Clinical trial registration information
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Your social/behavioral and some additional biomedical research may now be considered a "clinical trial"when it meets certain criteria. 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 new definition.
Criteria that define if a study is a clinical trial:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
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.
For new studies now considered clinical trials researchers must:
- Register the trial at study start, results at study conclusion, and post the approved consent form template on ClinicalTrials.gov when applicable.
Researchers must register, submit updates, and post results information on ClinicalTrials.gov. Effective January 1, 2019, for NIH-funded studies, researchers must post a copy of the IRB-approved consent form.
- Complete training in Good Clinical Practice (GCP) for NIH-funded research
Researchers conducting clinical research must complete GCP training. See Research Integrity's policy on training for which type of GCP training you need, or consult Research Integrity. Training is required every three years.
Clinical trial registry
- How to register your clinical study
- ClinicalTrials.gov registry page
- Clinical Trials initial data registration data elements
- Best practices for data entry - checks by Clinical Trial data entry administrators (to avoid the red data entry error messages)
- Results, data entry and sample studies
- Clinical research registry feedback
Standardized data entry across studies is required for the following data fields
- IRB Contact:
1661 N. Virginia Mailstop 0331
University of Nevada, Reno, Reno, NV 89557
- Central Contact = Principal Investigator
- Central Contact Backup = Clinical Research Coordinator (CRC) or Principal Investigator in the absence of a CRC
- Overall Study Official = Principal Investigator in most instances
- Facility Contact = Principle Investigator
- Facility Contact Backup = Clinical Research Coordinator (CRC) or Principal Investigator in the absence of a CRC
Changes and updates to study registration are required no less than every 12 months, although updates are recommended every 6 months, or if the study is significantly amended.
You can share the record with other users in the database, using the access list blue edit link at the top right side of the main data entry window:
Record initial data entry processing steps
- Record Owner: Enter all required information in the Protocol Section of the record.
- Record Owner: Select Entry Complete on the Record page.
- Record-designated PI or UNR administrator: Review the record for accuracy and completeness, assessing whether any corrections need to be made.
- Record-designated PI or UNR administrator: Select Approve on the Record page.
- Record-designated PI or UNR administrator: Select Release... on the Record page to submit the record to ClinicalTrials.gov.
- ClinicalTrials.gov administrator: Perform final review and processing of the record and assign ClinicalTrials.gov study identifier (NCT number).