Clinical trials registration and results reporting requirements

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Your biomedical or social/behavioral research is considered a "clinical trial" when it meets certain criteria. Both NIH and HHS define clinical trial as 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 the interventions on biomedical or behavioral health-related outcomes.

If you plan to apply for NIH funding, we advise you to contact Research Integrity to determine whether your study could be considered a clinical trial. This is critically important, because certain NIH Funding Opportunity Announcements (FOAs) are applicable only to clinical trials or non-clinical trials; applying for the wrong FOA will make your submission ineligible for funding. The NIH Clinical Trials website includes case studies, FAQs and a decision tool to help researchers understand the above definition.

Criteria that define if a study is a clinical trial

  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention*?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect being evaluated a health-related biomedical or behavioral outcome?

*An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies. A manipulation or task is an intervention if it is used to modify a health-related biomedical or behavioral outcome. However, a manipulation or task used expressly for measurement, and not modification, would not be an intervention. 

An answer of "yes" to all questions means your study is a clinical trial, even if...

  • You are studying healthy participants
  • Your study does not have a comparison group (e.g., placebo or control)
  • Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
  • Your study is utilizing a behavioral intervention

Examples of studies that are clinical trials

A study involves the recruitment of healthy volunteers to test a new behavioral intervention. It is designed to evaluate the effect of a meditation intervention on adherence to exercise regimens and quality of life to inform the design of a subsequent, fully-powered trial.

  • Does the study involve human participants? Yes, study participants are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to a behavioral intervention.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to evaluate the effect of the intervention on adherence, and quality of life.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, adherence and quality of life are health-related outcomes.

A study involves the recruitment of school children to evaluate two different tools for monitoring food intake. Food consumption behavior will be measured by asking children to activate a pocket camera during meals and to use a diary to record consumed food. Changes to eating behavior will be assessed.

  • Does the study involve human participants? Yes, children are human participants.
  • Are the participants prospectively assigned to an intervention? Yes, the participants are prospectively assigned to two food monitoring methods.
  • Is the study designed to evaluate the effect of the intervention on the participants? Yes, the study is designed to determine whether using the monitoring methods changes eating behavior.
  • Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes, eating behavior is a health-related outcome.

Posting of clinical trial consent form requirement

For each clinical trial that receives federal funding, one IRB-approved informed consent form must be posted on an established online repository. Two publicly available federal websites that will satisfy the consent form posting requirement are the ClinicalTrials.gov Protocol Registration and Results System and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). The consent form must have been used in enrolling participants in order to meet this requirement. The consent form must be posted on the federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any participant.

Clinical trial registration

 

ClinicalTrials.gov is a publicly available registry and results database administered by the National Library of Medicine. The site was created in 2000 as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA), and was meant to provide increased stewardship, transparency, and access to research and research results. Although posting requirements have been in place since that time for most FDA-regulated trials, they were significantly expanded on January 18, 2017. The revised requirements also apply to trials funded by NIH, whether or not they are FDA-regulated. The trials must be registered when they begin, the record must be updated throughout the study, and results must be provided when the study ends. Significant penalties can be applied by the agencies if these requirements are not met, including loss of an investigator’s ongoing or pending grant funding. In addition, many scientific journals have stated that they will not publish clinical trials that have not registered at ClinicalTrials.gov.

Registration required by federal agencies

Some studies are required to be registered at ClinicalTrials.gov in accordance with FDA regulations and/or NIH policy. Clinical trials that are subject to registration requirements are called applicable clinical trials. The following types of studies are considered to be applicable clinical trials:

  1. Clinical trials initiated on or after September 27, 2007 that evaluate at least one drug, biological, or device product that is regulated by the FDA (i.e., Applicable device clinical trials or Applicable drug clinical trials),
    1. IF at least one of the following applies:
      • At least one site is in the U.S. or its territories
      • The drug, biologic, or device is a product manufactured in and exported from the U.S. or one of its territories for study in another country
      • The study is conducted under a U.S. FDA Investigational New Drug application (IND) or Investigational Device Exemption(IDE)
    2. AND the clinical trial is none of the following:
      • A Phase 1 drug trial
      • A study whose primary purpose is to assess device feasibility
      • An expanded access study
    3. For a device trial to meet the definition of Applicable device clinical trial and be subject to the registration requirement, it must meet the below criteria:
      1. Prospective clinical study of health outcomes;
      2. Compares an intervention with a device against a control in human participants;
      3. The studied device is subject to section 510(k) – Premarket Notification, 515 – Premarket Approval, or 520(m) – Humanitarian Device Exemption of the Federal Food, Drug, and Cosmetic Act (FD&C Act);
      4. The study is not a small clinical trial 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. For a drug trial to meet the definition of Applicable drug clinical trial and be subject to the registration requirement, it must meet the below criteria:
      1. The study is a clinical investigation;
      2. The study us a controlled clinical investigation;
      3. The study is not a Phase 1 clinical investigation;
      4. The study investigates a drug (including a biological product) subject to section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or section 351 if the Public Health Service Act.
  2. Clinical trials funded in whole or in part by the National Institutes of Health (NIH) in response to any type of application for funding (including competing renewals) submitted on or after January 18, 2017.
  3. Studies that involve a pediatric postmarket surveillance of a device.

A University or Affiliate investigator conducting an applicable clinical trial must comply with the registration requirements if:

  • She or he is the Principal Investigator (PI), AND
  • The clinical trial is not an industry trial whose protocol is developed, owned, and sponsored by a company. (Industry sponsors are responsible for registering their trials.)

Voluntary registration and registration for publication

An investigator can voluntarily register a study, and many journals have editorial policies regarding registration of clinical trials in online registries that include, but are not limited to, ClinicalTrials.gov. For example, over 1,000 journals follow the recommendations of the International Committee of Medical Journal Editors (ICMJE), which requires trial registration as a condition for the publication of research results generated by a clinical trial. This publication requirement is not limited to applicable clinical trials, as defined above. Journals that do not adopt ICMJE recommendations may still have an editorial policy for clinical trial registration.

Reporting timeframe

The following reporting requirements pertain to applicable clinical trials only. ICMJE policy has different reporting requirements, and investigators should consult editorial policies to ensure compliance with journal publication standards.

  • Initial registration: No later than 21 days following enrollment of the first subject
  • Interim updates: The record must be updated at least once a year (even if nothing has changed) until final results are reported. Certain types of changes must be reported within 30 days.
  • Results Reporting: No later than 12 months after the Primary Completion Date (i.e., the last subject last visit)

Consent form statement

For all trials registered on ClinicalTrials.gov, regulations require the trial consent form(s) to include the following statement, without revision:

  • A description of this clinical trial will be available on 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.

How to register

  1. Request a user login name and temporary password, by sending an email to Ada Diaconu-Muresan.
    • Place "ClinicalTrials.gov registration" in the subject line.
    • Include in the message your name, telephone number, email address, study title, and IRBNet study ID number.
  2. You will then receive an email with your login name and a temporary password.
  3. Go to clinicaltrials.gov and enter your username.
    • In the “Organization” field, type “UNevadaReno”
    • Change your password under "User Account" on the Main Menu page
  4. To register a study, on the Main Menu page, under “Protocol Record”, click "Create" and complete the study description template.
  5. When you get to the information about Review Board, the following please complete the fields as follows:
    • Organization's Unique Protocol ID: MUST use the IRB number assigned to this protocol (e.g., 123456). Do not need the number after the dash (i.e. 123456 -12)
    • Brief Title: limited to 120 characters
    • Study Type: Please note that intervention may include not only drug or device, but dietary supplements, behavioral interventions, telemedicine, etc.
    • Record Verification Date: This is the date you enter information into this listing
    • Study Start Date: Month/Year first enrolling study participants
    • Study Primary Completion Date: Month/Year last study subject data is collected for the Primary Outcome Measure
    • Responsible Party: Sponsor (for sponsored research) or Principal Investigator
    • Sponsor: Sponsor name (for sponsored research) or University of Nevada, Reno
    • Collaborators: Organization other than the sponsor that provides support for a clinical study, if applicable
    • FDA Regulated Drug/Device: If participants are given any drug (investigational or already approved), device, vaccine, cosmetics, or dietary supplement the answer is YES
    • S. FDA IND/IDE: if you are an IND/IDE holder, provide the IND/IDE number: If you are an IND/IDE holder, provide the IND/IDE number
    • Human Subjects Protection Review: IRB Review
    • Board Name: University of Nevada, Reno Biomedical Institutional Review Board
    • Board Affiliation: University of Nevada, Reno
    • IRB Contact:
      Nancy Moody
      nmoody@unr.edu
      (775) 327-2368
      1661 N. Virginia Mailstop 0331
      University of Nevada, Reno, Reno, NV 89557
    • Oversight Authorities: "United States: Institutional Review Board" and, if FDA regulated, "United States: Food and Drug Administration"
    • FDA Regulated Intervention: If drug, device, or, dietary supplement, the answer is YES
    • Section 801 Clinical Trial: Does this trial qualify as an “FDAAA Applicable Clinical Trial” under the regulations?  See "applicable clinical trials" above
    • Conditions or Focus of the Study: once you start typing, the list of conditions pops up
    • Accepts Healthy Volunteers? If the eligibility criteria require participants to have some type of medical condition, then this answer is NO. If participants may be enrolled who DO NOT have any medical conditions, but will be given the investigational intervention as a study CONTROL subject, then the answer is YES
    • Study Official: This should be the Principal Investigator
    • Location: Where the study will take place. You must list a contact name/phone in this section. You will also be asked what the recruiting status is at this location.
  6. Once complete, submit the study.
  7. Research Integrity will verify the entry and approve it for release to the ClinicalTrials.gov registry.

Actions required after registration

  1. Changes and updates to study registration (e.g., study completed) are required no less than every 12 months, although updates are recommended every 6 months, or if the study is significantly amended. The “Record Verification Date” field should be updated in conjunction.
  2. Submit any adverse events.
  3. Submit basic study results.

ClinicalTrials.gov important links

Record initial data entry processing steps

  1. Record Owner: Enter all required information in the Protocol Section of the record.
  2. Record Owner: Select Entry Complete on the Record page.
  3. Record-designated PI or UNR administrator: Review the record for accuracy and completeness, assessing whether any corrections need to be made.
  4. Record-designated PI or UNR administrator: Select Approve on the Record page.
  5. Record-designated PI or UNR administrator: Select Release on the Record page to submit the record to ClinicalTrials.gov.
  6. gov administrator: Perform final review and processing of the record and assign ClinicalTrials.gov study identifier (NCT number).