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Clinical Trial Requirements for Grants and Contracts

NIH has launched a series of initiatives to enhance the accountability and transparency of clinical research. These initiatives target key points along the clinical trial lifecycle from concept to results reporting. Find key resources and tips for applicants and grantees.  

NIH Definition of a Clinical Trial

A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial. to one or more interventions interventionsAn "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. (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. health-related biomedical or behavioral outcomes.A "health-related biomedical or behavioral outcome" is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.    Learn more

DECISION TOOL

Your human subjects study may meet
the NIH definition of a clinical trial.

FIND OUT HERE

Buliding 1 at NIH campus
Credit: Lydia Polimeni, National Institutes of Health

Clinical Trial Definition

Learn more about why NIH has implemented changes to enhance the stewardship of clinical trials and how these changes impact your research.

Buliding 1 at NIH campus

Basic Experimental Studies Involving Humans (BESH)

Basic experimental studies involving humans (BESH) are studies that meet both the federal definition of basic research and the NIH definition of a clinical trial. Find new resources to help differentiate between a measurement and an intervention, learn about answering the 4 clinical trial questions for BESH, and more.

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Clinical Trial-specific Funding Opportunities

All applicants proposing clinical trials can learn about the requirement for submitting applications through a funding opportunity announcement (FOA) designated specifically for clinical trials.

Clinical Trial-Specific Review Criteria

Specific review criteria will be used to evaluate applications proposing clinical trials or clinical trial research experience. Learn more about these review criteria.

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Protocol Template

Discover our protocol templates with instructional and sample text to help write clinical protocols for the following types of research: 1) Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications, and 2) Behavioral and social sciences research involving humans

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Registration and Reporting

All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov. Learn more about these requirements. Learn more about what you need to know about these requirements.

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Good Clinical Practice

All NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials can learn about the requirement to be trained in Good Clinical Practice (GCP). Learn more.

Human Subjects and Clinical Trial Information

The Human Subjects and Clinical Trial Information form is required for all human subjects and/or clinical trial research beginning for January 25, 2018 due dates. Learn more about this form and tips for completing it.

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Human Subjects System

Effective June 9, 2018, the Human Subjects System (HSS) replaced the Inclusion Management System (IMS). HSS consolidates human subjects and clinical trial information in one place. The system is accessed by PIs/signing officials and NIH Staff via eRA Commons. Learn more.  

Buliding 1 at NIH campus
Credit: Lydia Polimeni, National Institutes of Health

Posting Informed Consent Forms

Learn more about the requirement that clinical trials post informed consent documents to a public federal government website.

Buliding 1 at NIH campus
Credit: Lydia Polimeni, National Institutes of Health

Clinical Trial Stewardship

Learn why clinical trial policies are key to enhancing the stewardship of clinical trials.

Buliding 1 at NIH campus
Credit: Lydia Polimeni, National Institutes of Health

Training & Resources

Learn more about training opportunities and use the resources below to help spread the word about NIH's clinical trial policies. We will continue to post additional resources, so check back frequently!

This page last updated on July 26, 2017
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