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Creation of BDS Datasets- Day 05 of Onco-ADaM Project

Introduction The Basic Data Structure (BDS) is a fundamental element within the Analysis Data Model (ADaM), which is a significant component of the Clinical Data Interchange Standards Consortium (CDISC). BDS is the standard domain structure in ADaM, designed to facilitate the creation of analysis-ready datasets. This structure allows for one or more records per subject per analysis parameter per analysis time point. All the BDS datasets usually follow same variables, with a sprinkle of dataset specific suffix's. Examples are ADVS, ADLB, ADEG. Some of the common variables in BDS datasets Common variables in BDS datasets: STUDYID USUBJID SUBJID SITEID TRTP TRTPN TRTA TRTAN SCRNFL ENRLFL ITTFL SAFFL PKFL ADT ADTM ATM ADY VISIT VISITNUM AVISIT AVISITN PARAM PARAMCD AVAL DTYPE ABLFL BASE CHG EPOCH APHASE ANL01FL —ORRES —STRESC —STRESN —STRESU —SEQ —DTC —DY AVALCAT01 variables in ADLB dataset: LBSTAT LBNAM LBSPEC LBNRIND LBSTNRLO LBS

Creation of OCCDS-ADAE Dataset- Day 04 of Onco-ADaM Project

Date & Time Imputation Variable

Creation of OCCDS-ADCM Dataset - Day:03 of Onco-ADaM Project

Creation of ADSL Dataset - Day:02 of Onco-ADaM Project

What is ADaM- Day:01 of Onco-ADaM project