SDTM

Description

Technical support questions about SDTM standard and validation rules

August 19, 2010

Hello Team,

 

I got this error message:

 

EG        TYPE, VARIABLE    Char, EGLOINC    SD0055    SDTM/dataset variable type mismatch

 

However, when I look in the eg.xpt file at the metadata EGLOINC is character.

 

EGLOINC    Char    10    10    $10.    .    LOINC Code

 

David

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August 10, 2010

Running the latest validator program I got this error message for the EG domain using SDTM V 3.1.2

"Value for EGSTRESC not found in EGSTRESC controlled terminology codelist"

The records that were highlighted were the direct copy of measurements from EGORRES to EGSTRESC. This may be a false positive result.

I noted in the SDTMIG that generally the assumption is that any value in --ORRES should be derived or copied into --STRESC. So flagging numeric values for the ECG intervals of 62 msec seems to be a false positive.

Can someone clarify this?

Thanks!

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August 9, 2010

Hello,

We are submitting data to the FDA and it appears that the rule CT0037 looks for the SOC to be in ALL UPPERCASE format. However, the FDA has asked us to provide the MedDRA coding in the standard MedDRA sentence case format.

The FDA advice letter said " The spelling and capitalization of MedDRA terms must match the way the terms are presented in the MedDRA dictionary. For example, do not provide MedDRA terms in all upper case letters"

Is there are way to modify Rule CT0037 to recognize this updated format request? 

Thanks -- Dave Borbas

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July 20, 2010

We work with vendors to generate the SDTM datasets we need. First we work on the specifications. Has anyone had experience with converting file specs from Excel into SAS and then checking the results with Open CDISC? This seems like it should be possible without incredible efforts.

Thanks!

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July 6, 2010

I'm pretty confused about this. I'm using NOTASSGN as the arm code for subjects who enter run-in but are not randomized, as described in impl guide 3.1.2. However I've also put records in EX for these subjects because they are receiving study treatment during run-in (placebo in this case, but I know of other trials which have active non-randomized run-in periods).

I'm guessing this means I can't use NOTASSGN and have to invent a new arm code for these people, but it just seems wrong! Anybody know more about the background to this rule?

 

Thanks,

Martin

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July 1, 2010

I have a sponsor-defined findings domain XX.

When I validate the dataset xx.xpt I get a warning that rule SD0057 is violated: variable XXDTC is missing. It is "expected".
I do indeed not have this variable in my dataset.

My question:
- I have not been able to find in the standards document nor in the IGs that --DTC is expected in the case of a sponsor-defined domain. Can you point me to the paragraph where this is stated?
Or has it simply be assumed that it is so as it always is expected in the standard findings domains?

Many thanks in advance,

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June 27, 2010

Are the OpenCDISC.org, SDTM 3.1.1 and 3.12 rules based on the latest WebSDm release 3.0? 

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June 21, 2010

1. Curious to know why this rule is specified in RULES link in home page and not in the latest download Config folder.

2. Are the SDTM 3.1.1 and 3.12 rules based on the latest WebSDm release 3.0? 

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June 7, 2010

How can I generate code lists from sdtm data(like webSDM)?  Also how can import code into openCDISC?

 

Thank you

AJ

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May 28, 2010

Hi All,

I was a bit confused by this. Since *DY variables can definitely be negative but apparently not zero this would imply that the day before 'Study Day 1' is 'Study day -1' (i.e. study days are rounded away from zero). Is this the case?

Thanks for any help!
Martin.

 

 

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