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Monika Kawohl Principal Statistical Programmer Accovion

Exposure in Draft SDTM IG 3.1.4 . Monika Kawohl Principal Statistical Programmer Accovion. Current Issues with Exposure in SDTMIG 3.1.2. Doses not taken may be of interest but only doses taken should be included There are no standard variables for commonly collected exposure information

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Monika Kawohl Principal Statistical Programmer Accovion

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  1. Exposurein Draft SDTM IG 3.1.4 Monika Kawohl Principal Statistical Programmer Accovion

  2. Current Issues with Exposure in SDTMIG 3.1.2 • Doses not taken may be of interest • but only doses taken should be included • There are no standard variables for commonly collected exposure information • e.g. planned doses • Dose collected in a different unit that specified in protocol and required for analysis • How to populate EX when the study is still blinded

  3. Proposed Solution in Draft SDTM IG 3.1.4 • 2 Interventions Domains • EX – Exposure (dose in protocol-specified units) • EC – Exposure as Collected • General Rules • EX domain required for all studies that include protocol-specified study treatment • EC should be used where collected exposure information cannot/ should not be directly represented in EX or DA • If EC is an exact duplicate of EX, then EC is not necessary • Exposure data either in EX only or EC & EX or DA & EX+ dose in alternative units (if needed) in FA • RELREC for relationhips

  4. Example EC – Exposure as Collected EX – Exposure + Many to One Link between ECLNKGRP – EXLNKGRP in RELREC

  5. Summary of New Variables for EX/EC

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