j Jennifer
on

 

DD0059 is reporting warnings on dataset labels in define.xml that are not incorrect.  It appears that you do not have the dataset labels from the SEND IG entirely correct.

(1) POOLDEF

Here are the values from the warning:  Pooled Definition, IG.POOLDEF, Pool Definition

The SENDIG 3.0 lists the POOLDEF label as "Pooled Definition" (not Pool Definition) on page 239:

pooldef.xpt, Pooled Definition - Relationship Datasets. One record per subject per pool, Tabulation.

 

(2) PP

Here are the values from the warning:  Pharmacokinetics Parameters, IG.PP, Pharmacokinetic Parameters

The SENDIG lists the PP label as " Pharmacokinetics Parameters" (not  Pharmacokinetic Parameters)  page 131:

pp.xpt, Pharmacokinetics Parameters - Findings. One record per pharmacokinetic parameter per time-concentration profile per specimen per subject, Tabulation.

(3) MA

Here are the values from the warning:  Macroscopic Findings, IG.MA, Macroscopic Findingss

You have a typo "Findingss"

(4)  BW

Here are the values from the warning: Body Weight, IG.BW, Body Weights

The SENDIG lists the PP label as " Body Weight" (not  Body Weights)  page 62

bw.xpt, Body Weight - Findings. One record per test per observation time per subject, Tabulation.

These are only the ones that cropped up in my dataset.  Please check the remainder against the IG.

 

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