Clinical Trials Registration and reporting in clinicaltrials.gov requirement, nih policy on dissemination of NIH-funded clinical trial information, clinical trial registration and results information submission, Food and Drug Administration Amendments Act, FDAAA, 42 CFR Part 11

4.1.3 Clinical Trials Registration and Reporting in ClinicalTrials.gov Requirement

4.1.3.1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information

For grant applications that request support for the conduct of a clinical trial, the NIH Policy on Dissemination of NIH-funded Clinical Trial Information establishes the expectation that all NIH-funded recipients and investigators conducting clinical trials, funded in whole or in part by NIH, will ensure that their clinical trials are registered at, and that summary results information is submitted to, ClinicalTrials.gov for public posting. The purpose of the policy is to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. Disseminating this information supports NIH mission to advance the translation of research results into knowledge, products, and procedures that improve human health. For basic experimental studies with humans (BESH) NIH continues to expect registration and results reporting, but with the additional flexibility to register and report results on alternative publicly available platforms. This flexibility only applicable to BESH studies submitted to funding opportunities designated as "basic experimental studies with humans" in the title and is available until September 24. 2023.

This policy is complementary to requirements in the Clinical Trial Registration and Results Information Submission regulation at 42 CFR Part 11, hereinafter referred to as the regulation.

This policy applies to all NIH-funded clinical trials regardless of study phase, type of intervention, or whether they are subject to the regulation. For example, NIH-funded phase 1 clinical trials of an FDA-regulated product are covered by this policy as are clinical trials studying interventions not regulated by the FDA, such as behavioral interventions. As such, the policy encompasses all NIH-funded clinical trials, including applicable clinical trials Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of clinical trials that may be subject to the registration and results reporting requirements in FDAAA. subject to the regulation. All NIH-funded clinical trials will be expected to register and submit results information to ClinicalTrials.gov according to the timelines described in the regulation.

This policy does not apply to a clinical trial that uses NIH-supported infrastructure but does not receive NIH funds to support its conduct.

Applicants seeking NIH funding for clinical trials will be required to submit a plan that will address how the expectations of this policy will be met. Recipients and investigators conducting clinical trials funded in whole or in part by NIH are required to comply with all terms and conditions of award, including following their plan for the dissemination of NIH-funded clinical trial information.

The signature of the AOR on the grant or progress report form certifies that, for any clinical trials funded under the NIH award, the recipient and all investigators are in compliance with the recipient's clinical trial information dissemination plan.

Responsibilities of recipients and investigators will fall within one of the following three categories:

1. If the NIH-funded clinical trial is an applicable clinical trial Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of clinical trials that may be subject to the registration and results reporting requirements in FDAAA. under the regulation and the recipient is the responsible party, the recipient will ensure that all regulatory requirements are met.
2. If the NIH-funded clinical trial is an applicable clinical trial Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of clinical trials that may be subject to the registration and results reporting requirements in FDAAA. under the regulation but the recipient is not the responsible party, the recipient will coordinate with the responsible party to ensure that all regulatory requirements are met.
3. If the NIH-funded clinical trial is not an applicable clinical trial Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of clinical trials that may be subject to the registration and results reporting requirements in FDAAA. under the regulation, the recipient will be responsible for carrying out the tasks and meeting the timelines described in regulation. Such tasks include registering the clinical trial in ClinicalTrials.gov and submitting results information to ClinicalTrials.gov.

Recipients of NIH funding conducting non-exempt human subjects research subject to the revised Common Rule and conducting a clinical trial as defined in 45 CFR Part 46.102(b) should be aware that for each funded trial, one IRB-approved consent form must be posted on a designated public federal website in accordance with 45 CFR Part 46.116(h). The forms must be posted on a designated public federal website after recruitment closes and no later than 60 days after the last study visit by any subject, as required by the protocol. More information about these requirements is available on the NIH web site.

• NIH-funded recipients using an English-language informed consent form to enroll participants may either:

Submit an IRB-approved English-language informed consent form to ClinicalTrials.gov. Documents that are uploaded to ClinicalTrials.gov should be uploaded in accordance with these instructions. ClinicalTrials.gov does not currently support upload of non-English documents. Or:

Submit an IRB-approved informed consent form to Regulations.gov following the instructions in the paragraph below. NIH recipients submitting informed consent forms to Regulations.gov must maintain a copy of their Regulations.gov receipt and tracking number, and make it available to NIH upon request.

• NIH-funded recipients using only non-English informed consent forms to enroll participants:

Submit an IRB-approved informed consent form to Docket ID: HHS-OPHS-2018-0021 on the Regulations.gov website in accordance with guidance issued by the Office for Human Research Protections. NIH recipients submitting informed consent forms to Regulations.gov must maintain a copy of their Regulations.gov receipt and tracking number, and make it available to NIH upon request.

Institutions submitting documents to either ClinicalTrials.gov or Regulations.gov must protect participant privacy in accordance with applicable federal, state, and local laws and regulations (e.g., the HIPAA Privacy Rule, Certificates of Confidentiality) and any applicable terms of their NIH award.

Each NIH-funded clinical trial should have only one entry in ClinicalTrials.gov that contains its registration and results information. Recipients need not and should not create a separate record of the applicable clinical trial Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of clinical trials that may be subject to the registration and results reporting requirements in FDAAA. to comply with this policy.

4.1.3.2 Food and Drug Administration Amendments Act (FDAAA)

Applicants and recipients should familiarize themselves with the requirements of 42 U.S.C. 282(j), also known as Sec. 801 of Public Law 110-85 (the FDA Amendments Act of 2007 or FDAAA), as implemented in regulation by 42 CFR Part 11, with respect to registration and results reporting requirements that apply to certain clinical trials. Of particular note is that, in general, results of applicable clinical trials Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of clinical trials that may be subject to the registration and results reporting requirements in FDAAA. are due not later than 12 months after the primary completion date. If this date occurs after the period of performance has ended, results reporting is still required in accordance with FDAAA and the terms and conditions of grant award.

The signature of the AOR on the grant or progress report form certifies that, for applicable clinical trials Applicable clinical trial is the term used in Title VIII of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) to designate the scope of clinical trials that may be subject to the registration and results reporting requirements in FDAAA. funded in whole or part by the award, the responsible party has made all registration and results submissions required by 42 CFR Part 11.