myCSG © |Area: SDTM| Concept: DA : Drug Accountability | Lesson: L101 : Drug Accountability - Dispensed and Returned Capsules |

Drug Accountability, Capsules dispensed and returned, linked using REFID

Lesson description will be added soon

DRUGACC : Drug Accountability
Question Response
Bottle identifier
[REFID]
Date capsules dispensed
[DISPAMT_DADAT]
Number of capules dispensed
[DISPAMT]
Dispensing unit
[DISPAMTU]

Capsules
Date capsules returned
[RETAMT_DADAT]
Number of capules returned
[RETAMT]
Return unit
[RETAMTU]

Capsules



VARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_DRUGACC_DISPAMTFORM_DRUGACC_RETAMT
STUDYID Study Identifier Char Set to 'statschoice'
DOMAIN Domain Abbreviation Char Set to 'DA'
USUBJID Unique Subject Identifier Char Concatenate DRUGACC.STUDYID and DRUGACC.SUBJECT with a hyphen in between. Concatenate DRUGACC.STUDYID and DRUGACC.SUBJECT with a hyphen in between.
DASEQ Sequence Number Num Sort the records by USUBJID, DAREFID, DATESTCD, DADTC and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject.
DAREFID Reference ID Char Populate using DRUGACC.REFID Populate using DRUGACC.REFID
DASPID Sponsor-Defined Identifier Char Populate using DRUGACC.RECORDPOSITION in three digit format padding with leading 0's where applicable. Populate using DRUGACC.RECORDPOSITION in three digit format padding with leading 0's where applicable.
DATESTCD Short Name of Accountability Assessment Char Create a record for dispensed amount. Populate as "DISPAMT". Create a record for returned amount. Populate as "RETAMT".
DATEST Name of Accountability Assessment Char Populate as 'Dispensed Amount' Populate as "Returned Amount"
DAORRES Result or Finding in Original Units Char Populate using DRUGACC.DISPAMT Populate using DRUGACC.RETAMT
DAORRESU Original Units Char Populate using DRUGACC.DISPAMTU Populate using DRUGACC.RETAMTU
DASTRESC Result or Finding in Standard Format Char Populate using SDTM.DA.DAORRES
DASTRESN Numeric Result/Finding in Standard Units Num Convert SDTM.DA.DASTRESC to numeric value where applicable.
DASTRESU Standard Units Char Populate using SDTM.DA.DAORRESU
DASTAT Completion Status Char Populate as 'Not Done' when DRUGACC.DISPAMT is null. Populate as 'Not Done' if DRUGACC.RETAMT is null.
VISITNUM Visit Number Num Populate using FOLDERSEQ.
VISIT Visit Name Char Populate using FOLDERNAME.
EPOCH Epoch Char Populate using SDTM.SE.EPOCH by comparing RPDTC with SESTDTC and SEENDTC of each element of the subject. Populate as 'TREATMENT' when the record falls on the boundary of SCREENING and TREATMENT elements. Populate as 'TREATMENT' when the record falls on the boundary of TREATMENT and FOLLOW-UP.
DADTC Date/Time of Collection Char Populate using DRUGACC.DISPAMT_DADAT in ISO 8601 format. Populate using DRUGACC.RETAMT_DADAT in ISO 8601 format.
DADY Study Day of Visit/Collection/Exam Num If the SDTM.DA.DADTC is on or after reference start date then SDTM.DASTDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.CM.DASTDTC-SDTM.DM.RFSTDTC.
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