Last December, CDISC (Clinical Data Interchange Standards Consortium) updated the Study Data Tabulation Model (SDTM) Implementation Guide for Medical Devices (http://www.cdisc.org/sdtm), in light of the FDA requirement that all data submitted must be in CDISC format by 2016. For those of you who have heard about this, but are not quite sure what it all means, here is a basic description of it - in layman’s terms - with more detailed information to come in future blogs.
What is CDISC data?
In short, CDISC data is data that looks a certain way. Everything must be set up a certain way and named a certain way, right down to whether or not a word is typed all in capital letters, versus just the first letter capitalized. There are so many rules that you really need people who are well-versed in the CDISC “language” to create your datasets for you.
Why is FDA requiring this?
The advances in technology and increase in storage capacity have meant a huge increase in the number of data points collected for a clinical trial in the past decade or so, therefore trying to figure out someone else’s data is frustrating. Picture the FDA reviewers, who are time-strapped as it is, trying to decipher yet another sponsor’s data. Where is the variable for ‘Gender’, they wonder? It must be in the demographic dataset, but which of the 50 datasets in the folder is the demographic dataset? They waste precious time looking for each variable. With CDISC data, the reviewer will know exactly where to find every single variable they need, for every submission they see.
When do I have to worry about this?
You need to start thinking about this now for all your trials going forward, so that the data collection process you choose for your studies lends itself to the CDISC format. This will make it really easy to go from “last patient out” to data lock and subsequently, submission. Your team should include 2 sets of programmers and statisticians: some who worked in the drug area and went through the CDISC process already, and some who work in devices and diagnostics who understand the study design and analysis methods typically used in this area. They need to talk to each other and plan the strategy for how the CRFs will be designed, how the data will be collected and how the database will be set up. There are a number of EDC vendors and software tools on the market now that put data in CDISC format, but these were designed to put the data in the CDER CDISC format. The CDRH CDISC format looks much different, in order to correspond to the different types of endpoints and analysis methods used in CDRH, so you’ll need to be cognizant of these differences.
Here’s to a successful and smooth transition to CDISC for all of us submitting data to CDRH!