Question 1: Are tables included in the total number of pages for a section?
Question 2: There seems to be formatting issues with Table 1. Will this be re-done?
Question 3: Table 1: question 6: “average 5 year annual accrual” Is there somewhere that we can count follow-up credits for 2010 and before?
Question 4: Table 1: question 6: "average 5 year annual accrual"... if a site has only been participating in CCOP trials for a year or 18 months, do you average that, or does the denominator stay 5?
Question 5: Table 1: question 5: “Report new cases diagnosed or receiving primary treatment at that hospital or physicians group practice” Does this mean new analytical cases or any NEW cases?
Question 6: For Table 1-we did not add ourselves because the table is called NCORP Community Site Components and Sub-Components which makes us believe that these are all our components. Should we have put our self as #1? Should we identify ourselves as the "primary site" because, if funded, we would be an awardee but so would another component because they would have all the Cancer Care Delivery Research and thus also be an awardee.
Question 7: Please clarify what info is needed for question 6 in Table 1; average annual accrual in 5 years. Is this grant years specifically versus calendar years, and is the reference to accrual or credits?
Question 8: Table 1. Does NCI want 5 year accrual just to research base studies or should we include other (Phase II consortia studies and Industry)?
Question 9: Table 1. Is it OK to combine the accrual for subcomponents into the totals for their related component? We may not have captured this information in a retrievable fashion. We can generate it if it's required.
Question 10: Table 1. For new cancer patients, again do you want this broken down by subcomponents, too? It won't be possible for the hospitals, but we might be able to do this for the private practice.
Question 11: Table 1: What do you mean by an integrated system?
Question 12: Table 1: Do we list component and subcomponents that currently have CTEP site codes only?
Question 13: Table 1: Should outreach sites or potential outreach sites that may conduct research in the future be included in Table 1?
Question 14: COG Registry trials: Can these be counted in Treatment accrual numbers i.e. Table 2?
Question 15: Please explain the dates used in Tables 2a and 2b. Or are they illustrative purposes?
Question 16: Do we need to list Alliance and CALGB separately or do we combine the accruals together for all info provided for them in this FOA?
Question 17: The tables ask for accrual per CCOP research base. When we report to NCI, CTSU is listed as a research base. Do you want CTSU listed as a research base or do those accruals have to be split out to the actual research base that got the credit for that enrollment?
Question 18: What do we list as accruals for example new accruals vs the SELECT ancillary studies or the P2 follow up. These technically are not new accruals but we did get credit. So I was wondering if we count them as accruals?
Question 19: Two CCOPs are merging and are submitting this FOA together. Do you want the accruals together for the tables or separate?
Question 20: Do you want the protocol number that the research base goes by or do you want the protocol number that is in the NCI CCOP accrual report system which can be quite different from the research base protocol number?
Question 21: We are to list all the research bases we plan to affiliate with but do we list all the cancer control research bases that we have participated in over the years since we do not know who will and will not be funded for the NCORP research bases?
Question 22: There is no end date for Tables 3A and 3B in the NCORP RFA. Do we just use our own date?
Question 23: Tables 3a & 3b: 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 24: Table 3a – Do you want each individual trial and the number of accruals to the trial... per trial??? Or do you want us to say, we have treatment trials- accrued 75 patients....? Also, if you want us to list per study, do you want us to list studies in which we have activated but do not yet no accrual, and just show the accrual as none?
Question 25: In reference to Table 3a, what is the definition of a currently active trial? Does active mean currently accruing patients or in follow up?
Question 26: Table 3b: NCORP Community Site NCI Clinical Trials Expected to Activate over the next 12 months not sure where to get this information. Should we go to the groups draft, Pending-pre-activated of is there a listing?
Question 27: I know the tables are just suggested, but for table 5 are they looking for just a check mark for the non-numbered items (e.g. cardiology) or are they looking for comment of whether service can be obtained off site or needs to be referred out?
Question 28: Can Table 7 (audits) reflect acceptable audits if they occurred after May 31, 2013?
Question 29: Table 7: Should the audit reports be listed chronologically since 2008 or should they be listed, e.g. starting with ACOSOG?
Question 30: If some components have been members of ACOSOG and GOG outside the CCOP should those reports be listed on this table along with the site code for the component?
Question 31: Table 7: When listing the research base name in the first box, we are trying to designate which site was audited, i.e., site code for one CCOP and another site code for another CCOP. Do you want us to list the site/CTEP code for who the audit is applicable especially those that were done outside the CCOP arena?
Question 32: 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 33: I am trying to locate the worksheet described in the RFA page 10 under Detailed Budget. Could you please indicate where located?
Question 34: The PHS form for planned enrollment report as noted in Part II section 4.3 states that each protocol (study title) should have total number of subjects proposed for each study. We have at least 150 protocols; therefore, we should provide a page for each protocol? In our last 5 yr report we just reported the numbers for treatment as a whole, cancer control as a whole, and then a summary of both. 150 protocols is a lot of pages and protocols to complete for this application. What do you really want?
Question 35: Do you know if we have to do the Planned Enrollment Report? Usually the directions tell us to skip this section, but they didn’t say one way or the other in the RFA.
Question 36: PHS Forms: 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 37: Face Page: Is NCORP an NIH defined phase III clinical trial in this context?
Question 38: Where should letters of support be provided?
Question 39: Still unclear about how to list QOL studies that have a separate protocol number, and for which credit is entered separately on our accrual reports. Also some studies like CALGB 80702 have 4 embedded components, all with separate study numbers. How do you want these listed?
Question 40: Under the line items for "Health Related Quality of Life Credits" and "Prevention, Control and/or Screening/Post Treatment Surveillance Trials Credits" what types of studies qualify?
Question 41: If the site is enrolling subjects for an active funded cancer control study, does this qualify for the credit? Or does the credit only pertain to studies that are funded after an NCORP award?
Question 42: If the credit is given for active cancer control trials, are those subjects to be included in the "planned enrollment table"?
Question 43: Table 4: Current and/or Planned Research Base Affiliation(s) Do you want NCI sponsored research bases only such as ECOG-ACRIN and Alliance or do you want these plus other non NCI sponsored research bases such as PrECOG, WON – Wisconsin Oncology Network (Univ. of WI, Madison WI, CRAB CTC (Cancer Research And Biostatistics – Seattle WA, ACCRU (Academic and Community Cancer Research United – Rochester MN)?
Question 44: Is a data safety and monitoring plan required for community sites that are not the sponsor of the NCI trial? According to the language below from the NCI site, the answer would be no. Please clarify.
Essential Elements of a Data Safety and Monitoring Plan for Clinical Trials Funded by the NCI This document outlines the essential elements of an adequate plan for data and safety monitoring (DSM) of clinical trials. It is intended to assist investigators and institutions in the formulation of DSM plans for all phases of cancer clinical trials, in accordance with National Institutes of Health (NIH) requirements. We suggest that institutions SPONSORING a significant number of clinical trials formulate institutional DSM plans that can be broadly applied to the individual trials in their portfolio.
Question 45: Bibliography/References Cited/Progress Report Publication:
Is this section required for this NCORP application? The publications are listed on the individual investigator biosketches.
Question 46: If a study currently has both treatment and cancer control aspects (and credits for CCOP), do we list the studies both under treatment and under cancer control? What about studies that have a screening component to determine eligibility (B-43 for instance). Should we list the study under both treatment and under screening? If not, how do we decide where to put it?
Question 47: Table 3b: NCORP Community Site NCI Clinical Trials Expected to Activate over the next 12 months not sure where to get this information. Should we go to the groups draft, Pending-pre-activated of is there a listing?
Question 48: In the Protection of Human Subjects of the Research Plan, should we include anything about the human protection training we do and/or copies of certificates like we have done in the past?
Question 49: In table 8 I noticed it is asking for the name of the component/subcomponents...traditionally we have used our local hospital registry data for this table. Should we continue to do that or do you really want the stats from our component/subcomponents?
Question 50: Table 5 asks for average annual CCDR accrual over 5 calendar years. Table 6 asks for CCDR accrual over the past 5 grant years. Do you actually want these to be different periods?
Question 51: In preparing for submitting for an NCORP grant, there is the Signatory Official (SO) worksheet. In our situation, we are partnering with three institutions for the grant, one institution will be the grant holder; however, there are 3 separate SOs. Do we describe how we will manage the process and, if awarded, do we submit 3 SO worksheets?
Question 52: Regarding tables 2a and 2b, Some people in my institution think that some trials get both cancer treatment and control and prevention credit and that our organization can place these trials in either table as long as the accrual is only counted once. I do not believe it. I believe that a trial gets treatment credit or control and prevention credit, not both. Can a trial be both treatment and control and prevention? If not, is there a simple way to determine if a trial gets treatment credit or control and prevention credit?
Question 53: The RFA instructions under Table of Contents say to "modify the Table of Contents" to include the 5 sub-sections of the Research Plan. But the TOC has restricted editing and will not allow this. Please advise.
Question 54: Table 3a: This table asks for ACTIVE trials. Can you please confirm if this is to include ACTIVE ENROLLING only or also ACTIVE NOT RECRUITING?
Question 55: Table 3b: It is difficult to project what studies we will want to open in the next 12 months as we are not aware of what studies will be opening. After attending study group meetings, we are interested in participating in studies that are still in the concept phase. Would we include those a full list of concept studies we are interested in on this table?
Question 56: Palinto is listed as an acceptable font, which no longer a choice in Word. Palinto Linotype is a choice. Are we allowed to use this?
Question 57: Should the budget on the face page be the total combined budget for clinical trials and CCDR or should they also be separated on the face page.
On the budget page, how should we show the division between the clinical trials and CCDR budgets? Should we submit separate budget pages for each or perhaps indicate percentages (e.g. for an individual salary, 90% Clinical Trials and 10% CCDR)?
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