A number of NIH-mandated changes related to NIH clinical trial requirements affect applications with receipt dates on or after January 25, 2018
These key points and selected resources relate to NIH’s 2017-2018 clinical research initiatives – both new changes for 2018 and those that went into effect in 2017. Visit the NIH website: Clinical Trial Requirements for Grants and Contracts for more information.
NIH Clinical Trial Definition
The differences between a clinical trial and a clinical study can be determined using the following four questions (answering “Yes” to all means 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?
Clinical Trial-Specific Funding Opportunities
Clinical Trial-Specific Review Criteria
New Human Subjects and Clinical Trial Information Form [FORMS-E]
A new Human Subjects and Clinical Trial Information form will be included in the new FORMS-E Application Packages and will be required for all applications with due dates on or after January 25, 2018. This new form consolidates all Human Subjects and Clinical Trial related information into one place and expands the information required for studies that meet the NIH definition of a clinical trial. If you’re wondering “Where can I find the new form?” or need assistance stepping through the form, NIH created a number of resoruces, including a Preview of FORMS-E Grant Application Form Changes as well as a short (9-minute) Video Walk-through of PHS Human Subjects and Clinical Trials Information. NIH also released a podcast about “Why it’s so important to Submit Applications Early” (MP3 & Transcript).
Clinical Trials Protocol Template
Single IRB Policy for Multi-Site Research
Good Clinical Practice Training
Clinicaltrials.gov Registration and Reporting
Use these resources provided by NIH to help determine if your research study meets the definition of a clinical trial:
- Clinical Trial Decision Tool (Tool to help determine if your research meets the NIH definition of a clinical trial)
- Clinical Trial Definition FAQ’s (A series of questions about the definition itself as well as specific cases)
- Clinical Trial Definition Case Studies (Simplified case studies that apply the four questions to determine whether NIH would consider the research study to be a clinical trial)