| Comment Record |
|
Commentor |
Ms. Theresa haedrich |
Date/Time |
2002-01-22 18:43:57 |
|
Organization |
Aviron |
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Category |
Company |
| Comments for FDA General |
| Questions |
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1. General Comments
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Dates
The revised VAERS form does not include directions for format. The previous form (VAERS-1) specified the preferred format in each date field (eg. mm/dd/yy). These instructions are critical for any company doing business outside the borders of the U.S. as the generally accepted international format is dd/mm/yyyy.
BOX D: Time of adverse event
The date and time of vaccination is collected on the VAERS-2 form. The date of the adverse event is also collected however the time of the adverse event is not requested. Although the time of the adverse event can be reported in the Description of Event, if the VAERS form is used as a data collection document, this information will likely be excluded since it is not specifically requested. I suggest that the question regarding the timing of event be re-phrased as “How soon after vaccination did these event(s) start? If less than 1 hour, give exact time.”
Box G2
The box asks for the “Tracking Number”. It is not clear that the BLA number should go here or another number.
E2b
How are the changes to the VAERS form going to effect electronic submission of safety data?
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