21 CFR Part 11 wouldn't apply to the Medicaid-related documents. 21 CFR Part 11 is not a common rule among all the agencies under US HHS. It is a predicate rule among all the GxPs under US FDA.
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Aldwin Aldana
Director, Clinical Quality Assurance (GCP)
West Newton MA
United States
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Original Message:
Sent: 01-Apr-2023 18:07
From: Tamiko Eto
Subject: Is Part 11 relevant to the new Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials??
So if it was an FDA-regulated medical device (or drug) clinical trial, in which Medicaid would be charged, would Part 11 require any Medicaid related documents obtained as part of that clinical trial require compliance?
Tamiko
Original Message:
Sent: 4/1/2023 5:21:00 PM
From: Aldwin Aldana
Subject: RE: Is Part 11 relevant to the new Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials??
21 CFR Part 11 only applies to the FDA-regulated clinical trials as defined in 21 CFR Part 312 for pharmaceuticals and 21 CFR Part 812 for medical devices.
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Aldwin Aldana
Director, Clinical Quality Assurance (GCP)
West Newton MA
United States
Original Message:
Sent: 31-Mar-2023 20:03
From: Tamiko Eto
Subject: Is Part 11 relevant to the new Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials??
When conducting human subjects research (that research that is bound to Common Rule and oftentimes FDA regulations) the new regulation effective now requires Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials. When documenting all these things via an electronic signature, does Part 11 come into effect?
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Tamiko Eto
Asst. Director
Anne & Robert H. Lurie Chidlren's Hospital
Office of Research Integrity and Compliance
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