General
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Yes, Advarra eRegulatory Management System (Advarra eReg) is a 21 CFR Part 11 compliant system. Please contact us for 21 CFR Part 11 Compliance Documents.
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Reviewers can log in and access the review session record to view the protocol’s requirements documentation.
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Complete a service now ticket including the study monitors Organization, official email address and name.
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Yes. Advarra has provided a HIPAA Compliance Statement. It is available at HIPAA Compliance Statement - Advarra.