6 Set up Reporting Rules
We recommend you retain the existing expedited reporting rules (#1, #2) for 15-day and periodic report types, and create the other new expedited reporting rules, below are the suggested reporting rules:
Country | License Type | Agency | Rule Name | Time Frame | Report Form | Condition |
---|---|---|---|---|---|---|
United States |
Marketed Drug |
FAERS |
15-day |
15 |
E2B |
Event Serious = Yes |
United States |
Marketed Drug |
FAERS |
Periodic |
60 |
E2B |
Case Serious = No or Case Serious = Yes Criteria using Advance conditions: Case Listedness = Yes Any other condition as per your company’s business process |
United States |
Marketed Drug |
FAERS |
5-day |
5 |
E2B |
Criteria using Advance conditions
Any other condition as per your company’s business process |
United States |
Marketed Drug |
FAERS |
30-day |
30 |
E2B |
Case Serious = No Criteria using Advance conditions
Any other condition as per your company’s business process |
World |
Marketed Drug |
FAERS |
30-day |
30 |
E2B |
Case Serious = No Criteria using Advance conditions:
|