Creating SDTM Data Set

In this section, we will look at how to create the SDTM DM (demographics) data set.

Let's have a quick look at the DM data set in the CDM library:

The DM data set contains the subjects' demographics data:

We will make use of this data set (along with the other CDM data sets) to create the SDTM DM data set.

First, let's open the SDTM specification file in the Documentations folder:

Go to the tab named DM, which lists the definition of each of the variables in the SDTM DM data set:

Each variable has a clear definition. 

We can simply create the variables, based on the requirement specified.

​Below is the program that creates the SDTM DM data set:

Data DM1 ;
Set CDM.DM ;

STUDYID = "XYZ" ;
DOMAIN  = "DM" ;
USUBJID = Strip(STUDYID) || "/" || Strip(Put(SUBJECT,best.)) ;

SUBJID = SUBJECT  ;
Run ;

Data SPCPKB1 ;
Set CDM.SPCPKB1 ;
Where IPFD1DAT ne " " and PSCHDAY = 1 and PART = "A";
RFSTDTC = IPFD1DAT || "T" || IPFD1TIM ;
run ;

Data EX ;
Set CDM.EX ;
if EXENDAT ne " " or EXSTDAT ne " " ;
proc sort ; By SUBJECT EXSTDAT EXENDAT ;  
run ;

Data EX1 ;
Set EX ;
By SUBJECT EXSTDAT EXENDAT ;
If last.SUBJECT ;
Run ; 

Data DM2 ;
Merge DM1 (in=a) SPCPKB1 EX1 CDM.DS CDM.DEATH (where=(DTHDESIG = "1" )) CDM.IE (where=(IEYN = "0")) ;
By SUBJECT ;
If = a ;
Run ; 

Data DM3 (rename=(ETHNIC1 =ETHNIC));
Length ETHNIC1 $60 ;
Set DM2 ;
If EXENDAT ne "" then RFENDTC = EXENDAT ;
Else If EXENDAT = "" then RFENDTC = EXSTDAT ; 
else RFENDTC = IPFD1DAT || "T" || IPFD1TIM ;

RFXSTDTC = RFSTDTC ;  
RFXENDTC = RFENDTC ; 
RFPENDTC = DSSTDAT ;
DTHDTC   = DTH_DAT ;
SITEID   = CENTRE  ;
BRTHDTC  = BRTHDAT ;
AGE = AGE ;
AGEU     = "YEARS" ; 

If DTHDTC ne " " then DTHFL = "Y" ;
If SEX='C20197' then SEX = "M" ;
Else if SEX ='C16576' then SEX = "F" ;
Else SEX = "U" ;

If RACE = 'C41260' then RACE = 'ASIAN';
If RACE = 'C41261' then RACE = 'WHITE';

If ETHNIC = 'C41222' then ETHNIC1 = 'NOT HISPANIC OR LATINO' ;

iF RFSTDTC NE " " then ARMCD = "A01-A02-A03" ;
Else if IEYN = "0" and RFSTDTC = " "  then ARMCD = "SCRNFAIL"  ;
Else ARMCD = "NOTASSGN" ;

Drop ETHNIC ;

Proc sort ; By ARMCD ;
Run ;

Data TA ;
Set SDTM.TA (keep= ARMCD ARM) ;
Proc sort nodupkey ; By ARMCD ;
Run ; 

Data DM4 ;
Merge DM3 (in=a) TA ;
By ARMCD ;
If a ;

If ARMCD = "SCRNFAIL" then ARM = "Screen Failure" ; 
If ARMCD = "NOTASSGN" then ARM = "Not Assigned" ;
Run ;

Data DM5 ;
Set DM4 ;
ACTARMCD = ARMCD ;  
ACTARM   = ARM ;

CO = put(CENTRE,6.) ;

If substr(Strip(CO),1,2) = "23" or substr(Strip(CO),1,2) = "23"  then COUNTRY = "FRA" ; 
If substr(Strip(CO),1,2) = "70" or substr(Strip(CO),1,2) = "70"  then COUNTRY = "ESP" ; 
If substr(Strip(CO),1,2) = "60" then COUNTRY = "KOR" ; 

DMDTC = VIS_DAT ;
CENTRE = CENTRE ; 
PART = PART ; 
RACEOTH = Upcase(RACEOTH) ; 
VISITDTC    = VIS_DAT  ;

run ;

Data DM6 ;
Length STUDYID $21 DOMAIN $8 USUBJID $30 SUBJID 8 RFSTDTC $19 RFENDTC $19 RFXSTDTC $19 RFXENDTC $19
   RFPENDTC $19 DTHDTC $19 DTHFL $1 SITEID 5 BRTHDTC $19 AGE 8 AGEU $10 SEX $1 RACE $60 ETHNIC $60
   ARMCD $20 ARM $200 ACTARMCD $20 ACTARM $200 COUNTRY $3 DMDTC $19 CENTRE 8 PART $1 RACEOTH $200
   VISITDTC$19 ;

Set DM5 (rename=(SEX=SEX1 SITEID = SITEID1));

Label  STUDYID ="Study Identifier"
DOMAIN ="Domain Abbreviation"
USUBJID ="Unique Subject Identifier"
SUBJID ="Subject Identifier for the Study"
RFSTDTC ="Subject Reference Start Date/Time"
RFENDTC ="Subject Reference End Date/Time"
RFXSTDTC ="Date/Time of First Study Treatment"
RFXENDTC ="Date/Time of Last Study Treatment"
RFPENDTC ="Date/Time of End of Participation"
DTHDTC ="Date/Time of Death"
DTHFL ="Subject Death Flag"
SITEID ="Study Site Identifier"
BRTHDTC ="Date/Time of Birth"
AGE ="Age"
AGEU ="Age Units"
SEX ="Sex"
RACE ="Race"
ETHNIC ="Ethnicity"
ARMCD ="Planned Arm Code"
ARM ="Description of Planned Arm"
ACTARMCD ="Actual Arm Code"
ACTARM ="Description of Actual Arm"
COUNTRY ="Country"
DMDTC ="Date/Time of Collection"
CENTRE ="Centre Number"
PART ="Study Part Code"
RACEOTH ="Other Race Specification"
VISITDTC="Date of Visit" ;

SEX = SEX1 ;
SITEID = SITEID1 ;

Keep STUDYID DOMAIN USUBJID SUBJID RFSTDTC RFENDTC RFXSTDTC RFXENDTC RFPENDTC DTHDTC DTHFL
SITEID BRTHDTC AGE AGEU SEX RACE ETHNIC ARMCD ARM ACTARMCD ACTARM COUNTRY DMDTC
CENTRE PART RACEOTH VISITDTC ;
Run ;

Data SDTM.DM ;
Set DM6 ;
Proc sort ; By USUBJID ;
Run ;

The program above creates the SDTM DM data set.​

Done! The SDTM data set is created.