STANDARDS FOR EXPEDITED REPORTING
INTRODUCTION:
During clinical investigations, adverse events may occur which, if suspected to be medicinal product-related (adverse drug reactions), might be significant enough to lead to important changes in the way the medicinal product is developed (e.g., change in dose, population, needed monitoring, consent forms). This is particularly true for reactions which, in their most severe forms, threaten life or function. Such reactions should be reported promptly to regulators. Therefore, special medical or administrative criteria are needed to define reactions that, either due to their nature ("serious") or due to the significant, unexpected information they provide, justify expedited reporting.
PURPOSE:
The purpose of expedited reporting is to make regulators, investigators, and other appropriate people aware of new, important information on serious reactions. Therefore, such reporting will generally involve events previously unobserved or undocumented, and a guideline is needed on how to define an event as "unexpected" or "expected".
WHAT CASES TO BE REPORTED:
Single cases of serious, unexpected ARDs
A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life threatening disease.
A major safety finding from a newly completed animal study.
EXPEDITED REPORTING TIME FRAMES:
Death or life threatening cases and SUGAR(Suspected Unexpected Serious Adverse Reaction) cases are reported within 7 calender days to the health authorities.
Clinical trial other serious unexpected cases and safety issues are reported in 15 calender days.
WHOM SHOULD BE REPORTED:
HOW TO REPORT:
The CIOMS-I form has been a widely accepted standard for expedited adverse event reporting. All reports must be sent to those regulators or other official parties requiring them in countries where drug is under development.
REFERENCES & RESOURCES:
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