trial preparedness and related capacity development activities.

  • Task 5.2: Create a module in CTC for the clinical trial preparedness framework of sites and laboratories.

  • Task 5.3: Implement and populate the system supporting the clinical trial preparedness framework with CD resources.

  • Task 5.4: Create a pandemic preparedness plan for the conduct of clinical trials in disease outbreaks.

 
Expected Outcomes

  • Designed a quality management framework for a clinical site/lab.

  • Identified training sources and resources.

  • CTC platform module created and resources available.

  • Designed framework for clinical trials to be conducted during an outbreak.

 
Freedoms

  • Other partners can be involved in the creation of CTC content, but it should be adapted to the local context when needed.

 
Constraints

  • CTC is only applicable for the African continent and infectious disease area.

  • Budget.

Responsible Consortium Partners

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