Send the Inclusion Enrollment Form With Your Progress Report

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NIH requires you to send an Inclusion Enrollment Report form as part of your reporting requirement. It shows the cumulative accrual and demographic information of participants enrolled in your study.

If you're going to include foreign participants, you must clearly document this in your inclusion enrollment tables.

Look at the requirements for domestic and foreign data in the following:

• For electronic applications, see Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan, in the Grant Application Guide for your Grant Application Package.
• For paper applications, see Part II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, in the PHS 398.

If you're conducting a clinical trial, send in the information semiannually; for other clinical studies, include it with the noncompeting renewal application. Failure to send us this information could jeopardize your award.

When conducting an NIH-defined phase III clinical trial, you must report on the annual cumulative enrollment, described above, and indicate if data analysis has begun for the trial. If so, you should report on progress made in conducting valid analyses for gender, ethnic, and racial differences.

• Electronic applications. Read the Part II Supplemental Instructions in your Grant Application Guide for your Grant Application Package to determine which Inclusion Enrollment Report form you should use.
• Paper applications. Read the Part II Supplemental Instructions in the PHS 398 to determine which Inclusion Enrollment Report form you should use.

When you have completed the trial, you'll also need to use the form to provide analyses showing the intervention differences.

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