SDTM

I have a question around the SDTM rule SD1011 for time duration.  Some of the records in the MK domain are being flagged "Invalid ISO 8601 value" for the MKDUR variable (i.e. values: PT360.0S, PT2.4S, PT2.3S, PT3.7S). The source data is muscle testing (MK domain) and it does collect very accurate measurements to the 10th of a second.

For the screening failures a disposition date (DSDTC) may exist, but since the DSSTDY is calculated based on reference date (RFSTDTC) from DM, which is missing for screening failures, a warning is issued. 

I think it should be ok to have a missing DSSTDY for screening failures.

KR Marianne

I just ran sdtm validation v 3.1.2 on the AE domain and got this error. But the data is not wrong as far as I can tell. The AE starts before the end date. Even the validation report seems to show this. Here it is

I just ran an SDTM validation for ver 3.1.2 and got a Duplicate AESEQ error. But this does not seem correct. I looked at the data and for this subject there are no duplicated AESEQ values.

Here is what the validator report shows:

I have one AE for one subject that has only a year for a start date (the same year that is in all of the start dates for the other AEs for this subject) and the last disposition date is a date in that same year.  This rule is firing for that one AE.

The checking rule SD1056 was changed in version 1.4:

"The length of IE Criterion Result variables (IEORRES, IESTRESC) is expected to be 2"

But the vaules of IEORRES & IESTRESC should be only "Y"/"N", does any reasons to modify the expected length to 2?

We have a genuine below issues for one of our project.

Dear All,

Per Rule ID CT0003, "TS dataset Parameter Value (TSVAL) values should be populated with terms found in 'Age Span' (C66780) CDISC controlled terminology codelist, when Trial Summary Parameter Short Name (TSPARMCD) value is 'AGESPAN'".

'Age Span' (C66780) codelist is not found in latest CDISC controlled terminology sheet.

Any idea this rule Id will be phased out? If not, how to validate this rule CT0003? Am i missing something here?

Kindly suggest.

Warm regards,

Shrishaila

Hi all,

I was wondering when/if the 5 new medical devices domains were going to be included for rules implementation soon, since I didn't see any rules for these domains. Thanks!

- DJ