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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.
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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