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Monika Kawohl Principal Statistical Programmer Accovion Exposure in Draft SDTM IG 3.1.4.

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Presentation on theme: "Monika Kawohl Principal Statistical Programmer Accovion Exposure in Draft SDTM IG 3.1.4."— Presentation transcript:

1 Monika Kawohl Principal Statistical Programmer Accovion Exposure in Draft SDTM IG 3.1.4

2 German Speaking CDISC UG Meeting, 25-Sep 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 Current Issues with Exposure in SDTMIG 3.1.2

3 German Speaking CDISC UG Meeting, 25-Sep 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 Proposed Solution in Draft SDTM IG 3.1.4

4 German Speaking CDISC UG Meeting, 25-Sep Example USUBJ- ID ECLNK- GRP ECTRTECMOODEC- OCCUR EC- REASND EC- DOSE EC- DOSEU EC- STDTC EC- PTTMFL 1V1SOLUTION ASCHEDULED10mg/kg Y 1V1SOLUTION APERFORMEDY95mL T14:00 Y 2V1SOLUTION ASCHEDULED10mg/kg Y 2V1SOLUTION APERFORMEDNPATIENT FORGOT EC – Exposure as Collected USUBJ- ID EXLNK- GRP EXTRTEX- OCCUR EX- REASND EX- DOSE EX- DOSEU EX- STDTC EX- PTTMFL 1V1 PLACEBO Y 0 mg T14:00 Y 2V1 DRUG X NPATIENT FORGOT EX – Exposure + Many to One Link between ECLNKGRP – EXLNKGRP in RELREC

5 German Speaking CDISC UG Meeting, 25-Sep Summary of New Variables for EX/EC VariableDescription --LNKIDLink ID (available as of SDTM 1.3) --LNKGRPLink Group ID (available as of SDTM 1.3) --MOODMood (valid values: SCHEDULED, PERFORMED) --OCCUROccurence (valid values: N, Y) --REASNDReason Not Done or Not Occurred --DOSTKNNumber of Doses Taken --LATLaterality (further specification of --LOC, valid values: LEFT,CENTRAL, RIGHT) --DIRDirectionality (further specification of --LOC, valid values: DIR Codelist, e.g. OUTER) --PORTOTDistribution (further specification of --LOC, valid values: PORTOT (Portion/Totality) Codelist, e.g. PARTIAL) --METHODMethod of Administration (e.g. INFUSION PUMP) --FASTFasting Status --MTHOBSMethod of Observation (e.g. OBSERVED, SUBJECT DIARY, SUBJECT RECALL) --PTTMFLPoint in Time Flag (valid values: Y) ECPSTRGPharmaceutical Strength (e.g., amount of active ingredient per dose unit (mg/mL)) ECPSTRGUPharmaceutical Strength Unit


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