SDTM

Hi,

It is sometimes convenient, as a contractor, to run checks quickly for SDTM datasets with the new Community 3_0 without running in Enterprise, which requires creating project and study setup.  I expect the rules to be roughly consistent with Enterprise, if I'm using new Community version 3.0.

Hi Team,

Can you please provide an example for Difference in RFSTDTC and RFXSTDTC variables? Are both the variables same i.e first study drug exposure date? If not, in what situation will the dates differ?

I am working with a protocol that includes survival follow-up conducted via phone calls or review of medical records.  We are struggling with how to approach the survival follow-up reviews which identified the subject to be deceased. At the moment we have:

When we place the June-2017 CT (SDTM Terminology 2017-06-30.odm.xml) in the config folder (\\components\lib\configs\data\CDISC\SDTM) of Pinnacle Community version, Its is not displaying the CT and we cannot use them for MDR sourced define.xml file.

We find old CTs are not compatible with Pinnacle Community 3.0.0 in the below url,

https://www.pinnacle21.com/downloads/cdisc-terminology

Hello, I really enjoy looking through the config files to see what the warnings and error messages are expecting.  In the new version 3.0 of the software they are located in an odd location and don't pull up correctly as an xml file.

Current 3.0 location: P21_FOLDER\resources\app.asar.unpacked\components\lib\configs\1903.1

Hello,

Is there a time schedule to when Pinnacle21 plans to support SDTM IG 3.3 validation?

Thank you!

According to the FDA Rule v1.3, SD1306 : 

Business or Conformance Rule Validated = If the study population is healthy subjects (i.e., healthy subjects flag is Y), this parameter is not expected. If the healthy subject flag is N, then this parameter would contain the diagnosis/medical problem of the study population. [Validation rule; IF healthy volunteers = N then TDIGRP must be present and not null 

For example, some crf raw data Visit 1 start date less than some raw data Screening visit end date. In SV domain, this patient will have overlapped visit on screening and Visit 1. Similar example for 'Early Termnation' page visit date overlap with the last scheduled visit end date. Can we just leave the visits dates overlapped in SV domain and explained in SDRG?

Hi, Can I get an explanation regarding the TS00xx queries that are firing in the P21E version?  These look like new checks, right?  Or are they a rehash of other checks.

Thanks.

We collect PANSS data and we map to RS per CDISC implementation, however, it seems that Pinnacle 21 is expecting the RSTESTCD to come from the Oncology Response Assessment Test Code.  The latest CT has PANSS mapped to Clinical Classification Test Code, so regardless of what we do, this Warning will always fall out in P21.  Do you have a recommendation of how I can get rid of this warning from P21 or how should we explain this warning if we leave it as is?