Glossary

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nervous system

The organized network of nerve tissue in the body. It includes the central nervous system (the brain and spinal cord), the peripheral nervous system (nerves that extend from the spinal cord to the rest of the body), and other nerve tissue.

A

Active Grant

A grant meeting the following criteria:

  1. Today's date is between the budget start and end dates.
  2. The grant has an eRA System (IMPAC II) application status code of "Awarded. Non-fellowships only." or "Awarded. Fellowships only."

Additive Alternative

A use of program income earned during or after the project period that permits income that is generated under a grant to be added to funds committed to the project by the Federal awarding agency and recipient and used to further eligible project or program objectives. (See definitions for deductive alternative and cost sharing or matching alternative and the NIH Grants Policy Statement: 8. Administrative Requirements 8.3 Management Systems and Procedures-Program Income

Application Submission System & Interface for Submission Tracking (ASSIST)

The Application Submission System & Interface for Submission Tracking (ASSIST) is a web-based system used to prepare grant applications using the SF424 Research & Related form set and to submit electronically through Grants.gov to NIH and other participating agencies. See Preparing Your Application Using ASSIST.

Application Viewing Window

Once an error-free application is submitted through Grants.gov to eRA, the eRA system assembles an application image and posts it in the PD/PI's eRA Commons account. The PD/PI, delegated Assistants, Administrative Officials (AOs) and Signing Officials (SOs) have 2 business days to view the assembled application in eRA Commons - just as a reviewer would see it. The application viewing window is linked to the time of submission, not the due date. It begins the day after the assembled application image is posted in eRA Commons and excludes weekends and Federal holidays.
Within the viewing window, an SO can Reject the application and stop it from moving further in the process. After the viewing window, the application automatically moves forward for further consideration and the submission process is complete.

Assistant Role (ASST)

In the NIH Commons the role designed to allow PIs to delegate certain responsibilities for data entry of grant information and upkeep of their personal profiles. The ASST does not have any other functions in the system.

Audit Resolution

The process of resolving audit findings, including those related to management and systems deficiencies and monetary findings (that is, questioned costs).

B

Basic Research

Systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (CFR 272.3)

C

Clinical Trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

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.

Computing Devices

Machines used to acquire, store, analyze, process, and publish data and other information electronically, including accessories (or "peripherals'') for printing, transmitting and receiving, or storing electronic information. See also "supplies" and "information technology systems."

Cost Sharing or Matching Alternative

An alternative use of program income whereby income accrued during the period of grant support may be used to satisfy a cost sharing or matching requirement. (See also definitions for additive alternative and deductive alternative and NIH Grants Policy Statement: 8 Administrative Requirements 8.3 Management Systems and Procedures 8.3.2 Program Income.)

D

Data Universal Numbering System (DUNS)

A nine-digit number established and assigned by Dun and Bradstreet to uniquely identify a business entity.

Deductive Alternative

An alternative for the use of program income earned during the period of grant support under which allowable costs of the project or program to be paid by the Federal government are offset by the amount of the program income. (See also definitions for additive alternative and cost sharing or matching alternative and NIH Grants Policy Statement: 8 Administrative Requirements 8.3 Management Systems and Procedures 8.3.2 Program Income.)

Dual Review System

Peer review process used by NIH. The first level of review provides a judgment of scientific merit. The second level of review (usually conducted by an ICD's advisory Council) assesses the quality of the first review, sets program priorities, and makes funding recommendations.

E

E-Business Point of Contact (POC)

An E-Business POC for an organization is designated during organization registration with the System for Award Management (SAM) and is the person responsible for the administration and management of grant activities in his/her organization. E-Business POCs give representatives of their organization the privilege to submit grant applications through Grants.gov by designating Authorized Organization Representative (AOR) authority.

ECB-Council Portal and Archive

web-based system that provides a variety of services in support of the second level of review of grant applications by a review group

Entity Identification Number (EIN)

A three-part coding scheme of 12 characters used in the Program Management System (PMS) to identify organizations and individuals. The first character identifies the recipient as an organization or an individual. The next nine characters are the Employer Identification Number. The last two characters are a suffix to provide distinction between organizational entities that are assigned a single EIN and those that have more than one.

Excluded Parties List System

A public database maintained by the General Services Administration which is the official government-wide system of record for debarments, suspensions, and other exclusionary actions.

Expiration Date

In context of awarded grant:
The date signifying the end of the current project period, after which the grantee is not authorized to obligate grant funds.

In context of funding opportunity announcement key dates:
The day after the last submission due date for the announcement. As of the Expiration Date, the announcement is no longer active and applications will not be accepted unless either the late policy or system issue policy apply.

G

General Purpose Equipment

Equipment which is not limited to research, medical, scientific or other technical activities. Examples include office equipment and furnishings, modular offices, telephone networks, information technology equipment and systems, air conditioning equipment, reproduction and printing equipment, and motor vehicles. See also "Equipment" and "Special Purpose Equipment."

Grant Compliance Review

An evaluation by grants management staff to assess an institution's business and financial management systems to ensure that regulations and policies are being followed.

I

iEdison

NIH's electronic invention reporting system. Go to iEdison.

Information Technology Systems

Computing devices, ancillary equipment, software, firmware, and similar procedures, services (including support services), and related resources. See also computing devices and equipment.

N

nervous system

The organized network of nerve tissue in the body. It includes the central nervous system (the brain and spinal cord), the peripheral nervous system (nerves that extend from the spinal cord to the rest of the body), and other nerve tissue.

neurogenetic

A branch of genetics that studies the role of genetics or genes in the development and function of the nervous system.

neurological

Relating to the anatomy, function, and disorders of the nervous system.

O

ORIS

Office of Research Information Systems - Provides data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans’ Administration).

ORIS

Office of Research Information Systems - Provides data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans’ Administration).

P

PROMIS

Patient-Reported Outcomes Measurement Information Systems

R

Research & Development

All research activities, both basic and applied, and all development activities that are performed by HHS award recipients. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function. "Research" is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development" is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes.

S

spinal cord

A column of nerve tissue that runs from the base of the skull down the center of the back. It is covered by three thin layers of protective tissue called membranes. The spinal cord and membranes are surrounded by the vertebrae (back bones). The spinal cord and the brain make up the central nervous system (CNS). Spinal cord nerves carry messages between the brain and the rest of the body.

X

XTRACT

Extramural Trainee Reporting and Career Tracking System

xTrain

xTrain provides program directors/principal investigators, university administrators, and trainees the ability to electronically prepare and submit PHS 2271 Statement of Appointment forms and PHS 416-7 Termination Notices associated with institutional research training grants, institutional career development awards, individual fellowships and research education awards.
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Form Approved OMB# 0925-0648 Exp. Date 05/31/2021