Medical Professional Publications

NIH Definition of a Clinical Trial

NIH recently released clarification on their definition of a clinical trial.

As a reminder, NIH classifies a proposed study as a clinical trial if it meets all of the following conditions:

  • The study involves human subjects
  • The participants are prospectively assigned to an intervention
  • The study is designed to evaluate the effect of the intervention on the participants
  • And the effect being evaluated is a health-related biomedical or behavioral outcome

Case studies and FAQs help clarify when human subject research studies meet the NIH definition of a clinical trial. In addition, they have included clarification of what it means to be “prospectively assigned;” evaluation of “health-related biomedical and behavioral outcome;” classification of “ancillary studies;” and when a mechanistic study could be considered a clinical trial.  

Also, please note that the NIH institute you are applying to may have additional requirements and expectations regarding clinical trials, so it would be advantageous to discuss a clinical trial submission with your program officer prior to submitting, if possible.  

Please follow this link for the NIH post.

Case studies can be found here.

FAQs regarding this can be found here.

New NIH Human Subjects Form

Effective January 25th, 2018, NIH will require new forms for collecting human subjects information. The new PHS Human Subject and Clinical Trial Information form consolidates human subjects information into a single form and allows NIH to capture descriptive information for each study.

The form helps identify whether the study is considered an NIH defined clinical study through a series of questions and also collects the protocol synopsis, study population characteristics, recruitment plans, and plans for statistical design and power in one place. Please note that this new form is not intended to duplicate the information provided in the research strategy section, but allows PIs to spell out methodological details in the study record, allowing more space in the research strategy for higher-level descriptions and justifications of experimental designs and methods.

You can read all about the details of the form and view a brief video guide by following this link.

Time and Effort Certification

The Finance and Sponsored Projects Department recently implemented a new process for time and effort approvals for individuals with time on federal projects. Certifiers for time and effort can find the “Online Effort Certification – PI” link to approve these records on their Lawson dashboard. If you happened to miss our trainings throughout the month of September you can click here to find a recording of the training event.

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