Thank you for your interest in a summary of the talk "A New CDISC Standard for Reliable Real World Data (RWD) by Droice Labs CTO Tasha Nagamine. Please sign up to receive the talk summary.
About the talk:
FDA submissions of RWD require it to be transformed into CDISC standards, however, the complex processing required to transform RWD into SDTM results in data loss and biases that render the RWD unreliable, precluding regulatory use. Droice recognized this gap and worked with CDISC to initiate the RWD Lineage Project, which aims to define a standardized and scalable approach to maintain data lineage for RWD in regulatory submissions. Droice Labs' CTO Tasha Nagamine is leading the RWD Lineage initiative along with Anita Umesh from Roche and they recently presented this project at the PHUSE RWD Spring Event.
Here are a couple related blog posts discussing the challenges involved in transforming RWD into reliable SDTM and Droice’s solutions:
