Rammell Consulting Limited

Ensure Your Informed Consent Forms Comply With New Requirements

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For those sponsors conducting clinical trials that need to comply with FDA regulations, remember that from 7th March 2012 your informed consent documentation must comply with the new 21 CFR § 50.25(c) requirement. This requires the informed consent form to inform the clinical trial subject about the clinicaltrials.gov website. Specifically, it has to include the following statement 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.”

A guidance document on the new requirements is available from the FDA website by following this link.

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