Part 3 of 3 of the Data transparency webinar series
This 3 part webinar series discussed the challenges at all stages of the data lifecycle, from study inception to data archive/disposal, and demonstrated strategies to manage and document data integrity based on the ALCOA+ attributes and FAIR principles.
WEBINAR 3 – The Data Lifecycle: Ethical use of data was held on 28 September 2022
The Data Lifecycle consists of “All phases of the process by which data are created, recorded, processed, reviewed, analysed and reported, transferred, stored and retrieved and monitored until retirement and disposal.” [… ]”commensurate with potential impact on patient safety, product quality and/or the reliability of the decisions made throughout all phases of the data life cycle” (WHO good data and record management practices – TRS 966 – Annex 5). In the presentation Ursula Garczarek will describe ethical issues and potential conflicts, and some initiatives that work on resolving the issues and conflicts.
Ursula Garczarek, Ph.D. is Research Principal at Strategic Consulting in Cytel. As a member of Cytel’s Strategic Consulting team, Ursula provides guidance to trial sponsors on optimizing their development strategy, and successfully implementing trial design innovations. She applies new and pragmatic methodologies to address the needs and requirements of the sponsor within the regulatory environment. She is experienced with interactions with the FDA and the EMA for general drug development, medical devices and in rare diseases. Prior to Cytel, Ursula was the Program Leader Data Science at Unilever R&D (NL), and Biostatistician at Roche Diagnostics GmBH (DE) developing multi-marker diagnostics based on proteomics and metabonomics approaches. She received her Ph.D. from the University of Dortmund.
Data Lifecycle: Ethical use of data webinar replay
Watch a replay of the 'Data Lifecycle: Ethical use of data webinar' that was held on 28 September 2022.