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NIAID Glossary of Funding and Policy Terms and Acronyms—C

For Institute program-specific acronyms, go to NIAID Profile and Fact Book.

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Term Definition
CAN See Common Accounting Number.
capability statement

For contracts, a statement of an organization's experience, staff, partners, and performance history that may include information on customer needs and how an offeror can satisfy them.

career development award (K)

Grant that supports Ph.D.s and clinicians who wish to develop a career in biomedical research; activity codes are in the K series.

Go to these NIAID resources on the Training and Career Awards portal:

carryover

Ability of grantees to use grant funds from one budget period in the next one without prior approval from NIAID. This applies to grants covered by 45 CFR Part 74, known as expanded authorities.

Go to the definition in 45 CFR Part 74 and these NIAID resources on the Grant Award and Management portal:

Catalog of Federal Domestic Assistance (CFDA)

Database of federal assistance programs with program descriptions and contacts. Each has a program number. Go to CFDA.

categorical budget See detailed budget.
category A, B, and C priority pathogen, NIAID See NIAID category A, B, and C priority pathogen.
CBO See Congressional Budget Office.
CC NIH Warren Grant Magnuson Clinical Center. Go to the NIH Clinical Center.
CCR

Formerly used term. See System for Award Management (SAM).

CDC See Centers for Disease Control and Prevention.
CEL See commercial evaluation license.
Center for Scientific Review (CSR)

NIH organization that conducts initial peer review of investigator-initiated grant applications for all activity codes (grant types) except those reviewed in institutes.

It also receives all NIH grant applications and assigns them to institutes in some cases for peer review and for administration after award. See Scientific Review Program for the application types NIAID reviews.

Also see study section and integrated review group. Go to the Center for Scientific Review.

Go to these resources on NIAID's Peer Review portal:

center See research center grant.
Centers for Disease Control and Prevention (CDC)

HHS agency heading disease prevention and control, environmental health, and health promotion and education. For select agent-related information, see select agent and overlap select agent.

Go to these CDC resources:

Centers for Medicare and Medicaid Services (CMS)

HHS agency heading federal health care programs: Medicare, Medicaid, and Children's Health Insurance Program. Go to CMS.

Central Contractor Registration (CCR) Formerly used term. See System for Award Management (SAM).
certification

For human subjects, see institutional review board certification.

For research animals, see institutional animal care and use committee certification.

certification, IACUC See institutional animal care and use committee certification.
certification, IRB See institutional review board certification.
certificate of confidentiality

Document that protects investigators and institutions from being forced to release information that would identify research participants. Certificates protect against legal demands for information such as court orders and subpoenas.

Go to NIAID's Certificates of Confidentiality SOP and NIH's Certificates of Confidentiality Kiosk.

CFDA See Catalog of Federal Domestic Assistance.
CFR See Code of Federal Regulations.
change in scope

Action taken by a grantee that significantly changes aims, objectives, or purposes of an approved project. See scope and prior approval for grants.

Go to NIAID's What Constitutes a Change in Scope? in the Strategy for NIH Funding.

change order

Written order a contracting officer signs directing a contractor to change a contract. For a legal description, see FAR 43.101.

chartered advisory committee

Advisory committee composed mostly of nonfederal experts. Under the Federal Advisory Committee Act, standing committees must be chartered, i.e., approved by the parent agency and the Government Services Agency, to ensure balanced representation for geographical area, women, and diversity and to satisfy other legal requirements.

Go to these resources:

Checklist Form Page

Form in the PHS 398 Grant Application for paper applications. Go to the PHS 398 Checklist form.

For electronic applications, see PHS 398 Checklist form.

Checklist, PHS 398

See PHS 398 Checklist (for electronic applications).

child

Person under legal age for consenting to research treatments or procedures under the law where the research is conducted. See assent.

NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects requires that children be included in clinical research barring a compelling rationale not to do so.

See human subjects, Targeted/Planned Enrollment Table and Inclusion Enrollment Report Table.

Go to these resources:

circulars, OMB See OMB circulars.
CIT NIH Center for Information Technology. Go to CIT.
clarification

Act by an offeror to clarify aspects or resolve minor errors of a proposal for a contract. Either an offeror or the government may initiate a clarification. Also see discussion.

Go to FAR 15.306.

class I, II, III device

FDA classification of medical devices by potential risks. Go to 21 CFR 812.3 and full 21 CFR 812.

clinical hold

Action FDA uses when it deems a clinical trial cannot be conducted without risk to patients. FDA contacts the sponsor within the 30-day initial review period to stop the clinical trial.

FDA may stop an ongoing study based on a review of newly submitted clinical protocols or safety reports.

clinical investigation

Research that involves an investigational drug or investigational medical device and human subjects.

Go to these resources:

clinical research

Human subjects term indicating research conducted on human subjects or material of human origin that can be personally identified. Policy covers three types of large- and small-scale exploratory and observational studies:
  1. Patient-oriented research.
  2. Epidemiologic and behavioral studies.
  3. Outcomes and health services research.

Go to the NIAID Human Subjects Resources portal.

Clinical Terms of Award

Legal requirements NIAID imposes on a clinical research grant. See terms of grant award.

Go to these NIAID resources on the NIAID Human Subjects Resources portal:

clinical trial

Human subjects term indicating a prospective study of human subjects designed to answer questions about biomedical or behavioral interventions, e.g., investigational drugs or investigational medical devices, or new ways of using known treatments.

Clinical trials determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.

Behavioral human subjects research involving an intervention to modify behavior (e.g., diet) fits this definition of a clinical trial.

Human subjects research to evaluate a laboratory test may be considered a clinical trial if the test would be used to make a medical decision, or the test entails more than minimal risk for subjects.

Clinical trials usually go through four phases:

  • Phase I tests a new intervention in 20 to 80 people for an initial evaluation of safety, e.g., to determine a safe dosage range and identify side effects.
  • Phase II studies an intervention in a larger group of people, usually several hundred, to determine efficacy and further evaluate safety.
  • Phase III studies the efficacy of an intervention in large groups of several hundred to several thousand subjects by comparing it to other standard or experimental interventions, while monitoring adverse events and collecting information that will allow safe use.
  • NIH-defined phase III clinical trial is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.
  • Phase IV study is done after an intervention has been marketed to monitor its effectiveness in the general population and collect information about adverse effects associated with widespread use.

Go to the NIAID Human Subjects Resources portal.

clinical trial agreement

Agreement governing the safety and efficacy of outside collaborators' proprietary biologics or pharmaceutical compounds in clinical research.

Go to NIAID's Technology Transfer and Intellectual Property Office.

clinical trial monitoring

Monitoring of a clinical trial by a person or group of people who are independent of the research.

  1. Clinical site monitoring performs several functions:
    • Ensures the rights, safety and well being of human subjects enrolled in clinical research studies.
    • Verifies the integrity of the data collected.
    • Ensures site compliance with the protocol approved by the institutional review board, other documents, regulatory requirements, International Conference on Harmonization and Good Clinical Practice guidelines, adequacy of staff and facilities, and other items.
  2. Data and safety monitoring, which can take a variety of forms including a data and safety monitoring board, does the following:
    • Periodically reviews interim results of the research with an emphasis on safety and efficacy to determine if a study should be changed or halted.
    • Ensures appropriateness of the research and protection of human subjects.

Go to these resources:

Clinical Trial Planning Award See Investigator-Initiated Clinical Trial Planning and Implementation Award (R34 or U01).
ClinicalTrials.gov Searchable database which provides patients, family members and the public with information about current ongoing clinical research studies. Go to ClinicalTrials.gov.
cloning Generation of an embryo by somatic cell nuclear transfer.
closing date Date a funding opportunity announcement expires in Grants.gov. Differs from receipt date and submission date.
closeout See contract closeout or grant closeout.
CMP See Office of Acquisitions.
CMS See Centers for Medicare and Medicaid Services.
Code of Federal Regulations (CFR)

Compilation of all regulations issued by the agencies of the federal government and presidential executive orders, which are published in the Federal Register.

The CFR is divided into 50 volumes known as titles. Each title is divided into chapters, subchapters, parts, subparts (in some parts), sections, and paragraphs. Titles are revised at least once a year and issued quarterly.

Go to these resources:

code, animals in research See animals in research code.
code, human subjects See human subjects code.
coded private information

Individually identifiable private information, such as a person's name or social security number, that is replaced with a code, e.g., number, letter, or symbol.

Investigators are considered to be conducting human subjects research only if they can identify subjects by linking the information to them directly or through a coding system. See investigators for human subjects research, identifier, and personally identifiable information.

Go to these resources:

cofunding Funding arrangement through which two or more institutes or centers pay for a grant.
commercial evaluation license

License agreement that grants a nonexclusive right to make and use, but not sell, a technology to evaluate its commercial potential for a limited number of months.

Go to NIAID's Technology Transfer and Intellectual Property Office.

commitment base

Funds used for noncompeting awards, typically 70 to 80 percent of the dollars NIAID spends annually for research project grants.

Go to NIAID's Financial Management Plan on the Paylines and Funding portal.

commitment overlap

Overlap of support that occurs when any project-supported personnel have time commitments exceeding 100 percent. See person month.

Go to NIAID's Prepare Your Other Support Submission in the Strategy for NIH Funding.

Common Accounting Number (CAN) Seven-character billing number that appears on a Notice of Award and other NIH accounting documents. A CAN specifies an appropriation and allowance to be charged.
Common Rule

Subpart A of the Code of Federal Regulations covering protection of human subjects. See 45 CFR Part 46.

Go to the definition in Subpart A of 45 CFR 46—Protection of Human Subjects.

Commons, NIH See eRA Commons.
Commons assistant role See assistant role for eRA Commons.
Commons signing official See signing official.
compassionate use See expanded access.
compensation

Tuition remission and other forms of compensation (e.g., salary and fringe benefits) paid as, or in lieu of, wages to students, including fellows and trainees.

Compensation may be paid from a research grant or cooperative agreement that does not support an NRSA training grant. The maximum amount allowed is the zero-level Kirschstein-NRSA stipend—go to PI Salary Cap and Stipends. Also see stipend.

Go to these NIAID resources:

competing application New, renewal, resubmission, or revision grant application that must undergo peer review before NIH may fund it. See application type.
competing continuation See renewal. NIH no longer uses this term.
competition

Procurement strategy soliciting more than one contractor to submit an offer. An agency's contracting and program officers select an offeror following peer review using technical evaluation criteria.

Go to NIAID's Contracts SOPs and Contracts portal.

Competition in Contracting Act Public law increasing the number of government procurements awarded competitively. Go to 41 USC 253.
competitive proposal Procurement that meets the following criteria:

Go to NIAID's Contracts SOPs and Contracts portal.

competitive range

Range of qualified offers for a competitive procurement. A contracting officer determines a competitive range based on the ratings of each proposal against all technical evaluation criteria. The competitive range comprises all the most highly rated proposals.

Go to NIAID's Competitive Range for Contracts SOP.

competitive range discussion

Oral or written communication between the government and an offeror, other than a minor clarification, which enables a contracting officer to determine whether a contract proposal is acceptable or allows an offeror to revise it.

Go to these resources:

competitive segment Period of grant support, usually up to five years, before an applicant must recompete for funds. Term differs from grant project period.
compliance review, grant See grant compliance review.
Computer Retrieval of Information on Scientific Programs (CRISP)

Formerly used term. See Research Portfolio Online Reporting Tool (RePORT).

concept

Earliest planning stage of an initiativerequest for applications, institute-specific program announcement, or solicitation. NIAID program officers develop concepts and present them to NIAID's advisory Council for concept clearance.

Only some concepts approved by the Council are published as initiatives, depending on their priority and the availability of funds.

Go to these NIAID resources:

concept clearance

Generally performed by NIAID's main advisory Council, a mandatory review of each initiativerequest for applications, program announcement, or solicitation.

After hearing presentations from NIAID program officers, Council recommends approval, modification, or deferral of an initiative and advises on the science.

Go to these NIAID resources on the Advisory Council portal:

conference committee

Ad hoc panel, composed of House and Senate conferees, that reconciles differences in legislation passed by both chambers of Congress. See conference report.

Go to NIAID's Funding Opportunity Planning and the Budget Cycle.

conference grant (R13, U13)

NIAID financial support for scientific meetings, conferences, and workshops in areas related to its mission. Activity codes are R13 and U13.

Go to NIAID's Conference Awards SOP.

conference report

Compromise legislation negotiated by a conference committee, which disseminates a conference report to each chamber for its approval or disapproval.

Go to NIAID's Funding Opportunity Planning and the Budget Cycle.

Confidential Disclosure Agreement

Agreement ensuring that government employees do not publicly disclose a company's proprietary information and that a company does not publicly disclose the government's scientific findings before publication or before the government secures patent rights.

Go to NIAID's Technology Transfer and Intellectual Property Office.

confidentiality

Human subjects term for not divulging information disclosed in a relationship of trust without permission, including fulfilling the expectation that it will remain private. See personally identifiable information.

Go to these NIAID resources:

conflict of interest

Financial, career, or other such interest, including interests of family members, that could be advanced by participation on an NIH advisory Council, institutional review board, study section, or other advisory body. See financial conflict of interest.

Go to these resources:

Congressional Budget Office

Legislative Branch office that provides Congress with objective analyses, information, and estimates of the budget and economy that assist the congressional budget process.

CBO presents options and alternatives for Congress to consider but does not make recommendations on policy.

Go to CBO.

Congressional Record

Largely verbatim account of proceedings of the Senate printed each day the Senate is in session. At the back of each issue is the "Daily Digest," which summarizes floor and committee activities.

Go to the Congressional Record.

consent See informed consent and assent.
consortium

See subaward.

constant dollars Budget term for dollar amounts adjusted for inflation derived from buying power in a base year. The BRDPI is used to determine constant dollars from current dollars.
constructive change

During contract performance, a contracting officer or other authorized government official's oral or written act, which has the same effect as a written change order.

consultant

Expert brought into a research project to provide advice, whose participation may be part of a grant's budget.

Go to these NIAID resources in the Strategy for NIH Funding:

Consumer Price Index (CPI) Measurement of changes in prices of a broad range of consumer items. See BRDPI.
contact PI

Principal investigator who serves as liaison with NIH and sends information to the other PIs of a multiple PI award.

Go to these NIAID resources in the Strategy for NIH Funding:

continuing resolution (CR)

Legislation in the form of a joint resolution enacted by Congress when a new fiscal year is about to begin or has begun, providing budget authority for federal agencies and programs to continue operating until regular appropriations are enacted. Also called continuing appropriations.

Go to these NIAID resources:

continuous submission

Policy that allows members of the following groups to submit R01, R21, and R34 applications any time, regardless of standard receipt dates:

Special rules may apply. Go to these resources:

contract award

Award made when a contracting officer signs a contract or notifies a contractor of an award. See contract, R&D.

Go to NIAID's Type of Contract SOP and Contracts portal.

contract closeout

Final actions taken after a contract is completed to certify that all services and deliverables are satisfactory.

Go to NIAID's Closeout SOPs.

Contract Management Program

NIAID no longer uses this name. See Office of Acquisitions.

contract modification Written change order in the contract terms. For a legal description, see FAR 43.101 and NIAID's Contract Modifications SOP.
contract proposal See proposal.
contract, R&D

Award establishing a binding legal procurement relationship between NIAID and a recipient, obligating the latter to furnish a product or service defined in detail by NIAID and binding the Institute to pay for it. See contract award.

Go to NIAID's Contracts portal.

contract requirements

Requirements in addition to performance requirements, including those defined in a statement of work, specifications, standards and related documents, management systems, and contract terms and conditions of award.

contract research organization

Independent contractor to a sponsor who assumes some of the sponsor's obligations for a clinical trial, e.g., protocol design.

Go to definitions in 21 CFR 312.3 and full 21 CFR 312.

contract specialist

Contracting staff who assists a contracting officer in negotiating and administering contracts.

Go to NIAID's Roles SOPs and Contracts portal.

contract type
  • Type 1—New contract.
  • Type 2—Renewal.
  • Type 3—Modification.
  • Type 4—Letter contract.
  • Type 5—Continuation of an incrementally funded contract, typically in one-year increments.
  • Type 6—Task order and subsequent modifications relating to existing ordering agreements.
  • Type 7—Exercise of option.

Go to NIAID's Contracts portal.

contract under a grant

Written agreement between a grantee and a third party to acquire routine goods and services. See subaward.

contracting office

Office in an agency authorized to award contracts. See Office of Acquisitions.

Go to NIAID's Contracts portal.

contracting officer

Government employee with the authority to enter into, administer, and terminate contracts, including a representative of a contracting officer acting within the limits of his or her authority. Also see contracting officer's representative (COR), and Office of Acquisitions.

Go to NIAID's Contracting Officer SOP.

contracting officer's representative (COR)

NIAID staff member who oversees a contract after an award is made. Also see contracting officer.

Go to NIAID's Contracting Officer's Representative (COR) SOP.

contractor-acquired property

Government-titled property acquired or otherwise provided by a contractor for performing a contract.

Go to FAR 45.101.

contributor, other significant

See other significant contributor.

control article

FDA term for a drug, device, biological, human food additive, color additive, electronic product, or other items regulated by FDA used as a basis for comparison with a test article.

Go to the definitions in 21 CFR 58.3 and full 21 CFR 58.

cooperative agreement (U)

Grant in the U series that features substantial scientific involvement by NIAID staff.

Go to Cooperative Agreements, U Series and Cooperative Agreements Staff Portal.

Cooperative Research and Development Agreement (CRADA)

Mechanism for collaboration between government and outside scientists that legally defines intellectual property rights and financial and other responsibilities. See technology transfer.

Go to these resources:

co-PI

NIH does not use this term. Below is related NIH terminology.

  1. For an application or grant with one principal investigator, other participants who contribute substantively to a project are called key personnel.
  2. For a multiple PI application or grant, each principal investigator is a full-fledged PI who has responsibilities appropriate to that role. Applicants must complete all requirements for a multiple PI application, which includes submitting a Multiple PI Leadership Plan.
COR See contracting officer's representative.
core

Resource that provides services or facilities to at least two research projects in a multiproject grant.

Go to NIAID's Guidance for Preparing a Multiproject Research Application.

corrected application

Grant application an applicant fixes after it fails either Grants.gov or eRA Commons validation. Differs from resubmission.

Go to these NIAID resources:

correction window

Formerly used term (since NIH eliminated it). See the related viewing window.

cost analysis

Analysis performed by a contracting officer to determine whether an offeror's proposed costs are fair and reasonable.

For a legal description, see FAR 15.404.

cost estimate Proposed expenditures necessary to accomplish the government's requirements.
cost management plan

See NIH cost management plan.

cost sharing See matching or cost sharing.
cost-plus-fixed-fee contract

Cost-reimbursement contract that provides for a negotiated fee fixed at the inception of a contract. The fee does not vary with actual cost but may be adjusted as a result of changes in the work.

This contract type is appropriate for efforts that might otherwise present too great a risk to contractors, but gives them minimum incentive to control costs.

For a legal description, see FAR 16.301-1.

cost-plus-incentive-fee contract

Cost-reimbursement contract that provides for an initially negotiated fee to be adjusted later by a formula based on the relationship of total allowable costs to total target costs. This increase or decrease gives a contractor an incentive to manage a contract efficiently.

For a legal description, see FAR 16.301-1.

cost-reimbursement contract

Type of contract that provides for payment of allowable incurred costs. These contracts estimate total costs and establish a ceiling a contractor may not exceed except at its own risk without approval of a contracting officer.

For a legal description, see FAR 16.301-1.

cost-sharing contract

Cost-reimbursement contract in which a contractor receives no fee and is reimbursed only for an agreed-upon portion of allowable costs.

For a legal description, see FAR 16.303.

Council subcommittee See NAAIDC subcommittee.
Council, advisory

Chartered NIH institute advisory committee that performs second-level review; makes recommendations on funding, policy, and program direction; helps develop concepts; and provides concept clearance for research initiatives. See National Advisory Allergy and Infectious Diseases Council.

Go to NIAID's Advisory Council portal.

countersigned Signing of a grant-related document by more than one official, e.g., a grantee or training grant director and an institutional business official.

cover letter

 

Letter attached to a grant application or contract proposal that may request an integrated review group, study section, or institute or provide other information such as documentation of NIAID's preapproval to submit.

A cover letter is required for late and corrected applications. For electronic applications, use the PHS 398 Cover Letter form.

Go to these NIAID resources in the Strategy for NIH Funding:

Cover Letter File, PHS 398

See PHS 398 Cover Letter File (for electronic grant applications).

Cover Page Supplement, PHS 398

See PHS 398 Cover Page Supplement (for electronic grant applications).
CR See continuing resolution.
CRADA See cooperative research and development agreement.
criminal offense

NIH term denoting bribery, fraud, conflict of interest, embezzlement, misuse of funds or resources, perjury; and other violations of criminal law by NIH employees, grantees, contractors, or others doing business with NIH.

The term is used for policies for fraud, waste, and abuse in NIH programs.

Go to NIAID's Reporting Fraud, Waste, and Abuse SOP.

CRISP Formerly used term. See Research Portfolio Online Reporting Tool (RePORT).
criterion score

Score that is given by assigned reviewers (e.g., a primary peer reviewer) for each review criterion before an initial peer review meeting and that appears on the summary statement. See critique and overall impact score.

Go to these NIAID resources on the Peer Review portal:

critique

Written evaluation that primary and secondary reviewers (and possibly a reader) prepare before an initial peer review meeting and present to a scientific review group at the meeting.

It recommends an overall impact score (unless not recommended for further consideration) based on scientific merit and addresses the requested budget.

For a renewal, the critique also discusses progress made; for an amended application, it addresses the principal investigator's responses to the critique from the previous review. Also see summary statement.

Go to NIAID's Initial Peer Review in the Strategy for NIH Funding.

CSR See Center for Scientific Review.
Cumulative Inclusion Enrollment Report

Form in a grant application package and PHS 2590 Non-Competing Continuation Progress Report for human subjects research to report participants' sex/gender, race, and ethnicity information. See the Cumulative Inclusion Enrollment Report. Used for progress reports with award dates after October 1, 2014. For progress reports with award dates before October 1, 2014, use the Inclusion Enrollment Report (PHS 2590 forms).

Also see Planned Enrollment Report.

Go to these NIH resources:

Other NIH resources:

NIAID resources:

current dollars

Actual dollars awarded without adjustment for inflation. Also see constant dollars and Biomedical Research and Development Price Index.

current and pending support

Term used by Grants.gov for other support.

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Last Updated July 15, 2014

Last Reviewed April 02, 2012