SDTM

Hi all,

We are currently conducting a clinical study that collects RACE on the CRF using the following terms: CAUCASIAN, BLACK, HISPANIC/LATINO, INDIAN, ASIAN/PACIFIC ISLANDER, and OTHER.

4.1.2.9 Variable Lengths
Very large transport files have become an issue for FDA to process. One of the main contributors to the large file sizes has been sponsors using the maximum length of 200 for character variables. To help rectify this situation:
• The maximum SAS Version 5 character variable length of 200 characters should not be used unless necessary.
• Sponsors should consider the nature of the data, and apply reasonable, appropriate lengths to variables. For example:
o The length of flags will always be 1

Dear authors,

Noticed a couple of issues with labels:

- EX dataset: the label for EXTRT per SDTM IG 3.2 is 'Name of Treatment', but the validator for SDTM 3.2 wants 'Name of Actual Treatment'

- TI dataset: the validator wants the label for IETESTCD to be 'Inclusion/Exclusion Criterion Short Name', which is longer than 40 character limit. per SDTM IG 3.2 the label is 'Incl/Excl Criterion Short Name'

Any reason for these discrepancies?

Thanks,

   Leonid

Hi CDISC,

I'm currently working on Legacy Study with Data having no proper structure(Pre-CDISC format).

In MH Domain, I have data like "Yes","No","Unknown", "Free text(for Suppqual)". After transposing the data, I got all MH variables -->MHTERM
eg:

 In my study, for one of the subject, DSSDTC for study completion is reported as 2015-05-30, however this information was collected on 2015-05-31 so we populated DSDTC on 2015-05-31. This subject had AE on 2015-05-31 which triggers SD0080 becuase AESTDTC is later than latest dispostion date of 2015-05-30. This happens for quiet a few subjects.This is not data issue nor SDTM issue. How do we handle this issue?

Thanks,

Sukanya

Hi, 

Hi

For the dose escalation studies i.e for the same drug different dose levels for different coherts, how the arms should be assigned.

Should we consider as only one arm, or else each dose level should be treated as separate arm.

And how would be the elements.

Dear all,

In a study tratment administered day is taken as DAY 0. And rest of the days are DAY 1, DAY 2....etc. Please helm me how to calculate the actual study day in this case.

When validating SDTM and inlcuding define.XML, should we expect warning to go away regarding values not being in extensible codelists?  I've confirmed that the define does inlcude all unit codes in the sdtm data.  Its true that the value is not technically in the extensible codelist (as provided by CT docs), but it is the define.xml so I was just wondering how the FDA would know that the extensible codelist has in fact been "extended" in the define.XML.  This applies to any CT2002 warning.

Thanks!  Amy

Should the issues with severity of "Warning" be included in the SDRG?  Or just those with a severity of "Error"?