SDTM

Description

Technical support questions about SDTM standard and validation rules

RP vs PE for Gyn Exam.

July 10, 2017
Forums

I am wondering if findings related to Gynecological Examination, Vaginal Examination, Vaginal Cell Maturation Index, Endometrial Biopsy and PAP Smear should go into the Reproductive System Findings (RP) or the Physical Examination (PE) domain. SDTMIG 3.2 does mention that the RP domain should capture all Reproductive information related to a subject but I find that these types of findings do not directly relate to “birth” as most examples provided in the SDTMIG 3.2 do.

SVSTDTC after RFPENDTC issue (SD1202)

June 26, 2017
Forums

Hi, I'm somewhat confused about rule SD1202 that specifies that a --STDTC must be before of equal RFPENDTC. I have an example of a patient who was lost to follow-up for which the last contact date was recorded in both DM.RFPENDTC and DS.DSSTDTC as the last line in DS domain.

The end of study visit was completed afterwards with an end of study visit date greater than the last contact date of the patient.

The problem is that I get an issue that says that my end of study visit date (SV.SVSTDTC) is greater than DM.RFPENDTC.

Custom Domain Naming

June 20, 2017
Forums

Hi Team,

We have created a custom domain with the name "LBUS" (Domain= LBUS) which is similar to "LB" and it is not a split domain. But when Pinnacle 21 checks the two datasets, it thinks LBUS as the split dataset of LB. It issues duplicated LBSEQ error. 

Can you please explain me why is this happening? Thanks in advance.

Regards,

Sai Krishna.

Does Pinnalce 21 check Domain labels when only SDTM xpt files are provided?

June 5, 2017
Forums

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.

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: