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Phs inclusion enrollment report

Nih inclusion enrollment report 2025

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The PHS Inclusion Enrollment Report is a structured document designed to collect demographic data related to study participants in clinical trials. It includes sections for study title, enrollment type, location, and various ethnic and racial categories. The report emphasizes that it should not be used for collecting data from participants directly and outlines specific requirements for reporting enrollment details.

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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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Facts about nih inclusion enrollment report

The NIH Inclusion Enrollment Report is a crucial tool for researchers to document and report demographic data on study participants, ensuring compliance with federal guidelines.

Use cases of the form

Form filing requirements

How to submit the nih inclusion enrollment report?

Other important aspects to understand about completing nih inclusion enrollment report

Use cases of the form

This form is primarily required by researchers and institutions conducting NIH-funded studies. It is essential for those involved in clinical trials, particularly when assessing participant demographics related to ethnicity and gender. For instance, a university conducting a Phase III clinical trial must file this report to demonstrate adherence to NIH policies on inclusion of diverse populations in research.

Form filing requirements

Researchers must submit the NIH Inclusion Enrollment Report annually or at specified intervals as dictated by their funding agreement. The report should include accurate demographic data and be filed alongside other required documentation such as study protocols and consent forms.

Submission must occur within the timeline set forth in the grant agreement.
Accurate demographic data must be collected and reported.

How to submit the nih inclusion enrollment report?

To submit the NIH Inclusion Enrollment Report, follow these steps: Obtain the latest version of the form from DocHub or the NIH website, fill it out with accurate participant data, and then submit it electronically through the designated NIH submission portal or print it out for mailing if required.

Access the form via DocHub or directly from the NIH website.
Complete all required fields accurately, ensuring demographic information is correctly represented.
Review your entries for completeness and accuracy before submission.
Submit electronically through the NIH portal or print and send via mail if necessary.

Other important aspects to understand about completing nih inclusion enrollment report

It is vital for researchers to understand that failure to comply with reporting requirements can lead to funding penalties. Additionally, maintaining confidentiality of participant data while accurately reporting demographics is crucial for ethical research practices.

The OMB number associated with this form is 0925-0001.
The expiration date for this reporting format was March 31, 2020; however, updates may have been issued since then.
'Delayed Onset Study' status affects how enrollment data is reported.