Technical support questions about SDTM standard and validation rules

FDAC341 (Variable value not found in extensible codelist)

November 30, 2017

"FDAC341 (Variable value not found in extensible codelist)" check is not being performed unless a define.xml is loaded. Is there a reason for that? It can theoretically be done without a sponsor define.xml e.g. EGTEST has the CT of EGTEST specified in SDTM 3.2 and hence EGTEST codelist can be used to do this check.

It is a useful check to have prior to generation of define.xml since it would catch the problems earlier.

Publisher ID for FDA rules

November 15, 2017

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.

Trial Summary: Difference between PLANSUB and ACTSUB

September 25, 2017



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?





Error in SDTM TS Domain of data pooling two studies

September 19, 2017

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?