SDTM

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

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!

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

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,

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

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? 

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

Thank you

AJ

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.

The SDTM Implementation guide states in section 5.2.1.1., that COVAL can be extended by additional variable like COVAL1, COVAL2, ... COVAL199 etc., when comment text is too long to fit into the 200 characters of COVAL.

But when doing this, OpenCDISC shows a warning as of a violation of rule SD0058. This rule should be modified to allow for such additional COVAL+i variables in CO.

(I'm thinking this is an easy one...)

LB1,LB2,LB3 and LB4 are LB datasets; PE1-PE5 are PE. I get a 'Configuration Unavailable' error when I attempt to validate together.

Can I validate in the same run? If so, how may I do that?

Thanks!

Sean