SDTM

Hi Team,

Can you please guide me through how Pinnacle 21 checks dataset label compliance? Does it check against SDTM IG "description" when only dataset xpt files are provided as input or is it irrespective of SDTM IG and just have to follow the conformance rules provided by FDA and should be meaningful?

Thanks,

Sai Krishna.

Hi Team,

I have encountered couple of issues when I ran Pinnacle 21 Community V2.2 on DU domain.

Hello,

Is there a limit on COVALn that n couldn't go over 10? 

We have COVAL1 to COVAL16, but Pinnacle 21 validation report will throw error message "Variable appears in dataset, but is not in SDTM model" on all the variables from COVAL11 to COVAL16.

Thanks,

Lu

Hi All,

I have generated the report using Define.XML fro SDTM Standard.

I could see the reports without Line numbers in details of generated report. But earlier i can see the line numbers of XML and i can identify the Errors/Rejects in the report.

Is anyone observed the change in report?

Please help me if anyone see the changes.

I have three questions in CO domain.

1) value for COVAL1-COVALn  (also in TSVAL1-TSVALn)

    Method A:  splitting long comment text with splitting a word

    Method B: splitting long comment text without splitting a word

    Which one?

2) label for COVAL1-COVALn

    Method A: Comment, Comment, ..........

    Method B: Comment1, Comment2, ......

    Which one?

3) leading space in COVAL1

I all,

I'm working on dermatological studies where the same subject can be treated with treatment A on the right side and treatment B on the left side. Both, right and left treatment are given at the same time. Treatment side is randomized.

For me, we have 4 elements:

- Screening

- Treatment A

- Treatment B

- Follow-up

I'm facing an issue with the TAETORD variable:

We have 2 options:

Dears,

I'd like your view on what the DV dataset should include.

The implementation guide says "The DV domain is an Events model for collected protocol deviations and not for derived protocol deviations that are more likely to be part of analysis".

1. Does "collected protocol deviation" mean those deviations highlighted by the CRAs and collected in the monitoring deviation log?

Dear all,

I have a question about SD1212: --STRESN does not equal --STRESC.

I validated my SDTMdata using Pinnacle 21 community ver. 2.1.3 and 2.2.0. (Configuration SDTM3.2(PMDA))

The SD1212 message was occurred

The Pinnacle Community edition version 2.2.0 throws an error for the rule SD1082, ‘Variable length is too long for actual data’, when the variable length is larger than the max data length within a single file.

Can we use the latest controlled Terminologies released for validation for version 2.2.0

or should we wait for new version of Pinnacle 21 community version..

any ideas?