Question 1: Should the concept/protocol development and accrual data timelines and audit summary tables include therapeutic trials that have a cancer prevention control or quality of life component?
Question 2: Regarding tables: Should they be placed within the Resources section or the Research Plan section, given the page limits? If within Resources section, are there any page limits on tables?
Question 3: Some of the tables are lengthy. Are they included as part of the page limitations?
Question 4: Several tables distinguish CCOP nuclei data vs. CCOP affiliates' data. Rather, can the data be submitted combined for the entire CCOP rather than that distinction?
Question 5: For Table 1, Key Leadership Staffing, do we want to include the disease committee chairs from the NCTN grant (e.g., breast, gastrointestinal, genitourinary, etc.)? The table instructions say to only include the NCORP Research Base personnel, but our disease committees will be interacting with those committee chairs as well. If we include them, would we need to add them to the budget, get bio-sketches, etc.? Under Title and Length of Service in Position, should this information be relative to the NCORP or relative to their own institution?
Question 6: For Table 2, only Prevention, Cancer Control, and Screening studies are in the template. Should we include relevant studies from other committees – e.g., Health Disparities, Health Outcomes, and Cancer in the Elderly in this table, also? If not, where would we highlight these accomplishments in the application - CCDR table 5?
Question 7: Please confirm that we can add table 2B other important scientific achievements for manuscripts other than time (unintelligible) analysis of studies and an eye to disparities analysis of embedded quality of life and therapeutic trials?
Question 8: Table 3 references to A, B, and C. Please confirm that we should add a section for embedded quality of life in therapeutic trials?
Question 9: Please confirm that a study should appear in all applicable lists both concept and protocol submissions?
Question 10: Table 4 on Page 262 of the NCORP Guidelines indicates the following: accrual tables are for cancer prevention control and screening clinical trials and cancer care deliver research studies only. Does this statement refer to Tables 4 and 5 only?
Question 11: Should Table 5 cancer care delivery research study accomplishment only include previous studies or can planned studies be included?
Question 12: How do we complete Table 5 which asks for annual accrual over the previous five years to cancer care delivery studies when we’re not participating in any?
Question 13: For Table Number 6: we assume this refers to all forms submitted by any participating site on cancer control and screening clinical trials opened at any time during the five year interval from June 01 2008 through 05-31-2013. Does it refer to data submitted within that window or all data submitted on the studies open in the window?
Question 14: Which studies should be included in table 6: Cancer Control, Screening and Prevention only? Or any study open to accrual by CCOPs? Or studies with QOL components?
Question 15: Table 7 separates the CCOP/MBCCOP COMPONENTS from presumably the CCOP "nucleus". The CTMB AIS allows for submission of a single (Combined) report for each CCOP and the generated CCOP AUDIT REPORT does not make the nucleus vs. component distinction. Since this distinction is not available through the CTMB, can the CCOP nucleus and component lines be combined in Table 7?
Question 16: Does Table 7 replace the standard Type V "Summary of Onsite Auditing Activity"?
Question 17: Referencing Table 8 should we include bio-specimens collected on therapeutic trials in relation to quality of life endpoints?
Question 18: Are letters of support required from current CCOP members that already participate in your Research Base activities?
Question 19 Can bio-sketches of advisory committee members be put in the appendix or should they be put into other bio sketches or not included?
Question 20: Can we include a picture from a training manual in the appendix?
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