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[Return to the OER FDAAA home page]
(Please note that “grantee” in these FAQs refers to recipients of both grants and cooperative agreements.)
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Thus applicable clinical trials generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S, involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).Complete statutory definitions and more detailed information on the NIH's current thinking about the meaning of "applicable clinical trials" may be found in the current "Elaboration of Definitions of Responsible Party and Applicable Clinical Trial".
The grantee institution is required to assure compliance with FDAAA. Investigators and institutional officials (e.g. sponsored research office, general counsel, and/or other similar office) are encouraged to work together to determine whether or not an NIH grant is supporting an applicable clinical trial, and whether or not that trial must be registered under FDAAA. This determination is communicated to the NIH in the grantee's certification of compliance with FDAAA. For further information on identifying applicable clinical trials, see step 1 of OER’s “Steps to Compliance for NIH Grantees”.
The account administrator should review the FAQ “Can a protocol record be transferred between organizations?” which is available once they have logged in to the PRS (click on “FAQ”).If the trial is currently registered in an NIH IC PRS organizational account, please contact that IC to make the transfer. The IC will use its administrative access to transfer the trial to the new account. Provide the same information described above.
The Director of NIH may provide an extension of the deadline for submission of results information if the responsible party submits a written request that demonstrates good cause for the extension and provides an estimate of the date on which the results information will be submitted. Pending publication is not considered a good cause for an extension.
For further information, please access the NLM Web site on Delayed Submission of Results with Certification or Request for Extension.