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Posted by / 11-Dec-2020 22:09

Validating controlled terminology in sdtm domains

In the case of a population analysis being subject to submission, which data used to create the population analysis datasets - e.

In the case of datasets translated at the time of their creation, this should be described in the data guide.

The purpose of this project is to evaluate the top 20 validation rule failures experienced at CBER.In the direction of multicenter or multiregional points, etc.If go results are written in the opinion contfolled, it is not poignant to facilitate the output sisters, but this should be notified and explained in the road good.According to Q, qualitative evaluation with figures could be the basis for dose setting. To ensure the need for electronic submission of study data, it is recommended that applicants use the clinical trial consultation.In cases where the original dataset is considered useful for explaining traceability between datasets or to show analysis specifications, it may be submitted and used for the explanation.

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Once validation of the datasets against the define.

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