This suggestion is a change to the following rule in the SEND 3.0 (FDA).xml rule set:
Validation Rule Suggestions
This is where folks can suggest additional rules for the Pinnacle 21 Validator.
The validation rule as implemented in Pinnacle 21 is incomplete for the MI domain. It doesn’t appear to include “per Finding Result” in its validation test. These domains should have a single record with the same USUBJID, --SPEC, and --ORRES.
Currently, Pinnacle only checks for non-ASCII data in VLM fields (e.g –TEST, --TESTCD, --PARM, --PARMCD, QLABEL, QNAM). What is your opinion about extending the rule to check ALL data fields for non-ascii characters? Can this be implemented in community version?
The Rules repository is down just when I was upadting the documentation to one of my tools.
I wanted to make the link between each of my checks and the OpenCDISC checks... Timing is a b****, :-).
When is this expected to be up again?
Pinnacle Community combines FDA rules FDAN014 and FDAN015, and assigns the lower severity of warning, where rule FDAN014 is listed as an ERROR by the FDA for the domains of TS, TX, and DM.
Pinnacle Community combines FDA rules FDAN018 and FDAN019, and assigns the lower severity of warning, where rule FDAN019 is listed as an ERROR by the FDA for the TS domain.
Pinnacle Community calls FDAN031 a Notice; the FDA rule set classifies it as a Warning.
Pinnacle Community calls FDAN055 a Notice; the FDA rule set classifies it as a Warning.
The tool warns about imputed values for these two variables. When POOLID is used instead of USUBJID for FW records (which is very common), the tool doesn't find the RFSTDTC and thinks the value is, therefore, imputed.
The message "EGSTRESC value not found in 'ECG Result' extensible codelist" needs to be refined so that it does not appear in the many instances when EGSTRESC is numeric.
I have some queries on the validation rule and they are mentioned below can you please look into it and provide your response.
1.If DSDY variable is added into SDTM.DS domain then OpenCDISC gives below warning.
Domain Values OpenCDISC ID Publisher ID Message