Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Limited Competition: NCI National Clinical Trials Network - Network Radiotherapy and Imaging Core Services Center (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

Reissue of RFA-CA-12-014

Related Notices
Funding Opportunity Announcement (FOA) Number

RFA-CA-17-060

Companion Funding Opportunity

RFA-CA-17-056, U10 Cooperative Clinical Research – Cooperative Agreements;

RFA-CA-17-057, U10 Cooperative Clinical Research – Cooperative Agreements;

RFA-CA-17-058, U10 Cooperative Clinical Research – Cooperative Agreements;

RFA-CA-17-059, UG1 Clinical Research Cooperative Agreements - Single Project;

RFA-CA-17-061, UG1 Clinical Research Cooperative Agreements - Single Project

Number of Applications

Each applicant organization may submit only one application as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.394; 93.395

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to solicit applications to maintain a Network Radiotherapy and Imaging Core Services Center for the NCI National Clinical Trials Network (NCTN) that provides scientific and technical expertise for incorporating integrated quality assurance and image data management for applicable NCTN clinical trials that involve interventions with radiotherapy and/or imaging modalities. In addition, the Center will have the capacity to provide similar services for other approved NCI-supported clinical trials network programs (e.g., the NCI/DCTD early phase clinical trial network program and the NCI/DCP NCI Community Oncology Research Program).

Key Dates

 

Posted Date

October 20, 2017

Open Date (Earliest Submission Date)

December 19, 2017

Letter of Intent Due Date(s)

December 19, 2017

Application Due Date(s)

January 19, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this FOA.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May-June 2018

Advisory Council Review

October 2018

Earliest Start Date

March 2019

Expiration Date

January 20, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  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. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) is one of six FOAs that support the comprehensive effort by the National Cancer Institute (NCI) to provide the infrastructure for the conduct of national clinical trials through the National Clinical Trials Network (NCTN). The primary goal of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and advanced imaging trials across a broad range of cancers, modalities, and diverse patient populations as part of the NCI's overall clinical research program for adults, adolescents and young adults, and children with cancer. The NCTN also conducts, as necessary, preliminary studies needed for development of definitive trials, especially umbrella/basket trials and rare tumor trials, when an extensive, national patient catchment area is required. 

The NCTN Program supports the following clinical trials infrastructure components through individual awards made under the respective FOAs indicated below:

NCTN - Network Group Operations Centers under RFA-CA-17-056 (U10)

NCTN - Network Group Statistics and Data Management Centers under RFA-CA-17-057 (U10)

NCTN - Canadian Collaborating Clinical Trials Network under RFA-CA-17-058 (U10)

NCTN - Network Lead Academic Participating Sites under RFA-CA-17-059 (UG1)

NCTN - Network Radiotherapy & Imaging Core Services Center under RFA-CA-17-060 (U24)- this FOA

NCTN - Network Group Integrated Translational Science Centers under RFA-CA-17-061 (UG1)

The purpose of this funding opportunity announcement (FOA) under the NCTN Program is to solicit applications to maintain a Network Radiotherapy and Imaging Core Services Center for the Network. The goal of this Center is to provide scientific and technical expertise for incorporating integrated quality assurance and image data management for applicable NCTN trials involving interventions with radiotherapy and/or imaging modalities. In addition, the Center has the capacity to provide similar services for other approved NCI-supported clinical trials network programs (e.g., the NCI/Division of Cancer Treatment and Diagnosis (DCTD) early phase clinical trial network program and the NCI/Division of Cancer Prevention (DCP) NCI Community Oncology Research Program).

 
Background

On March 1, 2014, after several years of extensive consultation and coordination with numerous stakeholders, the NCI transformed its longstanding Cooperative Group Clinical Trials infrastructure program into the new NCI National Clinical Trials Network (NCTN) for the conduct of large-scale, national, oncology treatment and advanced imaging clinical trials in an era of precision medicine. 

Recent advances in deciphering the cancer genome, along with the emergence of successful immunotherapies, have fundamentally changed our approach to cancer treatment and have introduced new challenges to performing clinical trials. Due to the low incidence of certain molecular abnormalities, the development of targeted therapies often requires an infrastructure for the conduct of clinical trials that can screen large numbers of patients with the same or different cancer type to identify those patients whose tumors contain the distinct molecular targets of the therapies being tested. Immunotherapeutic approaches also present a similar challenge in that not all tumor types respond to this approach, and selecting the cancer types most likely to respond is critical for success.

The NCTN's integrated and collaborative network infrastructure has allowed the Program to meet the challenges of evaluating emerging therapies within its broad investigator base drawn from NCI-designated Cancer Centers, the NCI Community Oncology Research Program (NCORP), Minority/Underserved NCORPs, and other academic and community hospitals and private practitioners across the U.S. and internationally. The primary focus of the NCTN is the conduct of multi-center, late-phase, clinical treatment trials (i.e., randomized phase 2 and phase 3 trials) and investigation of new advanced imaging techniques; however, appropriate preliminary studies needed for development of potential definitive trials, especially umbrella/basket trials and rare tumor trials oriented to discovery, are also conducted when an extensive, national patient catchment area is required. With its state-of-the-art clinical trials infrastructure, the NCTN implements and completes trials far more rapidly than in the past. The NCTN has streamlined trial registration, data management, and tumor banking processes. It has a Cancer Trials Support Unit (CTSU) to provide online access to all materials and a Central Institutional Review Board (CIRB) to make ethics review easier and less redundant across the country. The NCTN also has appeal for industry partners as evidenced by the large number of biotechnology and pharmaceutical companies that collaborate on NCTN precision medicine trials harnessing next generation DNA and RNA sequencing methods to inform treatment choices. NCTN's resources are ideal for screening large numbers of patients to identify patients whose tumors exhibit the molecular features that may be responsive to new, targeted treatments and/or immunotherapy approaches. In addition, biospecimens collected from patients on NCTN trials are available to help determine the underlying biological reasons for response and resistance to therapy

The NCTN has also continued to promote the evaluation of multi-modality treatments, including surgery and radiotherapy in combination with novel agents, and has maintained a commitment to the conduct of trials in special populations (e.g., children, adolescents, young adults, and underserved populations) and involving patient with rare tumors. This focus allows the NCTN Program to complement, rather than duplicate, research conducted by the private sector.  Annual accrual to NCTN trials has remained in the 17,500 to 22,000 patient range in mostly large phase 2 and phase 3 trials, but with a larger number of patients now screened on study to determine whether they might benefit from the therapy under evaluation.

Each of the key components of the NCTN Program is described briefly below.

  • Network Group Operations Centers: The Operations Centers provide scientific leadership for developing and implementing multi-disciplinary, multi-institutional trials in a range of diseases and special populations with specific scientific strategy and goals. The Operations Centers' scientific goals may include strategic innovation in advanced technology for specific research areas (e.g., advanced imaging methods/agents, radiotherapy) and the testing of innovative concepts and tools in prospective, multi-institutional clinical trials. Operations Centers are responsible for trial operations including timely protocol development and management, compliance with the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) regulatory and patient protection requirements, audits, training, quality assurance, and site support. The Operations Centers are expected to be closely integrated with their corresponding Statistics and Data Management Center in all aspects of trial operations through jointly developed policies and procedures for clinical trial development and conduct. The Operations Centers are also responsible for Network Group administration, including financial management, monitoring of member institution/site performance, coordination of biospecimen collection from patients on clinical trials, and adherence to all applicable NIH/NCI policies and regulations. Network Group Operations Centers may also provide trial operations for NCI Division of Cancer Treatment and Diagnosis (NCI/DCTD) approved, multi-center phase 2 and phase 3 trials originating outside the Network Groups.
  • Network Group Statistics and Data Management Centers: These Centers are responsible for providing the statistical expertise required to ensure effective scientific design and conduct of clinical trials as well as leadership in innovation in statistical methodology. These Centers are also responsible for data management, data analysis, and statistical analysis for NCTN trials led by their affiliated Network Group Operations Center as well as for translational and other ancillary studies associated with the trials.
  • Network Group Integrated Translational Science Centers: These awards provide support for leadership and expertise to facilitate incorporating translational science into Network Group clinical trials.
  • Network Lead Academic Participating Sites: These academic institutions/sites provide scientific leadership in development and conduct of clinical trials in association with one or more adult Network Groups as well as substantial accrual to clinical trials conducted across the entire NCTN.
  • Network Radiotherapy and Imaging Core Services Centers - this RFA: This institution/organization provides scientific and technical expertise for incorporation of appropriate, integrated quality assurance and image data management for applicable clinical trials conducted by the NCTN that require specialized quality assurance or imaging data management and/or assessment for radiotherapy and imaging interventions. In addition, the Center also provides similar services for other approved NCI-supported clinical trials network programs (e.g., NCI/DCTD early phase clinical trial network program, NCI Division of Cancer Prevention (NCI/DCP) NCI Community Oncology Research Program).
  • Canadian Collaborating Clinical Trials Network: This Canadian organization is a non-profit clinical trials organization capable of being a full partner with the U.S. Network in the conduct of large-scale, multi-site clinical trials. Incorporation of a Canadian Clinical Trials Network as a collaborating partner brings an additional advantage as U.S. Network Groups are anticipated to have Canadian member sites. A Canadian network is able to help reduce duplicative regulatory staff at each U.S. Network Operations Center.

Interactions with Other NCI-supported Programs. In addition to the six key components of the NCTN that are described above that are directly funded by the NCTN Program, other NCI grant and contract-supported Programs and their awardees as well as NCI Advisory Committees have important supporting roles in carrying out the research objectives of the NCTN Program. Thus the NCTN awardees are expected to interact as appropriate with such entities/programs as the NCI Clinical Trials Tumor Banks, the NCI Community Oncology Research Program (NCORP) and Minority/Underserved NCORPs, the NCI Cancer Trials Support Unit, the pediatric and adult NCI Central Institutional Review Boards, and NCI Advisory and Scientific Committees, including the NCI Scientific Steering Committees.

Main Research Objectives and Requirements of this FOA

The Network Group Radiotherapy and Imaging Core Services Center application must include the following 3 functional components:

  • Radiotherapy Core Services Program - This functional component should provide specific services for NCTN trials involving radiotherapy (RT) interventions, including policies and procedures for various types of RT quality assurance and credentialing.
  • Imaging Core Services Program - This functional component should provide specific services for NCTN trials involving imaging interventions/assessments, including policies and procedures for various types of imaging quality assurance and credentialing.
  • Program for Collaborations, Participation in Collective Network Management, and Support for Other NCI-Supported Clinical Trials Networks - This functional component should provide support for key collaborations with the Network Group Operations Centers and associated Statistics and Data Management Centers, especially with respect to development of standards and harmonization of processes and data collection for NCTN trials involving radiotherapy and imaging and participation in the collective management of the NCTN Program. This component should also provide support for other NCI-supported clinical trials network programs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NCI intends to commit $8 million in FY 2019 to fund one award.

Award Budget

The requested budget must not exceed $7,400,000 in direct costs per year.

Award Project Period

The total project period requested may not exceed 6 years. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

[Only the current Network Radiotherapy and Imaging Core Services Center awardees, supported under RFA-CA-12-014, are eligible to apply.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The named PDs/PIs for applications for NCTN Network Radiotherapy and Imaging Core Services Center cannot be named as PDs/PIs on applications for:

  • NCTN - Network Group Operations Centers (RFA-CA-17-056)
  • NCTN - Network Group Statistical and Data Management Centers (RFA-CA-17-057)
  • NCTN - Canadian Collaborating Clinical Trials Network (RFA-CA-17-058)
  • NCTN - Network Lead Academic Participating Sites (RFA-CA-17-059)

However, an individual who is designated as a PD/PI on the application for the NCTN Radiotherapy and Imaging Core Services Center can, if appropriate, be listed as key personnel on applications for the NCTN Network Lead Academic Participating Sites, but not on applications for the other RFAs listed above.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

Each organization may submit only 1 application in response to this FOA. 

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Meg Mooney, M.D.
National Cancer Institute
Telephone: 240-276-6086
Email: NCINCTNRFA@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the specific term of this FOA.

  • Research Strategy Section is limited to 30 pages.
Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources: In addition to standard aspects, provide a detailed description of the special facilities and equipment used for radiotherapy and imaging services.

Other Attachments: Applicants must provide the following additional materials specified below in support of their application. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Attachment 1. Summary of NCTN Clinical Trials Using RT Core Services (use filename RTCore).

In this attachment, provide documentation of RT Core services previously and currently being provided on NCTN clinical trials.  Two tables should be provided detailing the NCTN clinical trials for which the applicant has provided RT Core Services - one table for all active trials that are still open to accrual (or only temporarily closed to accrual) for which the applicant is providing RT Core Services and one table for all trials closed to accrual for which the applicant is currently providing RT Core Services.  The column headings for each table should include trial phase, major disease category (e.g., "breast cancer"), NCTN Group leading the trial, trial #, trial name, trial status (e.g., active, temporarily closed to accrual), # patients accrued to date on the trial, and a brief description of type of service (e.g., "RT Quality Assurance").  The table should be sorted in the order listed: by trial phase and then by major disease category, Lead NCTN Group, and trial #.  The timeframe for the period of services should be provided as a sub-heading for each table (e.g., March 1, 2014 through August 31, 2017).

Attachment 2. Summary of NCTN Clinical Trials Using Imaging Core Services (use filename ImagingCore). In this attachment, provide documentation of Imaging Core services previously and currently being provided on NCTN clinical trials. Two tables should be provided detailing the NCTN clinical trials for which the applicant has provided Imaging Core Services - one table for all active trials that are still open to accrual (or only temporarily closed to accrual) for which the applicant is providing Imaging Core Services and one table for all trials closed to accrual for which the applicant is currently providing Imaging Core Services. The column headings for each table should include trial phase, major disease category (e.g., "breast cancer"), NCTN Group leading the trial, trial #, trial name, trial status (e.g., active, temporarily closed to accrual), # patients accrued to date on the trial, and a brief description of type of service (e.g., "RT Quality Assurance").  The table should be sorted in the order listed: by trial phase and then by major disease category, Lead NCTN Group, and trial #. The timeframe for the period of services should be provided as a sub-heading for each table (e.g., March 1, 2014 through August 31, 2017).

Attachment 3. Summary of Other Clinical Trials Using RT Core Services and/or Imaging Core Services (use filename OtherTrialsCore). In this attachment, provide documentation of RT Core Services and/or Imaging Core services previously and currently being provided on clinical trials from other approved NCI-supported clinical trials network programs (e.g., NCI/DCP NCI Community Oncology Research Program, NCI/DCTD early phase clinical trials network program) if such services were provided under this grant in the previous project period. This information can be provided in a table similar to the ones described above for NCTN trials or in narrative form.

Attachment 4. Key Standard Operating Procedures for RT and Imaging Quality Assurance, Imaging Data Management, and Credentialing (use filename QASOPs). In this attachment, provide updated key standard operating procedures (SOPs) for RT and Imaging Quality Assurance as well as the key SOPs for Image Management and Credentialing for both areas.

Attachment 5. Security and Confidentiality (use filename Security). In this attachment, provide documentation as to how the Center will ensure security and confidentiality of patient data.

Attachment 6. Conflict of Interest (use filename COIPolicy). In this attachment, provide documentation on the Conflict of Interest Policy for the Center to ensure that there is no reasonable expectation that any investigator or staff member at the Center involved in the design, conduct, or reporting of research conducted by the Network Group Operations Centers and their associated Network Group Statistical and Data Management Centers will be biased by any conflict of interest (using the definition of investigator provided in the NIH grants policy).

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. The following additional instructions apply for this FOA.

a) Budget Breakdown. The application for this FOA consists of a single budget with the major budget categories (i.e., Personnel, Supplies, Travel, Other Expenses) showing the amounts for the entire application; however, a budget breakdown (general total amounts - not formal separate budgets) should be provided for the three main cores/activities of this application, including coordination activities, as this award will be made with restricted general budget allocations for each of these core activities.

         (1) RT Core Services for NCTN Clinical Trials;

         (2) Imaging Core Services for NCTN Clinical Trials; and

         (3) RT and Imaging Core Services for Other NCI-supported Clinical Trials Network Programs (e.g., NCI/DCP NCI Community Oncology Research Program, NCI/DCTD early phase clinical network trial program).

b) PD/PI Effort Commitment. The minimal effort commitment for the Contact PD/PI must be 1.8 person-months per year. The effort commitment for the other PDs/PIs (if multiple) must be a minimum of 1.8 person-months per year. These effort commitments cannot be reduced in later years of the award.

c) Travel Expenses. Applicants must budget travel funds for two persons (two PDs/PIs or one PD/PI and an additional senior investigator) to attend one NCTN Leadership Management Committee in-person meeting per year in additional to other travel expenses.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

Specific Aims: Outline the scope of the core radiotherapy and imaging services to be provided and their relevance/importance to the conduct of NCTN clinical treatment and advanced imaging trials (and oncology trials conducted by other NCI-supported clinical trials network programs).

Research Strategy: Organize the overall Research Strategy section with sub-sections in the specified order and using the instructions provided below. Start each sub-section with the appropriate sub-section heading: Sub-section A. Overview; Sub-section B. Radiotherapy (RT) Core Services Program; Sub-section C. Imaging Core Services; Sub-section D. Collaborations, Participation, in Collective Network Management, and Support for Other NCI-Supported Clinical Trials Network Programs; and Sub-section E. Progress Report.

Sub-section A. Overview

  • Outline the multi-disciplinary scientific and technical expertise provided by the Center staff as a whole for RT and imaging services, including its senior leadership team, and the organizational structure, governance policy, decision-making and prioritization policies for trials with NCTN Group input, and general facilities for the Center. Summarize the main collective strengths of team members in the context of the Center's goals. Explain how the diverse expertise of team members increases the capability for innovation, ability to anticipate new directions, and flexibility to redirect RT and imaging services for research in clinical trials when needed. Describe key accomplishments of the research team.
  • Summarize how RT and Imaging Cores interact with various Network Group Operations Centers and Network Group Statistics and Data Management Centers and how these organizations are represented on the Center's senior leadership team to enhance coordination of services for all NCTN trials starting at design of proposed trials through development and conduct.
  • Describe how the Center complies with NIH, NCI, and other federal regulations regarding study monitoring and clinical research as well as how the Center coordinates with the NCTN Groups to provide data for the NCTN Groups' onsite auditing programs. Describe how the activities of the radiotherapy core will be coordinated with the imaging core, especially with respect to IT services and image management, including development of standards and harmonization of processes and data collection.

Sub-section B. Radiotherapy (RT) Core Services Program

  • Outline the general approaches used and the specific RT services that are provided for NCTN trials, including the types of quality assurance and credentialing provided.
  • Describe how new techniques/types of radiotherapy in clinical research trials are being addressed. Key ongoing plans and accomplishments related to RT services provided for NCTN clinical trials should be highlighted in this section.

Sub-section C. Imaging Core Services Program

  • Outline the general approaches used and the specific Imaging services that are provided by for NCTN trials, including the types of quality assurance, credentialing, and imaging data management provided. In the description, include plans/actions taken for participation in the development of NEMA DICOM-RT standards and in support of trials which merge imaging from different platforms such as FDG PET, CT, MRI, and other platforms.
  • Describe how new areas of imaging research in clinical trial such as radiomics are being addressed. Key ongoing plans and accomplishments related to services provided for NCTN clinical trials should be highlighted in this section.

Sub-section D. Collaborations, Participation in Collective Network Management, and Support for Other NCI Supported Clinical Trials Network Programs

  • The Center should describe how it works with Network Group Operations Centers and associated Statistics and Data Management Centers with respect to development of standards and harmonization of processes and data collection for NCTN trials, including the Center's capacity for interoperability with the common data management system (CDMS) of the NCTN Program to collect clinical trial data and link it to Center data.
  • The Center should describe its ability to work with the NCTN Program tools and services employed for regulatory support and patient enrollment (i.e., the Regulatory Support System (RSS) and the Oncology Patient Enrollment Network (OPEN) for all NCTN clinical trials.
  • The Center should also describe its capacity to provide core services to NCTN trials that have registration/licensing intent and/or result from collaborations between the Network Groups and outside organizations as well as the Center's ability to collaborate with other NCI-supported clinical trials network programs (e.g., NCI/DCP NCI Community Oncology Research Program, NCI/DCTD early phase clinical trials network program).
  • In addition, the Center should describe its plans for participation in the collective management of the overall NCTN Program including participation in appropriate NCTN Program activities and initiatives.

Sub-section E. Progress Report

This Progress Report should cover the period of March 1, 2014, through August 31, 2017 and should include a summary of the most significant achievements of the Radiotherapy and Imaging Core Services Center in terms of providing harmonized services for standards and quality assurance for radiotherapy and advanced imaging techniques for applicable NCTN trials in a timely manner. This Progress Report should summarize how the Center's has provided real-time user support (e.g., "Help Desk") to collect feedback for continual improvement of functionality of the core services for sites participating in applicable NCTN trials. This Progress Report should also highlight the Center's major contributions to the collective management of the NCTN Program and any significant collaborations with other NCTN Groups and other NCI-sponsored programs.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. It is expected that the Center will follow the Resource Sharing Plans of the associated Network Groups' Operations Centers, and so the Center should submit a Resource Sharing Plan in its application that indicates that it understands and is bound by the NCTN Group Data Sharing Plans, including plans that link Center data from trials to genomic data (i.e., NCTN Group NIH/NCI Genomic Data Sharing Plans).

The Data Sharing Plan and other resource plans (or rationale for not providing sharing certain resources) should be provided in the research application; however, prior to funding of an award, all resource sharing plans will also need to be reviewed and approved by NCI/DCTD program staff prior to any award in order to ensure that the plans are in compliance with the NIH/NCI regulations and Terms of Award for this key component of the NCTN Program.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

 
Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

Specific for this FOA: Does the Center provide continued maintenance of robust physical hardware and information technology (IT) networks which ensure the operational integrity and security of the core services? Does the Center have procedures in place for data security and safeguards to protect medical/clinical trial information? How well does the Center provide basic interoperability between the radiotherapy and imaging service components as well as with other key components of the NCTN, including electronic exchange of digital planning data and images and web-based software tools to facilitate trial-specific digital data review by study chairs for NCTN trials?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Specific for this FOA: How adequately does the Center demonstrate the capacity for interoperability with the common data management system (CDMS) of the NCTN Program to collect clinical trial data and link information to clinical data collected by other key components of the NCTN Program such as Network Group Operations Centers and associated Network Group Statistics and Data Management Centers? How well does it appear that the Center will be able to work with the NCTN Program tools and services employed for regulatory support and patient enrollment (i.e., the Regulatory Support System (RSS) and the Oncology Patient Enrollment Network (OPEN) for all NCTN clinical trials?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

 With respect to RT services: 

  • How adequately does the plan for providing support services for radiotherapy in clinical trials address the key functional needs such as collection, distribution, analysis, and storage/archiving of all primary and adjunct radiotherapy treatment delivery data for applicable NCTN trials?
  • Does the Center have the appropriate infrastructure to provide appropriate uniform quality assurance (QA) procedures and review for advanced radiotherapy trials, including dosimetry, digital data capture, rapid analysis of volumetric treatment planning data, and physical dose assurance capabilities?
  • Does the Center have the infrastructure and ability to provide appropriate quality assurance support for the following elements associated with multi-institutional clinical trials involving RT: radiation dose delivery by photons, electron and protons for external beam radiotherapy and brachytherapy, use of anthropomorphic phantoms for complex treatment delivery, archiving and remote review of digital data including 3D and 4D images and RT objects?
  • Does the Center provide uniform credentialing of institutions that might participate in applicable NCTN trials including trials which use advanced radiotherapy treatment?

With respect to Imaging services: 

  • Does the Center have adequate and appropriate plans for future participation in the development of NEMA DICOM-RT standards and in the support of trials which merge imaging from different platforms such as FDG PET, CT, MRI, and other platforms? Are potential problems, alternative strategies, and benchmarks for success presented?
  • Does the plan for providing support services for imaging in clinical trials adequately address the key functional needs for an Imaging Core Services Center, including collection, distribution, analysis, and storage/archiving of all primary and adjunct imaging delivery data for applicable NCTN trials?
  • How well does it appear the Center would be able to provide quality assurance for imaging-related activities in applicable NCTN trials, including site and scanner qualification/calibration, review of imaging data for acceptability and protocol compliance as well as central analysis and evaluation of images?
  • How well is the Center able to maintain processes and procedures to allow NCTN Group investigators to conduct remote central imaging reads?
  • Is the Center able to provide expertise to the NCTN Group investigators as to the best approach for a particular trial with respect to "real-time" versus "post-review" of images?
  • How well does it appear the Center can provide reviewers with the required scientific expertise to perform central reads of images on an emergency basis if the image review cannot be done by the assigned NCTN Group investigator?
Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period covering the period of March 1, 2014, through August 31, 2017.

Revisions

Not applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 Not applicable

Applications from Foreign Organizations

Not applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement - an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibilities for:

  • Development of an overall strategy to provide scientific and technical expertise for incorporating integrated quality assurance and image data management for applicable NCTN clinical trials that involve interventions with radiotherapy and/or imaging modalities as well as for similar trials conducted by NCI-supported clinical trials network programs (e.g., NCI/DCTD early phase clinical trials network program, NCI/DCP NCI Community Oncology Research Program).  
  • Implementation of the strategy to support applicable clinical trials with quality assurance, credentialing, and image data management for radiotherapy and imaging interventions.
  • Compliance with Part 1 of the NCI National Clinical Trials Network (NCTN) Program Guidelines/Handbook dated December 15, 2012 (https://ctep.cancer.gov/initiativesPrograms/docs/NCTN_Program_Guidelines.pdf) and any subsequent updated versions of the Guidelines/Handbook.
  • Awardees will comply with NCI/DCTD CRADA agreements and with the Intellectual Property Option to Collaborators (https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm) for NCTN trials and other clinical trials conducted under a NCI/DCTD Investigational New Drug (IND) Application and/or Investigational Device Exemption (IDE).
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

Designated NCI Program Director(s) will have substantial involvement as a Project Scientist(s).

Additionally, an NCI Program Director, acting as Program Official will be responsible for the normal,

scientific and programmatic stewardship of the award and will be named in the award notice. A

Program Official may also have substantial programmatic involvement (as a Project Scientist).

  • Working with the Center awardees to collaboratively manage major issues associated with the coordination of their RT and Imaging services with the Network Groups and helping to coordinate and prioritize services across the Network trials.
  • Informing the PD(s)/PI(s) of the Center of scientific opportunities resulting from NCI-supported clinical research programs and facilitating collaborations among the Center, NCTN, and other NCI-sponsored programs.
  • Facilitating the Center awardees' scientific and technical involvement in radiation oncology and advanced imaging research associated with NCTN trials at an early stage in trial development.
  • Serving as scientific liaisons to the Center awardees and participation in scientific meetings of the Center awardees.
  • Review of compliance with applicable DHHS, FDA, OHRP, NIH, and NCI regulations for clinical research involving human research subjects.
  • Monitoring the progress and performance, including auditing of data if appropriate, of the Center awardees.
  • NCI will have access to all data (including imaging data) collected and/or generated under this Cooperative Agreement and may periodically review the data. NCI may also review all records related to awardees' performance under the award for appropriate collection, review, and distribution of images and data collected in association with NCTN trials.

Areas of Joint Responsibility include:

  • General aspects of collaboration with respect to quality assurance for radiotherapy and imaging in NCTN trials and other trials during trial development and conduct especially with respect to compliance with federal regulations for clinical trial research (and with respect to ensuring that when new avenues of cancer therapy involving investigational approaches are pursued, trials are designed, when appropriate, such that the clinical information obtained, including imaging and radiotherapy data, would be acceptable to the FDA for inclusion in a potential licensing application), development of collaborative trials and international trials, collective management of the NCTN including participating in the NCTN Leadership Management Committee that makes recommendations to NCI for modifications to the Program as well as to standard NCTN common tools and services.
  • Review of recommendations from the NCI Clinical Trials and Translational Research Advisory Committee (CTAC) on strategic directions for the NCTN Program related to RT and imaging services

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened.  It will have three members: a designee of the Steering Committee chosen without NIH staff voting; one NIH designee; and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

For general research programmatic and administrative information, contact:

Meg Mooney, M.D.
National Cancer Institute
Telephone: 240-276-6086
Email: NCINCTNRFA@mail.nih.gov

For inquiries specifically related to radiotherapy services information for this FOA, contact:

Bhadrasain Vikram, M.D.
National Cancer Institute
Telephone: 301-496-6111
Email: vikramb@mail.nih.gov

For inquiries specifically related to imaging services information for this FOA, contact:

Lalitha Shankar, M.D., Ph.D.
National Cancer Institute
Telephone: 301-451-9531
Email: Shankarl@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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