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DISCLAIMER

This set of de-identification rules defined for CDISC SDTM 3.2 is written with the goal of both facilitating the assessment of direct and quasi identifiers in SDTM datasets and ensuring consistency in anonymized data shared across sponsors.

The definitions of direct and quasi-identifiers and the decisions and concepts described in this deliverable represent the consensus of the working group rather than an endorsement of the companies represented in the working group.

However, the rules described here do not guarantee an acceptable or very small residual risk of re-identification in the data and it is the responsibility of the sponsors to define and measure what the residual risk is and define an acceptable risk threshold.

SDTM being also a normalized data model, not all direct nor quasi identifiers may be captured in this deliverable and it is the responsibility of the sponsor to ensure that such assessment is conducted and reviewed according to defined internal procedures.

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