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 Working Group has worked on defining de-identification standards for CDISC SDTM 3.2 and has recently reviewed the Health Canada Guidance document. The team will extend its scope to other CDISC standards in the future.
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