SD0087 and SD0088

Hi Carol, SD0087 and SD0088

Hi Carol,

SD0087 and SD0088 are Data Quality checks which purpose is to identify Randomized, but not Treated subjects. Also, until SDTM IG 3.1.3 ACTARM info was not included into tabulation data.

You are proposing new Data Consistency checks, which can be helpfull for QC of data programming. We can introduce them, but will keep SD0087/88 for different needs and different users.

Thank you for your new checks suggestion!

Kind Regards,

Sergiy 

Also note that a new check

Also note that a new check for RFENDTC would be a mix of Data Quality and Data Consistency categories.

All Treated Subjects must to have RFSTDTC value. However in some cases Treated subjects may not have RFENDTC value. E.g., when a study is still ongoing and they are still on treatment. 

SD0087 and SD0088

You say that "SD0087 and SD0088 are Data Quality checks which purpose is to identify Randomized, but not Treated subjects". Are you saying the purpose of the checks is to force the sponsor to provide an explanation for those subjects who are Randomized, but not Treated even though they are correctly identified with ACTARMCD = "NOTRT" (nothing wrong with the data so not "fixable")?  If so, I don't argue against this.  I just want to make sure I understand.

Thanks!

Carol

Hi Carol,  Yes, it's correct.

Hi Carol, 

Yes, it's correct. No data fix is needed. An explanation in SDRG is expected.

Thanks, 

Sergiy