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Improving the Reporting of Adverse Events
By Staff Reporters
According to its website, ‘ASTER’ stands for “ADE Spontaneous Triggered Event Reporting”. The ASTER study was conceived as a proof-of-concept project for a new model of gathering and reporting spontaneous adverse drug events (ADEs).
A Collaborative Project
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
Assessment
ASTER will implement automated ADE collection in an ambulatory clinic electronic health record (eHR). It employs a flexible standard for data collection known as “Retrieve Form for Data” (RFD) from CDISC and Integrating the Healthcare Enterprise (IHE), and will use CRIX International to host the application. The application allows direct downloading of data from the EHR and will forward the report to the FDA in the proper formats for electronic reporting of individual case safety reports (ICSRs).
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Filed under: Breaking News, Career Development, Drugs and Pharma, Information Technology, Practice Management | Tagged: ADE Spontaneous Triggered Event Reporting, ADEs, adverse drug events, adverse drug reactions, ASTER, CDISC, CRIX, Dr. David Bates, Dr. Jeffrey Linder, EHRs, EMRs, FDA, ICSRs, IHE, longitudinal medical records, Partners Healthcare, Pfizer | 2 Comments »
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