SD2239 incorrectly firing for 3.1.3 PMDA checks

d David

on January 6, 2016

Hi, Can someone point me to some documentation that explains the xxTPT and xxDTC relationship? I understand the xxTPT/xxTPTNUM/xxTPTREF relationships, but xxTPT and xxDTC is new to me. I have data coming from two different CRF pages. Times are not being collected on the pages, so xxDTC only holds date values. The xxTPTREF values assigned are different depending on what CRF page the data is originating from. If the rule was also looking at the xxTPTREF value, along with xxTPT and xxDTC, I could see it being somewhat beneficial. However as the rule stands now, I think it's incorrect and Pinnacle 21 Community 2.1.0 is stating that this is an "Error" in my data, which I disagree with. Furthermore, I believe it's coded incorrectly, as it is also flagging records for the same subject, with the same xxDTC value, but one record has xxTPT populated while the second record has xxTPT null. If this check is intended to stay, I think it should at least be updated so it does not consider records with null xxTPT values. Please note that this check is not firing when I select the FDA 3.1.3 checks. Thanks, David

Forums: SDTM

h Hajime

on October 10, 2017

The source of this check

The source of this check is PMDA's expectation. Please visit PMDA's site. You'd find validation rules for PMDA.

o Olga

on January 3, 2018

SD2239: Inconsistent value for --TPT

Hi,

I would like to add my question regarding SD2239 PMDA error, firing Inconsistent value for --TPT.
The rule states: Planned Time Point Name (--TPT) value must be consistent for all records with same Subject (USUBJID) and Assessment Date/Time (--DTC).

However, due to various data collection within same --DTC, planned timepoint name (--TPT) might not be unique.
Here are some examples when uniqueness of --TPT and --DTC is not feasible:

1. Cases where time is not collected but multiple assessments and planned timepoints are collected within same day.

2. Cases where multiple assessments collected within same minute but in sequential order per protocol, for example questionnaires collected accross more than one unique CRF pages.

3. Cases where planned and repeat assessments are collected within same minute.

4. Cases where time of assessment is collected for some tests while for others it's not collected, but planned timepoint is collected on CRF.

Could somebody please shed some light on what this rule supposed to catch?