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