Theory of solving issues found by OpenCDISC/Pinnacle 21

OpenCDISC validator (re-branded as Pinnacle 21) give us valuable inputs about data usefulness and compliance to CDISC standards. Recently, authorities recommend the use of this validator for NDA submissions. Thus, the handling of report by OpenCDISC is important for many sponsors and CROs.

In this entry, we'd like to mention 2 "tiers" to be considered.

1st tier, technical ground
As far as we listen Pinnacle webinars, all errors should be corrected before submission. Here, severity of errors is not considered. Severity means reliability of the validation results. For example, category "Error" means that the report is true error at high-probability. Category "Notice" means that the report may not be true error (pseudo error) in many cases. But "Notice" still can be true error. From technical perspective, all outputs should be carefully reviewed and problems should be fixed as much as possible. Less errors enables FDA to use JumpStart for a given submission and it end up with speedy review for sponsors. It's worth doing the best on error correction.

2nd tier, regulatory ground
On the other hand, regulatory authorities have different requirements. For example, PMDA sets forth a series of acceptance standards. They categorize OpenCDISC checks into 3 categories for their filing acceptance.

Reject: must be resolved, or review is never initiated.
Error: must be explained, or review is never initiated
Warning: no action is required

This is political guidance and completely different from technical notes.

As conclusion, we'd like to emphasize that technical aspects must be referred for all submissions. In addition to this, regulatory requirements would be taken into consideration. In case you submit data to PMDA, you must look into PMDA's guide. If you submit data to FDA, you should consult with FDA reviewers. The important point is to recognize 2 layers as different issues.





Author:TKD + SMZ