Question 1: When listing NCI protocols along with the brief title, do you want only the main treatment protocol and not the ancillary embedded treatment and/or cancer control protocols, or do you want both listed separately?
Question 2: When compiling accrual data for the last 5 calendar years, are we starting with June 2008 - May 2009 as year 1 and not calendar years?
Question 3: For what time period are we making projections, Jan-Dec 2014, June 2014 – May 2015?
Question 4: In new system, Sites will receive X amount/accrual—all the same-so previously some COG were 2.0 Treatment credits or CC was 0.5—These will all be the SAME amount/accrual?
Question 5: Do you have a list of assigned categories for protocols that are currently open? Example - CALGB 70807 The Men's Eating and Living (MEAL) Study - would this be prevention or control or treatment? ?
Question 6: From my reading of the NCORP RFA, the community sites are being selected primarily to open and enroll to trials designed by the research sites. Is this an accurate understanding, for both the Clinical Trials and CCDR pieces of the application? In other words, is there any value in community sites engaging in investigator-initiated studies as it pertains to this RFA?
Question 7: When NCORP talks about 80 annual accruals, will the accruals have to come solely from Cooperative Group studies (i.e., NCTN) and from NCORP Research Base designed studies? We have a number of single-site investigator-initiated NCI or NIH-funded studies that deal with cancer prevention/screening/control and I wondered if we put a person on one of those studies whether that would count as an accrual?
Question 8: On the call on Monday, December 2 it was mentioned that sites could include non-NCI trials in their counting of accruals. May sites count accruals to R01 and U54 subcontracts funded by the NCI?
Question 9: May we count accruals to studies that NCCCP sites participated in during the program (Project 9 – multidisciplinary care for lung colon and rectal cancer, and Project 14 – survivorship care navigation)?
Question 10: Are sites able to count accruals to NCI trials for patients referred to NCI Centers for American College of Surgeons?
Question 11: Do we use accruals (number of patients) to calculate our payments or do we use credits (given to us by the NCI)? Some studies only give us partial credit initially, even though we have accrued the patient, and will only give us full credit later.
Question 12: What is the definition of accrual? - Consented? Registered? Enrolled?
Question 13: Where do we include non-research based trial accrual (i.e., investigator-initiated trials & Pharma trials)?
Question 14: The window for the 3-year average accruals used to determine budget multiplier hits our program hard due to a one-time, 6-month interruption of our program (IRB transitions) in 2011. May we adjust our accrual numbers that year to account for the closure? If we do not, our budget would significantly under-represent our actual work load and accruals. Perhaps using accruals from 2010, 2012 and 2013 for our 3-year average? Or 2009, 2010 and 2012? Or estimating accrual for 2011 based on what we would have enrolled had we been open the whole year?
Question 15: To make sure I have a clear understanding; funding will be based upon a 3 year average annual credits received. i.e., if my 3-year average is 150 enrollments then this is what I will expect for the first year of the grant? Also, will this be the logic for each year after year 1 of the 5 year grant?
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