Question 1: Does the research strategy area need to include the sub-sections "organization and structure, leadership, clinical trials research program, cancer care delivery research program and operations/data management core" in addition to, or in lieu of, the PHS required section "significance, innovation and approach"?
Question 2: Is the RFA to be submitted electronically or as a paper submission?
Question 3: In section 5.5.4 of the PHS Part I, it states that Cumulative Inclusion Enrollment Report should be done for renewal or revision applications; therefore, this is not required for the NCORP application?
Question 4: RFA instructions say paper copies however the PHS states appendix (five identical CD’s) on OMB no-0925-0001page 3. Please clarify?
Question 5: Instructions for Human Protections state anyone under 21 is to be considered "children" and not adult research. Our site does not currently do children studies, and the NCI studies for eligibility usually state participant has to be 18 yrs. or older. Are the specific guidelines that we need to follow for the 18-21 yr. old?
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