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
• 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
German Speaking CDISC UG Meeting, 25-Sep-2012
2
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
German Speaking CDISC UG Meeting, 25-Sep-2012
3
Example
EC – Exposure as Collected
USUBJID
ECLNKGRP
ECTRT
ECMOOD
1
V1
SOLUTION A
SCHEDULED
1
V1
SOLUTION A
PERFORMED
2
V1
SOLUTION A
SCHEDULED
2
V1
SOLUTION A
PERFORMED
ECOCCUR
ECREASND
Y
N
ECDOSE
ECDOSEU
ECSTDTC
ECPTTMFL
10
mg/kg
2012-09-25
Y
95
mL
2012-09-25
T14:00
Y
10
mg/kg
2012-09-25
Y
EXDOSE
EXDOSEU
EXSTDTC
EXPTTMFL
0
mg
2012-09-25
T14:00
Y
PATIENT
FORGOT
EX – Exposure
USUBJID
EXLNKGRP
EXTRT
EXOCCUR
1
V1
PLACEBO
Y
2
V1
DRUG X
N
EXREASND
PATIENT
FORGOT
+ Many to One Link between ECLNKGRP – EXLNKGRP in RELREC
German Speaking CDISC UG Meeting, 25-Sep-2012
4
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
German Speaking CDISC UG Meeting, 25-Sep-2012
5