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An extension of the FHIR Patient Reported Outcomes (PRO) Implementation Guide (IG) for 21 CFR 11 Compliance

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FHIR Support for 21 CFR Part 11-compliant Patient Reported Outcomes

This is the repository for the FHIR 12 CFR 11 Patient Reported Outcomes Initiative (PRO) initiative supported by an FDA U24 grant.

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The current draft site is available here: https://chb.github.io/21cfr11pro-ig/

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An extension of the FHIR Patient Reported Outcomes (PRO) Implementation Guide (IG) for 21 CFR 11 Compliance

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