Trial Consent Forms Must Include Database Reference by March 7

Clinical trial sponsors and sites have less than a month before the FDA begins enforcing a new rule that requires informed consent documents to include a specific statement that trial information will be made public on ClinicalTrials.gov, a new guidance states. The final rule, required by the 2007 FDA Amendments Act, went into effect in March 2011 but applies only to applicable trials initiated on or after March 7, 2012.
Devices & Diagnostics Letter