What's the project goal?

The goal of the project is to create the SDTM DM data set based on the SDTM specification file (i.e. dm_only.xlsx).

Based on the specification file, we have to create 29 variables for the STDM DM data set:

• 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

Let's look at the first three variables:

• STUDYID
• DOMAIN
• USUBJID

​Creating these three variables is quite straightforward.

The STUDYID and DOMAIN column should just be assigned the values 'XYZ' and 'DM', respectively.

​The USERID is just to concatenate the STUDYID and SUBJECT, separated by a slash.

Below is the code to create these three variables:

data SDTM_DM;
set CDM.DM;
STUDYID = 'XYZ';
DOMAIN = 'DM';
USERID = catx('/', STUDYID, SUBJECT);
keep studyid domain userid;
run;

The remaining columns aren't as simple as the first three.

You can complete the remaining variables based on the specification file!

Don't know how to start? We will give you a hand:

• Download the data
• How do I import the CDM data?
• What are CDM data sets?
• What is the project goal?​

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