THOUGHT LEADERSHIP

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?

Last October, Susan Boquist, Associate Director, Statistical Programming, traveled to CDISC International Interchange in San Diego, California to present the poster, “Creating Harmonious SDTM Domains”.  The poster was created in collaboration with Principal Statistical Programmers: Elena Prosekova, Natalia Quinn and Sofia Tyryshkina. 

Mapping raw data into standardized, tabulated data sets can be a daunting task to undertake, especially if one has not done it before.  Even seasoned mappers could use the help of some additional ideas and tips.  The poster shared the authors’ thoughts, suggestions and examples to help turn a cacophony of raw data into a standardized symphony that will flow into analysis.

Due to the worldwide pandemic, the CDISC European Interchange, originally scheduled to take place in person in Berlin, Germany, was presented completely online. Susan Boquist, Associate Director, Statistical Programming, took advantage of the accessibility and logged in at 3:00 am her time both mornings. Though it may have become an April Fool’s Day to remember, with only a few weeks’ notice, the organizers were able to make the format transformation flawlessly. The conference schedule was consolidated into one track. A networking app was employed to allow for attendees to easily communicate with each other, ask questions of the presenters, and view and vote on the poster presentations. Training and workshops were rescheduled for another time. It was so successful that everyone hopes the organizers will consider adding a virtual option for future conferences.