UCM291085.pdf (application/pdf Object)

UCM291085.pdf (application/pdf Object)

New Mandatory Language in Certain Informed Consent Documents

In accordance with Section 801 of the FDAAA, the informed consent regulations of 21 CFR 50.25 were amended³ to require informed consent documents and processes for applicable drug (including biologic products) and device clinical trials initiated on or after March 7, 2012. The following statement must be included, word-for-word:

"A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time"