Define.xml

Getting a error DD0015 while referring SAS codes in define.xml v.2.0. I am getting this error while referring to leaf ID in the comments section of define.xml.  I am getting the same error if I am running the validation tool on the sample adam define.xml given on CDISC website.

Please advise.

Thanks,

Regards,

Jassi

Is this rule applicable for Non-PMDA studies? If yes, Can you provide a link to where guidelines are posted?

Thanks,

Regards,

Jassi

Hi,

As per define v2.0, it supports only transfer of SDTM metadata for IG v3.1.2 or higher...is there any specific reason that define v2.0 can't be used to transmit metadata for SDTM IG v3.1.1?

Thanks in advance.

Nathan

Hi, 

We modified define.xml provided with CDISC Define-XML v2 package and tested it with Define(PMDA) v2.1.0.

In the test, we have found that some Reject rules (DD0002, DD0003, DD0006, DD0020, DD0021, DD0022, DD0025, OD0001, OD0022 and OD0027) were not detected. For example, DD0003 is not detected if ODMVersion, which is one of the Required Attributes, is deleted.

Can you confirm that this is a bug?

Thanks, 

Takayuki

The DD0001 rule included in Define.xml (PMDA) with P21 Community v2.1.0 is Error in severity, but the PMDA guidance says the rule is "Reject".

-Ebi

We have a variable with value level metadata (VLM) and are specifying <def:Origin> at the variable level.  However, we are getting DD0072 (Missing Origin) for each of the VLM <ItemDef> elements as well as DD0074 (Variable/Value Level Origin Type mismatch.).

Here is an example:  

<!-- Variable -->

<ItemDef OID="IT.ADAU.AVAL" Name="AVAL" DataType="float" Length="24" SignificantDigits="14" SASFieldName="AVAL" def:DisplayFormat="8.3">

  <Description>

I am using Pinnacle Community 2.1.0 to create a define.xml for SDTM 3.1.2. I started with "Create Spec" to create specifications in .xls format. These specifications are then completed and afterwards used to create the corresponding define file. Most things worked very smoothly but what I didn't manage yet is how to get a link to a certain CRF page displayed for single variables in the define.xml.

The rule DD0086 "Invalid length of attributes in Define.xml - FDA's Clinical Trial Repository (CTR) software currently has a maximum length of 1000 characters for data attributes in Define.xml." is included in the Define.xml (PMDA) config xml, but the rule is for FDA and is not included in the PMDA guidance (http://www.pmda.go.jp/files/000208341.zip).

The rule should be removed from the PMDA config.

It looks like the ItemGroupDef/def:Class values are hard-coded, since "OCCURRENCE DATA STRUCTURE" for ADaM is deemed invalid (ERROR). However, the values are governed by CDISC/NCI CodeList C103329 (GNRLOBSC, "General Observation Class"). "OCCURRENCE DATA STRUCTURE" has been part of the CodeList since 2015-09.

Thanks,
Lex Jansen

Hi,

I used the Validator for define.xml and got a DD0046 error in the validation report.   I removed 'Domain="ADSL"' in define.xml and no more DD0046.