Module 12 2019

Submission Dataset Definitions

Dataset

Description

Location

Structure

Key Variables

BW

Body Weights

bw.xpt

Findings – One record per body weight per animal

STUDYID, USUBJID, BWTESTCD, BWDTC STUDYID, USUBJID, CPTESTCD

CP

Clinical Pathology

cp.xpt

Findings – One record per lab test per animal

CS

Clinical Signs, Physical and Ophthalmo- scopic Exam Drug/Metabolite Levels

cs.xpt

Findings – One record per clinical sign per animal Findings – One record per drug level measurement per animal

STUDYID, USUBJID, CSTESTCD, CSDTC, CSLOC STUDYID, USUBJID, DLTESTCD, DLSPEC, DLELTM

DL

dl.xpt

DS

Disposition

ds.xpt

Findings – One record per animal

STUDYID, USUBJID, DSTESTCD

The Organisation for Professionals in Regulatory Affairs

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