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PHS Inclusion Enrollment ReportOMB Number: 09250001 Expiration Date: 10/31/2018This report format should NOT be used for collecting data from study participants. *Study Title (must be unique): * Delayed.

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How to fill out the PHS Inclusion Enrollment Report online

The PHS Inclusion Enrollment Report is an essential document that captures the demographic details of participants in research studies. This guide provides clear, step-by-step instructions on how to complete this form efficiently and accurately in an online format.

Follow the steps to successfully complete the PHS Inclusion Enrollment Report.

  1. Click 'Get Form' button to obtain the report and open it in the editor.
  2. Provide a unique title for your study in the 'Study Title' field. Ensure that the title reflects the specific objectives of the research.
  3. Indicate if your study is a delayed onset study by selecting either 'Yes' or 'No.' If your study is not delayed onset, continue to the next required sections.
  4. Choose the enrollment type. You will need to select one of the following options: 'Planned,' 'Cumulative (Actual),' or 'Using an Existing Dataset or Resource.'
  5. Specify the enrollment location by selecting either 'Domestic' or 'Foreign.' This helps identify where participants in your study are based.
  6. Indicate whether your research involves a clinical trial by selecting 'Yes' or 'No.' If applicable, further specify if it is an NIH-defined Phase III clinical trial.
  7. Use the 'Comments' section for any additional information or notes relevant to the study that may assist in analyzing the data.
  8. Complete the ethnic and racial categories by filling in the totals for each category based on the participants. This includes providing counts for various ethnic groups such as 'Hispanic or Latino' and 'Not Hispanic or Latino,' along with gender distinctions.
  9. Review all entered information for accuracy. This is crucial as incorrect data can affect analysis and reporting.
  10. Finally, save your changes, and you have the option to download, print, or share the completed form as required.

Complete the PHS Inclusion Enrollment Report online today for accurate data collection.

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Annually, applicants/investigators must provide an update on their progress in meeting the NIH-funded objectives, including providing the number of individuals enrolled in research study, broken out by sex/gender, race, and ethnicity.

The purpose of the Inclusion Across the Lifespan Policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions.

While in the RPPR Menu screen, click the Edit button in the bottom left-hand corner of the screen. If inclusion enrollment updates are needed, first save any RPPR data entered thus far, then click the G Special Reporting Req tab.

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 in the web form. You can upload participant-level data using the Upload Participant Level Data Attachment button.

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.

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