For additional information about caBIG™, see the caBIG™ webpage.
Seven of the CanCORS sites were supported by NCI grants funded through a cooperative agreement. The VA funded the eighth site.
This initiative concluded in July 2014.
For additional information, visit the CanCORS Website.
Quoted from the NCI Dictionary of Cancer Terms.
For additional information, visit the NCI Office of Cancer Centers webpage and the NCI Grant Activity Codes/Mechanisms webpage.
Quoted from the NCI DCTD RRP Program Collaborations webpage.
Please note: NCI no longer accepts applications for the R25T. The last standard application receipt date for R25T applications was May 25, 2013; see NIH Guide Notice NOT-CA-13-008.
Quoted from the NCI Office of Cancer Genomics webpage.
These population groups may be characterized by race, ethnicity, disability, gender and sexual identity, geographic location, income, education, and other characteristics. Generally, people who are from low socioeconomic backgrounds (poor, lack health insurance, and are medically underserved with limited or no access to effective health care) often bear a greater burden of disease than the general U.S. population.
Quoted from the NCI CRCHD About Cancer Disparities Cancer Health Disparities Definitions.
For current information about nanotechnology research at NCI, visit the Nanodelivery Systems and Devices Branch website.
Quoted from the Postbaccalaureate Intramural Research Training Award (Postbac IRTA/CRTA) webpage.
CTEP-AERS replaces the Adverse Event Expedited Reporting System (AdEERS) and was built using the Cancer Adverse Event Reporting System (caAERS) developed by caBIG®.
For additional information, visit the CTEP-AERS webpage.
Quoted from the NIH OER Glossary & Acronym List.
See also Carryover Unobligated Funds on NCI's website.
Quoted from GAO's "A Glossary of Terms Used in the Federal Budget Process".
Quoted from the NCI Thesaurus.
Quoted from GAO's "Glossary of Terms Used in the Federal Budget Process".
For additional information, see NCI Grant Activity Codes/Mechanisms.
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs."
The Center for Strategic Scientific Initiatives (CSSI) is an operating entity of the Office of the Director (OD), National Cancer Institute (NCI). The beginning of CSSI dates back to the late 1990s with the creation of the Unconventional Innovation Program (UIP), trans-divisional Integrated Molecular Analysis Technologies program (IMAT), and Cancer Genome Anatomy Program (CGAP). Building upon the success of these initial programs, the concept of an innovation center for NCI began to develop in 2002 to not only capitalize on advances in areas such as genomics and nanotechnology but also to ensure that state-of-the-art foundational resources are broadly available to all cancer researchers. Established in 2004, CSSI serves as a strategic focus for innovative programs that range from exploratory pilot programs to the development of national resources that serve the overall cancer research community. In aggregate, these efforts are designed to accelerate progress toward future of individualized cancer medicine.
Quoted from the NIH OER Glossary & Acronym List
CMS covers 100 million people through Medicare, Medicaid, the Children's Health Insurance Program, and the Health Insurance Marketplace. But coverage isn't our only goal. To achieve a high quality health care system, we also aim for better care at lower costs and improved health.
This second iteration of the CECCR initiative remains the centerpiece of NCI's's Extraordinary Opportunity in Cancer Communication, a broad initiative that supported research and outreach aimed at increasing the knowledge about, tools for, access to, and use of cancer communications by the public, patients, survivors, and health professionals.
Quoted from the NIH OER Glossary & Acronym List.
CIRB enables an investigator to enroll patients into NCI-sponsored clinical trials significantly faster than when employing the traditional method of IRB review.
The CIRB Initiative is sponsored by NCI in consultation with the Department of Health and Human Services Office for Human Research Protections (OHRP).
For additional information, visit the NCI Central Institutional Review Board Initiative webpage.
Quoted from the NIH Certificates of Confidentiality Kiosk webpage.
For a more thorough overview of Chair responsibilities, please visit the NIH OER Chair Orientation webpage.
For additional information, visit the NIH OER Attendees Roles and the NIH OER Know Assignment Role webpages.
Quoted from NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
For additional information, see §8.1.2.7 of the NIH Grants Policy Statement
Quoted from §2.101 of the Federal Acquisition Regulation.
Also see Subpart 43.2 of the Federal Acquisition Regulation.
Excerpted from 5 USC App §9.(c).
Quoted from the NIH OER Glossary & Acronym List.
For information about NIH Advisory Committees, see the NIH Office of Federal Advisory Committee Policy (OFACP) website.
DHHS Regulations (45 CFR part 46, Subpart D, Sec.401-409) provide additional protections for children involved as subjects in research, based on this definition: "Children are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted." Generally, state laws define what constitutes a 'child.' Consequently, the age at which a child's own consent is required and sufficient to participate in research will vary according to state law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from 45 CFR 46.402.
For additional information, visit the OMB Circulars webpage.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the §4.1.2 of the NIH Grants Policy Manual.
Quoted from §15.306 of the Federal Acquisition Regulation.
Quoted from the NCI Dictionary of Cancer Terms.
Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NCI Thesaurus.
Quoted from the NCI Thesaurus.
See Common Rule definition of "research" at 45 CFR 46.102(d).
See Common Rule definition of "human subject" at 45 CFR 46.102(f).
The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.
An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and, treatment, prevention, and diagnostic strategies.
A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life.
Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases:
Phase I. Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
Phase II. Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the interventions to be used safely.
Phase IV. Studies conducted after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
Quoted from the NIH OER Glossary & Acronym List.
For additional information, visit these websites:
● NCI's Conducting Clinical Trials
● NIH's Clinical Trial Requirements for Grants and Contracts.
Quoted from the NCI Dictionary of Cancer Terms.
Quoted from the NCI Thesaurus.
For additional information, visit the CTMB.
Quoted from NIH Research Involving Human Subjects Clinical Trials webpage.
NCI expects Clinical Trials Reporting Program (CTRP) registration for all NCI-supported interventional clinical trials open to accrual as of January 1, 2009.
Per NCI CTRP and ClinicalTrials.gov, NCI cannot submit data to ClinicalTrials.gov on behalf of NCI awardees.
Excerpted from the ClinicalTrials.gov Background webpage.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the HHS ACF Common Ethics Concerns webpage.
Research that involves only coded private information/data or coded human biological specimens may not constitute human subjects research under the HHS human subjects regulations (45 CFR 46) if:
(See the following guidance from the Office for Human Research Protections (OHRP) for additional information and examples: https://www.hhs.gov/ohrp/policy/cdebiol.html.)
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NCI Thesaurus.
Visit the NCI Technology Transfer Center website for further information.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
For additional information see the NIH Commercialization Accelerator Program (CAP) webpage.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from NIH Guide Notice NOT-OD-03-029.
Quoted from the NCI DEA Annual Report 2015 – "The RAS Initiative".
I/C CMO: Each IC has a CMO or uses the resources of a service center to support the committee management function within the Institute or Center. The IC CMO is responsible for developing charters for committees, preparing nomination and appointment documents for membership to committees, providing technical assistance to committee members, providing initial review of conflict of interest disclosures and other responsibilities.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OAMP Acquisition Process Mapping Glossary.
Quoted from §300-3.1 of the Federal Travel Regulation.
Quoted from the NCI Thesaurus.
The HHS regulations, 45 CFR part 46, include five subparts:
Quoted from the HHS Office for Human Research Protections website.
Quoted from the NCI Thesaurus.
The CTC/CTCAE Dictionary and Index is a web-base application to assist in locating appropriate adverse event terms.
For additional information on Health Communication Strategies, see the following NCI publications: "Making DataTalk: A Workbook" and "Making Health Communication Programs Work (Pink Book)".
For additional informantion, visit the Community Networks Program Centers (CNPC) webpage.
Quoted from the NIH AIDSinfo Glossary.
Quoted from the NCI Dictionary of Cancer Terms.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the Summary of the Congressional Research Service's Competition in Federal Contracting: An Overview of the Legal Requirements.
Quoted from the NIH OAMP Acquisition Process Mapping Glossary.
Quoted from NIH Policy Manual Chapter 6315-1.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
For example, a specific multi-project application includes one Administrative Core, two Core and three Project components. In this example, the application includes 6 components using three different component types (Administrative Core, Core, Project).
'Overall' is a special component type, used by the applicant organization, with a single occurrence in every multi-project grant application. The Overall component typically contains information about the application as a whole and how the various other components fit together.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NCI Dictionary of Cancer Terms.
Quoted from the NCI Dictionary of Cancer Terms.
Quoted from the NIH OER Glossary & Acronym List.
Contracts: NIH Scientific Peer Review regulations require that ICs obtain peer review of each R&D contract project concept before issuing a Request for Proposals for biomedical and behavioral research (42 CFR 52h.10). The concept identifies the basic purpose, scope and objectives of the project. (§E.1.a. of NIH Policy Manual Chapter 6315-1)
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
For additional information, visit the Managing Conflict of Interest in NIH Peer Review of Grants and Contracts webpage.
Quoted from the 2016 HHS Open Government Plan Section 3.10 "Congressional Requests" webpage.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from §2.101 of the Federal Acquisition Regulation.
Continental United States (CONUS)–The 48 contiguous States and the District of Columbia.(§300–3.1 of the Federal Travel Regulation)
Quoted from the GAO's "A Glossary of Terms Used in the Federal Budget Process".
The CURE-funded training opportunities are designed to:
For additional information, visit the NCI CRCHD's Continuing Umbrella of Research Experiences website.
Quoted from §2.101 of the Federal Acquisition Regulation.
A legal instrument by which a non-Federal entity purchases property or services needed to carry out the project or program under a Federal award. The term as used in this part does not include a legal instrument, even if the non-Federal entity considers it a contract, when the substance of the transaction meets the definition of a Federal award or subaward
Quoted from 45 CFR §75.2.
Quoted from the NIH OAMP Acquisition Process Mapping Glossary.
Quoted from jobs@NIH.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the §2.101 of the Federal Acquisition Regulation.
Quoted from the §302.101(b) of the HHS Acquisition Regulation (HHSAR).
Quoted from 45 CFR §75.2.
Quoted from: §45.101 of the Federal Acquisition Regulation.
Quoted from the NCI Dictionary of Cancer Terms.
Quoted from 45 CFR §75.2.
For additional information, visit the NCI Grant Activity Codes/Mechanisms webpage.
Quoted from the NIH OER Glossary & Acronym List.
Visit the NIH Office of Technology Transfer's Cooperative Research and Development Agreements (CRADAs) webpage for additional information.
Excerpted from the NIH OER Funding FAQs - Core Facilities webpage.
Quoted from §15.404-1(c)of the Federal Acquisition Regulation.
Quoted from the GAO Cost Estimating and Assessment Guide.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the §16.3 of the Federal Acquisition Regulation.
Most Research and Development (R&D) contracts are cost-reimbursement
Quoted from §16.306 of the Federal Acquisition Regulation.
Quoted from §16.303 of the Federal Acquisition Regulation.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.
The Advisory Council/Board for the National Cancer Institute is the National Cancer Advisory Board.
For additional information about NIH Advisory Committees, visit the NIH Office of Federal Advisory Committee Policy (OFACP) website.
Quoted from the NIH OER Glossary & Acronym List.
Refer to G.200 - SF 424 (R&R) Form Cover Letter Attachment Instructions to find out who must complete the "Cover Letter Attachment" and the information it should contain.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NCI Dictionary of Cancer Terms.
Quoted from the NCI Thesaurus.
Quoted from the NCI Dictionary of Cancer Terms.
For more details about completing these forms, please see the Supplemental Instruction Guide.
Quoted from the NIH OER Glossary & Acronym List.
Quoted from the NIH OER Glossary & Acronym List.