Friday, January 16, 2009

GIDB - Global Integrated DataBase

From the desk of Dante.

Early in the planning stage of your GIDB and SAP {Statistical Analysis Plan} remember for clinical safety data, FDA is asking pharmaceutical companies to integrate their data in this manner:

  • Phase 2-3 database - dose-finding and pivotal studies
  • Phase 1 database - "some pooling across all studies".

Also, an ISS {Integrated Safety Summary} is often required, even though the eCTD submission backbone assigns safety data to Module 2.7.4, the Clinical Summary of Safety.

I strongly advise an open communication and negotiation with FDA concerning data presentation and integration in your submission, however, in my experience, the above rule almost always applies with global safety data.

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