SEND

hi,

SD1138 is not listed in FDA Validator Rules v1.3, but has been validated in the validation report.
Could you tell me why SD1138 is verified?

Sincerely,

Hi,

In Pinnacle21 community version 3.1.0, we find that there is no Warnings and Errors severity level in validator report. However the Errors and Warnings findings are part of section in nSDRG. Base on this validator report (version3.1.0), how do we report the findings to nSDRG?

Many thanks,

Amparo

Hii

Received this type of Warning after validate my datasets

FDAB011- Missing DOSENDTC Trial Summary Parameter

FDAB011- Missing DOSSTDTC Trial Summary Parameter

FDAB011- Missing PDOSFRQ Trial Summary Parameter

FDAB011- Missing SEXPOP Trial Summary Parameter

Hello Team,

Can i create STF (study tagging file) from Pinnacle21 community? 

Also please share how to create STF file for define.xml.

Thanks

Hi, I have internet connection in my laptop. In spite of having internet connection in my laptop I always get a message "No internet connection" on the top of the validator.

Can someone help me to resolve this issue?

Thank You

Navin

In the original publication by the FDA (which should be NORMATIVE), the rule definition and error message of FDA rule SE2306 conflict with each other.
The rule definition states: "At least one of the these variables or sets of variables should be populated: (DM.RFSTDTC and --DTC) or --STDY, or --VISITDY".
The error message states: "Missing values for all required set(s) of timing variables [DM.RFSTDTC with --DTC] , --DY and VISITDY".

Hello,

while validate datasets with SEND CT 2019-12-20, software gives non standard terminology warning, but same warning has not been detected when select and validate datasets with SEND CT 2020-03-27. please suggest.

Hi,

We have an issue about SD1082/FDAB018. We use Pinnacle21 community version 3.0.2 to validate our SEND datasets (configuration as IG 3.0) and get errors about "Variable length is too long for actual data". No matter what we do to the value of QLABEL (re-sized the length) the report still give us same result (please find snapshot in the attachment).  or is there any we misunderstanding?

thank you

Best regards,

Amparo

Hi,

I'm curious if we could get a fix (or explanation) for a few validation issues we've spotted in the EG domain for SEND 3.0.  Specifically, the two identified are below:

1.  "Variable is in wrong order within domain" for EGLEAD:  In the dataset, EGLEAD is correctly placed after EGNAM and before EGMETHOD, in accordance with the SEND Implementation Guide 3.0.  

Hi,

we found that there are some issues not be detected at Pinnacle21 v2.2.0.

Our SE dataset is against rule SD1087, SD1091 and SD1092 (our SE dataset only include  8 variable STUDYID, DOMAIN, USUBJID, SESEQ, ETCD, ELEMENT, SESTDTC and SEENDTC) however after verifying we didn't find any warnings.  

does it any workaround?

Best regards,

Amparo