FDA, NIH collaborate on AE reporting

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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. 

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