SDTM

 

 

SDTM 3.1.2 Amendment 1 variables are still being flagged as invalid, as per rule SD0058. What could the problem be?

Dear OpenCDISC users,

The OpenCDISC team receive many questions through Contact Form. Unfortunately about 20% users misspelled their email address. Sometimes we can figure out the correct one ;), but in most cases it’s impossible to answer your question because that issue. Now I use the forum to handle one of such cases.

Original question:

"1. In the open cdisc report detail sheet, is the "record" is the actual record number in dataset?

In the v1.3 configuration file, rule SD1048 ("Total Daily Dose (--DOSTOT) must not be populated, when there is no data in Dose (--DOSE) and Dose Description (--DOSTXT)") isn't supported by the SDTM IG rules and is opposite to the intent of --DOSTOT. --DOSTOT is to be used when individual --DOSE is NOT collected. Likewise, --DOSTOT (and --DOSE) are mutually exclusive with --DOSTXT; they shouldn't be populated concurrently.

So SD1048 needs to be removed.

Randall Austin

Hi, I've come across many submission packages, and it is quite interesting to see the many variations for domain names (not abbreviations or custom domains). I provided some examples across the board for this, just to exemplify how many variations exist. Based on CDISC input, the SDTMIG should be utilized and, at some point in the future, a correlating CodeList will exist for standard domains. Out of curiosity, why does OpenCDISC utilize the mentioned domain name over the SDTMIG? SDTM Terminology 2011-07-22 CT Code C61536 IE = Inclusion/Exclusion SDTMIG 3.1.2

Hi,

FDA CDER and CDISC have released new documents for data submission last week (Dec. 2011), and CDER recommends implementation of CDISC's "Amendment 1 to the SDTM v1.2 and the SDTM Implementation Guide V3.1.2." Refer to FDA document at

Hello,

It seems that SDTM variables should not attach any sponsor defined formats. I have one senario:

1. Define format $SEXC as M--Male, F--Female;

2. Attach $SEXC to DM.sex varable;

3. Send the DM (in XPT) to the OpenCDISC SDTM Validator.

How will the OpenCDISC SDTM Validator respond to sex ? Any errors or warnings (by which Rule ID) ?

Similar issues to ADaM dataset.

Thanks,

Cheng

 

Hello,

Our medical history data record is quite simple and only includes: free-text Mddical history term and Past/Active status,

Therefore, I create the MH.xpt includes variable subject's MHTERM record with MHSTDTC and MHENDTC are blank.

When I validate MH.xpt, it shows warning:

SD0021: --ENRF expected when --ENDTC is null

Hi,

I am under the impression that result qualifiers, eg. LBORRES, CMDOSE cannot be used to generate xxSEQ, but I am unable to find this in the IG. Am I correct?

Thanks,
Matt

 

Update, managed to locate this in section 4.1.2.8.2. of the IG for result qualifiers (findings class), but have not come across anything for record qualifiers, e.g. CMDOSE (interventions class).

Hi,

I was wondering what the advantages are of using the defineXML option when running SDTM XPT files through openCDISC?  I have tried running the XPT files both with and without the defineXML option being used and i seem to get the same results.

Thanks.

Hello,

 

the data files for OpenCDISC contain a variable DVGRPID for 3.1.1. and 3.1.2. But this variable does not occur in the SDTMIMG. So is this an error, and whose error is it? Is DVGRPID legal?