FDA Submission Package

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    • #4292
      Cedric De Smet
      Participant

      Dear all,

      Could you tell me where to file the FDA Submission Package containing CDISC Data? We would propose to file the FDA Submission Package (including Final Analysis Data) in a subfolder or zip-file that contains the whole package in 11.03.10 (FA Output). Is this correct in your opinion?

      Thank you,
      Best regards,
      Cedric

    • #4302
      Kathie Clark
      Participant

      You would probably file this under
      11.03.09 Final Analysis Datasets The datasets used for the final analysis/case report tabulation (CRT) package. If required, study-level submission datasets can be filed here.
      11.03.01 Data Definitions for Analysis Datasets To define the programming logic required to transform the raw dataset to the analysis dataset; includes populations, etc.; as outlined in the SAP.

      But a couple of additional points here:
      * Although not unheard of, it’s actually pretty rare to maintain datasets in eTMF. This is because they can’t usually be accessed directly from eTMF. MHRA, for example, recommends leaving live datasets were they can be accessed. However, if you have no other secure and compliant repository, this may be an option.
      * Where is this information maintained when used for regulatory publishing? Will you end up with multiple sources of truth? There will need to be a strong process to ensure that submitted datasets = datasets stored in eTMF
      * SAS data normally needs to be maintained as a package or collection that includes specific program versions, input files, etc. so that the HA can recreate your results. Will this approach support this?
      * If you decide to go ahead I think a zip file is fine

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