Tao Synergies Inc (TAOX)

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Registration

This final rule specifies requirements for registering applicable clinical trials at ClinicalTrials.gov. It requires that the responsible party register an applicable clinical trial not later than 21 calendar days after enrolling the first human subject (also referred to as participant or subject), and it specifies the data elements of clinical trial information that must be submitted at the time of registration. These data elements include the descriptive information, recruitment information, location and contact information, and administrative data elements listed in section 402(j) of the PHS Act, as well as additional required data elements under the Secretary's authority to modify the registration information requirements by rulemaking as long as such modifications improve, and do not reduce, the clinical trial information available to the public in ClinicalTrials.gov. We consider these additional required registration data elements necessary to enable the NIH to implement other statutory provisions, indicate the status of human subjects protection review of the trial, facilitate the public's ability to search and retrieve information from ClinicalTrials.gov, and help ensure that entries are meaningful and unambiguous. We note that some of these additional data elements required under this rule were included in ClinicalTrials.gov before FDAAA was enacted or have been implemented since 2007 as optional data elements (see Section IV.B).

Although section 402(j) of the PHS Act includes a provision delaying public posting of registration information for applicable clinical trials of unapproved or uncleared device products until the device product is approved or cleared, the final rule includes a provision under which the responsible party for an applicable device clinical trial can indicate to the Agency that it is authorizing the public posting of clinical trial registration information that would otherwise fall under the delayed posting provision prior to approval or clearance of the product (see Section IV.B.5).