The FDA and the NIH have agreed to develop a harmonizedadverse 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 tobe an “interactive help system” that will assist AE reporters in determiningwhich data need to be submitted and to whom. The prototype system will allowthe agencies to test the feasibility of a central, federal web-based portal toprovide direct, seamless, online submission of adverse event reports toappropriate agencies.

A harmonized reporting system would reduce the amount ofreporting by clinical investigators, according to the MOU. Currentlyinvestigators must submit separate AE reports to multiple agencies usingdifferent forms.

“Oversight bodies and agencies receiving this informationare often faced with tremendous volumes of data reported in idiosyncratic ways,which often frustrates efforts to conduct meaningful aggregations and analysesof data, or to cull from reports information key to important safety concerns,”the MOU explains.

A joint Federal AdverseEvent Task Force has been formed and they are tasked with developing aconsensus standard for adverse event reporting called the Basal Adverse EventReport.