Can anyone explain the difference Between FDA(2204.0) & FDA Legacy(2010.1) Validation Engine ?
The Description of the validation rule SD0065 contains an exception for records where Status (--STAT) is populated. Does this exception also apply to records where the Occurrence (--OCCUR) is populated? For example in the EC dataset when ECOCCUR = N. If this is the case, could the description of the validation rule be updated to include --OCCUR?
as i read the various FDA guidlines the only two rules that need to be adhered to in order to avoid a technical rejection are 1734 and 1736. Is this still the case or have other rules been added?
To elaborate a bit further. Especially i TS the start date parameter must be in place. Let's for argue sake say that ACTUB was filled out incorrect. That would not lead to a technical rejection since it won't be checked by a machine.
I see that you can tell me when rules are implemented in each version P21. But can you tell me which versions of FDA and CDISC rules are implemented for each configuration of P21 Community 3.0.2?
For example, for FDA Engine 1903.1, which CDISC SDTM and ADaM rules are programmed? And which FDA SDTM and ADaM rules are programmed?
I think this needs to be a part of the CHANGELOG.txt.
Thanks, Lisa Brooks
ADaMiG (v1.0 and 1.1) is strictly in favour of restricting the allowed scenarios for creating new variables. While the various fragments - prefixed radicals (e.g. 'WA' used for references to wash-out) and suffixes *FL, *DT etc - suggest this should probably not even be a warning, it would be great of p21 could identify all variables not in ADSL and not named in one of ADaMiG, OCCDS or TTE.
As per FDA study technical conformance guide:
3.3.3 Dataset Column Length
The allotted length for each column containing character (text) data should be set to the maximum length of the variable used across all datasets in the study except for suppqual datasets. For suppqual datasets, the allotted length for each column containing character (text) data should be set to the maximum length of the variable used in the individual dataset.
* Required Field