Table of Contents
- Title and Copyright Information
- Preface
- 1 Introduction
- 2 Minimum Requirement for MIR Report Generation
- 3 Configurations to enable MIR Reporting
- 4 Case Processing and Reporting
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5
Frequently Asked Questions
- How is MIR reporting handled for Non-serious Reportable Incidents?
- How are MIR XML and MIR PDF transmitted together to the same destination?
- Does Oracle Argus Safety generate electronically signed non-editable MIR PDF?
- Is Similar Incident Data automatically populated by the system?
- How to overcome population of non-existing countries such as "World" in the Other Countries field of Section 2.5 Market distribution of device in a MIR Report?
- Are IMDRF Codes auto populated for legacy cases after upgrade to Oracle Argus Safety 8.2.2 or 8.2.3?
- If obsolete FDA Codes are used in the legacy cases, how is the recoding of such cases handled?
- Are IMDRF codes automatically derived from MedDRA PT for Clinical Signs (Annex E)?
- If earlier version of MIR – EU Device Vigilance report in Oracle Argus Safety was used to send out the Initial Report, can the follow-up or Final Report be sent on the New MIR Report format?
- How is Incident Classification handled in the new MIR Report?
- Are FDA Coding and IMDRF done separately for Device Problem and Evaluation/Investigation Code Information?
- How does the system determine the MIR Report type?
- When I generate an MIR Report generated by Oracle Argus Safety, would it be acceptable by NCAs or NBs?
- If multiple events in a case form are coded with IMDRF Clinical Sign Codes, which events are considered for clinical sign population in Section 3.3, Patient information, IMDRF Clinical signs, symptoms, and conditions codes (Annex E)?
- Can MIR XML be transmitted over email?
- If the MIR Report submitter is a Local Company Representative, what would be the required configuration?
- How are partial dates handled in MIR?