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TransCelerate BioPharma has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) that are shared with researchers, patients and others. The document describes an approach to apply when redacting or removing personal information from CSRs and other related clinical trial documents, and is available here. According to TransCelerate, the approach provides practical details to help implement the July 2013 commitment by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies titled, "Principles for Responsible Clinical Trial Data Sharing."
The goal of the TransCelerate CSR Redaction approach is to provide organizations that share CSRs with a consistent way of protecting personal data that is contained in these documents. Information in CSRs will be removed or redacted in order to protect the privacy of patients and those associated with a clinical trial.
Read the full release here.