SDTM

Hi All,

The check SD0040 only checks for inconsistent test names against same test code. Does it also check if 2 different testcodes use the same Test name?

Hi All,

I would like to know which domain would be suitable for "Polysomnography (PSG)" and "Evoked Potentials" forms. I can see in SDTM IG Page 281 that "SL" domain is reserved for Sleep (Polysomnography) Data however it is still under discussion.

So, in this case, which domain would be suitable for this data?

 

Should I map it to FA domain?

Is check SD0065 a bi-directional check? Does it check the presence of USUBJID, VISIT, VIISTNUM combination match between other domains and SV both the ways? To be precise, if a VISIT/VISITNUM combination exists in SDTM domains and does not exist in SV, it flags a warning message in the report. Does it hold true for the other way round too? If there exists a visit in SV but is not there in any other domain will it mark this as a warning too? This case is particularly for Screen Failure subjects.

Hi There, For our new study we are following 3.1.3 SDTM implementation. We are validating the domains with 1.4 validator against 3.1.3. I observe few issues as specified below along with variable length warning/error messages which we took care by creating a macro to assign the exact length based on highest length of the observations at the end. 1. I am getting a constant warning message of 'FDA Expected variable not found' for EPOCH in many domains. Is it mandatory to include EPOCH in all those domains?

Hi,

A sponsor and collaborating CRO has this domain included. The Associated Persons standard under development is really part of Model 1.3/1.4 of SDTM, but nonetheless it ends up in our database.  Since it is new, it makes sense that the current validators through OpenCDISC 1.4 would not have the validation rules implemented yet for this dataset, and would give a message like "Class Unknown" and reason "Configuration Missing".

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!

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.

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' -