This collaborative process prepares the FDA for th
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Posted On: 05/08/2020 1:04:48 PM
This collaborative process prepares the FDA for the changes that will be implemented in future versions of standards. However,
without a mock dataset submission from the SDOs that incorporates the updates to be included in the new version of the standard,
FDA is not able to fully determine the impact, through testing, that the proposed changes have on their ability to analyze future data
with current analysis tools.
To provide specialized guidance under the SDTM standard, CDISC is also generating therapeutic area user guides to outline
considerations specific to certain disease areas. As outlined in Figure 3-13, CDISC has released 25 user guides and is in the process
without a mock dataset submission from the SDOs that incorporates the updates to be included in the new version of the standard,
FDA is not able to fully determine the impact, through testing, that the proposed changes have on their ability to analyze future data
with current analysis tools.
To provide specialized guidance under the SDTM standard, CDISC is also generating therapeutic area user guides to outline
considerations specific to certain disease areas. As outlined in Figure 3-13, CDISC has released 25 user guides and is in the process
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