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Device MedWatch Does Not Fulfill Regulatory Requirements For Clinical Trials (Doc ID 2833925.1)

Last updated on JANUARY 24, 2022

Applies to:

Oracle Argus Safety - Version 8.1.3 and later
Information in this document applies to any platform.

Goal

Device MedWatch does not appear to fulfill regulatory requirements for clinical trials with respect to reporting for Date of Event for Non-Serious cases.

Code of Federal Regulations - Title 21, Volume 8 - 21CFR812.150 request to report "Unanticipated adverse device effects", per
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=812.150

Currently, the Oracle Argus Device Medwatch completes for serious adverse effects the fields B2, B3, and B5 which is fine.

However, for non-serious adverse effects the fields B2 and B3 are not populated which is okay for B2. B5 is completed as required per regulations.

The problem is that field B3 (Date of event) is not populated. This is not okay. The Date of event must be populated for non-serious cases.


 

Solution

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In this Document
Goal
Solution
References


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