Category: Clinical Trial

SDTM LB2

SDTM Day 3 : LB, Laboratory Dataset   Last Time we introduced SDTM.LB for laboratory Test Results in Finding General Observation Class and Showed an example of how to merge with SV(Subject Visit) to get Epoch. SDTM.LB is one of the most crucial datasets for Drug Safety Analysis, it could be challenging due to the vast amount of records. This…

SDTM QS

SDTM Day 2: QS Background: As the novice treatments for Cancer therapy have been developed, not only we care about prolonging the lives of patients, scientists also put their endeavor to improve the life qualities. SDTM.QS is designed for capturing the patients’ questions info. Definition: QS domain is a questionaries domain that contains a variety of patient information about different questionnaires. Such…

SDTM LAB1

  SDTM Day 1: SDTM stands for Study Data Tabulation Model. It is a standard structure for human clinical trial data submitted as a part of CDISC for FDA reviews. LB: Laboratory Test Results is one of Findings General Observation Classes. LB includes information such as, Laboratory Test Category(LBCAT), Laboratory Test Code(LBTESTCD), Lab Test Name (LBTEST), Unit, Lab Test Result, VISIT, Laboratory…

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