NIAID Glossary of Funding and Policy Terms and Acronyms: C-D

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

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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. Go to NIAID's R&D Contracts.

Award that supports Ph.D.s and clinicians who wish to develop a career in biomedical research; activity codes are in the K series. For descriptions, go to NIAID's Career Development Grants SOP, Career Development Grants questions and answers, Career Development Awards tutorial page, Extramural Activity Codes, and Training and Career Awards.

NIH organization that conducts initial peer review of investigator-initiated grant applications for all award types except those reviewed within institutes.

It also receives all NIH grant applications and assigns them to institutes for administration after award and possibly peer review. Find out which application types NIAID reviews at SRP. Go to NIAID's Peer Review of Applications -- CSR questions and answers. Go to CSR .

HHS agency heading disease prevention and control, environmental health, and health promotion and education efforts.

Investigators who possess or use a select agent must register with and get approval from either the CDC Select Agent Program or USDA APHIS Agricultural Select Agent Program, depending on the agent.

Go to NIAID's Select Agent Awards SOP. Go to CDC.

For human subjects, see institutional review board certification. For research animals, see institutional animal care and use committee certification. Go to NIAID's Human Subjects, Clinical Research and Research Animals.

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 satisfy other legal requirements.

Go to NIAID's advisory Council.

Checklist Form Page

Form in the PHS 398 grant application for paper applications.

For electronic applications, see PHS 398 Checklist form.

Checklist, PHS 398

See PHS 398 Checklist (for electronic applications).

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

Go to definition 45 CFR 46.402, 45 CFR 46.116 general requirements for informed consent, and full 45 CFR 46. See definition 21 CFR 50.3 (o).

For policy information, see definitions in the PHS 398 and SF424 (R&R) Application Guide and NIAID's Children in Research Policy SOP.

FDA classification of medical devices by potential risks. See definition in section 513 [21 U.S.C. 360c] Federal Food, Drug, and Cosmetic Act. Go also to 21 CFR 812.2 and full 21 CFR 812.

Action FDA uses when it does not believe a study can be conducted without reasonable 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 reviewing newly submitted clinical protocols or safety reports. See Clinical Hold Decision in FDA's Handbook for more information.

Clinical research

1. Patient-oriented research.
2. Epidemiologic and behavioral studies.
3. Outcomes and health services research.

Go to NIAID's Human Subjects, Clinical Research.

• 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.
• Phase IV is a study 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 NIAID's Investigator-Initiated Clinical Trial Planning and Implementation Grants SOP, Investigator-Initiated Clinical Trial Planning and Implementation Grants questions and answers, and Human Subjects, Clinical Research.

1. Clinical site monitoring. Monitoring of a clinical trial by people outside of the research site. This independent group performs several functions:
• Ensure the rights, safety and well being of human subjects enrolled in clinical research studies.
• Verify the integrity of the data collected.
• Ensure site compliance with the protocol approved by the institutional review board, other documents, applicable regulatory requirements, ICH GCP guidelines, adequacy of staff and facilities, and more.
2. Data and safety monitoring. Monitoring of a clinical trial by a person or group of people independent from the study.
   • With an emphasis on safety and efficacy, the group periodically reviews the interim results of the research to determine if the study should be changed or halted.
   • This monitoring ensures the appropriateness of the research and protection of human subjects.
   • The monitoring can take a variety of forms, including an independent data and safety monitoring board.

Go to NIAID's Clinical Trial Monitoring SOP and Human Subjects, Clinical Research.

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 CFR. For a list of CFR regulations applicable to NIH, go to Regulations Relevant to NIH.

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. Go to NIAID's Are You Conducting Human Subjects Research? tutorial page on Human Subjects, Clinical Research.

1. Salary, fringe benefits, and tuition remission paid to a fellow or trainee for teaching or lab work. Compensated services must be limited, part-time, and paid from a research grant that does not support NRSA training grants.

2. Salary, fringe benefits, and tuition remission for graduate students supported by NIH research grants and cooperative agreements. Go to NIAID's Paylines and Budget for annual salary caps and stipend levels.

• Is initiated by a request for proposals.
• Accepts submission of timely proposals by the maximum number of offerors.
• Usually provides discussions with offerors in the competitive range.
• Awards a contract to the offeror whose proposal is most advantageous to the government.

Go to NIAID's R&D Contracts and Contracts SOPs.

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 and R&D Contracts.

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 FAR 15.6 and NIAID's Competitive Range for Contracts SOP and R&D Contracts.

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

Only some concepts approved by Council are published as initiatives; this depends on their priority and the availability of funds. Go to NIAID's Concepts Approved by Council, Concept Development SOP, and High-Priority Topics: Concepts and Initiatives questions and answers.

Generally performed by NIAID's main advisory Council, a mandatory review of each initiative -- request for applications, request for proposals, request for contracts, or program announcement.

After hearing presentations from NIAID program officers, Council recommends approval, modification, or deferral of an initiative and advises on the science. Go to NIAID's Council and Concept Development SOP.

Ad hoc panel, composed of House and Senate conferees, that reconciles differences in legislation passed by both chambers. See conference report. Go to NIAID's tutorial pages starting with Planning and Budget Cycle: NIAID Budget and Planning.

NIAID financial support for scientific meetings, conferences, and workshops in areas related to its mission. Activity code is R13. Go to NIAID's Conference Awards SOP.

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

Agreement ensuring 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 Office of Technology Development.

Financial, career, or other such interest, including interests of family members, that could be advanced by participation on an NIH advisory Council, IRB, study section, or other advisory body. Go to 45 CFR 73 and 42 CFR 50.

Go to NIAID's Conflict of Interest in Peer Review SOP and Privacy, Conduct, Conflict of Interest, and Clinical Research Ethics questions and answers.

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.

See subaward.

PHS 398 term for paper grant applications; see modular budget justification page and detailed budget page.

For electronic applications, called sub-award budget. See Research and Related Budget form. Go to NIAID's Where to Add Consortium and Contractual Agreements in the NIH Grant Cycle: Application to Renewal.

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 acts are enacted.

Go to NIAID's Planning and Budget Cycle: NIAID Budget and Planning tutorial page, Budgets and Planning questions and answers, and Paylines and Budget.

See Office of Acquisitions.

For a clinical trial, independent contractor to a sponsor who assumes some of the sponsor's obligations, e.g., protocol design. Go to definition 21 CFR 312.3 and full 21 CFR 312.

Go to NIAID's Human Subjects, Clinical Research.

• 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 R&D Contracts.

See other significant contributor.

Grant application an applicant fixes after it fails either Grants.gov or eRA Commons validation. Differs from resubmission. Go to NIAID's Corrected or Late Electronic Applications questions and answers.

For electronic grant applications, two-day period an applicant can use to fix errors and warnings resulting from eRA Commons validation after the deadline for a grant application has passed. Go to If You Want to Correct After Passing Commons Validation in the NIH Grant Cycle: Application to Renewal.

See NIH cost management plan.

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 is appropriate for efforts that might otherwise present too great a risk to contractors, but gives them minimum incentive to control costs. Go to FAR 16.301-1 and NIAID's R&D Contracts.

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. Go to FAR 16.301-1 and NIAID's R&D Contracts.

Chartered NIH institute advisory committee that performs second-level review, makes funding and policy recommendations, and helps develop and provide concept clearance for research initiatives.

See National Advisory Allergy and Infectious Diseases Council; go to NIAID's Advisory Council SOP, Advisory Council questions and answers, and Council.

Cover letter

Cover Letter File, PHS 398

Cover Page Supplement, PHS 398

Written evaluation primary, secondary, and tertiary reviewers prepare before an initial peer review meeting and present to a scientific review group at the meeting.

It recommends a priority score (or deems not recommended for further consideration) and addresses the requested budget, initial peer review criteria, progress made (for a renewal), and responses to the critique from a previous review (for an amended application).

Go to NIAID's Initial Peer Review Assesses Scientific Merit and subsequent tutorial pages.

Current dollars

Current and pending support

Independent committee that reviews a clinical trial's progress and safety and advises NIAID whether to continue, modify, or terminate it. One of several types of clinical trial monitoring options.

Go to NIAID's Data and Safety Monitoring Boards SOP and Human Subjects, Clinical Research.

Policy requiring researchers requesting $500,000 or more in direct costs in any year to share final research data. Applicants must include a data sharing plan in their grant application or explain why data sharing is not possible.

NIH's genome-wide association study requirement is part of its data sharing policy.

Go to NIAID's Data Sharing for Grants: Final Research Data SOP, Data Sharing for Grants: Genome-Wide Association Studies SOP, and Sharing Data questions and answers.

1. Describing postponement of initial peer review of a grant application by a scientific review group, often to the next review cycle, because information is missing. NIAID's advisory Council may also recommend deferral of an application.

2. Describing postponement of a funding decision for applications that rank beyond the payline until the end of the fiscal year, including some selective pay applications. NIAID funds the selective pay applications first and then the others in percentile or priority score order until money is used up for that fiscal year. Also see gray zone.

Go to NIAID's If Your Application Is Unscored and subsequent tutorial pages, NIAID Funding Decisions questions and answers, Council, and NIAID R01 Application to Award Timeline.

Part of PHS 398 grant application, Form Page 2; also known as abstract. A succinct description of major aspects of a grant application, it is public information.

For electronic applications, see Project Summary/Abstract and Project Narrative. Go to NIAID's Project Summary/Abstract and Project Narrative in the NIH Grant Cycle: Application to Renewal.

Detailed Budget for Initial Budget Period

For electronic applications, see Research and Related Budget components. Go to NIAID's Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal.

For paper grant applications, Form page 4 in the PHS 398 grant application, used to request a budget over $250,000 for the initial budget period. Also see Entire Proposed Project Period Budget.

See Detailed Budget for Initial Budget Period and Entire Proposed Project Period Budget.

For electronic applications, see Research and Related Budget components. Go to NIAID's Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal.

Cost in a grant or contract that support a project or program. Allowable direct costs may include:

• Salaries and fringe benefits of principal investigators and supporting staff.
• Equipment and supplies.
• Travel expenses.
• Fees and supporting costs for consultant services.
• Contract services (also called sub-award).
• Costs for consortium participants.
• Inpatient and outpatient costs for human subjects.
• Alterations and renovations to facilities. Foreign grants need preapproval.
• Publications and other miscellaneous expenses.

Compare with facilities and administrative costs. Go to NIAID's Strategy for Planning a Budget in the NIH Grant Cycle: Application to Renewal.

NIAID committee that recommends funding for training, fellowship, career development, conference grant, and small business awards, based on peer review results and Council recommendation.

DAG also serves as an NIAID advisory board on training issues.

One of the requirements for being part of an underrepresented group. Includes the following:

• Annual family income below established low-income thresholds, based on family size, as described at Poverty Guidelines, Research, and Measurement.
• A rural, inner-city, or other environment that has inhibited a person from getting the knowledge, skills, and abilities needed for a research career.

Different than socially and economically disadvantaged.

NIAID division that facilitates the conduct of domestic and international NIAID research programs. It provides and supports services including oversight and management for Division of Intramural Research clinical research and Institute clinical research processes.

Go to DCR and DCR Contacts.

NIAID division for extramural administration and policy that oversees initial peer review for some application types and all NIAID R&D contracts, administers grants and contracts, manages the NIAID advisory Council, and advises the NIAID director on extramural policy.

Go to Research Funding and DEA Contacts, and see Scientific Review Program, Grants Management Program, and Office of Acquisitions,

Assignment of a grant application to two NIH institutes. The primary institute administers the application and awards and administers the funded grant.

The secondary institute assumes this responsibility only if the primary institute is unable or unwilling to support it. Go to NIAID's Dual Assignments SOP and Request for Primary IC Assignment SOP.

Peer review process used by NIH. The first level, initial peer review, provides a judgment of scientific merit.

Generally conducted by an institute's advisory council, second-level review makes funding recommendations in the context of program priorities and balance. Also see scientific review group, integrated review group, and NIAID Council.

Go to NIAID's Council and Initial Peer Review Assesses Scientific Merit and subsequent tutorial pages.