by Jean-Marc Ferran | Jan 24, 2020 | Data Anonymisation & Sharing
This presentation provides an overview of regulatory requirements across agencies with regards to data sharing, reviews the FDA Clinical Data Summary Pilot, and provides some insight into 2020 main announcements to come in the field. 
by Jean-Marc Ferran | Nov 7, 2019 | Data Anonymisation & Sharing
This publication features the highlights of a review of 13 academic research reports, with the goal to better understand Data Utility in anonymised CSRs. Their different research purposes have been analysed and classified against the required data to support... by Jean-Marc Ferran | Jun 28, 2019 | Data Anonymisation & Sharing
This presentation features the highlights of a review of 13 academic research reports, with the goal to better understand Data Utility in anonymised CSRs. Their different research purposes have been analysed and classified against the required data to support... 
by Jean-Marc Ferran | Mar 6, 2019 | Data Anonymisation & Sharing
There are various policies around Data Sharing of submission documents which are effective or in preparation. This paper explores how four agencies’ policies differ or align in terms of processes and anonymisation requirements. by Jean-Marc Ferran | Nov 17, 2017 | Data Anonymisation & Sharing
This Industry presentation features key principles around risk quantification, use of different disclosure contexts and reference populations. It also provides insights into the PHUSE De-Identification Standards for SDTM 3.2. by Jean-Marc Ferran | Jun 15, 2016 | Data Anonymisation & Sharing
This presentation compares requirements between ClinicalTrials.gov and EudraCT and discusses the process of publishing study results in multiple registries. It also tackles the future of Policy 0070 and how sponsors could consider updating their processes.
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