1. EC Manufacturer Incident Report (MIR) Best Practices
  2. Frequently Asked Questions
  3. 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)?

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)?

The system picks the first six events in the case form that has the IMDRF Code coded for Clinical Signs based on the following priority:

  • Priority-1 - Serious Related Events
  • Priority-2 Non Serious Related Events
  • Priority 3 - Other Events with Clinical Sign IMDRF Code

Note:

Relatedness is based on product for which the report is scheduled.

Parent topic: Frequently Asked Questions