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Changes to ClinicalTrials.gov

This article was originally published in The Silver Sheet

Executive Summary

The National Institutes of Health (NIH) is making minor revisions to the existing ClinicalTrials.gov adverse events reporting module to allow device and drug companies to post adverse event information to the database in accordance with requirements outlined in the 2007 FDA Amendments Act. Firms must begin posting serious and frequent adverse event data from applicable clinical trials on ClinicalTrials.gov beginning Sept. 27 ("The Silver Sheet" May 2009). The refined module will be available by Sept. 1, NIH says. After Sept. 27, companies submitting trial results data or updating a record that contains results data must submit the adverse event data before their submissions will be accepted by the system
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