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The *ASTER Pilot Project: Improving the Reporting of Adverse Events

‘ASTER’ stands for:  “ADE 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).

Click here to link to a recent presentation that describes the ASTER Study. 


ASTER is a collaboration of the following organizations and individuals:

- Brigham and Women’s Hospital (Dr. David Bates is sponsor, Dr. Jeffrey Linder is Lead Investigator)
- Partners Healthcare – use of the Longitudinal Medical Record
- CDISC (an international standards group)
- CRIX International (a public/private not-for-profit organization)
- Pfizer Incorporated

ASTER implemented automated ADE collection in an ambulatory clinic electronic health record (EHR), using a flexible standard for data collection known as “Retrieve Form for Data” (RFD) from CDISC and Integrating the Healthcare Enterprise (IHE).  CRIX International hosted the application.  The application allows direct downloading of data from the EHR and direct submission to the FDA in the proper formats for electronic reporting of individual case safety reports (ICSRs).

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