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1.29 ClinicalTrials.gov Reporting

1.0 Purpose

The purpose of this policy is to describe the requirements for registration of clinical trials, and compliance with ClinicalTrials.gov.

2.0 Policy

It is the policy of the organization that:

  • 2.1. All Applicable Clinical Trials (ACTs) will be registered and updated as required on ClinicalTrials.gov in compliance with HHS regulations at 42 CFR 11 (Final Rule for Clinical Trials Registration and Results Information Submission).
    • 2.1.1. Investigators are required to adhere to the statutory provisions of 42 CFR 11 (rather than the abbreviated provisions described in this policy when there are discrepancies), as well as clarifications and definitions found at www.clinicaltrials.gov.
  • 2.2. All NIH funded clinical trials will be registered and updated as required on ClinicalTrials.gov in compliance with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.
  • 2.3. All Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS) will be registered and updated on ClinicalTrials.gov as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1.
  • 2.4. If an investigator voluntarily registers a study on ClinicalTrials.gov even though registration is not required as above, all ClinicalTrials.gov requirements and UNMC HRPP policies related to ClinicalTrials.gov reporting apply.

3.0 Definitions

  • 3.1. Clinical Trial:
    • 3.1.1. Per 42 CFR 11.10(a) a clinical trial is a “clinical investigation (or clinical study) in which human subject(s) are prospectively assigned, according to a protocol, to one or more interventions (or no intervention) to evaluate the effect(s) of the intervention(s) on biomedical or health-related outcomes”
    • 3.1.2. Per NIH Policy NOT-OD-16-149 a clinical trial is a "research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
      • 3.1.2.1. For the purposes of this Policy, the regulatory definition at 42 CFR 11.10(a) and the definition in NIH policy are treated as synonymous.
      • 3.1.2.2. The NIH definition of "clinical trial" is, however, broader than the term "applicable clinical trial" as defined in 42 CFR 11 (below).
      • 3.1.2.3. The NIH definition of a clinical trial includes “Basic Experimental Studies involving Humans” (BESH) that meet both the definition of basic research and the NIH definition of a clinical trial (https://grants.nih.gov/policy/clinical-trials/besh.htm). BESH are subject to NIH clinical trials policies such as registration and results reporting.
    • 3.1.3. Per ICJME a clinical trial is “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.” (https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html)
  • 3.2. Applicable Clinical Trials (ACTs)
    • 3.2.1. ACT generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions:
      • 3.2.1.1. The trial has one or more sites in the United States.
      • 3.2.1.2. The trial is conducted under an FDA investigational new drug application or investigational device exemption.
      • 3.2.1.3. The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research.
    • 3.2.2. Applicable Clinical Trials include the following:
      • 3.2.2.1. Trials of drugs and biologics: Controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to Food and Drug Administration (FDA) regulation.
      • 3.2.2.2. Trials of devices: 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric postmarket surveillance required by FDA.
  • 3.3. Responsible Party:
    • 3.3.1. The sponsor of the trial will be considered the responsible party unless and until a principal investigator has been designated the responsible party in accordance with 42 CFR 11.4(c)(2).
    • 3.3.2. If an ACT or clinical trial is being conducted under an IND or IDE, then the holder of the IND or IDE is the responsible party regardless of how the clinical trial is being funded.
    • 3.3.3. For clinical trials not conducted under an IND or IDE:
      • 3.3.3.1. If the clinical trial is being conducted under a grant or sponsored research agreement, the funding recipient is generally considered to be responsible party.
      • 3.3.3.2. If the clinical trial is being conducted under a contract, the funder is generally considered to be the responsible party
      • 3.3.3.3. If there is no funding agreement supporting the clinical trial, the person or entity who initiated the clinical trial by preparing and/or planning the clinical trial is considered to be the responsible party.
    • 3.3.4. The sponsor of the clinical trial may designate the principal investigator to be the responsible party, if the PI satisfies the requirements of 42 CFR 11.4(c)(2).
    • 3.3.5. For NIH funded clinical trials, the awardee is usually the responsible party. If he/she is not the responsible party, then he/she is still obligated to coordinate with the responsible party to ensure that all regulatory requirements are met.
  • 3.4. Record Owner – ClinicalTrials.gov Protocol Registration and Results System (PRS) account holder who creates a study record in PRS, and is authorized to enter information into the PRS.

4.0 Investigator Responsibilities

The following describes the responsibilities of the PI if he/she is the Responsible Party. If he/she is not the Responsible Party, then the UNMC HRPP Policies do not apply:

  • 4.1. The PI must register the following trials in the ClinicalTrials.gov PRS database:

    • 4.1.1. All trials that meet the definition of an "applicable clinical trial" (ACT) provided in section 3 above and in FDA regulations.

      • 4.1.1.1. The following types of studies are generally excluded from the registration and results submission requirements of 42 CFR 11. This is not a complete list.
        • 4.1.1.1.1. Phase 1 drug trials, including studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes
        • 4.1.1.1.2. Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices, where the primary outcome measure relates to feasibility and not to health outcomes
        • 4.1.1.1.3. Trials that do not include drugs, biologics, or devices (such as behavioral interventions)
        • 4.1.1.1.4. Non-interventional (observational) clinical research (such as cohort or case-control studies)

    • 4.1.2. All NIH-funded clinical trials

      • 4.1.2.1. All NIH-funded awardees and investigators conducting clinical trials will register and report the results of their trial in Clinicaltrials.gov regardless of study phase, type of intervention, or whether they are subject to 42 CFR 11.

      Note: 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.

      • 4.1.2.2. The investigator is responsible for submitting to the ORA a copy of the award letter or other documentation from the NIH which specifies whether the trial constitutes a clinical trial subject to NIH Policy NOT-OD-16-149.

    • 4.1.3. All Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS) will be registered and updated on ClinicalTrials.gov as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1.

    • 4.1.4. Though not a requirement by the Organization, investigators should be aware that the International Committee of Medical Journal Editors (ICMJE) requires, and recommends that all medical journal editors require, registration of clinical trials in a public registry at or before the time of first patient enrollment as a condition of consideration for publication. ICJME accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP), including ClinicalTrials.gov. A listing of non-ICJME journals that follow ICJME’s recommendations is available on the ICJME website (https://www.icmje.org/journals-following-the-icmje-recommendations/).

  • 4.2. The PI must update the ClinicalTrials.gov PRS database:

    • 4.2.1. at the time of any amendment to the protocol For ACTs subject to 42 CFR 11, if the ACT is amended in such a manner that changes are communicated to human subjects in the clinical trial, the PI must update any relevant clinical trial registration information data elements not later than 30 days after the protocol amendment is approved by the IRB (42 CFR 11.64(a)(1)(ii)(O)). For NIH-funded clinical trials, or other trials for which reporting is required per this policy, the PI must update any relevant clinical trial registration information data elements as specified in the NIH Policy
    • 4.2.2. For ACTs subject to 42 CFR 11, at additional timepoints described in 42 CFR 11.64(a)(1)(ii) For NIH-funded clinical trials, or other trials subject to this policy, as specified in the NIH Policy
    • 4.2.3. For all clinical trials subject to this policy, at the time of each annual Continuing Review.

  • 4.3. The PI must submit results to the ClinicalTrials.gov PRS database:

    • 4.3.1. For ACTs subject to 42 CFR 11, no later than 1 year after the study's Primary Completion Date, unless the ACT satisfies the conditions for delayed submission of results information under 42 CFR 11.44(b).
      • 4.3.1.1. If the ACT includes a device not previously approved or cleared by FDA for any use, full posting of the trial information on ClinicalTrials.gov will be delayed until after the device has been approved or cleared.
    • 4.3.2. For NIH-funded clinical trials, or other trials subject to this policy, as specified in the NIH Policy.

  • 4.4. The PI is responsible for assuring that the IRB Application correctly reflects that a clinical trial is registered with clinicaltrials.gov and that the NCT number is accurate.

  • 4.5. If a trial which does not require registration (as per sections 2.1 thru 2.3 above) is registered with clinicaltrials.gov, then the responsible party is obligated to satisfy all requirements noted in this policy.

  • 4.6. If the clinical trial is not registered with ClinicalTrials.gov the PI must provide justification why the trial is not registered.

  • 4.7. Should the PI or the Record Owner leave the Organization, the PI is responsible for assuring that the Responsible Party and/or Record Owner are updated in the PRS database.

5.0. ORA responsibilities

The following describes the responsibilities of the ORA for clinical trials where faculty, student or employee of the organization is the Responsible Party; otherwise the UNMC HRPP Policies do not apply.

  • 5.1. The ORA will not issue full approval of any protocol where the Responsible Person is part of the Organization until the trial is registered.

    Note: Per the requirements of 42 CFR 11 the Responsible Party for an ACT must submit the required clinical trial information no later than 21 days after enrollment of the first participant; however, the Organization requires registration prior to full ORA approval.

    • 5.1.1. At the time of the initial IRB review and approval of all clinical trials, the IRB analyst responsible for the trial will confirm that the application states the trial is registered, and that the NCT number is entered into RSS, or that adequate justification is provided for waiver of the requirement.

  • 5.2. The ORA will review the ClinicalTrials.gov PRS database when a protocol amendment is submitted and will assure that the record is promptly updated by the Responsible Party.

  • 5.3. The ORA will not issue full re-approval of the protocol until the ClinicalTrials.gov PRS database has been updated

  • 5.4. When trial subject to this policy is completed (that is, when the investigator files a completion report, or when the trial is closed by the ORA for non-response to continuing review), the ORA will notify the responsible party that submission deadline for results information is no later than 1 year after the study's Primary Completion Date, unless the ACT satisfies the conditions for delayed submission of results information under 42 CFR 11.44(b). The ORA will repeat the notification as per standard operating procedures.

    • 5.3.4. The ORA will periodically review the Clinicaltrials.gov PRS database to determine any trials that are non-compliant.
    • 5.3.5. The ORA will contact Responsible Party of non-compliant trials as per standard operating procedures. Investigators who remain non-compliant will be subject to actions as per HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel), and per the Office of the Vice-Chancellor for Research.

DOCUMENT HISTORY:

 Written: 5/31/2018 (Approved: 5/31/2018) - original author not recorded

 Revised 1/6/2023 - Added requirement that CMS qualifying clinical trials must be registered and updated as required on ClinicalTrials.gov; specifically noted that BESH constitute clinical trials subject to this policy; added recommendation that clinical trials that meet the clinical trial definition of The International Committee of Medical Journal Editors (ICMJE) be registered and updated as required on ClinicalTrials.gov; clarified that if an investigator voluntarily registers a study on ClinicalTrials.gov even though registration is not required, all ClinicalTrials.gov requirements and UNMC HRPP policies related to ClinicalTrials.gov reporting apply; added that should the PI or the Record Owner leave the Organization, the PI is responsible for assuring that the Responsible Party and/or Record Owner are updated in the PRS database; revised ORA responsibilities and processes; added that investigator is responsible for submitting documentation from NIH specifying whether the trial constitutes a clinical trial; text reorganized and stylistic changes made for clarity. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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