Please Advise On What Oracle Is Doing With Argus Interchange To Accommodate An Upcoming FDA Requirement - New regional data element, A.1.FDA.16 (FDA Safety Report Type)
(Doc ID 2756135.1)
Last updated on OCTOBER 11, 2021
Applies to:Oracle Argus Safety - Version 8.2 and later
Information in this document applies to any platform.
Please advise on what Oracle is doing with Argus Interchange to accommodate an upcoming FDA requirement for electronic submissions of ICSRs:
Postmarketing Safety Reporting
Starting June 28, 2021, FDA is implementing a new mandatory regional data element for the electronic submission of ICSRs. The new regional data element, A.1.FDA.16 (FDA Safety Report Type), will distinguish the safety report type as IND Safety Reports, IND Exempt BA/BE Safety Reports, or Postmarketing Safety Reports. For more information about the regional data element, A.1.FDA.16 (FDA Safety Report Type), and submission rules, please see the revised technical specifications document Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments (December 2020) and revised DTD 2.1 OR ( text file format) and DTD 2.2. OR (text file format)
The link to this info is: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions
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