In a two-part series, guest blogger Jasmine Kestemont, Managing Partner at Innovion, shares her findings from a cost-benefit analysis for CDISC data standards implementation during clinical trial setup. In this article, Kestemont reviews study setup activities from protocol to Define.xml creation, highlighting that any level of standardization has a direct and immediate impact on the effort required for trial setup.Read More
With FDA now regulating for all new studies to use CDISC standards when submitting data, it's vital that our processes are up to date with the latest standards and fit for purpose.
An FDA presentation at the recent PhUSE Computational Science Symposium tried to shed some light on how we're doing as an industry. It analysed all eCTD submissions from January-February 2017 that used standardized data.
The festive period is in full swing, and in the Formedix office, we’re no exception. While we sample festive chocolates, raise a glass over Christmas lunch, or add the star to the top of the office tree, we look back over the year and give a nod to all the great things we’re excited to offer, here at Formedix.Read More
Earlier this month, I participated on the Q&A panel for our CDISC SDTM-IG webinar. During the webinar we received an interesting and very timely question around the use of CDISC SDTM v1.5. I was asked “CDISC have released SDTM 1.5, should we use this instead of SDTM 1.4?” So here is my quick guide on the appropriate use of the standard…
REGULATORY DEADLINE UPDATE: The FDA Data Standards Catalog has recently been updated to state that Define-XML v1.0 cannot be used in studies starting after March 15, 2018 . The Catalog previously stated March 2017, however the update now aligns with the date communicated on the Federal Register Notice.Read More
In last week’s blog, we looked at the SDTM mapping process and ended on the cliffhanger of the supplemental qualifier. These tricky little tidbits are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard. Let’s look at them in a little more detail.Read More
One of the most important standards when it comes to clinical trial submission, the Analysis Data Model (ADaM) outlines how to create analysis datasets and associated metadata. This in turn allows a statistical programmer to generate figures, listings and tables more easily, and ensures traceability, which means that reviewers are able to review and approve a submission more quickly.Read More
This is the second of a two-part blog discussing CDISC standards from the start with Formedix CEO Mark Wheeldon. If you haven't read the first part yet, you'll find it here. Below are the slides from Mark's CDISC International Interchange 2014 presentation, CDISC: Standards from the Start, which accompany the discussion.Read More
Just like Dr. Pepper, Define-XML is so misunderstood. There’s a common misconception among CDISC users that it is simply a way to document what datasets look like. Sure, Define-XML can be used to document the names and labels of dataset variables, and it can document what terminology is used. It does that brilliantly. But thinking of Define-XML solely as a dataset descriptor does this standard a massive injustice.Read More