SDTM

Description

Technical support questions about SDTM standard and validation rules

Limits on COVALn

May 19, 2017
Forums

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

Not getting the Line Numbers in the report generated from Pnnacle 21 Tool

May 12, 2017
Forums

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.

Issues in CO domain

May 5, 2017
Forums

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

TAETORD in multi-zone studies

May 2, 2017
Forums

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:

Protocol deviation: SDTM.DV content and link with ADAM.DV

May 2, 2017
Forums

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?

FDAB036: Study Day must not be negative in EX

March 28, 2017
Forums

I am confused about business rule FDAB036 which says "Study Day must not be negative" for EX. This rule is different from the SDTM IG rule which is Study Day must be >=0. I have been given a study where the protocol and SAP definition of Study Day is date of first dose is Day 0. The SDTM datasets used the SAP definition of Study Day instead of the SDTM IG definition of Study Day. Day 0 in the EX dataset meets the requirement for the business rule because all the study days in EX are >=0.