monika kawohl principal statistical programmer accovion
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
Monika Kawohl
Principal Statistical Programmer
Accovion
Exposure
in Draft SDTM IG 3.1.4
German Speaking CDISC UG Meeting, 25-Sep-2012 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
Current Issues with Exposure in SDTMIG 3.1.2
German Speaking CDISC UG Meeting, 25-Sep-2012 3
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
Proposed Solution in Draft SDTM IG 3.1.4
German Speaking CDISC UG Meeting, 25-Sep-2012 4
Example
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 T14:00
Y
2 V1 SOLUTION A SCHEDULED 10 mg/kg 2012-09-25 Y
2 V1 SOLUTION A PERFORMED N PATIENT FORGOT
EC – Exposure as Collected
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 T14:00
Y
2 V1 DRUG X N PATIENT FORGOT
EX – Exposure
+ Many to One Link between ECLNKGRP – EXLNKGRP in RELREC
German Speaking CDISC UG Meeting, 25-Sep-2012 5
Summary of New Variables for EX/ECVariable 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