I can actually say that I have been working in the Clinical Trials industry since the last century. I started as a database programmer, part of data management in a large (now huge) CRO. In those days we used paper CRFs, entered by hand into a database platform that was built and maintained inhouse.
We had our own naming conventions for variables and could pretty much build whatever we wanted and group the data however it made sense to us. Prior to deliverables, we printed out the entire database so data managers could review it. All the files were burned to floppy discs and we’d pop them in the mail to the sponsor. With the amount of data we collect, and the requirement to do more, faster, can you even imagine doing that now?
Fast forward a few years and I was asked to get involved with an internal group whose focus was data standards. The brief description of the group mentioned that official standards of some sort coming and we needed to prepare. I thought data standards sounded like a great idea. The initiative never got going. More time elapsed and there was an opportunity to travel to Berlin, Germany to be trained on CDISC SDTM. My professional life was suddenly about to change, and for the better.
The standards then for SDTM in clinical trials were simpler than they are now but took some getting used to; there was a decent learning curve. Even though they were “standards” there was a lot of grey area and perceived latitude for mapping the data. By attending conferences and asking questions of more experienced people, I learned a great deal. Some parts of the guidance I didn’t really fully understand until I started teaching others.
Over the years, SDTM has developed to tabulate data in more meaningful ways, which helps to streamline the analysis process.
CDASH has been developed to organize how data are collected, which helps to streamline tabulating data. Validation tools have also been developed to help determine the quality of the mapped domains. One problem, though, has been the lack of a standard way to determine the skills of potential new hires or a company engaged to help a sponsor. I developed my own set of questions for the interview process but, occasionally, someone would give good answers but not actually be able to perform the job properly.
CDISC listened and in 2020 announced that they would be launching a CDISC Tabulate Certification pilot program.
To be accepted for one of the limited testing seats, I had to submit my resume demonstrating that I had at least three years of CDISC SDTM mapping experience. The exam lasted for approximately 5 hours and included about 125 questions covering everything from General Concepts, Terms and Assumptions, and Conformant Dataset Structure to, Controlled Terminology, The Trial Design Model and Relationships Among Datasets and Record.
There were no recommendations for how to prepare for the test. I went back and reviewed all my slides, quizzes, and notes from the training that I had given over the years. I also reviewed differences between the more recent version of the implementation guide and the one with which I was most familiar. Even though the test is supposed to be version agnostic, some of the test group descriptions indicated that it would be advantageous to be familiar with multiple versions. One of my PROMETRIKA colleagues, was also taking the test, so we scheduled some meetings together to talk through the categories and discuss what we thought the questions might cover.
It was very interesting to take the exam. I found I actually learned a couple of new things, and the rationales for a few other things seemed a little clearer. The exam highlighted how much I consult the IG and Model while I am creating specifications and programming, but also how much I do know about the standards. I felt that the exam covered a good portion of required knowledge and that certification would be a good measure of new candidates or employees of companies being engaged to do the work. If you are looking for help with SDTM mapping, I recommend looking for someone with CDISC Tabulation Certification.