Description of Collaborative Activity: |
Development of a portal to streamline the process of reporting pre- and post-market safety data to the FDA and NIH and to serve as a prototype for a federal-wide system. The Portal is an important policy innovation and major step forward in the effort to eliminate unnecessary complexities and inefficiencies associated with the current system of reporting adverse events. The Portal uses a harmonized set of terms, the Basal Adverse Event Report, to provide a single, web-based interface for standardized electronic reporting of adverse events and unanticipated problems to NIH and FDA and also enables the transmission of reports to local oversight bodies such as IRBs and DSMBs. |
