*ASTER

'ASTER' stands for: “Adverse Drug Event Spontaneous Triggered Event Reporting”
The ASTER study was conceived as a proof of concept for a new model of gathering and reporting spontaneous adverse drug events (ADEs).

Here’s what we’re doing. ASTER will:
- Implement automated ADE collection in an ambulatory clinic electronic health record (EHR)
- Employ a flexible standard for data collection known as “Retrieve Form for Data” (RFD) from CDISC and Integrating the Healthcare Enterprise (IHE)
- Allow for direct downloading of data from the EHR via a webform
- Use a not-for-profit third party organization to host the form and do some simple data processing
- Will forward the report to the FDA in the proper formats for electronic reporting of individual case safety reports (ICSRs).

More information about the *ASTER pilot
– The Vision
– Workflow
– Milestones
– Goals

If you’re not familiar with pharmacovigilance and spontaneous reporting…
- This site is primarily for people with a working knowledge of spontaneous reporting, but if you’re not familiar with these concepts, there are a number of places you can go to, to learn more about it.
- To learn about drug safety:
http://www.fda.gov/Cder/drugSafety.htm
http://www.iom.edu/?id=37339
http://psnet.ahrq.gov/resource.aspx?resourceID=8693&rss=yes
http://www.pfizer.com/responsibility/medicine_safety/medicine_safety_education.jsp