General Discussion

Dear OpenCDISC: Are there any plans to support Associated Persons (which is part of 3,2) and Devices? Thanks, Joyce

Dear All!

Is there any possibility to validate the odm file itself with opencdisc validator? Or are there other free features?

 

Regards, Nina

Dear All

 

There is Java application which needs to read SAS XPT file. Is there any API avaliable for that?

 

Regards

Shailesh

Hi Everyone,

I am looking for suggestions as to when to run OpenCDISC. I know that we will run it before data reviews and at DBL. 
However, I was wondering if anyone is re-running it prior to submission? The thought being that a newer version of OpenCDISC Validator, with a new rule configuration was updated and we would want to see results before the FDA runs it.

Any feedback would be appreciated.

 

Thanks,

Jim Miller

 

Hi,

Per CDISC and SDTM IG - ISO 8601 format for Hours (HH) should follow :

[hh] = two digits of hour (00 through 23) (am/pm is NOT allowed).

But the Open CDISC Validator even passes the data when hh = 24, whereas ideally it should fail such a data point.

Any comments.

 

 

Hi,

I see that the Rules used in OCV 1.4.1 are not the same as shown in Rules Repository for SDTM 3.1.2 and SEND 3.0.

Ideally the latest updates should be synchronised in Rules Repository as well, right ?

Incase I am mistaken, May I know which is best to be considered as base rules to validate against - Rules Repository or OCV 1.4.1 Report - Rules Tab.

Regards,

Sandeep

Is it possible to add .sas7bdat file format as input datasets along with xpt file format?

If yes, then may be this link will be helful http://sassyreader.eobjects.org/

Thanks

Hi,

I am wondering. What is the rationale in 1.4.1 that has lengths tested strictly for SDTM to avoid excess, and does not do the same check for ADaM datasets? I'm not sure why excess is okay for one and is impermissible in the other.  Note I am not requesting or advocating for more length checks for ADaM.

Thanks!

Joan

We are developing dataset of SDTM/ADaM/SEND/define.xml following OpenCDISC Validator v1.3

The version we followed is as below
* SDTM 3.1.2 Amendment 1
* Define.xml 1.0
* ADaM 1.0
* SEND 3.0

However, the version of validator and rule is updated as 3/14

Dear All,

I have a question regarding appearance of labels for suppqual and custom domain for SDTM xpt files. When I run OpenCDISC on SDTM xpt files, for suppqual domains it shows labels as "Supplemental Qualifier" and for custom domain instead of showing label it shows class as its label such as "Findings".

I have tried labelling suppqual as "Supplemental Qualifier - LB" and "Supplemental Qualifier [Laboratory Test Results]". In both case, labels appeared as "Supplemental Qualifier".