Ever wonder what makes a database design “smart”? Or when a sponsor should begin thinking about data collection and analysis? PharPoint Senior Database Programmer Michelle Morcos covers these topics and more in this video.
Smart Database Design Transcript“What makes a database design “smart”? And when should a sponsor begin thinking about data collection and analysis? We cover that and more in this video.
Achieving a balance between data capture and data analysis can be tough. The goal of data collection is to provide complete, high quality data. Here we want to consider how database design can ease some of the burden of data entry and monitoring – by being flexible while also reducing entry errors, by allowing for easier entry through intuitive design and by increasing collection efficiency.
The goal for data analysis is to receive complete, high quality data that is most conducive to the review process. This is best done by maintaining the ability to link data together, by ensuring data quality and consistency, by handling missing or questionable data, and by conforming output to expected standards.
The challenge we face in database design is meeting the needs of both the database end users and the data consumers. This is where CDASH comes in.
Designing the database to meet data collection needs up front while reducing the efforts to meet SDTM compliance downstream can be achieved with proper planning and use of CDASH. But there are potential issues even when following the CDASH model so it is critical they be addressed during database design.
By taking an intelligent approach to CDASH, you can not only make data entry more efficient but also reduce the number of custom edit checks and manual reviews by building the database to allow for enforcement of numeric precision, correct units of measurement, range checks and more.
Smart database design begins with SDTM compliance and data analysis in mind. This should be considered during form design but it’s never too early to begin thinking about it.
Ideally this would start at protocol development where the CDISC PRM, or Protocol Representation Model, could be utilized. For instance, why not use CDISC Controlled Terminology right from the start, thereby eliminating the need to map the data on the backend?
So “Beginning with the End in Mind” is a great way to work when feasible. However, SDTM can still be implemented after all data is collected as part of the submission preparation process. While it’s best to start early, it’s never too late!
If you’re interested in hearing more about intelligent database design with SDTM compliance in mind or how to bring your existing program of studies into compliance, please reach out to the PharPoint Programming team via pharpoint.com.”