ACDM

Presenters: Julie Ann Hood, Principal CDISC Consultant & Jen Manzi, Senior CDISC Consultant

要旨： Selecting players armed with unique abilities to collaborate is key to crafting an unbeatable strategy, whether on the field, navigating a quest, or in the office. In standardized clinical trial data, this can break down departmental silos and enhance study data quality, leading to more effective treatments sooner. Historically, SDTM programmers handled validation report issues, but some rules require tracing SDTM data back to raw data or data collection to optimize decision-making.

Integrating data managers can slash resolution time and boost data quality. This poster will provide guidance on weaving data managers into the SDTM validation process and unveil different workflows to level up your approach to resolving validation issues.

Curating appropriate FDA validation rules will showcase how these are best served by the unique positioning of data managers. Lastly, suggested training and ideas to power-up your data managers will equip you to battle issues and conquer those data demons.