SDTM LAB1

 

SDTM Day 1:

SDTM stands for Study Data Tabulation Model.

It is a standard structure for human clinical trial data submitted as a part of CDISC for FDA reviews.

LB: Laboratory Test Results is one of Findings General Observation Classes.

LB includes information such as, Laboratory Test Category(LBCAT), Laboratory Test Code(LBTESTCD), Lab Test Name (LBTEST), Unit, Lab Test Result, VISIT, Laboratory Test Date (LBDTC).

Problem:
How to assign a VISIT to Lab records if the CPEVENT is “Unscheduled” ?

CPEVENTVISITLBDTCUSUBJID
FUP 1Follow-up 12103-11-27TF-001
FUP14_33DFollow-up 14_33D2013-11-28TF-001
UNSCHEDULED2013-10-31TF-001
SCREENINGSCREENING2012-04-30TF-002

Solution:
For the unscheduled visits, we merge with SV (Subject Visits) by Unique Subject ID(USUBJID) and Laboratory Test Date(LBDTC).

 

Code:

proc sql;
create table lb99_ as
select a.*, b.visitnum , b.visit
from lb99 as a left join sv99 as b
on a.usubjid = b.usubjid and 
b.svstdtc <= a.lbdtc <= b.svendtc;
quit;

Output:

CPEVENTVISITLBDTCUSUBJID
FUP 1Follow-up 12103-11-27TF-001
FUP14_33DFollow-up 14_33D2013-11-28TF-001
UNSCHEDULEDUnscheduled Visit 312013-10-31TF-001
SCREENINGSCREENING2012-04-30TF-002

Additional info:

Depends on the category of drugs, LBCAT usual includes:

Biochemistry, Blood Smear, Coagulation, Haematology, Urinalysis, and Other.

 

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