The FDA and the NIH have agreed to develop a harmonized
adverse event (AE) reporting mechanism for consumers, health professionals,
investigators, sponsors and other parties to electronically submit reports.
The project is aimed at developing a “Rational Questionnaire”
and electronic prototype system for reporting. The questionnaire is intended to
be an “interactive help system” that will assist AE reporters in determining
which data need to be submitted and to whom. The prototype system will allow
the agencies to test the feasibility of a central, federal web-based portal to
provide direct, seamless, online submission of adverse event reports to
appropriate agencies.
A harmonized reporting system would reduce the amount of
reporting by clinical investigators, according to the MOU. Currently
investigators must submit separate AE reports to multiple agencies using
different forms.
“Oversight bodies and agencies receiving this information
are often faced with tremendous volumes of data reported in idiosyncratic ways,
which often frustrates efforts to conduct meaningful aggregations and analyses
of data, or to cull from reports information key to important safety concerns,”
the MOU explains.
A joint Federal Adverse
Event Task Force has been formed and they are tasked with developing a
consensus standard for adverse event reporting called the Basal Adverse Event
Report.