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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.
Keep in mind that NIH's policy on including women and minority groups
is the same both inside and outside the U.S.
Read the following to determine 1) your requirements for
collecting data and 2) which Inclusion Enrollment Report form
to use to report your data:
- Electronic applications. See Part
II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan, in the Grant Application Guide for the Grant
Application Package.
- Paper applications. See Part
II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan, in the PHS
398 (PDF).
If you're conducting a clinical trial, send in the Inclusion Enrollment Report
semiannually. For other clinical studies, send it with your progress report.
When conducting an NIH-defined phase III clinical trial,
you have additional requirements:
- Report annual cumulative enrollment, as described above, and indicate
if data analysis has begun for the trial. If it has, report progress made in conducting valid analyses for gender, ethnic, and racial differences.
- When you have completed the trial,
you'll also need to use the Inclusion Enrollment Report form to provide
analyses
showing the
intervention differences among those groups.
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