Thursday, March 1, 2012

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"

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