NCI Community Oncology Research Program (NCORP) Academic Community Sites (UG1 Clinical Trials Not Allowed) is sponsored by National Cancer Institute (NCI) / National Institutes of Health (NIH). This funding opportunity from NCI supports academic community sites involved in the NCI Community Oncology Research Program.

RFA-CA-27-008: NCI Community Oncology Research Program (NCORP) Academic Community Sites (UG1 Clinical Trials Not Allowed) 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 NCI Community Oncology Research Program (NCORP) Academic Community Sites (UG1 Clinical Trials Not Allowed) UG1 Clinical Research Cooperative Agreements - Single Project Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity Clinical Research Cooperative Agreements - Single Project Clinical Research Cooperative Agreements - Single Project See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) is one of three NOFOs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to enhance generalizability and dissemination of clinical trial and other human subject research study results through accrual in a variety of community settings.

The purpose of NCORP is to engage cancer patient populations, those at risk of cancer, and organizations in rigorous studies focused on cancer control, prevention, treatment and care delivery.

NCORP is a community-based research network that: Designs and conducts clinical trials and other human subject studies for adults and children in cancer control, prevention, screening, and care delivery, as well as quality-of-life studies embedded within treatment trials; Enhances patient and provider access to treatment and imaging trials conducted under the National Clinical Trials Network (NCTN); NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below: NCORP Research Bases (UG1 Clinical Trials Required); NCORP Community Sites (UG1 Clinical Trials Not Allowed); and NCORP Academic Community Sites (UG1 Clinical Trials Not Allowed)(covered by this NOFO) NCORP Academic Community Sites are a consortium led by an academic center with a network of community hospitals and/or oncology practices, public hospitals, and/ or other healthcare centers that serve a patient population that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research.

The academic medical center should have a robust infrastructure to support the accrual of participants across their affiliate organizations. Funding Opportunity Goal(s) To identify cancer risks and risk reduction strategies, to identify factors that cause cancer in humans, and to discover and develop mechanisms for cancer prevention and preventive interventions in humans.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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. Use the NIH ASSIST system to prepare, submit and track your application online. 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. Use Grants.

gov Workspace to prepare and submit your application and eRA Commons to track your application. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of 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. Notice of Funding Opportunity Description This Notice of Funding Opportunity (NOFO) is one of three NOFOs for the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). NCORP is designed to enhance generalizability and dissemination of clinical trial and other human research study results through accrual in a variety of community settings.

The purpose of NCORP is to engage cancer patient populations, those at risk of cancer, and organizations in rigorous studies focused on cancer control, prevention, treatment and care delivery.

NCORP will support the following components that will be individually awarded through the respective Request for Applications (RFAs) indicated below: RFA-CA-27-006: NCORP Research Bases (UG1 Clinical Trials Required); RFA-CA-27-007: NCORP Community Sites (UG1 Clinical Trials Not Allowed); and RFA-CA-27-008 (This NOFO): NCORP Academic Community Sites (UG1 Clinical Trials Not Allowed) NCORP Academic Community Sites are a consortium led by an academic center with a network of community hospitals and/or oncology practices, public hospitals, and/ or other healthcare centers that serve a patient population that can enhance the representativeness of participants accrued to cancer control, prevention, treatment and care delivery clinical trials and other human subjects research.

The academic medical center should have a robust infrastructure to support the accrual of participants across their affiliate organizations.

NCORP Research Bases will serve as the program's research hubs and are expected to: Provide an established organizational structure, with scientific and statistical leadership for developing, implementing, and analyzing multi-institutional cancer control, prevention, and care delivery (CCP&CD) clinical research, as well as quality-of-life studies embedded in treatment and imaging studies.

Assume responsibility for study operations and data management, including efficient protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements; auditing; training; quality assurance; and support to Community Sites and Academic Community Sites.

Be based at institutions with comprehensive cancer clinical research expertise (e.g., cancer foundation, NCI-designated Cancer Center, or healthcare research organization – including NCI's National Clinical Trials Network Group Operations Centers).

NCORP Community Sites are consortia of community hospitals and/or oncology practices, which may or may not be formally affiliated with a healthcare system, that accrues participants to cancer control, prevention, treatment, and care delivery clinical trials and other human subjects research.

Key Definitions for the context of this NOFO: The terms “Clinical Research” and “Clinical Trials” in this NOFO follow the NIH definitions ( https://grants. nih. gov/policy/clinical-trials/glossary-ct.

htm#ClinicalResearch ). The terms “ Human Subject ” and “Human Subjects Research” in this NOFO follow the NIH definitions ( https://grants. nih.

gov/grants/glossary. htm#HumanSubject ) NCI Central Institutional Review Board (Central IRB): is a centralized approach to human subject protection through a process that streamlines local IRB review of selected NCI-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards ( https://www. ncicirb.

org/about-cirb/ ). Community Site Primary Affiliate: In the context of NCORP community-based structure, an "affiliate" refers to a hospital, cancer center, physician practice, or other institution where patients/participants are enrolled on a regular and ongoing basis to the menu of NCI-approved clinical trials and other human subjects research available to the NCORP Community Site or Academic Community Site.

Community Site Sub-Affiliate : In the context of NCORP community-based structure, a "sub-affiliate" refers to a practice or organization that contributes to the overall accrual of a primary affiliate site but is located in a separate geographic location(s), is part of the primary affiliate’s business entity, and is managed by the primary affiliate under the primary Affiliate Site’s Federal Wide Assurance (FWA).

Research Base Member Sites: Members sites affiliated with a given Research Base may include NCORP Community and Academic Community Sites, Main members, affiliates, and Lead Academic Participating sites. Whereas various academic medical centers play a crucial role in cancer clinical research, the majority of cancer care takes place in the community setting.

Academic centers can play a critical role in helping to support enrollment in their network of community sites.

Expanding clinical research beyond the academic environment allows access to a larger and more diverse patient population treated in a variety of healthcare delivery settings, which can accelerate accrual to cancer clinical trials and other human subjects research and increase the generalizability and relevance of study findings.

In addition, research in community settings reflects the complexity of cancer care delivery and engages community oncologists in research to develop care delivery approaches that can be implemented within usual clinical workflow. NCI has supported cancer clinical research within community settings for over three decades.

The participation of community oncologists, clinicians, non-oncology specialists, and primary care physicians in cancer clinical trials has facilitated the introduction of research advances into practices throughout the country. The era of genomics and molecularly-targeted therapy necessitates shifts in the delivery of cancer-related care.

The foundation of NCORP is the conduct of multi-site cancer clinical trials and other human subjects research in primary focus areas of cancer control, prevention and care delivery. In addition, NCORP plays an important role in the National Clinical Trials Network (NCTN), a major NCI-supported infrastructure for cancer clinical trials.

Approximately 30 -35% of the patients enrolled on NCTN clinical trials, including precision medicine studies, are from NCORP sites.

The Academic Community Sites, in particular, allow academic centers with strong research in cancer control, prevention, and cancer care delivery to link physicians caring for large numbers of patients to the NCI clinical trials network and provide support to their affiliate community sites to accrue a representative patient population to clinical trials.

The NCORP Community Sites and Academic Community Sites have responded to many of the challenges associated with implementation of precision medicine by providing quality specimens for genomic sequencing and establishing a multidisciplinary team to support the newer generations of clinical research.

Recent advances in technology are providing new opportunities to characterize premalignancies in ways that will enhance the development of cancer prevention interventions, and biomarkers of response to those interventions, and biomarkers of risk.

NCORP’s diversity in patient age, race/ethnicity, and geographic location as well as partnerships with non-oncology practices provides a natural laboratory for the development of strategies for precision prevention to improve efficiency and to balance the risks and benefits of interventions.

Community organizations have proven to be well positioned to promote science of symptom management, cancer prevention, and surveillance and increase the representativeness of clinical research.

NCORP has streamlined its scientific and operational processes and expanded its review structure with three NCI Coordinating Center for Clinical Trials (CCCT) dedicated scientific Steering Committees, (Symptom Management & Quality of Life, Cancer Care Delivery, and Cancer Prevention) that provide peer-review for scientific concepts.

Access to the Clinical Trials Support Unit (CTSU) allows sites access to all current study materials and the Central Investigational Review Board (CIRB) provides human subject review, all of which increase efficiency and reduce redundancy. The infrastructure supports all areas of science and study designs including observational, interventional, and mixed methods.

Overall Goals of NCORP and Scope of this NOFO The overall goal of NCORP is to bring cancer clinical research studies to individuals in their own communities, thereby generating a broadly applicable evidence base that contributes to improved patient outcomes. The role of NCORP Research Bases is to serve as a main research infrastructure for NCORP Community Sites and Academic Community Sites.

Through affiliations with one or more NCORP Research Bases the Sites gain access to this infrastructure as well as provide valuable community perspective and input on the relevance and feasibility of the trial menu. The roles of NCORP Community Sites and Academic Community Sites are to provide access to clinical trials close to where patients live in the community.

To address the NCORP goals, NCORP Academic Community Sites will be expected to contribute to and focus on the following activities: Participate as part of an integrated national network of community organizations to increase the involvement of community oncologists and other medical specialists, and their patients, in multi-institutional cancer control, prevention, and care delivery research, as well as quality-of-life studies embedded within treatment and imaging studies conducted under the NCORP and NCTN.

Interact with the NCORP Research Bases by: 1) providing insight into clinical significance during concept development; 2) identifying care challenges in their local populations that could be studied; 3) providing input on feasibility during protocol development; and 4) serving as community champions for trials.

Meeting or exceeding the required annual 70 new unique patient/participant accruals evenly distributed between cancer control, prevention, and screening/post-treatment surveillance trials, and treatment and imaging trials, respectively. Pediatric NCORP Sites must meet or exceed 50 new unique patient/participant accruals evenly distributed between cancer control and treatment trials.

If accrual exceeds 200 unique patient accruals per year, the site will be considered high performance and must continue to meet this performance metric to continue reimbursement at the higher rate. Assessment of high performance status will occur every 2 years.

For those who propose cancer care delivery participation, sites must meet or exceed a required annual minimum of enrolling individual participants or organizations to cancer care delivery protocols. These minima are defined as follows: Adult and combined adult/pediatric NCORP Sites will be required to have three care delivery protocols actively enrolling per year.

Pediatric NCORP Sites will be required to have one care delivery protocol actively enrolling per year. Meeting or exceeding a required minimum of one Primary Affiliate participating in each capacity assessment as offered. Sites with adult and pediatric affiliates are required to have a minimum of one adult and one pediatric affiliate participating.

Participating in bio-specimen collection for biobanks that serve as a scientific resource for NCORP Research Bases. Participating in NCORP initiatives to document screening efforts including participation in DCP-001 for clinical trial enrollment. Pediatric sites are expected to participate in screening efforts through the Children's Oncology Group.

Engaging with their community on the importance and impact of clinical trials. Scope of Activities for NCORP Academic Community Sites The scope of research activities for the proposed NCORP Academic Community Sites should encompass three major areas delineated below. Area 1 : Cancer Control Research; and Area 2 : Cancer Prevention Research; and Area 3 : Cancer Care Delivery Research (optional).

Cancer control research is aimed at reducing the morbidities associated with cancer and its treatment, as well as improving the quality of life of individuals undergoing cancer treatment or with a history of cancer. Cancer prevention research is aimed at reducing cancer risk, incidence and mortality.

Cancer care delivery research seeks to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery. Academic Community Sites must be capable of participation and accrual to NCTN treatment trials.

NCORP Trans-network Interactions All NCORP participants will be expected to work jointly towards the overall NCORP goals by using the following general strategies: Development and maintenance of a governance and organizational structure to coordinate NCORP activities at the Academic Community Site.

The organizational structure of the Academic Community Site should be established with clear and appropriate staff roles and reporting responsibilities. Development of a plan and process for prioritizing the NCORP and NCTN trials to be activated at their institutions and assessing if the study can be successful at the Affiliate community sites.

Development of procedures for high-quality, timely protocol data submission that are clearly communicated to all investigators at the Academic Community Site. Support other research activities as a research base member site contributing to industry support or foundation supported studies. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Cooperative Agreement: A financial assistance 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 NOFO.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Applications may propose activities involving human subjects that are not deemed clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The National Cancer Institute intends to commit $73 million in FY 2027 for up to 50 awards across the Community and Academic Community Sites.

Application budgets are not limited but need to reflect the actual needs of the proposed project and should be based on a projected annual accrual plus necessary infrastructure costs to support accrual at the proposed Affiliate sites. All applicants should request a 6-year project period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Additional eligibility provisions : Eligible institution/organization for the purposes of this application is defined as an academic hospital and/or academic clinic program providing direct medical care to patients that is considered one integral organizational entity under a single financial management system and governance structure.

Academic centers for this application are distinguished from large medical centers whose primary mission is patient care. In addition to patient care, academic centers have comprehensive medical training programs and have preclinical laboratories that perform basic research.

Institutions not eligible to apply include : An institution that is an awardee or an affiliate of a NCTN Lead Academic Participating Site funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI. Department of Veterans Affairs hospitals or military treatment facilities are not eligible to apply.

Such institutions may be included in an application as a member(s) of a consortium led by an eligible applicant institution, provided that they are not meant to be the major contributor to patient accrual. Foreign Organizations/Foreign Collaborations Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2. 3.

9. 2 Electronically Submitted Applications for additional information System for Award Management (SAM) – 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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registrations; all registrations must be in place by time of submission. 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 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.

All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

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 their organization to develop an application for 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 How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms.

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

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 NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. 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 instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ).

Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. Facilities & Other Resources : Provide documentation on the characteristics of the scientific environment in which the cancer clinical trials and other human subjects research will be conducted.

Include such aspects as: For the most prevalent populations served in the catchment area, list the populations or cancers that are considered to be high risk or to have significant risk factors within them. Ability to accrue under insured or uninsured patient to clinical trials. The salient features of the facilities and other resources available (committed) for use by the proposed Academic Community Site.

Appropriate space must be available for administrative activities and personnel to serve as primary locus for data management, quality control, patient recruitment and evaluation, and communication. Include what services will be provided to the affiliate sites to support their accrual efforts.

Organizational chart and a list of the primary affiliate(s) and sub-affiliate(s) (as applicable) that will be accruing participants to NCORP and NCTN clinical trials and other human subjects' studies. Definitions of primary affiliate and sub-affiliate can be found under the key definitions section of this NOFO.

A table can be used to list this information for the entity category (primary affiliate or sub-affiliate), name of entity, site identifier (e.g. Cancer Therapy Evaluation Program (CTEP) ID), City and state where the entity is located. A diagram (and/or map) showing the distances between the above entities (including administrative office and shared resources) and location of proposed personnel.

A table documenting the radiation oncology treatment facilities within the applicant’s practice detailing by individual Community primary- and sub-affiliate Sites those with radiation therapy treatment machines on site.

Characteristics of the catchment area from which the primary affiliate(s) and sub-affiliate(s) patients are drawn, including geographic boundaries, referral patterns, and cancer care delivery resources that are not included in the application (i.e., cancer centers, hospitals, clinics, and physicians).

Also include estimates of the population demographics in the area, including percentages by age category (1 to 14, 15 to 39, 40 to 64, and 65+); sex; race/ethnicity; and at least one measure of socioeconomic deprivation (e.g., poverty or insurance coverage levels).

A table documenting an estimate of the incident cancer cases receiving care at the primary affiliate(s) and sub-affiliate(s) in the past 12-month period for which data are available, including percentages by age category (1 to 14, 15 to 39, 40 to 64, and 65+); sex; race/ethnicity; and at least one measure of socioeconomic deprivation (e.g., poverty or insurance coverage levels).

A list of the applicant’s current collaboration(s) and engagement(s) with professional organizations and research organizations to further define relevant cancer care delivery protocols for community settings. Applicants must provide the following additional materials specified below. Each attachment should be uploaded as a separate PDF using the indicated filenames (which will serve as application bookmarks).

Suggested table templates to capture information for Attachments 1-6 are available at: https://ncorp. cancer. gov/resources/applicants.

html . Attachment 1: Accrual Cancer Control, Prevention, and Screening Trials (use filename: Accrual CPS). Provide a summary table on accrual accomplished by the applicant team to NCI-sponsored cancer control, prevention and screening trials.

This information should be provided only for trials that activated on or after August 1, 2020 through July 31, 2025. The summary table should include information about enrollment onto NCI-tissue acquisition studies, if applicable. Please note the number of affiliate sites that activated the trial.

Attachment 2: Accrual Cancer Treatment, QoL, and Imaging Studies (use filename: Accrual CTI) Provide a summary table on accrual accomplished by the applicant team to NCI-sponsored treatment and imaging trials noting the number of QoL accrual where applicable. This information should be provided only for NCTN trials that activated on or after August 1, 2020, through July 31, 2025.

Please note the number of affiliate sites that activated the trial. Attachment 3: Accrual to other Research Base and Industry Studies (use filename: Accrual Other) Provide a summary table on accrual accomplished by the applicant team to Research Base and Industry sponsored studies not sponsored by the NCI for cancer control, prevention, screening/ surveillance, treatment, and imaging trials.

This information should be provided only for trials that activated on or after August 1, 2020, through July 31, 2025. The summary table should include information about enrollment onto biospecimen acquisition studies, if applicable. Attachment 4: Collective Bodies/Committees (use filename: Committee Memberships).

Renewal Applications : Provide a table summarizing the participation of members of the applicant team (over the past 5 years) on research base or NCI clinical trials committees as well as other oversight boards or steering committees related to clinical trials. A table can be used to show the Category (e.g. type of committee, Steering Committee), member status (e.g. chair, vice chair, member),and length of service in the role.

New Applications : Without repeating information in biosketches, list local, state or national roles held by senior/key personnel staff that demonstrate leadership or activities that highlight involvement in the cooperative groups and support of cancer clinical trials. Attachment 5. S ummary of Timelines for Local Activation of NCTN and NCORP Clinical Trials at Affiliate Sites (use filename SummaryActivationTimelines ).

Provide information on the timeline for the initial activation/opening of NCTN and NCORP trials at the affiliate sites. This information should be provided only for trials that activated on or after August 1, 2020, through July 31, 2025.

This information may be provided in a table with column headings for the site name, site category (main academic site or integral component), major disease category, trial phase, trial number and brief title, date the study was activated/opened for patient accrual by the Lead Group,