Metadata is data about data. That may sound confusing, but it will come clear in a moment, I promise. The background for this is the fact that FDA now requires electronic rather than paper submissions. The idea here is that electronic submissions will be easier to review because submissions will be more consistent and will be readily searchable. And, if the reviewer’s job is easier, then it should help your drug move through the process more reliably, if not necessarily faster.
In an earlier blog entry, I talked about opportunity costs in terms of the steps required to prepare an electronic submission. Those steps are:
- Transform the documents into PDF format.
- Place the individual PDFs into the electronic common technical document (eCTD) backbone.
- Submit through the FDA’s electronic gateway.
It is during the second step that metadata is an issue. As the regulator’s system files your submission, it uses metadata in multiple ways, so let’s expand our definition of metadata. Let’s take the music you have downloaded to your phone as an example. Metadata is more than data about the data, it is:
- Data about the way in which data are organized—data about the file structures built to hold the data. Call this structural metadata. We see this for clinical data files which must be put into certain expected formats. For the music on your phone, these are the MP3 or other file formats used to encode the sounds.
- Data about the data content. For example, when you submit certain eCTD quality documents, you are required to provide the dosage form and strength of the drug product. Call this descriptive metadata. This equates to the album and track data for your music.
What does this mean for a firm who has completed paper submissions in the past and now needs to submit an IND amendment or an NDA annual report? First, it must be submitted to FDA electronically. That means that you will need to answer questions that you may not have thought much about when preparing paper submissions.; however, you will be able to provide those answers with information that you already have. After all, you know what your dosage form is. You know its strength. In other words, descriptive metadata is likely to be easy to provide.
What about structural metadata? This, remember, is all about how the data are set up in the files transmitted to regulators. The standards for this are well known for different types of data; the majority can be found on the FDA’s website.
So, do you need to worry about metadata? Yes, certainly if you are creating your own eCTD submissions. If, instead, you choose Pearl Pathways (or another contract organization) to do this, all you will need to do is answer some simple questions (e.g. regarding dosage form and strength) and work with us to ensure that the data structures are the expected ones.
See, it is just data about data. And you already know the answers.