This is the second in a series of posts where we answer questions from our recent webinar on the more commonly occurring validation rules and some potential reasons why they fired. In this post, we focus on submission recommendations.
These Data Standards Catalogs from the FDA and PMDA show the valid ADaM-IG versions for your submission’s date.
Using the Data Standards Catalog is easy. Navigate to the Submission Data Exchange Standards worksheet pictured below and look for the rows that are applicable to CDISC ADaM. Note: the dates in these columns are “Study start date.”
You need to use the ADRG to document and explain the items below. Future releases of Enterprise will include our recommended "Fix Tips" and examples of common issue explanations.
We recommend using the latest versions of Controlled Terminology (CT). Else you’ll need more explanations.
The P21 Issues Report spreadsheet is not a required part of the submission package for the FDA or PMDA, but is helpful to include. ADRG Section 6 is sufficient to meet the requirement. More to Come We hope these points assist you in your workflow. Please check back as we continue this series of posts!
We hope these points assist you in your workflow. Please check back as we continue this series of posts!
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