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Monika Kawohl

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Exposure in Draft SDTM IG 3.1.4 Monika Kawohl Principal Statistical Programmer Accovion Doses not taken may be of interest but only doses taken should be included ... – PowerPoint PPT presentation

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Title: Monika Kawohl


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
USUBJ-ID ECLNK-GRP ECTRT ECMOOD EC-OCCUR EC-REASND EC-DOSE EC-DOSEU EC-STDTC EC-PTTMFL
1 V1 SOLUTION A SCHEDULED 10 mg/kg 2012-09-25 Y
1 V1 SOLUTION A PERFORMED Y 95 mL 2012-09-25 T1400 Y
2 V1 SOLUTION A SCHEDULED 10 mg/kg 2012-09-25 Y
2 V1 SOLUTION A PERFORMED N PATIENT FORGOT
EX Exposure
USUBJ-ID EXLNK-GRP EXTRT EX-OCCUR EX-REASND EX-DOSE EX-DOSEU EX-STDTC EX-PTTMFL
1 V1 PLACEBO Y 0 mg 2012-09-25 T1400 Y
2 V1 DRUG X N PATIENT FORGOT
Many to One Link between ECLNKGRP EXLNKGRP in
RELREC
5
Summary of New Variables for EX/EC
Variable Description
--LNKID Link ID (available as of SDTM 1.3)
--LNKGRP Link Group ID (available as of SDTM 1.3)
--MOOD Mood (valid values SCHEDULED, PERFORMED)
--OCCUR Occurence (valid values N, Y)
--REASND Reason Not Done or Not Occurred
--DOSTKN Number of Doses Taken
--LAT Laterality (further specification of --LOC, valid values LEFT,CENTRAL, RIGHT)
--DIR Directionality (further specification of --LOC, valid values DIR Codelist, e.g. OUTER)
--PORTOT Distribution (further specification of --LOC, valid values PORTOT (Portion/Totality) Codelist, e.g. PARTIAL)
--METHOD Method of Administration (e.g. INFUSION PUMP)
--FAST Fasting Status
--MTHOBS Method of Observation (e.g. OBSERVED, SUBJECT DIARY, SUBJECT RECALL)
--PTTMFL Point in Time Flag (valid values Y)
ECPSTRG Pharmaceutical Strength (e.g., amount of active ingredient per dose unit (mg/mL))
ECPSTRGU Pharmaceutical Strength Unit
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