Privacy Methodology for Data Sharing Solutions

The TransCelerate Privacy Methodology for Data Sharing solutions below were developed to promote reuse of clinical trial data while protecting patient privacy.
The Solutions comprise two distinct sets of tools: 

Privacy Methodology for Clinical Data Sharing​ 

Building upon existing solutions in the industry, the Privacy Methodology for Clinical Data Sharing solutions identifies privacy safeguard approaches for relevant variable types and provides logic, allowing sponsors to define approaches at the actual variable level within each SDTM (Study Data Tabulation Model).
It includes the final Clinical Data Sharing: A Proposed Methodology to Enable Data Privacy While Improving Secondary Use and a Transparency Checklist that can be used independently of the methodology. 

Educational Toolkit for Consent Specific to Data Reuse  

This customizable educational tool, published in February 2022, explains methods of protecting patient privacy. It also includes an Educational Poster about privacy safeguards applied to patient data provided and an FAQ to assist sponsors in answering questions from IRBs (International Review Boards) and Ethics Committees on privacy terminology and data sharing.