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PHS
Supplemental Instructions
for preparing Human Subjects section
Reports required in Human Subjects section:
Targeted Enrollment Table (fillable form)
(Used for new applications, competing renewals and progress reports.)
Inclusion Enrollment Report (fillable form)
(Used in competing renewals and progress reports.)
Link to
NIH Data Sharing Policy and Implementation Guidelines
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to guidelines for the Protection of Human Subjects (Federal Code of Regulations)
Link
to guidelines for FDA regulated protocols
An Evidence-Based Guide to Writing Grant Proposals for Clinical Research (Inouye 2005)