SDTM Day 5: SDTM.EX
Exposure dataset contains the details of subjects’ study treatment information, it is one of the key safety datasets, and it is critical to efficacy analysis. The EX domain is intended for “protocol-specified study treatments” including placebo dosing. The EX dataset would present a complete and accurate of subjects’ exposure in one record per constant dosing to the reviewers.
SDTM.EX dataset building steps:
1. Read in the Raw.EX data and derive the key variables.
2. Merge with SDTM.DM data for common variables
3. Merge with SDTM.SE data for Epoch
4*.Compare with the production dataset
STUDYID, USUBJID, EXDOSE, EXDOSU, EXDOSFRQ, EPOCH, EXTRT, EXGRPID,EXROUTE, EXLOT, EXSTDTC, EXENDTC, EXSTDY, EXENDY, EXTPT
Key variables Derivation:
STUDYID, Study Identifier, Assigned Variable.
USUBJID, Unique Subject Identifier, Derived from raw.lb.SUBJID.
EPOCH, Derived Variable base on SDTM.SE(Subject Elements) Start and End Day
proc sql; create table aeqc2 as select a.*, b.epoch from aeqc1 as a left join se as b on case when a.usubjid = b.usubjid and fl=. and b.sestdy <= a.aestdy < b.seendy then "a" when a.usubjid=b.usubjid and fl=1 and b.sestdy <= a.aestdy <= b.seendy then "b" end; quit;
EXTRT, Name of Actual Treatment, CRF variable
if shtreat=1 then extrt='PLACEBO'; else if shtreat in (2,3) then extrt='SAR302503'; if missing(extrt) and missing(exdose) and missing(exstdtc) then delete;
EXDOSE, Dose per Administration, Derived Variable
if armcd in("500MG" "PL-400MG") then exdose = (actual dose)*100 if armcd in("300MG") then exdose = ((actual dose)-1)*100 Note:Where (actual dose) is 0, exdose kept as 0. Where (actual dose) is missing, exdose kept missing.
EXDOSU, Dose Units, Assigned Variable
EXDOSFRQ, Dosing Frequency per Interval
EXROUTE, Route of Administration
if _exdose ne . then do; exdosu = "mg"; exdosfrq = "QD"; exroute = "ORAL"; end; else do; exdosu = ""; exdosfrq = " "; exroute = ""; end;
EXGRPID, Group ID, eDT variable
exgrpid = strip(put(raw.subsetsn,best.));
EXLOT, Lot Number, CRF variable
EXSTDTC, Start Date/ Time of Treatment
EXENDTC, End Date/Time of Treatment
EXSTDY, Study Day of Start of Treatment
If (EXSTDTC < DM.RFSTDTC) then EXSTDY=EXSTDTC-DM.RFSTDTC; Else if (EXSTDTC >= DM.RFSTDTC) then EXSTDY=(EXSTDTC-DM.RFSTDTC)+1.
EXENDY, Study Day of End of Treatment
If (EXSTDTC < DM.RFSTDTC) then EXENDY=EXSTDTC-DM.RFSTDTC; Else if (EXSTDTC >= DM.RFSTDTC) then EXENDY=(EXSTDTC-DM.RFSTDTC)+1.
EXTPT, Planned Time Point Name, eDT variable
EXSEQ, Sequence Number, Derived Variable.
The sequential number uniquely identifying the records within the domain by USUBJID and generated using the key sequence from the domain level metadata.
Data exseq; set ex; by usubjid ; retain aeseq EXTRT EXSTDTC EXENDTC EXTPT; if first.usubjid then exseq=1; else exseq=exseq+1; run;
Sample SDTM.EX dummy dataset: