SDTM

In LB Domain, if the specimen is collected over a period of time, what does LBELTM refers to- Start or End of such interval?

Thanks.

Dear P21 Team,

I understand the publisher IDs for FDA currently referenced in the reports came from the FDA validator rules first released sometime back in 2014. However, these IDs have since then changed and in the latest v1.1 released in Mar 2017, they are all different to the ones stated in the report.  For example, the rule 'No Treatment Emergent info for Adverse Event' was FDAC022 but in the latest version it is FDAB001.  Are there any plans in future releases to actually align these rule IDs to the latest version? 

Thank you.

Hi,

There is a warning for DOMAIN variable value in SS data stating: DOMAIN value not found in 'SDTM Domain Abbreviation' extensible codelist.

SS domain has already been included in the 3.2 IG in findings category, but still warning appears. Is this a bug? Could you please provide further input? 

Thanks,

Abdul. 

Hi,

Is there a possibility to add a new rule that cross-checks the data in DM.ARM/ARMCD with IE? Currently, there is only a rule that checks the following:

"No records for "SCRFAIL" subject are found in IE domain" -> FDAC103, SD1033.

Hi

What is the difference between planned number of subjects and actual number of subjects in Trial Summary domain?

In one of the study I am working on, 30 subjects were planned as per protocol and all of them (30) were screened. Later on, one subject withdrew from study and did not receive the dosing. In such scenario, what should be the actual number of subjects, 29 or 30?

Thanks.

Regards,
Wick

I have a problem in the TS Domain SDTM datasets were integrated the two studies.

The following errors have occurred:

Non-unique value for TSSEQ variable within TSPARMCD
Multiple ADDON records
Multiple AGEMAX records
Multiple AGEMIN records
Multiple LENGTH records
Multiple PLANSUB records
Multiple RANDOM records
Multiple SEXPOP records
Multiple NARMS records

I think it is not validation by STUDYID. Why do I get these errors when STUDYID is different?

Hi,

Few mathematical symbols like >= and unit values like uL(microliter) are present in value of IETEST in TI domain. Pinnacle(v 3.2) does not throw an error for non-ascii and non-printable chars for TI domain, but in the IE it seems that there is a validation rule to check IETEST values and it threw an error FDAC241 in IE stating non-ascii or non-printable chars are present in the text. 

Is it something that tool does not check for non-ascii or non-printable char in TI domain(or entire Trial Design)? 

Thanks,

Abdul.

Hello,

I have to export study data in .xpt version 5 format (for submission to FDA). I develop it in C#.

So far so good, I have troubles understanding the remaining validation errors: Non-unique value for TAETORD within ARMCD

Please can someone help me understanding the correct format for TAETORD variable? It it described in SDTM 1.5 as a numeric value.

[EDIT] I think I have to convert the integer to the IBM mainframe number format, this gives me a byte[8], then I have to properly encode this. I'm testing encoding each of the 8 byte values to ascii chars.

Hi,

We try to make the report as clean as possible, but it seems we can't implement this. It seems there are some rules that conflict with each other, either way, there will be a warning in the report. For example, for the following 2 rules, if we add EPOCH, we will violate the 1st rule; if we remove EPOCH, we will violate the 2nd rule. Can you suggest what should we do to get rid of the warning?

SD1076/FDAC031

Model permissible variable added into standard domain

We noticed that CO.COVALn and TS.TSVALn variable labels have the number appended. The IG gives advice in case 2 below that seems to conflict with this.

There are two scenarios where this topic arises: