Validating controlled terminology in sdtm domains
So all submitted datasets should be validated against the metadata in the Now you will say "Wait a minute Jozef, being valid against the metadata in the doesn't mean that the datasets are in accordance with what is written in the corresponding IG". So the should always be to validate the contents of the against the contents of the IG.We have the CDISC standards specifications, the implementation guides (further abbreviated as "IG") and we have the Furthermore we currently have two formats for the datasets themselves: SAS Transport 5 and Dataset-XML.It is very important that the rules are very clear and not open for different interpretations.As well the FDA as a CDISC-team have published or will be publishing sets of rules (remark that even the "FDA SDTM rules" are not always clear and some are even completely wrong in some cases).software is considered to be the lowest cost - highest benefit software for creating SDTM and SEND datasets in the industry.All that is required is that your EDC system can export clinical data in CDISC ODM format (most EDC systems do so).
When then in another domain/dataset "planned" or "actual" ARMCD/ACTARMCD is present, and its value also corresponds to one of the entries in the codelist of define.xml, the value is valid, even without needing to do any direct cross-dataset validation.
In the define.xml, a codelist will be associated with the variable ARMCD for TA.
So one should test whether the value of ARMCD in the TA dataset is one from the associated codelist in the (note that also e.g.
For example, the CDISC-CT for lab test codes contains several hundred terms, but the should only list those that have actually been used in the study.
Also the maximal lengths, labels and datatypes from the should be checked against the IG.
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I took one of the FDA rules on purpose here, as it is a clear rule, and e.g.