If, like me, you have been involved in clinical trials for any period of time, you are used to the FDA Form 1572 for documentation of the principal investigators(s) and study site. Though FDA Form 3674 has been required for nearly all data submitted to the FDA since December 2007, it is not nearly as well recognized.
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The form is a notification of compliance signifying that the trials have been correctly registered and documented on clinicaltrials.gov (CT.g), and it came about through Title VIII of FDAAA, public law 110-85 (in case you really want to know the details!).
This is the only link from the FDA to the clinicaltrials.gov registry run by the National Institutes of Health (NIH). Since the NIH runs the registry, the FDA are not concerned about the contents of CT.g—it’s not under the jurisdiction of the FDA. But if you are developing a product (device or biopharmaceutical) you will need to know exactly how and when to use this form to ensure compliance with CT.g. The other aspect of this form documented in the guidelines is that it helps the FDA “assist the NIH in ‘linking’ information posted on FDA’s website regarding certain FDA regulatory actions to specific applicable clinical trials….” Hence the FDA/NIH connection—but it is interesting to note this is primarily for the NIH and not the FDA.
The requirements for registration of clinical trials as well as their data transparency are growing and this form will no doubt become part of our regular clinical trial lexicon. A guidance document fully describes the requirements for submission of a Form 3674, and provides details of the various submissions requiring inclusion of a Form 3674. In addition you can access our quick checklist (including all the links for complete reference) by clicking on the link below.
Summary of Study Types that Require a Form 3674 with the Submission
The list below is a summary from the FDA guidance document that lists the applications/submissions (including resubmissions) that require the form:
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IND
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New Clinical Protocol Submitted to an IND
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NDA
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Efficacy Supplement to an Approved NDA
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BLA
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Efficacy Supplement
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ANDA
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PMA
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PMA Panel Track Supplement
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HDE
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510(k) that refers to, relates to, or includes information on a clinical trial
The guidance document can be found here:
