Define.xml

Hi Team,

I am using pinnacle 21 to validate a SEND define.xml v2.1, but got an Error below: 

DD0073: For Define-XML v2.0, the Origin Type attribute must have a value of 'CRF', 'Derived', 'Assigned', 'Protocol', 'eDT', or 'Predecessor' for SDTM and ADaM data and 'COLLECTED', 'DERIVED', 'OTHER', or 'NOT AVAILABLE' for SEND data. For Define-XML v2.1, the Origin Type attribute must have a value of 'Collected', 'Derived', 'Assigned', 'Protocol', or 'Predecessor' for SDTM and SEND data and 'Derived', 'Assigned', or 'Predecessor' for ADaM.

Hi Community. 

We're working on CRT review and based on my knowledge, we should create UNIT codelists separately per domains. 

While reviewing AVISIT codelist, I see also that analysis visits differ from domain to domain. 

Should the approach be the same for Anlysis Visits too? Separate codelists per domains?

I appreciate your opinions.

Thank you. 

Hi all,

does anyone know how to handle different TESTCD codelists in define.xml without getting P21 issues? For example, we can have several different codelists for QSTESTCD as per cdisc CT depending on questionnaires. In Order to define them I would need to remove the codelist “QSTESTCD” on variable level. How do I put the information in VLM and codelists tab? Or do we still create one QSTESTCD codelist and put all values in there? 
 

Best

Manolya

Hi Everyone, 

we're working on specification on a project and we've encountered two different approaches in derivations. 

One uses symbols like =, =>, <= in derivation and other uses SAS symbols EQ, NE, LE, GE etc. 

Could you please advise if there is any unification established? I was not able to find any. 

Thank you in advance. 

In my XPT dataset, CMSTDTC is recognized as Data_Type="Text", CMSTDTC is recognized as Data_Type="datetime", but the attributes of these two variables in XPT are the same.

Why is CMSTDTC not correctly recognized, what could be the possible reasons?

Hi,

I have a question for value level metadata. If a --TESTCD was planned to be collected in a study, but there was no data after DBL, do we need to include this --TESTCD into the VLM? Under my understanding, we should present all possible value in codelist, but it seems to have no rule for VLM? Do you have any suggestion for how to handle this condition in VLM? If we need to present this kind of no data in VLM, how to decide its length, type?

Thank you so much.

Best Regards,

Nien

We added PRMODIFY in the study and assign the label as "Modified Reported Name". We created define 2.0 firstly and validate it, DD0137 didn't appear. However, after updating the define version from 2.0 to 2.1, then validate define 2.1, we got the issue "DD0137: Invalid variable label value". To solve it, we have to update the label as "Modified Treatment Name".

It seems that define 2.0 and 2.1 use different SDTM to check variable's label. Could you please me know which version SDTM used separately? 

I want to use a supplemental variable as a where clause in variable-level-metadata, how to use P21E to generate define 2.1?

For example: a study is set up based on SDTMIG 3.3, --TSTOPO should be stored in SUPP-- instead of parent domain. We would have two rows for ISORRES in variable-level metadata, one row is SUPPIS.QNAM=ISTSTOPO and SUPPIS.QVAL=QUANTIFY, the other one is SUPPIS.QNAM=ISTSTOPO and SUPPIS.QVAL IN (SCREEN, CONFIRM). 

Could we make it via P21E? I can't find the supplemental variable here. 

As I understand, empty datasets should not be documented in the define.xml (v2.0). A current study has a set of conditional CRFs (30+ pages) that are event driven (if the event does not occur then there is no data). The event driven CRFs are mapped to standard domains (FA, CE, PR, etc) which contain data from other  sections of the CRF (so, there are no 'empty' datasets). At end of study, there were no data collected for the event driven CRFs for any subject.