SDTM

Description

Technical support questions about SDTM standard and validation rules

August 8, 2013

Hi,

I am continuously getting the error message SD 1011 and SD 1021 for my TEDUR variable in the TE dataset. The format is ISO 8601 and my values are , for example, P4D or P13W. Why do I always get this error message?

Thanks in advance!

Read More
August 6, 2013

We have a situation where the length of DAORRES is set to 5 and we have values like 35.00, 4.00 and nulls. However, we still are getting messages about the variable being oversized for the content. Are the decimal points not being included in the count or is there another reason for this? For your information, the numbers of tablets are being collected to two places of decimals.

Read More
August 1, 2013

Hi,

I think there is an error with rule SD1039 in openCDISC v1.4. 

LBTERM, LBBODSYS, LBTRT, LBTESTCD, DOMAIN, LBCAT

 'Redundancy in paired variables values' - 

Read More
July 31, 2013

Read More
July 25, 2013

Hi We have few customs findings domains and following variables are flagged as expected in v1.4 using IGv3.1.3:

DTC, STRESN, ORRESU, STRESU.

In some SDTM findings domains like EG these are permissible so in any findings domain they should be permisible as well.

Read More
July 18, 2013

Hi This warning shows up for

1) SE.TAETORD (Label=Planned Order of Element within Arm) Updated label from IG 3.1.3

2) TS.TSVAL1 (Label=Parameter Value) as used by earlier version of opencdisc metadata file

Read More
July 18, 2013

Hi, I am getting this warning for 4 variables (in bold) with v1.4 even though variables are in correct order in TA: Studyid, Domain, Armcd, Arm, Taetord, Etcd, Element, Tabranch, Tatrans, Epoch

Read More
July 18, 2013

Hi!

Why does "PKUNIT" exist in the CT if the SDTMIG only lists "UNIT" as a CT for PCORRESU? Can I manually change it to PKUNIT for the codelist in the define.xml later?

 

Best regards!

Read More
July 9, 2013

Hi OpenCDISC team,

In OpenCDISC v1.4, there are rules for check variables length, such like SD1080, SD1081 and SD1082.

Read More
July 7, 2013

Hi, is it possible to run OpenCDISC against SUPPxx domains? Currently when I run the validator against a study all SUPPxx domains are flagged as "unprocessed resource". Also, can you explain how/if I can add customised domains to the validation process?

 

I apologise if these are basic questions but its my first time using OpenCDISC. Thanks for your help.

Read More
Subscribe to SDTM

Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.