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The Anonymization of Clinical Trial Data: Methodology Course
Thu, 29 Jun 2017, 9:00 AM – Fri, 30 Jun 2017, 5:00 PM BST
This two-day comprehensive course, led by Dr Khaled El Emam, will provide attendees with the skills needed to manage the risk of re-identification when clinical trials data is shared for secondary purposes. This includes voluntary sharing as well as mandatory sharing under EMA Policy 0070.
Contemporary standards and guidelines for anonymizing clinical trials data will be covered, such as IOM and PhUSE. We will go through a series of case studies on anonymizing datasets and discuss specific concerns and issues with small datasets and rare diseases.
Our peer-reviewed, standards-based and scalable risk-based anonymization methodology has been used across North America and the European Union for anonymizing health data for over eight years. This methodology provides quantitative methods to objectively measure risk, and a well-defined and auditable approach for managing those risks. Its application to clinical trials is supported by case studies and discussions of specific data release mechanisms, such as portals.
Recently the European Medicines Agency has updated their guidelines for meeting Policy 0070. This course will place a strong emphasis on the methods that are needed to operationalize these guidelines. Multiple scenarios will be covered, including:
- Preparation of the Redaction Proposal Document package;
- Preparation of the Final Redacted Document package;
- What are the contents of the anonymization report;
- How to perform risk analysis on clinical reports; and,
- Workflow for redaction and anonymization. Attendees will go through examples of preparing clinical reports for Policy 0070 submission.
Any questions about the course can be sent to Erin: firstname.lastname@example.org