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
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project has worked on defining
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De-identification standards for CDISC SDTM 3.2 and has recently
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review the Health Canada Guidance document. The team will extend
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it's scope to other CDISC standards in the future
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Project
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Lead:
Beate Hientzsch - beate.hientzsch@mainanalytics.de
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