Latest FDA eCTD Validation Criteria Draft Guidance Adds, Removes Error Conditions
The US FDA has posted a draft version of a new “Specification for eCTD Validation Criteria” which can be found here. This document outlines many of the new error conditions that the FDA will be checking for in the next version of the validation software. I will be highlighting some of the more important changes to the criteria.
When is the FDA going to move to the new validation criteria?
The FDA has mentioned various estimated dates and the draft version does mention that the deployment is scheduled for June 2011; however, the new criteria have yet to be formally implemented. The last I’ve heard is that the new criteria is currently under test. The FDA is evaluating the changes, and will be moving to the new version sometime in the next few months. Currently they are still validating with the previous criteria, and using the GlobalSubmit VALIDATE version 4 to do so.
So what are some of the major changes to the criteria?
First off, there has been a lot of work done on cleaning up existing errors. Within the draft guidance, fourteen errors have been removed from the list. This was to clean up redundant checks, a change in the criteria, or the error can no longer be triggered based on the validation tools behavior.
The document has good descriptions for the reasons for deletion, but does not list the specifics of the removed error codes. If you are interested in these descriptions, you can find them in the 1.0 Validation Criteria.
I also wanted to repeat something that was mentioned in a previous post. In the new criteria, error number 1952 (STF doc-content title and leaf element title do not match) is to be replaced by 1950. There is no error 1950 in the draft guidance. During the formation of the criteria, it was decided to drop 1950 and replace this check with 3001 (STF doc-content title used). Basically when using STF 2.2 the stf.xml file should not contain doc-content elements that contain titles. These titles are not used during the review process (viewers should display the title specified on the leaf in the index.xml file) and were only mentioned in the STF 2.0 version.
As for the error checks that are new to this version, the bulk of the changes, around 35 new checks, are for the validation of PDFs (5000-5300). The validation is now concerned with a whole host of PDF errors, including broken bookmarks and hyperlinks. The FDA was not previously checking for these errors but because of the impact to the review process when poorly created PDFs were submitted, this new criteria has now been added.
One note concerning the PDF errors listed in the criteria is that error 5080 from the draft guidance has already been eliminated. This flag in a PDF file was too dependent on other settings and caused the error to appear in the report when the PDF was essentially optimized.