SD0006 - checking baseline flags

Hi Susan,  Yes, SDTM IG does

Hi Susan, 

Yes, SDTM IG does not use PCBLFL variable in PC domain specifications or examples. However the SDTM standard allows to add the Baseline Flag (--BLFL) variable into all Findings domains.

FDA expect to see Baseline Flag variable in PC domain. Please see page 10 of "CDER Common Data Standards Issues Document" for details.

Regards, 

Sergiy

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM254113.pdf

"Required vs. Expected vs. Permissible 

CDISC data standards categorize SDTM and SEND variables as being Required, Expected, and 

Permissible. Some sponsors have interpreted Permissible variables as being optional and in some 

cases even expected variables are excluded. However, for the purposes of SDTM and SEND 

submissions to CDER, all Permissible and Expected variables for which data were collected or for 

which derivations are possible should be submitted. Examples of some of the Permissible and 

Expected variables in SDTM and SEND that CDER expects to see include: 

• Baseline flags for Laboratory results, Vital Signs, ECG, Pharmacokinetic 

Concentrations, and Microbiology results "