Khaled El Emam
Articles
Are Clinical Trial Data Shared by the EMA Under Policy 0070 Really Public Data?
June 25th 2018The general assumption that the Policy 0070 data releases were public data releases can be challenged since there is a mechanism to enforce the ToU, and this mechanism will continue to exist after the Agency moves to the Netherlands.
An Analysis of Anonymization Practices in Initial Data Releases Pursuant to EMA Policy 0070
April 13th 2017Examining early learnings from approaches used to comply with EMA’s requirement to publish anonymized versions of clinical study reports and other submission documents, including how privacy protection was balanced against data utility.
De-identifying Data in Clinical Trials
August 1st 2015Whether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.
De-identifying Clinical Trials Data
March 20th 2015Whether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.
