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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. FAERS Quarterly Data Files Documentation
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

FAERS Quarterly Data Files Documentation

 

The FDA AERS (FAERS) Program Team is providing information and current thinking about the changes to the FAERS Quarterly Data Extract (QDE) output files. This update contains sample XML and ASCII files for users to review and test in their systems. The purpose of these sample files is for users to review the changes, test the extracts in their systems, and to provide feedback to FDA if there are any questions or concerns.

The sample XML and ASCII files contain one month of test cases (approximately 72,000 cases) generated from the new FAERS database deployed in September 2012. While the cases were pulled from the January 2012 timeframe, they should be considered as test data only. This data is not meant to match data in your production systems. It is meant only to be used as test data to identify changes you will have to make to your system.

On Thursday, May 2, 2013, FDA will post a sample Quarterly Data File from the FDA Adverse Event Reporting System (FAERS).   For the next two weeks (until May 15, 2013), FDA welcomes feedback regarding consistency between the sample data and the draft technical documentations. Please send your feedback by email to cderosetracking@fda.hhs.gov.

The new FAERS QDE output contains new fields that were not included in the Legacy AERS QDE extracts. Additional changes are due to a shift from an Individual Safety Report (ISR) based system in Legacy AERS to a Case/Versioning based system in FAERS. Changes in the XML output file include new tags. Changes in the ASCII output file include new tags, field name changes and logic changes for some existing fields. Please refer to the README.doc, XML_NTS.doc, and ASC_NTS.doc files for more details and a complete listing of highlighted changes included as a table at the end of each NTS document.

One of our goals is to make the XML and ASCII fields consistent, so the new fields added to the XML files will also be provided in the ASCII file.

FDA will provide you with more information as it becomes available. You may contact FDA with any questions or concerns related to the FAERS QDE by emailing cderosetracking@fda.hhs.gov.

 

Documentation Files

Sample Files

FAERS Data Statistical Reports

 
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