Project Scope |
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There are current efforts by regulators |
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and sponsors to make Clinical Study Reports ( |
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CSR) and Individual Patient Data (IPD) from clinical trials shared more widely. The PHUSE De- |
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Identification Project work on defining de-identification standards for CDISC standards and released in 2015 the PHUSE De-Identification standard for SDTM 3.2 |
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. The |
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goal is to define standards to reduce efforts for companies to de-identify IPD and provide consistent data to researchers where data utility is considered. |
Project Leads |
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Beate Hientzsch |
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Lauren White (PHUSE Project Coordinator) |
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Project concluded. |
| Resources | |
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PHUSE De-Identification Working Group:Providing De-Identification Standards to CDISC Data Models, Ferran et al., PHUSE Conference DH01 2015 (Paper) (Presentation) | |
Data De-Identification Made Simple, Jørgen Mangor Iversen,LEO Pharma, PHUSE Conference DH02 2016 (Paper) (Presentation) | Data De-Identification Standard for SDTM 3.2 –Date offsetting appendix updated to address the case of imputed dates in Analysis Dataset (e.g. ADaM) |
| Data De-Identification Standard for SDTM 3.2 – Appendix 2: Low Frequencies Version 1.0 |