Question 1: Component and sub-component definition on page 23 of the RFA: please clarify. Please discuss the rationale and specifics on this.
Question 2: What does NCI mean stating that a subcomponent must be part of a component's business entity? Does this mean that a subcomponent must be legally managed/owned/controlled by the component, or are other relationships possible?
Question 3: What is the intent of the "Primary Component" of a community site? Is the intent for the Primary Component to be the grant holder and also have the Contact PI?
Question 4: A private practice would like to be a part of our NCORP. If this other site is already a member of another group (for example, ECOG), do they have to choose between their ECOG membership or being a component/subcomponent of our NCORP? Can NCORP sites continue to be main member institutes of as many groups as they wish?
Question 5: Will there be future opportunities to add additional sites to an existing NCORP site?
Question 6: Can there be two co-primary components? In other words, can two components share the management and distribute the expertise and management capacity?
Question 7: What exactly is meant in IV.B.2.2.1, Page 98 (Guidelines document) Definition, Eligibility and Accrual Threshold: "In addition, throughout these Terms and Conditions of Award, NCORP Community Site, refers to the main community site as well as any component and sub-component site(s) included in the award if the Community Site provides complete management services for the component and sub-component site(s) relating to enrolling patients on NCORP studies". What do you mean by 'main community site'? Is "main community site" also referred to as the "primary component"?
Question 8: Will foreign (outside of U.S.) sites be allowed as a sub-recipient or affiliate site on the NCORP community site RFA?
Question 9: When will sites that applied for a LAPS grant be notified if they were selected or not? There are quite a few institutions around here that joined forces on an application – if they aren't funded they may be looking for other options.
Question 10: The proposed components of our NCORP have various relationships to Cooperative Groups. How will this affect our application? For example, a hospital component will be a main member of NRG in March 2014 and a private practice component is currently an affiliate member of Alliance, through a designated cancer center. Can the hospital and private practice be components of an NCORP?
Question 11: Please describe in more detail what you mean by 'sub-component' for a Community Site. The RFA states 'a sub-component refers to a practice or organization that contributes to the overall accrual of a component site but is located in a separate geographic location, is part of the component's business entity, and is managed by the component'. Can you provide an example please? Our assumption as a CCOP was that our CCOP's current 'affiliates' would be sub-component sites of a component (our current CCOP grant holder).
Question 12: In IV.B.2.2.1, Page 99 (Guidelines document). Component & Sub-Component Network: Please explain "Community Site is responsible for complete monitoring and management of the enrollment of patients at the components and sub-components sites". But if the definition of 'Community Site' is a consortium of sites, what is the expectation of management? Can management be shared between two strong components?
Question 13: Do you want all the sub-components listed that treat patients (that would be all performance sites) under the sub-components?
Question 14: Right now our CCOP is structured such that our central office is the component and all others are affiliates. Our CCOP is an independent administrative office. We do not treat patients in our office, but we do register patients from our office on behalf of our affiliate sites. Based on the definitions of component and sub-component in the RFA, I am concerned if the CCOP office can still be classified as a component. If so, as I am reading the definitions, our CCOP would be the community site awardee or primary component and each of our affiliate sites would be considered components as well since they all see and treat patients.
Question 15: Within the NCTN Groups are components being looked at differently than subcomponents with respect to accrual expectations?
Question 16: We have rural outreach clinics that are under their own business models, not in "the control of an overall component site, i.e., legally managed/owned/controlled by the component. However, our medical oncologists provide professional services at those sites. I "assumed" for purposes of the grant application that these would be "subcomponents" even though they have always had their own FWA number and now have CTEP IDs.
Question 17: How do you define a private practice (privately owned) versus a hospital owned practice (business entity)? Does business agreement apply to indicate that it is a subcomponent?
Question 18: My site is applying to be an NCORP Minority site. A private practice would like to be a part of our NCORP. Under the new structure, are affiliate sites now considered a 'component'? If this other site is already a member of another group, (for example ECOG) do they have to choose between their ECOG membership or being an affiliate/component of our NCORP? Can NCORP sites continue to be main member institutes of as many groups as they wish?
Question 19: Will NCORP sites have access to the full menu of cooperative group trials to the same extent as main members? Including the new hybrid government/pharma trials?
Question 20: Will there be any financial repercussions to switching from being a main member to being a member through the NCORP? Will the reimbursement rate for credits be any different?
Question 21: If a component is currently a member of Alliance and NRG, will we have to re-apply and is there a chance that our application be now denied as an NCORP site?
Question 22: If we do have to re-apply, will our re-application process to cooperative groups as an NCORP site be expedited in any way if our components had previously been members?
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