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US FDA three lines addition to consent documents cost $3 per trial participant

This article was originally published in Scrip

Executive Summary

When US Congress passed the Drug Administration Amendments Act of 2007 (FDAAA) that, amongst other measures, introduced the publicly accessible database of clinical trials (www.ClinicalTrials.gov), it may not have realised how complicated it would be to introduce wording into informed consent document telling trial subjects that results of their trials would be included on that website.

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