Phuse US Connect

Presenter: Michael Beers

Preparing Bioresearch Monitoring (BIMO) Clinical Site (CLINSITE) datasets for submission can be challenging, and issues are frequently identified during regulatory review. This presentation reviews the most common problems seen in CLINSITE datasets and supporting documentation, explains why they occur, and provides practical guidance on how to address them to ensure compliance with FDA specifications and guidance.

Presenters: Jeffrey Abolafia, Ingeborg Holt, Sarah Ferko

As the use of real-world data (RWD) in regulatory submissions continues to grow, both sponsors and regulators face new challenges. This session examines the current regulatory landscape and required standards for submitting RWD, evaluates emerging initiatives such as expanded CDISC standards, JSON submissions, and HL7 FHIR, and provides short- and long-term recommendations for submitting both randomized controlled trial and non-interventional study data.

Presenter: Kristin Kelly

The release of CDISC SDTMIG v4.0 represents a major shift in SDTM standards. This presentation explores key updates – including Multiple Subject Instances (MSI), Non-Standard Variables (NSVs), metadata restructuring aligned with SDTM v3.0, new and updated domains, and reorganized guidance sections, and provides practical recommendations to help sponsors prepare for and successfully navigate this significant transition.