The document discusses a collaboration between several organizations including healthcare providers, technology companies, and regulators to improve the system of spontaneous adverse event reporting. They aim to demonstrate that utilizing standardized data and new technologies can enhance data quality, reduce the burden on reporters, and ultimately benefit public health monitoring. The project calls for incorporating reporting into normal clinical workflows using structured EHR data to create safety reports.

1. Different Approaches to Spontaneous Reporting: A New Business Model How a collaboration between Partners Healthcare, CRIX, Int’l., FDA, CDISC, Pfizer and others is trying to demonstrate that it’s possible to improve spontaneous reporting

8. The ASTER Project

14. Spontaneous Reporting the problem