Science & Research
FDA's Role: ClinicalTrials.gov Information
What is FDA’s Role Related to ClinicalTrials.gov?
Portions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) require that the “Responsible Party” for certain clinical trials register with, and submit the results of some trials to, the ClinicalTrials.gov databank (www.ClinicalTrials.gov).
FDA has been given certain implementation and compliance/enforcement responsibilities related to Title VIII of FDAAA.
These responsibilities include:
- Requiring a certification regarding compliance with ClinicalTrials.gov requirements to accompany certain human drug, biological product, and device applications and submissions to FDA.
- Requiring the inclusion of a particular statement in the informed consent documents for "applicable clinical trials" (trials that will be entered into the ClinicalTrials.gov databank as required by FDAAA).
- Compliance and enforcement activities related to the failure to submit required clinical trial information to ClinicalTrials.gov.
What Does FDA Require Regarding Certification?
To certify compliance with ClinicalTrials.gov requirements, FDA requires that applicants complete and submit Form FDA 3674 with certain human drug, biological product, and device applications and submissions. In general, FDA recommends that a Form FDA 3674 accompany the following applications and submissions to FDA:
- Investigational New Drug Application (IND)
- New Clinical Protocol Submitted to an IND
- New Drug Application (NDA)
- Efficacy Supplement to an Approved NDA
- Biologics License Application (BLA)
- Efficacy Supplement to an Approved BLA
- Abbreviated New Drug Application (ANDA)
- Premarket Approval Application (PMA)
- PMA Panel Track Supplement
- Humanitarian Device Exemption (HDE)
- 510(k) submissions that refers to, relates to, or includes information on a clinical trial
Note – FDA does not require the submission of a Form FDA 3674 with an Investigational Device Exemption (IDE) application as this was not required by FDAAA.
In addition, FDA has issued guidance related to Form FDA 3674.
What Are the Informed Consent Requirements Related to ClinicalTrials.gov?
The following exact statement must be included in the informed consent documents of "applicable clinical trials":
“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.”
FDA has issued guidance related to this new informed consent element.
Historical Background Information
The Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law 110-85 (September 27, 2007), amended the Public Health Service (PHS) Act and is designed, in part, to promote transparency of clinical research to trial participants and the public.
Title VIII of FDAAA amended the PHS Act by adding new section 402(j), 42 U.S.C. § 282(j). The new provisions require that additional information be submitted to the clinical trials data bank (www.ClinicalTrials.gov) previously established by the NIH/ NLM, including expanded information on clinical trials and information regarding the results of clinical trials.
A certification of compliance with ClinicalTrials.gov requirements is required by 42 U.S.C. § 282(j)(5)(B), section 402(j)(5)(B) of the PHS Act. The certification requirement went into effect on December 26, 2007. To assist sponsors, industry, researchers, and investigators in complying with the requirement, FDA created a certification form to be used to satisfy the certification requirement. This form is Form FDA 3674, OMB Control No. 0910-0616
As required by FDAAA, FDA published a final regulation (21 CFR § 50.25(c)) [January 4, 2011, 76 FR 256] amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information may be entered into the ClinicalTrials.gov databank. Compliance with this new requirement was effective on March 7, 2012.
Questions for FDA Related to ClinicalTrials.gov
Questions, information, or complaints (other than technical issues) related to compliance and enforcement of NIH ClinicalTrials.gov databank requirements can be addressed to FDA at email@example.com. Any questions related to how to register studies and enter clinical trial results information, as well as technical issues related to information in the ClinicalTrials.gov databank, should be addressed to the ClincialTrials.gov staff at the NIH/ at NLM Helpdesk
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