CP-CTNet Site FAQs

Errors in published Notice RFA-CA-24-024

1. Letter of Intent (LOI) Due Date

The due date for Letters of Intent is listed as August 23, 2024, which is incorrect. LOI are due 30 days before proposals are due.

The Letter of Intent is due October 1, 2024, and Applications are due by October 31, 2024.

2. Section III.3 Additional Information on Eligibility. Number of Applications Permitted

The RFA currently has contradictory information that applicant organizations may submit one or more than one application. Only one application per institution is allowed.

Questions Posted: 10/15/2024

If a cross-network trial is proposed by one grantee and there are site co-PIs from other grantees, should the non-lead LAOs still propose 2 concepts in Attachment 2?

Yes, the lead for a cross-network trial is the one who proposes the cross-network trial in their grant. The other grantees who plan to participate in the cross-network trial but not as the leads should propose 2 of their own trials.

Must the Protocol Chairs and Lead Site Coordinators be included in our personnel budget at time of submission? Typically, we’ve included these positions in our clinical trial budgets that are submitted in the concept stage. If we follow that pattern, we would include these positions in the Cost of Clinical Trial Performance line item in our budget and justification at submission.

You can propose the protocol chair and lead site coordinator salaries either in your Personnel Costs or in the Clinical Trial budgets that are submitted with your concepts. Please remember that clinical trial costs are restricted until you have protocols approved, whereas the Personnel Costs are not restricted.

Question Posted: 10/07/2024

With regard to the sample concepts in Attachment 2:

1. Is a separate budget required for each concept?
2. Are letters of support required from participating sites, or is the letter of support we have for consortium participation in a more general way sufficient?

A budget for each concept is not needed and should not be submitted.
A letter of commitment from the PI of each concept is needed, but the general letters of support for consortium participation are sufficient for the participating sites (AOs) and therefore there is no need for additional letters of support from participating sites for each concept. Additionally, please submit evidence of ability to obtain the agents for the concepts, such as letters of support from the pharmaceutical company for experimental agents.

Question Posted: 09/30/2024

Is a Plan for Enhancing Diverse Perspectives (PEDP) required? The PI Responsibility section indicates that PD(s)/PI(s) will have the primary responsibility to:

• Provide updates at least annually on progress in PEDP implementation.

A PEDP is not required for this RFA. The PI responsibility language was automatically inserted but the RFA instructions did not ask for a PEDP and thus it should not be included.

Questions Posted: 09/26/2024

Should existing ongoing trials be included into the Subaward Budgets?
Previous answer found on the web page was: “This can be done post award, although the funds should be accounted for in your proposals.” Question: What is the mechanism to account for the funds in the proposals? Should we submit detailed budgets or one amount for Subaward under the R&R Budget?

Your overall clinical budget should be constructed with the following guidelines – accrual of 40 participants per year, starting year 1, and all associated costs for trials accruing these participants (e.g., biomarker analyses) should form the basis for your clinical trial program. Since it typically takes 1-2 years to get new studies approved and open, that means that for a renewal application, in the initial years of the program, you will be primarily accruing from studies that are already open. So, the current studies will give you a realistic budget for those initial years and you can build from this information. Your justification for the budget can include these real numbers. The subawards for the actual trials can be put in place post award.

Our submission is a renewal. We are submitting a Project. The Assist application does not have the “R&R Subaward Budget” on the Menu for this submission. Our application does not allow me to “Add New Subaward.” What is the solution?

See answer above, the subawards for trials will wait until post-award.

We are submitting a renewal application. Our studies have already been entered in Assist under the current grant. In Assist, on page “Human Subjects and Clinical Trials” under “Study Records” should we add our ongoing clinical trials from the current UG1 grant program? This will create a duplicate record for the same studies.

No, don’t enter the studies again, just update the information that is already in HSS (and insure that any recently approved studies are also entered in HSS).

Should we also use the “Delayed Onset Studies” section to enter the studies that we have described as our new concepts?

No, the 2 concepts that you are describing in Attachment 2 should only be described in that Attachment, they are samples that illustrate your capabilities and will subsequently be reviewed by DCP if your grant gets funded. They may or may not be approved post award.

In the budget for the renewal application, should we include the budgets per year for the ongoing UG1 studies (the ones that we hope to continue in the renewal) into the renewal application budget?

Your budget should be based on the required yearly accrual (40 participants per year, years 1-6 for renewal applications, and associated costs for each trial), regardless of what studies you have ongoing. You can use your current studies to provide realistic costs for the initial years and as a guide to estimate patient care costs, biomarker costs, and other study-related costs for later years.

Is there a minimum level of effort expected for Protocol Chairs or Lead Site Coordinators? I didn’t see anything listed specifically in the RFA. I’m planning to budget what is typical for us on past protocols. I wanted to make sure the 1.2 Cal months minimum for PD/PI’s does not apply to Protocol Chairs.

No, there is no minimum or maximum effort. The effort should be commensurate with the need and appropriately justified.

Statement from the RFA. “Study Title - use: "Multiple Delayed Onset Studies" Justification Attachment: Indicate that the clinical trials will be designed and conducted by the CP-CTNet Site during the Project Period. Each clinical trial protocol developed will be subject to approval through the standard NCI procedure that involves an initial concept submission and subsequent review. If the concept receives approval, the next stage will be development of the full clinical trial protocol, which will be subject to review and approval by NCI prior to activation through the CP-CTNet. Although all new studies will be delayed onset, human subject protection must be addressed in the appropriate grant section.”
Where should we include the actual titles of the two new clinical trials if the study title requirement is multiple delayed onset studies?

The 2 new concepts are samples only, they should not be entered into HSS at the time of application or in any section of the grant other than Attachment 2. If the grant is approved, DCP will review the sample concepts and determine if they are approved for protocol development. You can describe your plans on how will human subject protection be ensured in CP-CTNet clinical trials, and this should be addressed in a generic/descriptive fashion for all planned future studies as part of the grant application’s research strategy.

Relating to the question above, do we need to fill out a human subject study record for the delayed onset clinical trials? The RFA seems like it’s a requirement to do so. Typically for delayed onset studies, a delayed onset study record is all that is needed so I just wanted to confirm.

You can’t—and should not - fill out HSS for the new concepts that you are proposing since those are delayed and are not DCP approved yet. For the delayed onset justification in the study record, follow the instructions for the justification language as indicated in the RFA. However, for the studies that you have ongoing from the current program, we request that you update the HSS record.

Questions Posted: 09/18/2024

If we plan to use an agent supplied by NCI (e.g., through CTEP) for one of our Attachment 2 samples concepts, do we need to obtain a letter of support/commitment from NCI for this?

Yes, proof of agent availability, such as a letter of support/commitment, is needed for all concepts.

If 2 institutions submit an application using the MPI model, will both of them be considered LAO’s and theoretically receive two separate NOA’s? Or would the second institution be considered an AO and receive funds via a subaward?

Only 1 institution submits the grant and is therefore considered the LAO. The second institution would technically be an AO and receive funds via subaward. However, the PI at the second institution would nevertheless be considered an MPI.

With regard to the budget for Data Management and Sharing, which is a direct cost line item, there will not be a budget line in the application since the DMASC assumes these costs. Should we specify DMASC’s coverage of these costs in the budget justification even though there is no dollar amount allocated in the Data Management and Sharing line item?

Yes, the costs for Data Management and Sharing will be covered by the DMASC as you indicate, so please make this clear in the budget justification that DMASC will assume the costs.

Is there a deadline for questions regarding the RFA?

No, there is no deadline for questions.

Is a separate Equipment document is required? We plan to describe all equipment within our Facilities section, as we don’t have any separate equipment not located in a facility.

We don’t expect a separate Equipment document, the description within the Facilities section is adequate.

Questions Received: 08/27/2024 (at Informational Webinar)

Provide more information about the Community Engagement Board, should the activities be considered on a ‘per trial’ basis?

The Community Engagement Board should probably be part of the Core and its activities will be allotted to trials post award. Costs that could be considered would include travel, honoraria for work performed or meetings attended, and similar activities.

Can non-pharmaceutical interventions, such as diet or exercise, alone or in combination with pharmaceutical interventions, be proposed for studies?

This program is primarily designed for pharmaceutical-type interventions (drugs, vaccine, immune modulators, etc.), although this includes well characterized dietary agents. Purely dietary and exercise interventions fall outside the expertise and focus of DCP, although they may be considered on a case by case basis.

For the current CP-CTNet program, the last scheduled solicitation will be sent out on January 2025. Will there be a break in solicitation cycles until the new program is established?

Solicitations will continue to be sent out on a quarterly basis, but the recommendation is to respond only if ‘there is a burning need’. In the case that a current grantee does not successfully recompete, this will minimize effort on studies that would not move forward. Studies that can be delayed until the new program should be delayed until the fall of 2025.

Should existing ongoing trials be included in the subawards?

This can be done post award, although the funds should be accounted for in your proposals.

Discuss the difference between direct and indirect costs.

Indirect costs are negotiated by your institution with the federal government. Once you determine your direct costs (e.g., salaries, supplies, patient care costs, biomarker analyses, etc.), the indirect costs will flow from your institution’s negotiated rates. Please remember that patient care costs do not get indirect costs.

What were the changes in dates on your slides?

The LOI due date was incorrect in the RFA, it is October 1 (30 days before applications are due). The LOI is not mandatory.

Provide more information on what is expected from the mentorship plan.

You do not need to have a specific person in mind for mentorship, so the plan can be generically described. However, having someone specific identified (or identifying the position of a potential mentee, such as an early career faculty member or a clinical fellow or post-doc) will help you develop a targeted plan on how to mentor/support such a person. Given that the program will begin almost a year after the applications are due, you may not be able to identify any given individual. Instead, use a potential person’s role (e.g., young faculty, etc.) to discuss how you will attract the person to the field of cancer prevention and train them appropriately to be successful.

How do we include multiple PI’s from other institutions without subawards?

Multiple PIs for future clinical trials should be listed under ‘Other Personnel’, without being named (since you don’t necessarily know who they will be). Subawards are not needed since you don’t know who the multiple PIs will be.

However, for the MPI, you do want to have a subaward in place since that relationship is defined before the application is submitted and you know who the person will be. An MPI plan is needed as well.

Questions Posted: 08/28/2024

For current UG1 grantees with type-2 (renewal) application, should we add information about existing (and proposed to continue) sub-awards supporting ongoing clinical trials?

Yes, information on sub-awards for existing (and proposed to continue) trials should be included.

May we submit a cross-network trial for Sample Concept (Attachment 2)? If so, should we have a commitment from other LAO(s) and mention this in the concept?

Yes, cross-network trials are allowed, commitment from current LAOs should be obtained.

Should potential accrual sites within the Sample Concept (Attachment 2) be part of our network in the renewal application? Or may they be added to the network upon concept approval?

Letters of commitment from the PIs should be obtained and ideally the sites would be proposed as AOs in the renewal application. If there are some unexpected logistical hurdles that prevent the sites from being on your AO list, they can be added upon concept approval.

Can multiple performance sites be described together within the application? For example, if a VA is associated with a University, does it need to be listed as its own performance site or can it be described within the University performance site?

Institutions that are closely linked, especially if PIs have appointments in both institutions (eg, a university and a VA), can be described together. The distinct components and how they function as a unit should be described

Should all AOs participating in trials we expect to continue from the 2019 cycle be included in our application?

If AOs are part of ongoing studies that will continue, they should be included as AOs in your application. You do not need to include AOs from your current list that are not participating in open trials. And you can add new AOs, even if they are not part of your 2 submitted concepts.

Will we be allowed to carryforward money from the last performance period of the current award into the new award?

If there is a bona fide need, carryovers can be requested after the FFR is submitted. Carryovers will need NCI approval and a new NOA would be issued during the year they are requested.

Please provide additional clarification for this mentioned in the RFA?

Describe ability to develop new laboratory assays or biomarkers to be used in fit-for-purpose assays ready to be transferred to or already implemented in Clinical Laboratory       Improvement Amendments (CLIA)-certified laboratories.

We need to understand your current laboratory capabilities and ability to develop new assays. While we generally accept ‘home-grown assays’ for biomarker analyses in investigators’ labs, ideally assays would undergo validation and would be performed in CLIA-approved labs.

When will the first solicitation of new concepts be announced?

In the beginning of the fiscal year after funding (~October 2025).

For current LAOs who have new protocols in the pipeline, if they don't get renewed funding, will funding still be available for those protocols?

Decisions will be made on a case-by-case basis regarding protocols that have not yet opened to accrual or are recently opened.

How do we include multiple PIs from other sites without a sub award agreement in place at time of submission? Do we include the individual (MPI) in our budget, include the performance site, as well as the senior key profile & Biosketch? I know that we will also need a MPI plan in place as well.

While subawards are not needed for the multiple study PIs for studies that will be designed/approved post-award, the same is not true of the MPI. The MPI is a key personnel who needs to be named in the proposal and the site should be part of your network. A subaward for the MPI and the site should be included, along with the MPI plan.

For the multiple protocol PIs, their role and estimated salary should be listed under “Other Personnel”.

Questions Posted: 08/23/2024

How do we address protocol chair and lead site coordinator salaries for studies that will be designed in the future?

Protocol PI and Lead Site Coordinator salaries over the 6 grant years will need to be estimated, keeping in mind that 1 to 3 new studies are expected to be initiated each year (even though only 2 sample concepts are requested in Attachment 2). One or both of the sample concepts in Attachment 2 may be approved for protocol development, but the other studies to be performed during the lifetime of the grant will be planned and executed in the future and thus will not be described now. Therefore, subawards for the studies should not be submitted with the proposals. Salaries for PIs and Lead Site Coordinators should be submitted under “other personnel”. The individuals do not need to be named, but their roles (e.g., Protocol PI) need to be delineated and commensurate salary amounts should be listed (realizing that these amounts are informed approximations, or guesstimates, and may change as personnel are finalized post-award). The proposed Affiliated Sites (AOs) should be listed in the proposal, although no budget is assigned to any AO and no subaward is negotiated until a study is approved.

Do we need to submit the grant proposal via ASSIST or is this a system-to-system application?

Both mechanisms for submission are acceptable. Application instructions (under Part 1. Overview Information) state that one of the following 3 options to access application forms must be used:

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Please clarify direct and indirect costs allowable each year for a center

$1,375,000 per year direct costs are allowable. Indirect costs vary by institution since they are all negotiated separately, you should use your institution’s negotiated indirect rate. You can refer to the NIH Grants Policy Statement for additional information. See: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.3_direct_….

Could you please elaborate on what is required regarding the statement below from the RFA? Does this just include a total each year of direct costs allocated toward clinical trial programs and site accrual programs separately? Could you define the costs that you would expect to see for clinical trial programs and site accrual programs? Does this breakdown also need to occur for the costs of clinical trials line item?

“In addition to the standard items for this attachment, provide a breakdown of the direct costs to show separate amounts for each functional unit (Clinical Trial Program and Site Accrual Program)”

As outlined in the RFA section IV.2 under “Research Plan/Research Strategy”, the Clinical Trial Program encompasses the leadership and infrastructure that supports the clinical trials (such as, but not limited to, LAO salaries, consumables, shipping, operational efficiencies supporting study accrual/recruitment/retention and community engagement activities, trial activation, etc.). The Site Accrual Program encompasses the actual accrual and study conduct (such as, but not limited to, accrual and patient care costs not covered by insurance, obtaining biospecimens, etc.). The RFA requires that the total each year of direct costs allocated toward the Clinical Trials Program and Site Accrual Program are itemized separately. For specific clinical trials, some costs will come from the Site Accrual Program, other costs can come from the Clinical Trials Program. Note that clinical trial costs will be restricted until studies are approved by DCP and therefore these costs need to be itemized separately. However, it is not necessary to differentiate between the two Programs within the clinical trials line item.

Question Regarding the PHS Human Subjects and Clinical Trials Section statement below

Renewal applications will have ongoing studies that should be updated in the Human Subjects System (HSS). Both renewal and new applications will be designing trials with delayed onset and therefore applicants must add and complete the Delayed Onset Study record and must check the box "Anticipated Clinical Trial?"

Does this mean existing clinical trials that are rolled into the renewal will need to be updated in the clinical trials information section of the proposal?

Answer: The existing clinical trials should be included using the Human Subjects and Clinical Trial Information form in the application and related study records should be included via the Human Subject System (HSS) (completed via ASSIST), without making any changes at this time to the current clinicaltrials.gov record.