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Click ‘Get Form’ to open the nih inclusion enrollment report in our editor.
Begin by entering the unique study title in the designated field. Ensure that it accurately reflects your research project.
Indicate whether your study is a delayed onset study by selecting 'Yes' or 'No'. If not, proceed to select the appropriate enrollment type: Planned, Cumulative (Actual), or Using an Existing Dataset or Resource.
Specify the enrollment location as either Domestic or Foreign and indicate if it is a Clinical Trial and/or an NIH-Defined Phase III Clinical Trial by selecting 'Yes' or 'No'.
Fill in the comments section if necessary, providing any additional context relevant to your report.
Complete the ethnic and racial categories by entering data into each corresponding field. Ensure accuracy for proper reporting.
Review all entries for completeness and accuracy before saving your document frequently to avoid data loss.

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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.

inclusion enrollment report template

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