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- W2186384329 abstract "As the management of FDA submission data has become more automated, the amount of data that the FDA has to keep track of has grown rapidly. In an attempt to manage this growing mountain of data, the FDA issues Technical Specifications Documents that stipulate rules that submission data should follow to help the review process proceed as smoothly as possible. The most recent version, Study Data Technical Conformance Guide, was issued in December 2014, and contains a link to 314 validation rules that are being proposed to take effect with the Prescription Drug User Fee Act VI (PDUFA VI) in 2017. This presentation includes a survey of the validation rules and identifies resources that you can use to ensure that submission data complies with them. We provide a detailed discussion of 12 high-level rules that apply to folders, transport files, and data sets; we also provide utility programs to help evaluate whether your submission complies with those rules. Currently, FDAC036 – Variable length is too long for actual data is a rule that is not often observed. We explain why it is so important to comply with this rule and provide access to a utility program that ensures that your character variables are just wide enough to store the longest value that they need to contain. Another rule, FDAC016, is that data sets whose transport files are larger than 1 GB must be split into several data sets and that the corresponding transport files do not exceed the 1 GB limit. We explain the rationale behind this rule and discuss the problems that the FDA encounters when this rule is not observed." @default.
- W2186384329 created "2016-06-24" @default.
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- W2186384329 date "2015-01-01" @default.
- W2186384329 modified "2023-09-24" @default.
- W2186384329 title "Getting Rid of Bloated Data in FDA Submissions" @default.
- W2186384329 hasPublicationYear "2015" @default.
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