SDTM

In the new validator v2.0, the message "Variable length is too long for actual data" is becoming an error. I usually keep the length of each variable = the maximum length of all observations within that variable. What about the empty variables? The empty variables have a length of 1. But I keep getting the error messages “Variable length is too long for actual data”.

I notice that in the new openCDISC validator v2.0, the message "RACE value not found in 'Race' non-extensible codelist" is no longer a warning but an error.

Is there anyway to resovle this error? The RACE codelist does not have "MULTIPLE" or "OTHER" races, how should we handle people with multiple races?

Is there a reason why this message is changing from "warning" to "error" in the new validator?

 

Thank you!

 

Ceci

Hello,

Do you have any advice for users preparing submissions on interim data cuts, other than documenting this in the SDRG?

Interim data cuts can look very non-conforming.

Thanks in advance.

Jane

The documentation for the use of terminology files at:

http://www.opencdisc.org/configuring-opencdisc-validator-cdisc-controlled-terminology

refers to OpenCDISC v1.4 and shows examples of CT .txt files stored in Config/Data/CDISC/SDTM.  However, the actual installation of OpenCDISC Community 2.0 contains .odm.xml files in these locations.

(1) Does OpenCDISC Community require .odm.xml files, or can it also handle text files?

When a user runs OpenCDISC Validator on SDTM data is the set of SDTM checks the same set of SDTM checks used when OpenCDISC Validator runs using SDTM data plus the define.xml?  

Is the first option (SDTM only) a subset of the checks of the second option (SDTM + define)?  OR are there differences in the suite of checks that are used by OpenCDISC Validator for these 2 options?  We want to be sure we aren't missing any checks when running option 1 vs option 2.

Hi, In v2.0 is there a way to specify MedDRA dictionary version? I did the MedDRA setup and added different versions but could not find a way to inform validator to use a specific version.

Thanks. 

Could you please update text for the 'Message' column in Issue Summary worksheet of excel report from v2.0. Currently it displays

I am using the config file SDTM 3.1.2 (FDA).xml in the v2.0 validator and have a question about the codelist association for AE.AECONTRT.  My SDTM.AE data has values of 'Y' and 'N' for this variable, and the validator throws errors for the 'N' values.

As you know, FDA Technical Conformance Guide is inconsistent with CDISC SDTMIG regarding populating ARM/ARMCD for screen failures and not assigned.  Of course you know better than anyone else that many OpenCDISC FDA validation rules use logic assuming SDTMIG rules of ARMCD = 'SCRNFAIL' and ARMCD = 'NOTASSGN' are used.  If we follow FDA guidance (ignoring CDISC), various errors will be trig

Which DataType of TAETORD is correct: integer or float? Using OCC 1.5, we should set All TAETORD DataTypes to integer(setting of OCC 2.0)? Reason for this question: TAETORD DataType has difference between Domains, SDTM version, or OCC version. ->difference between Domains: TA.TAETORD:float and FA.TAETORD:integer of SDTM 3.1.2 and OCC 1.5 ->difference between SDTM ver: TA.TAETORD:float(SDTM 3.1.2) and TA.TAETORD:integer(SDTM 3.1.3) of OCC 1.5 ->difference between OCC ver: TA.TAETORD:float(OCC 1.5) and all of TAETORD:integer(OCC 2.0) Best regards.