The Clinical Study Data Flow Diagram

About this session

Part of Session 5, Track D: Inspection Readiness (Chair: Steph Viscomi, Kymera Therapeutics).

The clinical study data flow diagram might be described as a visual representation of how data (which includes data, documents, metadata, and other electronic content which is created and collected) moves through a clinical study's lifetime, from its initial capture to final archiving. It may include the processes, systems, and stakeholders involved in that journey. The clinical study data flow diagram is increasingly being requested during audit and inspections to provide clarity on how study data is generated, processed, and managed across the clinical trial lifecycle.
This presentation will include 2 speakers, the 1st speaker who will provide an overview of the clinical study data flow diagram, its purpose, scope, stakeholders, and contents, and the 2nd speaker, a sponsor, who will provide case study details of the clinical study data flow diagram incorporation into their clinical study management processes and audit/inspection related preparation and conduct activities.

Speakers

• LF

  Liz Farrell

  Agios Pharmaceuticals

  Speaker

• LM

  Lisa Mulcahy

  Mulcahy Consulting

  Speaker

• SV

  Steph Viscomi

  Kymera Therapeutics

  Chair