INSTRUCTIONS FOR RESOLVING BUG 5874162 - MEDWATCH 7-DAY ALERT REPORT CHECKBOX FOR SUBMISSIONS CONNECTION (Doc ID 1120763.1)

Last updated on JUNE 09, 2010

Applies to:

Adverse Event Reporting System - Version: 4.5.1 to 4.6.2 - Release: 4.5 to 4.6
Information in this document applies to any platform.

Goal

Bug/enhancement 5874162 addresses the issue that the 7-day MedWatch report is available without being the “7-day blood” MedWatch report (the only option available currently). This option does not accurately reflect some AERS customers’ needs since their reporting involves fulfilling the 21CFR312.32 requirement (IND fatalities or life-threatening reports), and does not involve blood collection or blood transfusion fatalities as required for filling out the 7-day blood MedWatch report form.

Solution

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