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NCI Glossary of Terms

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C

Cancer Center Support Grants (P30): Center grant to support shared resources, clinical translational research infrastructure and administrative needs for a group of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort. The NCI Cancer Center Support Grants support research programs in more than 60 institutions across the United States.

Career Development Awards: Award that supports Ph.D.s and clinicians who wish to develop or enhance a career in biomedical research; activity codes are in the K series.

Carryover: As indicated by the Notice of Award (NoA), carryover authority provides grantees permission to carry over funds unobligated at the end of a budget period to the next budget period.

Catchment Area: The geographical area served by a medical facility and from which the majority of its patients are drawn.

CCR: See Central Contractor Registration Database.

CCSG: See Cancer Center Support Grants.

Center Grants: Financial assistance awards to institutions on behalf of research leaders and groups of collaborating investigators. Center grants provide support for long-term, multidisciplinary programs of research and development.

Center for Scientific Review (CSR): The NIH component responsible for the receipt and referral of applications to the PHS, as well as the initial review for scientific merit of most applications submitted to the NIH.

Central Contractor Registration database: Primary database for organizations and persons who do business with the federal government. Grant-applicant institutions need to register with the CCR (http://www.ccr.gov/)to apply for a grant through http://Grants.gov.

Chartered Advisory Committee: Any committee formed for advisory purposes composed not wholly of Federal officials. Under the Federal Advisory Committee Act, standing committees must be chartered (i.e., approved by their parent agency in collaboration with the Government Services Agency) to ensure a properly balanced representation (in terms of geography, gender, and minority) and that other legal requirements are met.

Child: For NIH purposes, a child is a person under 21 years of age. This policy and definition do not affect the human subject protection regulations for research on children (45 CFR 46), and their provisions for assent. This definition pertains notwithstanding the FDA definition of a child as a person from infancy to 16 years of age, or varying definitions employed by some States. Children included in this policy (persons under the age of 21) may differ in the age at which their own consent is required and is sufficient to participate in research under State law.

Clinical Research: The NIH definition is based on the 1997 Report of the NIH Directors Panel on Clinical Research that defines clinical research in three parts: (1) Patient-oriented research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that use human tissues that cannot be linked to a living person. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes and health services research. Autopsy material is not covered by the policy.

Clinical Trial: For review of applications submitted to the NIH, a clinical trial is defined as a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Clinical trials of experimental drug, treatment, device, or behavioral intervention may proceed through four phases: Phase I, Phase II, Phase III, and Phase IV. [See separate definitions below.]

Close Out: A procedure to officially conclude a grant.

CO: See Contracting Officer/Contract Specialist.

Co-funding: Funding arrangement through which two or more Institutes or Centers pay for a grant.

Commercialization: The third phase of the NCI’s Small Business Innovation Research contracting process is commercialization. In this phase, small businesses aim to advance the results of research and development performed in Phase I and II contracts into commercially viable products or services for Government use.

Commons: See Electronic Research Administration.

Competing Applications: Applications that are either new or renewal. They must undergo initial peer review.

Competing Continuation (Application): An application that requires competitive peer review and Institute/Center action to continue beyond the current competitive segment. Also known as a renewal or type 2 application.

Competitive Range: A contracting term denoting a group of proposals considered acceptable by the initial peer review group and to be potential candidates for an award.

Competitive Revision: Grants.gov term for money added to a grant to expand its scope or meet needs of a research protocol. Applicants must apply and undergo peer review.

Computer Retrieval of Information on Scientific Projects (CRISP): A searchable biomedical database of federally-supported proposed research conducted at universities, hospitals, and other research institutions. Go to" http://crisp.cit.nih.gov/.

Concept: The earliest planning stage of an initiative [request for applications (RFA), request for proposals (RFP), or program announcement (PA)]. Concepts for RFAs and RFPs are brought before the Advisory Council for concept clearance.

Concern: In the context of research involving human subjects and/or vertebrate animals, a concern is an issue so critical that it must be resolved before funds can be awarded.

Conflict of Interest: Regulations exist to ensure that Government employees, Scientific Review Group members, Council members, or others having the ability to influence funding decisions have no personal interest in the outcome.

Consortium Agreement: A collaborative arrangement in support of a research project in which some portion of the programmatic activity is carried out through a formalized agreement between the grantee and one or more other organizations that are separate legal entities administratively independent of the grantee.

Consultant: A Federal or non-Federal employee who is retained, designated, or appointed to an individual review group or serves as an ad hoc reviewer.

Consumer Advocate: A person chosen to serve on a Scientific Review Group (IRG) or Special Emphasis Panel (SEP) as a public member. This person is allowed to serve based on his/her experience and knowledge of a disease, health status, or public health problem.

Contract (R&D): An award instrument establishing a binding legal procurement relationship between NIH and a recipient, obligating the latter to furnish a product or service defined in detail by NIH and binding the Institute(s) involved to pay for it.

Contracting Officer (CO)/Contract Specialist (CS): The CO and/or CS serve as resources on contract regulations, policies, and procedures during the Technical Evaluation Panel (TEP) meetings in which contract proposals undergo peer review.

Cooperative Agreement: A financial assistance mechanism (U series) used when substantial Federal programmatic involvement with the recipient during performance is anticipated by the NIH Institute or Center.

Core: A separately budgeted component of a multi-component application that provides essential facilities or services to proposed research projects.

Core Director: The investigator responsible for the scientific direction and conduct of a core component of a multi-component application.

Council/Board, Advisory: National Advisory Council or Board, mandated by statute, that provides the second level of review for grant applications for each Institute/Center that awards grants. The Councils/Boards are composed of scientific and lay representatives. Council/Board recommendations are based on scientific merit (as judged by the Initial Review Groups) and the relevance of the proposed study to an Institute’s programs and priorities. With some exceptions, grants cannot be awarded without recommendations for approval by a Council/Board.

Council Round: At the NCI, there are three NCAB rounds each February, June, and September for second level review of grant applications. In addition, there is an NCAB meeting in December for intramural reviews.

Cover Letter: Letter attached to a grant application that may request a scientific review group or institute or provide other information (e.g., list of individuals in conflict, disciplines involved). For late applications, include an explanation of the delay as part of the cover letter attachment. A cover letter is required for late applications. Use the PHS 398 Cover Letter File for SF424 applications. The cover letter is for internal use only and will not be shared with peer reviewers.

Critique: A written evaluation is prepared by a reviewer before an initial peer review meeting and presented to a Scientific Review Group at the meeting.

CS: See Contracting Officer/Contract Specialist.

CSR: See Center for Scientific Review.

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