Ensure Your Informed Consent Forms Comply With New Requirements

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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About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in Compliance, Regulations. Bookmark the permalink.

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