RWD Quality Challenges – different perspectives |
insert abstract This presentation emphasises the critical role of data provenance in Real World Evidence (RWE) studies, highlighting its importance in ensuring data traceability from vendor to analysis. Data provenance, described as a "fingerprint" for data, allows researchers to trace information through curation, transformation, and analysis steps, addressing the challenges posed by the substantial increase in data volumes in RWE studies. After watching this presentation, you'll understand the need to plan for provenance up-front, as you design your study, and how you can approach it to ensure you achieve traceability from analysis back to your data source. Elizabeth will add more to abstract |
Presenter | Bio |
|---|---|
| Dr Cheryl Grandinetti, FDADr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and scientific and clinical oversight to FDA field investigators. She participates as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials, including in studies using RWD. |
Kris Wenzel, MMS HoldingsKris Wenzel is a Senior Manager, Data Science with over 30 years of global IT technical and managerial experience and proven leadership with large scale projects, digital transformation, data engineering and analytics. Mr. Wenzel holds a Masters in Business Administration with a concentration in Finance and a Bachelor of Science Engineering with a Concentration in Computer Engineering. |
