CDISC US 2024

Selecting players armed with unique abilities to collaborate with is the key to crafting an unbeatable strategy while on the field, navigating a quest, or in the office. In the realm of standardized clinical trial data, not only can this break down departmental siloes, but it can also enhance the quality of study data, leading to the availability of more effective, efficient treatments earlier.

Historically, due to the timing and content of SDTM validation, many organizations enlisted SDTM programmers with unraveling issues in these reports. However, there are some rules that require tracing SDTM data back to raw data or data collection to optimize decision-making. Seamlessly integrating data managers into this process can help slash time to resolution of these types of issues as well as boost overall data quality.

This poster will provide important considerations and guidance on weaving data managers into the SDTM validation process. Unveiling different types of workflows will illustrate how to level up your approach to resolving validation issues. Curating appropriate FDA validation rules along with detailed examples will showcase how these are best served by the unique positioning of data managers. Lastly, suggested training as well as ideas to power-up your data managers will equip you to battle issues at the source and conquer those data demons.

Can’t attend the conference? Get up to speed on best practices for mapping your clinical trial data to CDISC SDTM with our free guide.