05-25-2017 minutes

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In today’s meeting, we took up the topic of nSDRG section 5, and how to handle the table of issues identified with validation rules, considering the new approach by FDA. See FDA Business Rules/Validator Rules

We explored ways to fulfill and disucced different uses of the table by preparers and consumers of the information (FDA + other possible stakeholders), considering that the current FDA Validator Rule list does not number the technical rules.

The (CDISC) SEND Conformance Rules team, has had some discussions regarding the need or not for ID numbers on the validator rules already. To further this discussion, as it is continuing, we documented our thoughts to help make our case of recommending that numbers be attached to the validator rules and these numbers should show the relationship to the associated Business Rule. Below is the result of this discussion. Feel free to add content if you have further contribution, and/or contact Christy.Kubin@mpiresearch.com (co-lead for the CDISC SEND Conformance Rules team) with your input.
Numbering FDA Validator Rules Pros and Cons
PROS:

  • An advantage to all stakeholders, to have each val rule uniquely identified and associated to the relevant business rule.
  • Data loaders will know the technical reason for the failure to meet business rule – giving better possibility to mitigate.
  • Software vendors will have standard reference for programming automated SDRG tables.
  • Data providers, such as CROs, data services vendors, will have standard reference to communicate technical issues.
  • Standard numbering of validator rules allows for detection of common problems across data providers
  • The relationship between the Business Rule and the Validator Rule(s) could provide information that helps maintain and improve the list for optimal public conformance.

CONS

  • Keeping accurate numbering consistency and version control of numbers through lifecycle of the list.
  • Asks FDA to manage indexing they don’t need for their purposes.
.....led to “who else could manage this?” and discussion on whether CDISC should manage the numbering.
  • The FDA business/validator rule list is not yet complete, since nonclinical content is not yet included. Not yet clear how the nonclinical rules will be integrated into existing list.

Additional discussion questions raised....

  • Are the “FDA Validator Rules” the same as “CDISC Conformance Rules”? How are they different?
Since CDISC has not published conformance rules until now, perhaps this is a direction to go?
Idea that CDISC should number the technical rules used to validate datasets…. then maybe FDA uses those rules?
  • Do we need to think about what happens to validation and rule numbering if/when other countries issue their own business rules?