The FDA has a system called MEDWATCH.  Forms are available for both
mandatory and voluntary adverse event reporting.  You could probably
use those as is or use them as a template. I don't have a Web address
but there is probably something on the Web.  Or... the CFRs are very
will certainly tell you the information that is reportable.  Finally,
ask any of your PIs doing clinical trials for drug companies for a copy of the
adverse event report provided to them by the pharmaceutical company.