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What is the NIH inclusion enrollment report?

The PHS Inclusion Enrollment Report form is used for all applications involving NIH-defined clinical research. This form is used to report both planned and cumulative (or actual) enrollment, and describes the sex/gender, race, and ethnicity of the study participants.

What is the NIH policy on dissemination of NIH funded clinical trial information?

The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information sets the expectation that all NIH-funded awardees and investigators conducting clinical trials will register and report results of their trial in Clinicaltrials.gov.

What is the NIH inclusion across the lifespan policy?

The Inclusion Across the Lifespan Policy requires research supported by the NIH to include individuals of all ages, unless there is a scientific or ethical reason not to include a specific age group.

How do I update my inclusion enrollment report?

There are two ways to edit the existing Inclusion Enrollment Report (IER) data for Cumulative (Actual) counts: You can update the cells online in the existing report itself. You can download a template for entering participant-level data by clicking the Download Participant Level Data Template button.

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