Designing a clinical trial database is a balancing act. Any clinical program has multiple stakeholders who have both short-term and long-term goals to achieve. A good database designer must understand the needs and goals of the sponsor and its various functional project team members. The designer must consider the ease of use for the clinical trial sites who will be entering the trial data, with the needs of the downstream stakeholders in biostatistics, programming, and medical writing. Additionally, we not only need to consider today’s priorities, we also must understand the overall strategy of the clinical program, especially as it moves forward past the current stage. In this webinar, we explore the key considerations that must be discussed prior to designing your clinical trial database.
View the webinar video to:
- Understand how database design can affect SDTM in both the short- and long-term goals of your trial and program as a whole
- Determine the needs and wants of your investigator sites and clinical monitors in CRF design
- Balance sponsor/site needs in database design with real-life examples