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WP n.º

9

Title

T&C Database and Interactive assessment tool 

Short description 

The WP9 is responsible for producing the dynamic tools that incorporate the methodologies and technical information developed by the EuroGTP II project.

Specific objectives

 

  • To produce the Interactive Assessment Tool that will be developed based on the outcomes defined in the EuroGTP II Guide. The Interactive Assessment Tool will provide information related with procedures, protocols and clinical data required to ensure quality and safety.
  • To produce the T&C Database based on contents developed by the WP 6, 7 and 8, and an overview of the present “state of the art”

 

Expected outcomes

 

  • Global T&C Database of products, processes, therapies and current state of implementation and authorisation, will be produced based on bibliographic review of reference documents. This compendium will contain dynamic information, in an easy to interpret format that should be continuously assessed and updated to keep pace with technical and clinical developments.
  • Interactive assessment tool will consist in an “algorithm” implemented in a user friendly interface that should become available on-line, and could be used by TEs professionals and National Competent Authorities for practical assessment of extended studies and follow-up programs needed to implement, evaluate and authorise a novel T&C product, process or therapy.

 

How the work will be carried out

Both outcomes of WP9 will be highly dependent on the information gathered by experts of WP5, 6, 7 and 8.T&C Database will integrate a maximum number of cases (products/therapies) in order to allow the validation of its structure and functionality.

The interactive assessment tool will be based on the risk factors associated to novel products/processes/therapies identified by the WP5,6 7 and 8, and will consist in a website/online platform with a user friendly accessibility, that applies the ‘decision algorithm’ developed as methodologies and criteria for demonstrating safety and quality.

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