GENE THERAPY ROAD MAP

GTAC Submission

Key Questions:

1. When should I submit my application?

   GTAC require all documents to be submitted 60 days before an agreed meeting date

2. What do I need to submit?

   These are some of the documents that will be required, full information can be found at http://www.advisorybodies.doh.gov.uk/genetics/gtac/

   1. GTAC application form
   2. Study protocol
   3. Patient information leaflet
   4. Consent form
   5. GP letter
   6. Investigators brochure
   7. Key researchers CVs

   NB. You will need to state a European Clinical Trials number (EudraCT) on your application. This can be obtained from http://eudract.emea.europa.eu/

3. What else will be required?

   Long-term monitoring of UK gene therapy recipients:
   Gene therapy is a novel approach to treating disease. It is hoped that it will eventually lead to effective and safe medical treatments. However, because long term effects of gene therapy treatments are unknown, GTAC has initiated a long term monitoring study of patients involved in gene therapy. For details, please see: http://www.advisorybodies.doh.gov.uk/genetics/gtac/flagging.htm

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