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There are current efforts by regulators such as the EMA to make Clinical Study Reports (CSRs) and Individual Patient Data (IPD) from clinical trials shared more widely. The PHUSE De-identification Standards project has worked on defining De-identification standards for CDISC SDTM 3.2 and has recently review the Health Canada Guidance document. The team will extend it's scope to other CDISC standards in the future

Project Lead:

Beate Hientzsch - beate.hientzsch@mainanalytics.de


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