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.