World OF DRUG SAFETY MODULE

FAQ

1. How do you determine and delete duplicate reports?

   1. OSE never deletes a report from the AERS database. When there is an analysis of a case series, the duplicate is removed from the analysis and counted once. A lot of duplication occurs when manufacturers submit follow-up reports as new reports. FDA controls duplicates by using a manufacturer control number. The control number on the form identifies the manufacturer and the case. Follow-up reports link to the original manufacturer control number and are entered in the system. Of course, the other way to make a final determination about removing a duplicate report from an analysis is to read the whole report.