Common eCTD Mistakes - as Described by FDA (Part 2)

Continued from last time... Notes from my discussion with Virginia Ventura.

Virginia mentioned lack of a cover letter, or lack of a useful cover letter, as a significant issue. Although the cover letter is not a regulatory requirement, it serves as the reviewers' "Road Map" to the submission, and Virginia can't understand why a sponsor would not take advantage of the opportunity to provide clarity on the structure and contents of the submission. Her recommendations here:

• When you reference documents in your cover letter, provide hyperlinks to those documents.
• Review your cover letter closely for accuracy. Mistakes in the cover letter can cause significant confusion.

We discussed the concept of providing more detailed reviewer guides as well. Again, these are not a regulatory requirement, but some companies consistently provide well-structured guides that make reviewing much easier. These should not just reproduce the TOC, but might included details and discussions such as the following:

• How the eCTD was constructed (for example, using which software package) and how it was submitted (via the gateway, etc.)
• Version of specs used
• Brief description of pivotal studies, with mention of where they are located and hyperlinks to key documents and summary sections
• Discussion of how study reports were constructed (ICH granularity, etc.)

You also may wish to discuss placement issues (for example, when a study could legitimately be placed in more than one section), instances when the same document was submitted in more than one section, etc.

As a reminder, FDA has organized documents related to electronic submissions on http://www.fda.gov/cder/regulatory/ersr/. This is a great collection of resources, and Virginia mentioned that not all sponsors are aware that this page exists before they contact her.

Specifically pertinent to this post, FDA has a posted presentation, eCTD Validation, available on their website. This was presented by Don Duggan in February at DIA EDM in Philadelphia.