In answer to the broad question, you really should not and CANNOT have a clean report, at least not under the current rules as they are implemented.
The current rule set is a mix of conformance, informational, and data quality checks, and understanding which kind a given rule is, and how to address it, is critical. Unfortunately, the information provided in the report is not always presented with enough clarity or context, and it is incumbent on the user to more broadly understand the issues.
In the instance you note above, while both rules are “Warnings” they are fundamentally different in terms of meaning and importance:
- SD1076/FDAC031 is informational, and your only action should be to document in the cSDRG that yes, you did in fact use a variable allowed by the SDTM model.
- SD1077/FDAC021 is identifying that you did not include a variable that FDA expects you to. If you opt not to include, for example, EPOCH, you would need to provide a rationale as to why you did not follow agency guidance, hopefully one with enough justification to be acceptable.
Obviously, and ideally, it would be clear that addressing SD1077/FDAC021 imposes a corrective action (add the variable), while SD1076/FDAC031 imposes a documentation activity.
The evolution of the ruleset this point has, unfortunately, led to a broad range of misunderstandings in terms of how companies interpret the findings and how they address them. With the publication of CDISC rules for SDTM, as well as the more thoughtful FDA ruleset, my hope is that future rules as implemented in Pinnacle21 (or any software) will be more clear in terms of meaning and resolution.
Regards,
Carlo