Glossary of Terms

Private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

This regulation has been replaced by 2 CFR 200 "Uniform Guidance."

Amounts a company owes because it purchased goods or services on credit from a supplier or vendor.

Amounts a company has a right to collect because it sold goods or services on credit to a customer. 

In accordance with desire.

Voluntary action by an investigator to temporarily or permanently stop some or all approved research activities. Protocols remain open and require continuing review.

An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention. Also referred to as an adverse event.

All non-Augusta University research institutions, organizations, or study sites other than the local VA.

Institution's employees or agents refer to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities.  This can include staff, students, contractors and volunteers, among others, regardless of whether the individual is receiving compensation.  A student's affiliation with an academic institution makes him/her an agent of that institution; and thus the academic institution is engaged in the research regardless of where the research takes place.

Unproved assertion of non-compliance.

Those allowable costs that actually benefit the grant or contract to which they are being charged.  If a cost benefits two or more projects or activities in proportions that can be determined without undue effort or cost, the cost must be allocated to the projects based on the proportional benefit. 

Categories of costs that can be charged to a grant, such as salaries and equipment.  

Per 2 CFR 200.403, for a cost to be allowable it must:

(a) Be necessary and reasonable for the performance of the Federal award and be allocable thereto under these principles.

(b) Conform to any limitations or exclusions set forth in these principles or in the Federal award as to types or amount of cost items.

(c) Be consistent with policies and procedures that apply uniformly to both federally-financed and other activities of the non-Federal entity.

(d) Be accorded consistent treatment. A cost may not be assigned to a Federal award as a direct cost if any other cost incurred for the same purpose in like circumstances has been allocated to the Federal award as an indirect cost.

(e) Be determined in accordance with generally accepted accounting principles (GAAP), except, for state and local governments and Indian tribes only, as otherwise provided for in this part.

(f) Not be included as a cost or used to meet cost sharing or matching requirements of any other federally-financed program in either the current or a prior period. See also §200.306 Cost sharing or matching paragraph (b).

(g) Be adequately documented. See also §§200.300 Statutory and national policy requirements through 200.309 Period of performance of this part.

Alternate Institutional Review Board (IRB) committee members may be designated, as needed, for regular voting members. The appointment of alternate members should be based on expertise similar to that of the regular voting member. An alternate member may vote only when the regular voting member is absent.

Born in an undeveloped state and requiring care and feeding by the parents.

Any change to an IRB-approved study protocol regardless of the level of review it receives initially. Also referred to as a modification.

All vertebrate animals must be covered by an animal use protocol (AUP) approved by the Institutional Animal Care and Use Committee (IACUC) prior to acquisition and/or use of animals and throughout the entire period of animal use or maintenance.

Lacking appetite.

Fluid collection in the peritoneal cavity.

Affirmative agreement to participate in research obtained from an individual who is not of legal age (18 years old) to give informed consent. Assent is obtained in conjunction with permission of the individual’s parents or legally authorized representative. Mere failure to object should not be construed as assent.

Promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs).

Electronic funds-transfer system run by the National Automated Clearing House Association (NACHA). This payment system deals with payroll, direct deposit, tax refunds, consumer bills, tax payments and many more payment services.

Funds that have been obligated by a funding agency or sponsor for a particular project.  An award can be either a grant or a contract.

Statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.

Ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm.  The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

Valued or desired outcome; an advantage.

Type or donation or gift. Bequests and gifts are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available. The unique flexibility, or lack of restrictions, makes gifts attractive sources of support.

In terms of Intellectual Property law, beta-test agreement is a software license agreement between a software developer and a customer. The agreement allows the customer to use the software program in a “live” environment before its release to the general public. Beta-test agreements differ from more conventional software licenses. They typically have more significant limitations on liability; contain few warranties, if any; and require user evaluation and feedback. This is also known as software beta-test agreement.

Line item list of study activities and visit schedule which displays the billing designation(s) for each event and/or item.

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

Assessment of the animal's weight for age and weight for height rations, and its relative proportions of muscle and fat.

Created in 1931 as a part of a reorganization of Georgia's state government, public higher education in Georgia was unified for the first time under a single governing and management authority.

Announcement of a federal agency's general research interests that invites proposals and specifies the general terms and conditions under which an award may be made.

Detailed statement outlining estimated project costs to support work under a grant or contract.

Act of amending the budget by moving funds from one category or line item to another.

Interval of time--usually twelve months--into which the project period is divided for budgetary and funding purposes.

Comprehensive and centralized foundation for the annual publication of federal domestic assistance programs, which is a government-wide compendium of federal programs, projects, services, and activities that provide assistance or benefits to the public. 

Protection of research subject's privacy by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the subject consents or in a few other specific situations.

Grant that provides monies in response to monies from other sources, usually according to a formula. A challenge grant may, for example, offer two dollars for every one that is obtained from a fund drive. The grant usually has a fixed upper limit, and may have a challenge minimum below which no grant will be made. This form of grant is fairly common in the arts, humanities, and some other fields, but is less common in the sciences. A challenge grant differs from a matching grant in at least one important respect: The amount of money that the recipient organization realizes from a challenge grant may vary widely, depending upon how successful that organization is in meeting the challenge. Matching grants usually award a clearly defined amount and require that a specified sum be obtained before any award is made.

Written order signed by the contracting officer, directing the contractor to make changes that the changes clause of the contract authorizes the contracting officer to order without the consent of the contractor.

Defines events, such as clinical labs and procedures, administrative tasks, and budgeting tasks that can be
associated with a budget for a study. The events contain descriptions, identifying codes, and charge information.
Some events are created as a collection of items, where those individual items have their own descriptions,
codes, and charge information. Charge Master Events (protocol- and subject-related procedures, labs, facility
fees) are linked to calendar events to pull in charges, which are then used in invoicing.

Also known as the “account string”, the CFC is a set of numerical characters that indicate important financial data.  A CFC is assigned when a project is initiated.

Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)] .  In Georgia, the age of majority is 18.  A child under the age of 18 is considered a minor. 

Biomedical or behavioral research study of human subjects designed to answer specific questions about diagnostic procedures or therapeutic interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new diagnostic procedures or therapeutic interventions are safe, efficacious, and effective.

Any experiment that involves a test article (in this case – device) on one or more human subjects (participants) and that either must meet the requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding non‐clinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part [21 CFR 56.102(c)].

Contracted by another company to manage and lead the company's trials, duties, and functions.

Legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication, input into further intellectual property.

Act of completing all internal procedures and sponsor requirements to terminate or complete a research project.

Continuing review and re-approval of a study is required so long as the project continues to involve human subjects. When research activities no longer involves subjects or their identifiable data, the study may be closed with the IRB.  If the all of the following are true, a study may be closed:

• The protocol is permanently closed to enrollment.
• All subjects enrolled have completed all protocol related interventions and interactions, including interventions and interactions related to collection of long-term follow-up data.
• No additional identifiable private information about the subjects is being obtained by this organization’s investigator(s).

Analysis of private identifiable information at this organization is completed.

Rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.

Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.

Web Based Training in Human Research Subjects Protections.

Collaborative Research Agreements (CRAs) are contracts between the institution and one or more organizations that are cooperating in the conduct of a research program. In these agreements, there is generally no transfer of funds between organizations (referred to as a “No Cost Collaboration”). Instead, the agreement describes the actions that each organization has agreed to undertake, and defines the obligations each party has to the others participating in the collaborative research effort.

Collaborative Research Agreements may include terms governing the following:

• Scope of work to be conducted
• Management and staffing of the research project
• Schedules and deliverables
• Publication of the research results
• Options to license the intellectual property arising from the research collaboration
• Care of data and confidential information exchanged during the research
• Transfer of materials among the collaborating organizations
• Compliance with export control and other laws and regulations
• Use of institution’s name and the collaborator’s name
• Rights and procedures to terminate the project
• Taxes, insurance, warranties, liability, governing law, and other items necessary for contracts

Mandatory cost sharing, which is required by the sponsor, and voluntary committed cost sharing, which is voluntarily committed in the proposal by AU to the sponsor. It excludes voluntary uncommitted cost sharing, which is cost sharing that is not required by the sponsor and not committed in the proposal, and it is not required to be tracked or recorded by AU. When an award is made which includes committed cost-sharing, Augusta University agrees to ensure that the cost sharing is funded and the obligation is met. Committed cost sharing expenditures must be identified, administered, recorded, accounted for consistently, and reported as stipulated by the sponsor.

Any part of ‘University effort’ that is quantified and included in a sponsored program proposal and the subsequent award (e.g., two summer months, 12% time, one half of a year, three person-months, et cetera.). This quantified effort/time is associated with a specific dollar amount of the employee’s compensation.

Associated effort and funding to support this devoted effort/time can be in the form of

 Direct Charged Effort: Any portion of ‘committed effort’ toward a sponsored activity for which the sponsor pays salary/benefits.

• Cost Shared Effort: Any portion of ‘committed effort’ toward a sponsored activity for which the sponsor does not pay salary/benefits, which instead are paid using other, non-federal Augusta University sources.
• Uncommitted Effort: Any portion of ‘University effort’ devoted to a sponsored activity that is above the amount committed in the proposal and the subsequent award. This ‘extra effort’ is neither pledged explicitly in the proposal nor included in the award documentation as a formal commitment. 
  • For Principal Investigators/Project Directors and key personnel, uncommitted effort is not considered cost shared effort. However, the uncommitted effort percentage must be accounted for and documented as part of one’s 100% ‘University effort’ on the periodic effort report.
  • For other contributing personnel, uncommitted effort is considered cost shared effort and must be documented as such in Section I on the periodic effort report.

Use of an investigational drug or biologic or unapproved medical device for a single subject (or small group of subjects) with a serious disease or condition, who does not meet the requirements for inclusion in a clinical investigation, and for whom no standard acceptable treatment is available. Prior FDA and IRB approval are required for compassionate use.  Note: The terms compassionate use and emergency use are not synonymous.

Compensation for personal services includes all remuneration, paid currently or accrued, for services of employees rendered during the period of performance under the Federal award, including but not necessarily limited to wages and salaries. Compensation for personal services may also include fringe benefits.

Technically, a legal term used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. See also incapacity and cognitively impaired.

Proposals that are submitted for the first time or unfunded proposals that are resubmitted; either must compete for research funds. Ongoing projects must compete again if the term of the original award has expired.

Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure, without permission. Compare to anonymity and privacy.

Designed to protect the confidential information that may be released between an industry sponsor or other entity and the AU faculty and staff so that they can determine whether or not to enter into a subsequent agreement for either a clinical trial (CTA) or basic research (SRA).  CDAs may be one-way or mutual and are generally requested by sponsors prior to disclosing a study protocol or other information which the sponsor considers proprietary.  Not all sponsors require a CDA prior to disclosure of confidential information.

Percentage of effort attributed to activity on each sponsored program during the reporting period is reasonable in relation to 100% of the total effort for all activities for which the individual is paid by the Augusta University Enterprise; and furthermore that the charge to each award is appropriate in relation to the work performed.

An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s spouse, domestic partner, children, and dependents have any of the following interests in the sponsor, product or service being tested, or competitor of the sponsor held by the individual or the individual’s immediate family:

• Involvement in the design, conduct, or reporting of the research.
• Ownership interest, stock options, or other ownership interest of any value exclusive of interests in publicly-traded, diversified mutual funds.
• Compensation of any amount in the past year or of any amount expected in the next year, excluding compensation for costs directly related to conducting research.
• Proprietary interest including, but not limited to, a patent, trademark, copyright or licensing agreement.
• Board or executive relationship, regardless of compensation.
• Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated research institute, academic teaching hospital, or medical center.

Any other reason for which the individual believes that he or she cannot be independent.

See informed consent.

Group of collaborative investigators/institutions; arrangement can be formalized with specified terms and conditions.

Applicable to grants and cooperative agreements only. A project approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, an award is made for the next budget period, subject to the availability of funds. Continuation projects typically do not compete with new project proposals and are not subjected to peer review beyond the initial project approval.

Persistent failure to adhere to the laws, regulations, or policies governing human research.

Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once per year.  The criteria for approval are defined by federal regulations. 

Contact information includes a staff ID, first and last name, phone number, and email address.  Credentials (along with expiration dates) will not be maintained by OnCore as the source of record; IRBNet is responsible for this function.  Contact records (user accounts) are created for clinical and non-clinical personnel working on studies.  Each contact record is associated with the staff member’s organization (default).  Staff access to protocols are based on organizational unit, department, management group, and/or institution affiliation.

Mechanism for procurement of a product or service with specific obligations for both sponsor and recipient. Typically, a research topic and the methods for conducting the research are specified in detail by the sponsor, although some sponsors award contracts in response to unsolicited proposals.

Sponsor's designated individual who is officially responsible for the business management aspects of a particular grant, cooperative agreement, or contract. Serving as the counterpart to the business officer of the grantee/contractor organization, the grant/contract officer is responsible for all business management matters associated with the review, negotiation, award, and administration of a grant or contract and interprets the associated administration policies, regulations, and provisions. (For definition of scientific officer, see Program Project Officer.)

Award similar to a grant, but in which the sponsor's staff may be actively involved in proposal preparation, and anticipates having substantial involvement in research activities once the award has been made.

Unique number assigned to a study that uses billable hospital services.

Federally mandated accounting standards intended to ensure uniformity in budgeting and spending funds.

Contract / grant for which the sponsor pays for the full costs incurred in the conduct of the work up to an agreed-upon amount.

The portion of project costs not paid by sponsor funds. The costs may be incurred by the university or a third party via an in-kind contribution.

After-the-fact transfer of costs from one account/CFC to another.

An association of research universities, affiliated medical centers, and independent research institutes whose primary function is to advocate for policies and practices that fairly reflect the mutual interests and separate obligations of federal agencies and research institutions as it relates to research and graduate education.

Also known as a Medicare Coverage Analysis or "MCA"

Used to record information about the charges and their billing designations made for a particular protocol.  It is a detailed review of clinical research items, services, procedures, and Medicare billing rules to determine the appropriate payer/funding source for each item or service.

Health plan, health care clearinghouse, or health care provider who transmits any health information in electronic form in connection with a transaction covered by the Privacy Rule.

Examples of data collection instruments include, but are not limited to:

• Questionnaires, surveys;
• Videotapes, audiotapes, and photographs;
• Interview and focus group questions, guides, and notes;
• Field notes, observation guides and notes;
• Data collection forms and spreadsheets;
• Verbal or written instructions given to participants for research activities; and/or
• May also include visual images, objects, tools, or devices used in the data collection.
• Copies and/or detailed descriptions of all data collection instruments are required in the initial review, and submitted materials (and versions) are noted in the IRB approval.  Proposed changes to approved study instruments must be submitted via a modification and must be reviewed and approved by the IRB before any changes are implemented.

Also known as the Data Safety Monitoring Committee (DSMC)

An independent group of experts that advise the principal investigator and study team.  Members of the board serve in an individual capacity and provide their expertise and recommendations.  The DSMB is responsible for patient safety and privacy protection, compliance with required reporting, and study integrity for all trials conducted at Augusta University.

A Data and Safety Monitoring Plan (DSMP) is a written plan designed to ensure the safety of clinical research subjects, the validity and integrity of research data and to ensure that research subjects are not exposed to undue risks.

Proprietary system developed and regulated by Dun & Bradstreet (D&B) that assigns a unique numeric identifier, referred to as a "DUNS number" to a single business entity.

Used for the transfer of data that has been developed by nonprofit, government, or private industry, where the data is nonpublic or is otherwise subject to some restrictions on its use.

Fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

Giving subjects previously undisclosed information about the research following completion of their participation in research activities.  Debriefing is often used as an extension of the informed consent process when incomplete disclosure or deception is used.  Debriefing may also be used as an educational tool.  (Note that this usage, which occurs within the behavioral sciences, departs from Standard English where debriefing is obtaining rather than imparting information.)

Incomplete disclosure, occurs when an investigator gives false, or incomplete, information to subjects or intentionally misleads them about some key aspect of the research. (This is sometimes referred to as "active deception.")

 Examples of deception:

• The subject is given a "cover story" which falsely describes the purpose of the study, but provides a feasible account of the researcher's objective.
• The study includes a researcher's "confederate," an individual who poses as a participant, but whose behavior in the study is actually part of the researcher's experimental design.
• The subject is informed about the purpose of the study or a certain procedure in general terms that are true, but not detailed enough to reveal the researcher's main or specific objective.
• The study involves audiotaping or videotaping of subjects without their knowledge or prior consent.

Code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.

Source regulations for research projects sponsored by the Department of Defense. 

Expenditures exceed funds available or payments that are ultimately going to be received.

Data that has been stripped of all identifiers so that the information cannot be traced back to an individual.  De-identified data may also pertain to information that has been assigned and retains a code provided that:

• The code is not derived from or related to the information about the individual;
• The code could not be translated to identify the individual; and
• No link to identifiers exists, or the holder of the link record does not use or disclose the code for other purposes or disclose the mechanism for re-identification.

Deliverables may include, but are not limited to records, detailed research results, study data, research publications, completion of milestones, or the completion of project actions, etc.

Complete separation of the fetus from the woman by expulsion or extraction or any other means

Reporting group that engages in research activities that are monitored by the institution.  Departments (*also known as Funded Departments) are typically used to identify financial reporting areas.  Departments are independent of OUs.  A department can contain protocols from different OUs and different management groups.  Staff can belong to multiple departments.  Departments can be used to manage user privileges.  In OnCore, the department will be the same as the user’s NetID department.

Cabinet-level department of the U.S. federal government with the goal of protecting the health of all Americans and providing essential human services.  The DHHS regulations on the Protection of Human Subjects, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

Department of the U.S. federal government charged with ensuring that the military capacity of the U.S. is adequate to safeguard the national security.

Department of the U.S. federal government that sets forth and maintains the national energy policy, including energy conservation, environmental protection, etc.

IRB Chair or an experienced IRB member designated to conduct non-committee reviews (e.g., expedited review).

Research participants who have a diminished capacity to consent are referred to as “cognitively impaired” throughout this document.

Clearly identifiable costs related to a specific project. General categories of direct costs include but are not limited to salaries and wages, fringe benefits, supplies, contractual services, travel, equipment, and subawards.

Release, transfer, provision of, access to, or divulging in any other manner of information outside the entity holding the information.

Act or an instance of furnishing or authenticating with documents.  Documentation of informed consent includes use of a written consent form (approved by the IRB) and signed and dated by the subject or the subject's legally authorized representative and, typically, by the person obtaining consent.

Any item of value give to the University by a donor who expects nothing significant of value in return, other than recognition and disposition of the gift in accordance with the donor’s wishes.

In general, the following characteristics describe a gift:

• The agreement does not impose and there are no "deliverables" to the donor.
• Gifts may be accompanied by an agreement that restricts the use of the funds to a particular purpose.
• A gift is typically irrevocable. Gifts may be intended for a specific use within a certain timeframe, but there is no specified "period of performance" or "start"/ "end" dates as associated with sponsored projects.
• There is no formal fiscal accountability to the donor beyond periodic progress reports and summary reports of expenditures. These reports may be thought of as requirements of good stewardship, and, as such, may be required by the terms of a gift. They are not characterized as contractual obligations or "deliverables."

The institution agrees to use restricted gifts as the donor specifies, and does not accept gifts that it cannot use as the donor intends. University approval for changes in the purpose of a gift fund may be required.

Requirements that must be met, or characteristics that he or she must have, for an individual to be included in a study. These include inclusion criteria and exclusion criteria.  For example, a study might only accept participants who are above or below certain ages.

Also known as "forms"

The eCRF function in OnCore is used primarily in investigator-initiated trials where there are no sponsor-provided case report forms. 

Online system used to manage patient care. Also referred to as the electronic health record (EHR).

Allows departments to submit online requests to update employee job records, including payroll distributions amongst CFCs. These requests are moved through a predefined approval queue and then posted to the employee's record.

Paperless committee management system.  It is designed to assist the workflow of a Protocol Review and Monitoring Committee (PRMC).

Industry term for doing what used to be done on paper, except electronically – using software to manage the data and to automate many of the processes that facilitate the administrative work involved in research.

Legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation.

Use of an investigational drug or biologic or unapproved medical device for a human subject in a life-threatening situation for which no standard acceptable treatment is available and when there is not sufficient time to obtain IRB approval. [21CFR56.102(d)]. Note: Under FDA regulations, emergency use is a category of research (i.e., clinical investigation) that is exempt from the requirements for IRB review.

An institution’s employees or agents refers to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. “Employees and agents” can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.

Funds that have been set aside or "claimed" for projected expenses pending actual expenditure of the funds.

Fund usually in the form of an income-generating investment, established to provide long-term support for faculty/research positions (e.g., endowed chair).

Institution is considered engaged in a particular non‐exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Occurs when an eligible, prospective subject undergoes the initial informed consent process and voluntarily agrees to participate in a research project.  The number of enrolled subjects includes withdrawals.

Unique identification number that is assigned to a business entity so that they can easily be identified by the Internal Revenue Service.

OnCore’s electronic protocol review and monitoring system is a paperless committee management system.  It is designed to assist the workflow of a Protocol Review and Monitoring Committee (PRMC).

Asset property (including information technology systems) having a useful life of more than one year and a per-unit acquisition cost which equals or exceeds $5,000.

Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.

Web-based product comprising a fully integrated group of applications to manage IACUC and Animal Resource Facility (ARF) functions.

Electronic Internal Routing System for Grants and Contracts

Intentionally termination of life in a humane manner.

Factors (or reasons) that prevent a person from participating in a research study.

Certain categories of human research may be exempt from federal regulation but require IRB review.  It is the responsibility of the institution, not the investigator, to determine whether human research is exempt from IRB review. 

Review of proposed research by the IRB Chair, a designated voting member, or group of voting members rather than by the convened IRB.  Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. 

Date signifying the end of the performance period, as indicated on the Notice of Grant Award.

When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically.  The study expires on the date specified on the approval letter and the consent document.  No activities can occur after the expiration date.  Also referred to as a lapsed study or protocol.

Additional period of time given by the sponsor to an organization for the completion of work on an approved grant or contract. An extension allows previously allocated funds to be spent after the original expiration date.

Site that is not owned or operated by AU or AU affiliates. For purposes of this policy, the CNVAMC is not considered an affiliated site.

Costs that are incurred for common or joint objectives and, therefore, cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity. F&A costs are synonymous with Indirect Costs, and may also be referred to as overhead costs.

Exception to the appropriate F&A rate which results in an F&A recovery that is reduced from the maximum amount allowed. All waiver requests must be approved by the appropriate Dean, AURI Executive Director, and Senior Vice President for Research.

Faculty member who serves as a guiding mentor for an undergraduate or graduate student (including residents) research project.

Federal legislation in the United States that protects the privacy of students' personally identifiable information (PII).  The act applies to all educational institutions that receive federal funds. 

Association of federal agencies, academic research institutions with administrative, faculty and technical representation, and research policy organizations that work to streamline the administration of federally sponsored research. 

Formerly [Financial Status Report (FSR)].  Accounting of expenditures and obligations incurred during the period of performance and/or at the conclusion of the sponsored project. The financial report reflects the institution's official accounting records.

All institution’s human subjects research activities, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), will be guided by a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution.  This is accomplished via contract with the federal government allowing research involving human subjects to take place.

Rates assigned by a Federal agency that are the result of the Augusta University’s Division of Sponsored Program Administration developing and negotiating a F&A Cost Rate Agreement applicable to federal awards for both Augusta University campuses and AURI.

The product of conception from implantation until delivery.

Non-Compliance in fact.

Final technical or financial report required by the sponsor to complete a research project.

Direct evidence of work performed. One may have this knowledge of work performance by either performing the work or through supervising the individual performing the work.

Any twelve-month period for which annual accounts are kept (at AU, July 1 through June 30).

Contract/grant for which one party pays the other party a predetermined price, regardless of actual costs, for services rendered. Quite often this is a fee-for-service agreement.

Agency within the US Public Health Service that provides a number of health-related services. Abbreviated FDA. The FDA's services include inspecting food and food-processing facilities to ensure wholesomeness and safety; scrutinizing food and drugs for pets and farm animals; ensuring that cosmetics will not cause harm; monitoring the health of the nation's blood supply; ensuring that medicines, medical devices, and biologicals (such as insulin and vaccines) are safe and effective; and testing radiation-emitting products such as microwave ovens to protect the public.

Combination of an intradermal and subcutaneous injection used primarily in models of immunization, inflammation, arthritis, pain, and to administer certain types of neurotracer dyes.

Employee benefits paid by the employer. (e.g., FICA, Worker's Compensation, Withholding Tax, Insurance, etc.)

Solution of antigen emulsified i mineral oil and used as an immunopotentiator (booster).

Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.

Hours worked by one employee on a full-time basis. The concept is used to convert the hours worked by several part-time employees into the hours worked by full-time employees. On an annual basis, an FTE is considered to be 2,080 hours, which is calculated as 8 hours per day.

Range of time during which proposals are accepted, reviewed, and funds are awarded. If a sponsor has standing proposal review committees (or boards) that meet at specified times during the year, application deadlines are set to correspond with those meetings. For some sponsors, if proposals are received too late to be considered in the current funding cycle, they may be held over for the next review meeting (i.e., National Science Foundation's Target Dates).

Publicly available document that a Federal agency uses to announce its intention to award grants or cooperative agreements that are usually the result of a competition of funds.  Synonyms:  Program Announcements, Requests for Application, Notices of Funding, etc. 

Main accounting record of a company or organization.

Knowledge from which conclusions will be drawn that can be applied to populations outside of the specific study population. This may include one or more of the following concepts: (1) Knowledge that contributes to a theoretical framework of an established body of knowledge; the primary beneficiaries of the research are other researchers, scholars, and practitioners in the field of study; dissemination of the results is intended to inform the field of study (this alone doesn’t make an activity designed to contribute to generalizable knowledge)l the results are expected to be generalized to a larger population beyond the site of data collection; the results are intended to be replicated in other settings.

Collection of commonly-followed accounting rules and standards for financial reporting. The acronym is pronounced "gap." GAAP specifications include definitions of concepts and principles, as well as industry-specific rules.

Gifts and bequests are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available. The unique flexibility, or lack of restrictions, makes gifts attractive sources of support. (Also see Donation.)

International ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Researcher employed, often on a temporary contract, by a university or research institute, for the purpose of assisting in academic research.

Type of financial assistance awarded to an organization for the conduct of research or other program as specified in an approved proposal. A grant, as opposed to a cooperative agreement, is used whenever the awarding office anticipates no substantial programmatic involvement with the recipient during the performance of the activities. 

Sponsor's designated individual who is officially responsible for the business management aspects of a particular grant, cooperative agreement, or contract. Serving as the counterpart to the business officer of the grantee/contractor organization, the grant/contract officer is responsible for all business management matters associated with the review, negotiation, award, and administration of a grant or contract and interprets the associated administration policies regulations, and provisions. (For definition of scientific officer, see Program/Project Officer.) 

When research involves more than minimal risk to subjects. See minimal risk.

An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care. The guardian's role also includes declining to provide permission for the ward to participate in the research, if the guardian judges that participation is not in the ward's best interest. The guardian is acting in lieu of the biological or adoptive parent in considering whether participation is in the child's best interest, and consenting or not as appropriate.

"dew claw" or "little toe" or "thumb"

Any information, whether oral or recorded in any form or medium, that: (1) Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and   (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.

Agency of the U.S. Department of Health and Human Services, which is the primary federal agency for improving access to health care services for people who are uninsured, isolated or medically vulnerable.

Sets standards and regulations to protect patients from inappropriate disclosures of their protected health information (PHI) that could cause harm to their insurability, employability and their privacy.  Also known as “The Privacy Rule.” 

Customized document or form that gives permission to use specified protected health information (PHI) for a specific purpose, or to disclose PHI to a third party specified by the investigator other than for treatment, payment or health care operations.

Lateral tarsal region just above the ankle.

Living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. 

Any activity that is research as defined by DHHS and involves human subjects as defined by DHHS 

Linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.  Identifiable information can include, but are not limited to:

Many demographics (e.g. age, sex, ethnicity, etc.) on their own are not considered identifiable to individual subjects.  However, researchers should be aware that a combination of demographic information may be sufficient to identify an individual within a group or a limited population. 

Descriptions of personal and highly specific events may be sufficient to identify an individual in a known community even when typical identifiers, like names, are removed.

Contributions or assistance in a form other than money. Equipment, materials, or services of recognized value that are offered in lieu of cash.

Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.  Often used as a synonym for incompetence. See also competence and cognitively impaired.

Factors (or reasons) that allow a person to participate in a research study.

Method of funding contracts that provides specific spending limits below the total estimated costs. These limits may be exceeded only at the contractor's own risk. Each increment is, in essence, a funding action.

Entity or individual who has entered into a contractual agreement to provide goods or services to the University, and meets the following criteria:

• Is not currently an employee of the University
• Has no expectation of becoming an employee at the end of contractual service
• Did not have an official university appointment within the three months prior to the commencement of the contractual service
• Relied or will rely upon own expertise rather than following specific instructions from the department regarding performance of the required work
• Performed the work to the specifications of, but not under the direction of, a University employee or student
• Did not have the required number of work hours and/or days of the week set by the University.

See Facilities and Administrative Costs.

A rate, expressed as a percentage of a base amount, such as modified total direct costs (MTDC) or total direct costs (TDC). The rate is applied to a grant’s direct costs to come up with total costs. AU negotiates federal indirect cost rates with its federal cognizant agency for indirect costs, the DHHS Cost Allocation Services, once every 4 years. Other rates may be used when a sponsor has a specific limitation to indirect costs. Industry clinical trials have their own rate, which is set by the university.

A subset of health information, including demographic information collected from an individual, and: (1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (i) That identifies the individual; or (ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual.

A document that contains all the required elements of informed consent without a signature line. The act of participation is considered consent. Waiver of documentation of consent is required.

Voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [45 CFR 46.116; 21 CFR 50.20 and 50.25].  In the review and conduct of human research, informed consent refers as much to the process as to any particular form or document.  The goal of the informed consent process is to protect participants.  It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends.  Because giving consent to participate in research is not a contract, participants can leave a study at any time.

1) Any public or private entity or agency (including federal, state, and local agencies. 
Or,
2) a residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care. Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.

Institutions are the logical business units of clinical trials, generally the hospitals and clinics that participate in a protocol.  An institution may also represent the administrative arm of OnCore (the group of people who work with and manage the OnCore software).  An institution is necessary to define study sites, which are the locations where subjects are seen.  Study sites may be institutions, clinics, doctor’s offices, etc.  An institution is necessary to define study sites, which are the locations where subjects are seen.  Study sits may be institution, clinics, doctor’s offices, etc.  An institution is necessary to define staff records, which are created to track clinical and non-clinical personnel that are working on trials.  Additional institution data includes labs that the institution uses along with lab regulatory information.  Institutions are assigned to a type, such as Office of Clinical Trials, Research Center, Study Site, Organizations, Network Affiliations, or VA.

Federally mandated committee responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and the Guide for the Care and Use of Laboratory Animals.

Annual compensation rate, as determined by the Augusta University, for an employee’s appointment (‘University effort’) devoted toward Augusta University-related activities. Institutional base salary includes both compensation for University-related effort, and compensation from the Medical Center and AUMA for clinical effort. However, some specific types of compensation are not included for the purposes of effort reporting. These types include bonuses, reward/recognition compensation, et cetera.

Institution becomes "engaged" in human research when its employees or agents 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes.  An institution is also considered engaged in human research when it receives a direct Federal award to support the research.  See also agent.

Person at an institution who is designated as the Institutional Official and is the Signatory Authority on the University’s federal-wide assurance (FWA) with OHRP.  Also referred to as the Organizational Official.

Administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).

Work or invention that is the result of creativity, such as a manuscript or a design, to which one has rights and for which one may apply for a patent, copyright, trademark, etc.

Communication or interpersonal contact between investigator and subject.

Request for service from one department to another department within an institution/organization.

Authorization to expend funds on a project to a specified limit before the award document has been received from the sponsor.

Organization that brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

Physical procedures by which data are gathered (for example, venipuncture) or manipulations of the subject or the subject’s environment that are performed for research purposes.

Comprehensive and coordinated competitive grant program that is committed to the advancement of knowledge through basic and applied research, to the enrichment of society through creative initiatives, to promoting faculty research in all disciplines, and recognizing that scholarly activity can take different forms across disciplines.  It is designed to support faculty in becoming competitive in securing external funding and sponsorship.

Invention disclosure form is useful for easily documenting your invention, providing evidence of your earliest invention date and submitting your invention to your patent attorney. 

Drugs, vitamins, biologics, and nutraceuticals that are in clinical evaluation, for which a sponsor or PI has filed an Investigational new Drug (IND) Application with the FDA, has not been released by the FDA for general use, and is not available through regular channels of interstate commerce, but has been granted approval to use for research or humanitarian purposes by the FDA; FDA approved drugs, biologics, and nutraceuticals which are used in a non‐FDA approved manner under a study protocol (i.e., change in therapeutic indication, dosage, route of administration); and 3) any drug, biologic, and nutraceutical that is deemed “investigational” by the FDA. For all Charlie Norwood Veterans Administration Medical Center (CNVAMC) research, any approved drug, biologic, and nutraceutical that is being studied in a controlled, randomized, or blinded clinical trial is also considered an “investigational drug” VHA Handbook 1200.5 14(b).

IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data. 

Substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well investigational drugs work and whether they are safe to use. An investigational drug may be approved by the FDA for use in one disease or condition but still be considered investigational in other diseases or conditions. Also called experimental drug, IND, investigational agent, and investigational new drug.

Request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

Pharmacist at a study site or institution where the research involving the investigational drug is being conducted. The Investigational Pharmacist will ultimately dispense the investigational drug pursuant to authorized orders for investigational drugs stored in the Research Pharmacy.

A test article/investigational product is any drug, biologic, or medical device for human use, or human food additive, color additive, electronic product, or any other article subject to FDA regulations.

Individual (researcher, member of the research team, etc.) who interacts or intervenes with subjects for the purposes of the research or who has access to identifiable private information for research purposes.  In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3].  See also Principal Investigator.

Proposal submitted to a sponsor that is not in response to an RFP, RFA, or a specific program announcement.

In drug development, the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.

Solicitation issued to prospective bidders. An IFB describes what is required and how the bidders will be evaluated. Award is based on the lowest bid. Negotiations are not conducted.

Determination of the IRB that the research study has been reviewed and meets the criteria set forth by the IRB, the institution, and other federal, state, and local requirements.

Formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying institution, including an academic institution.  Agreements are generally used to cover a single research study, categories of research studies, or research studies within a research program.

Electronic IRB Submission System for Review and Approval of Protocols Used in Human Subjects Research.

Reviewing IRB that assumes IRB responsibilities for another organization and is designated to do so through an approved Federal wide Assurance (FWA) on file with the Federal Office of Human Research Protection (OHRP).

Generally an Information Technology employee that assesses and/or coordinates the effort to develop the plan for hardware or operating system changes at the server level.  The IT System Administrator ensures that the System Administrator is notified when critical changes to the computer configuration (i.e., hardware, operating system, development, and supporting software) occur that may affect the integrity of the application.  The IT System Administrator typically has full access rights to the application on the server.

Ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.

Selected information that is requested at the time a decision is made to fund a project.  Examples included, compliance approvals/training, Other Support, etc.  

Personnel considered to be of primary importance to the successful conduct of a research project. The term usually applies to the senior members of the project staff.

Labs are those used by the institution, and lists regulatory details such as CAP and CLIA information.  Sponsor central laboratories are not included in this console.

Each lab and panel has been configured for Augusta University with associated items (i.e. tests or exams).  In the case of labs, “lab normal” values can be defined for each item.  Labs and panels are based on the Hospital’s Charge Master.

Person authorized either by statute or by court appointment to make decisions on behalf of another person.  In human subjects research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Each workgroup in a research institution can define a library that customizes its clinical research and data management environment.  A library is a set of forms, reference codes, protocol annotations, notifications, and sign offs.  Libraries support a group’s workflow while sharing common data elements across the institution.  When a protocol is created in OnCore, a library is assigned to the protocol Libraries drives which Forms, Protocol Annotations, Notifications, and Signoff information that can be used and/or revised.

Business incubator on the AU campus with approximately 16,000 gross square feet of space that accommodate the incubator and the technology transfer offices.

Refers to diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; also diseases or conditions with potentially fatal outcomes.

Mandatory clause for cost-reimbursement type contracts. Under the clause, the sponsor is not obligated to reimburse the contractor for costs in excess of the stated amount. The contractor, however, is not obligated to continue performance once expenses reach the stated amount.

Limited data set allows retention of specific elements of identifying private information: geographic subdivisions, town, city, state, ZIP code, dates, age.  Limited data sets are not considered to be de-identified information.

Within each OU, management groups are defined.  Staff can be assigned to multiple management groups.  Management groups are used to limit user access and the scope of reports.  Each OU can have several management groups.  The user’s supervisor will be responsible for assigning the user to a particular management group via the User Access Request Form.

Comprehensive contract that governs all research activities supported by a particular sponsor. Individual project specific addendums (or task orders) are issued each time a new project is engaged. Each addendum details such aspects as the personnel, funding amount, performance period, and scope of work for the individual project, along with any deviations from the terms of the Master Agreement that may be necessary for performance of the specific project. Also called “umbrella” agreements, this mechanism often takes much longer to establish than a traditional agreement, however it virtually eliminates any need to negotiate the individual project addendums.

Grant that requires a specified portion of the cost of a supported item of equipment or project be obtained from other sources. The required match may be more or less than the amount of the grant. Some matching grants require that the additional funds be obtained from sources outside the recipient organization. Many matching grants are paid in installments, the payments coinciding with the attainment of pre-specified levels of additional funding. Matching grants are very common in the sciences, especially for equipment. They are standard practice in some government agencies.

Permit the exchange of real property with non-profit institutions or with for-profit companies. 

Using certified electronic health record (EHR) technology to: Improve quality, safety, efficiency, and reduce health disparities; Engage patients and family; Improve care coordination, and population and public health; Maintain privacy and security of patient health information.  Ultimately, it is hoped that the meaningful use compliance will result in: Better clinical outcomes; Improved population health outcomes; Increased transparency and efficiency; Empowered individuals; More robust research data on health systems.  Meaningful use sets specific objectives that eligible professionals (EPs) and hospitals must achieve to qualify for Centers for Medicare & Medicaid Services (CMS) Incentive Programs.

Unique 9 -digit number assigned to an Augusta University Health patient.

See cognitively impaired.

Probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

Fabrication, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.

Sponsor's stated purpose, which is designed to address a specified set of problems. Almost all federal research agencies are designated as mission agencies.

Award document that modifies any aspect of an existing award. Example: Carryover approvals, adding or deleting special terms and conditions, changes in funding levels (including NSF's Research Experience for Undergraduates ; NIH's Minority Supplement, DOD's ASSERT Programs), administrative changes initiated by the agency, extensions that include changes in terms, change of principal investigator , etc. OR any change to an IRB-approved study protocol regardless of the level of review it receives initially.  Also referred to as an amendment.

MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and up to the first $25,000 of each subaward (regardless of the period of performance of the subawards under the award). MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward in excess of $25,000. Other items may only be excluded when necessary to avoid a serious inequity in the distribution of indirect costs, and with the approval of the cognizant agency for indirect costs.

Collection and analysis of information or data as the project progresses to assure the appropriateness of the research, its design, and subject protections.

Research conducted at more than one location and under the jurisdiction of more than one IRB.

Research conducted at more than one location and under the jurisdiction of only one IRB.

NCURA advances the field of research administration through education and professional development programs, the sharing of knowledge and experience, and by fostering a professional, collegial, and respected community.

Family of grants provided by the United States National Institutes of Health for training researchers in the behavioral sciences and health sciences.

United States government agency that supports fundamental research and education in all the non-medical fields of science and engineering. Its medical counterpart is the National Institutes of Health.

Assigned to staff, faculty, students for accessing Outlook, Desire2Learn, Citrix, axiUm, and other university applications; sometimes referred to as JagID.

Award not previously awarded or a renewal or continuation award treated as a new award by the sponsor and given a new agency number.

Proposals that are submitted for the first time or ongoing projects that must re-compete for funding prior to expiration of the original award.

A Newborn.

Extension of the period of performance beyond the expiration data to allow the principal investigator to finish a project. Usually, no additional costs are provided.

Member of an Institutional Review Board who has no ties (and whose immediate family has no ties) to the parent institution, its staff, or faculty.  This individual is usually from the local community (e.g., minister, business person, attorney, teacher, and homemaker).

Applicable to grants and cooperative agreements only. A project approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, an award is made for the next budget period, subject to the availability of funds. Continuation projects typically do not compete with new project proposals and are not subjected to peer review beyond the initial project approval.

Failure to follow the regulations, the requirements, and/or determinations of the IRB.

Confidentiality Agreement, also sometimes referred to as a non-disclosure agreement (CDA or NDA), is designed to protect the confidential information that may be released between an industry sponsor or other entity and the AU faculty and staff so that they can determine whether or not to enter into a subsequent agreement for either a clinical trial (CTA) or basic research (SRA).  CDAs may be one-way or mutual and are generally requested by sponsors prior to disclosing a study protocol or other information which the sponsor considers proprietary.  Not all sponsors require a CDA prior to disclosure of confidential information.

Neonate after delivery that,  although living, is not viable.

A description of the protocol-specific method of accomplishing a process. This document can also be used to describe the reason for a discrepancy, missing data or missing documentation and can include information regarding the location of central files.

Legally binding document that serves as a notification to the recipient and others that a grant or cooperative agreement has been made; contains or references all terms of the award; and documents the obligation of funds.

Code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.

Broad umbrella term that is used to describe any product derived from food sources with extra health benefits in addition to the basic nutritional value found in foods. They can be considered non-specific biological therapies used to promote general well-being, control symptoms and prevent malignant processes.

Award is considered to be performed off-campus when the majority of the sponsored activity is conducted in a facility that is not owned by Augusta University and the facility-related costs (i.e. rent, utilities, etc.) are charged directly to the award. The award is also considered to be off-campus when the majority of the sponsored activity is conducted in a facility not owned by Augusta University and the university incurs no costs for using the non-AU owned facility.

Provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

Supports the collaboration between AU and our industry partners, AU faculty and staff inventions, and intellectual property commercialization-related activities with companies from the Fortune 100 to the newest startup firm.  The OIC hosts the Life Sciences Business Development Center (LSBDC).

Develops and distributes resources to assist the health care industry in its efforts to comply with the Nation’s fraud and abuse laws and to educate the public about fraudulent schemes to they can protect themselves and report suspicious activities.  Most federal agencies have their own OIG office, and they also perform audits and investigations.

Provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.

Business division of the Executive Office of the President of the United States that administers the United States federal budget and oversees the performance of federal agencies.

Process of transferring scientific findings from one organization to another for the purpose of further development and commercialization.

Authorized by the National Coordinator, ONC-Authorized Testing and Certification Bodies  test and certify that certain types of electronic health record (EHR) technology (Complete EHRs and EHR Modules) are compliant with the standards, implementation specifications, and certification criteria adopted by the U.S. Department of Health and Human Services (HHS) Secretary and meet the definition of “certified EHR technology.”

Award is considered to be on-campus when the majority of the sponsored activity is conducted in a facility that is owned by Augusta University.  An award is also considered to be on-campus when the majority of the sponsored activity is conducted in a facility that is leased by Augusta University but the facility costs (rent, utilities, etc.) are not charged directly to the award.

The OnCore Administrator/Coordinator/Trainer may all be the same person who functions as the “product manager for OnCore.  This person is the link between OnCore users, technical support personnel, and policy makers.

Person responsible for financial management, which may include feasibility, pre- and post-award activities such as billing, invoicing, and account reconciliation.

Vendor training videos and documents for the OnCore database.

Person responsible for entering initial protocol data that includes the protocol definition, management and treatment staff, sponsor, participating institutions, regulatory information, investigational drug and device information, and the protocol’s calendar. 

Functions as the primary point of contact with investigators and clinical trial coordinators for preparation of study components, including study protocol, calendar of events, and Case Report Forms (CRFs) based upon protocol specifications for investigator-initiated trials.  The Specialist analyzes clinical data from the eCRFs and generates tables for use in presentations, publications, and posters, and prepares customized reports about Augusta University clinical trials and their accrual for the Principal Investigators.  The Specialist also assists with Training.

Assists with super user and end user training during the implementation and supports ongoing training needs.  The ongoing training needs range from follow-up training with existing staff to regular new employee training.  The OnCore trainer participates in the training for both the initial functional area that goes live and for each subsequent area that your organization brings live.  Frequently the OnCore Coordinator and the OnCore Trainer is the same person.

Anyone who is granted access to OnCore with a user ID and password (includes affiliate organizations and research team members).

Clinical Research Management System for Augusta University

Member of the Information Technology (IT) department and is usually charged with installing, supporting, and maintaining servers or other computer systems, and planning for  and responding to service outages and other problems.  Other duties may include scripting or light programming, project management for systems-related projects

Spoken presentation of the elements of informed consent to the prospective subject or their legally authorized representative and received agreement (or refusal).  The presentation may be based on information contained within an oral consent script or the written consent document.  Oral consent is often associated with waiving the documentation of consent.  Oral consent is usually documented in the research project files or, in some cases, may be audio or video recorded.  Also referred to as verbal consent.

See Institutional Official

Used to organize protocols into logical structural divisions, which is useful for reporting purposes and to restrict access to protocols.  For Augusta University, there are four:  Enterprise, Enterprise Non-ePRMS, Cancer Center, and Cancer Center Non-ePRMS. 

Includes all financial resources, whether Federal, non-Federal, commercial or organizational, available in direct support of an individual's research endeavors, including, but not limited to, research grants, cooperative agreements, contracts, or organizational awards. Other support does not include training awards, prizes, or gifts.

Broad funding opportunity announcements that enable investigator-initiated applications to be submitted.

The agreement of parent(s) or guardian(s) to the participation of their child or ward in research.

Direct costs for items such as stipends or subsistence allowances, travel allowances, and registration fees paid to or on behalf of participants or trainees (but not employees) in connection with conferences, or training projects.

Cost of routine and ancillary services provided by hospitals to participants in research studies. Routine services include regular room services, medical and surgical supplies, and the use of equipment and facilities for which a separate charge is not customarily made. Ancillary services are those special services in addition to routine services, e.g., x-ray, operating room, laboratory, pharmacy, blood bank, and pathology.

See Compensation.

Centralized grants payment system operated by the Division of Payment Management, Program Support Center. 

System using reviewers who are the professional equals of the principal investigator or program director who is to be responsible for directing or conducting the proposed project. It is a form of objective review. Peer review is legislatively mandated in some programs and in other programs is administratively required.

Site where research is performed.

Period of performance means the time during which the non-Federal entity may incur new obligations to carry out the work authorized under the Federal award. The Federal awarding agency or pass-through entity must include start and end dates of the period of performance in the Federal award (see §§200.210 Information contained in a Federal award paragraph (a)(5) and 200.331 Requirements for pass-through entities, paragraph (a)(1)(iv)).

Documents effort devoted to Sponsored, University, and Clinical activities. Sections of the effort report are separated by types of activities included in one’s 100% ‘University Effort’ as follows:

• Sponsored Activities (All report types): the certification requirement to appropriately record the effort for each specific sponsored project.
• Other University Activities (All report types) (e.g., Instruction, Administration, Non-Sponsored Research, University Service, Competitive Proposal Preparation): Certification requirement = recording of effort as a subtotal of these activities toward one’s 100% ‘University Effort’.
• Clinical Care and Medical Center-Related Activities – Time Allotment for Medicare Cost Reporting (Only Clinical Faculty report type): Certification requirement = recording an average number of hours worked during a week in addition to recording specific effort devoted in: 1) Direct Patient Care; 2) Instruction for
• Residents/Fellows/Trainees; 3) Administration of Residency/Fellowship Programs; and 4) Medical Center- Related Clinical Administration and Management.

Agreement of parent(s) or guardian to the participation of their child or ward in research [45 CFR 46.402(c)].  Permission may also be used more generally to refer to the consent of an adult participant or to the assent of a child participant.

Method of expressing the amount of time (or effort) devoted to a project.  PM takes into account the individual’s type of appointment (i.e. calendar year CY, academic year AY, or summer month SM) and the percentage of effort.

Information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual.  The definition of PII is not anchored to any single category of information or technology.  Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified.  In performing this assessment, it is important to recognize that non-PII can become PII whenever additional information is made publicly available that, when combined with other available information, could be used to identify an individual.  See also identifiable information and FERPA.

An IND may be submitted for one or more phases of investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general, the phases are conducted sequentially, they may overlap.

• Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer participants (subjects). These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects (participants) and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20‐80 [21 CFR 312.21(a)(1)].
  
  Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes [21 CFR 312.21(a)(2)].
• Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short‐term side effects and risks associated with the drug.
  
  Phase 2 studies are typically well‐controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects (participants).
• Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about the effectiveness and safety that is needed to evaluate the overall benefit‐risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects (participants) [21 CFR 312.21(c)].

Application for Continuation of a PHS Grant ( National Institutes of Health).

Application Form for a PHS Grant ( National Institutes of Health).

Defining characteristic of single-specialty practice is the presence of two or more physicians providing patients with one specific type of care (i.e., primary care or a specific subspecialty practice), while multispecialty group practices are defined as offering various types of medical specialty care within one organization.

Name of the electronic medical record used by Augusta University Health system.

Research module that resides within the Electronic Health Record at Augusta University Medical Center and the Children’s Hospital of Georgia.

Person or a department serving as the coordinator or focal point of an activity or program.

Refers to species in which the young are relatively mature and mobile from the moment of birth.

Agreement between an institution and a study sponsor that is executed prior to enrollment of subjects into a clinical trial.  This agreement ensures all payments for services done to prepare for the study are paid for by the sponsor should the study not initiate.

Brief description, usually 2-10 pages, of research plans and estimated budget that is sometimes submitted to determine the interest of a particular sponsor prior to submission of a formal proposal. Also termed Preliminary Proposal.

Period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e. has been delivered).  Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test [45 CFR 46.203(b)].

Individual responsible for the conduct of research or other activity described in a proposal for an award.  For DSPA internal purposes, a PI/PD must be a faculty member.  For the IRB, the Principal Investigator is the individual who assumes overall responsibility for the ethical conduct of the study.  AU's IRB requires that the Principal Investigator be a member of the University's faculty or staff.  Multiple PIs are not allowed on an IRB submission.  Students may serve as the Principal Investigator on a research study as long as they have a Faculty Advisor (Faculty Sponsor) who is a Faculty Member of AU.  Submissions to the IRB must be made by the PI and IRB correspondence will be directed to the PI.

Requirement for written documentation of permission to use project funds for purposes not in the approved budget, or to change aspects of the program from those originally planned and approved. Prior approval must be obtained before the performance of the act that requires such approval under the terms of the agreement.

Score derived from the rating given a proposal by each member on a review committee. It is used to help determine which approved proposals will be granted awards, based on funds available.

Individual involuntarily confined or detained in a penal institution.  The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. [45 CFR 46.303(c)].  For Department of Defense (DOD) research the term includes military personnel in either civilian or military custody. 

Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.  Compare to confidentiality.

Review body that may be established to act upon requests for a waiver or an alteration of the Authorization requirement under the Privacy Rule for uses and disclosures of PHI for a particular research study. A Privacy Board may waive or alter all or part of the Authorization requirements for a specified research project or protocol. A covered entity may use and disclose PHI, without an Authorization, or with an altered Authorization, if it receives the proper documentation of approval of such alteration or waiver from a Privacy Board.

1) Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. 
Or,
2) information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]

Typically responsible for reviewing those submissions that do not require Full Review.  The Chair requires access to meeting attendee lists, reviewer assignments, reviews, and decisions (except for those protocols where the Chair is listed as protocol staff).

Manages the PRMC meeting agendas, tracks submissions, tracks committee decisions, and manages communications between the investigators and the PRMC.  The Coordinator requires access to all PRMC submissions, reviews, and decisions.  The Coordinator is responsible for assigning Reviewers to submissions.

Individuals who have been appointed to the PRMC and whose period of appointment is current.  Members require access to view all the submission on the agenda for a PRMC meeting.  Members cannot be assigned to review their own protocols nor can they view the reviewer assignments or notes.

Reviewers (as opposed to Members) are individuals who may be assigned to review a protocol for the PRMC but who are not currently committee members.  Reviewers may access all the submissions on the agenda for a PRMC meeting.  Reviewers cannot be assigned to review their own protocols.

An investigator (or staff person acting on their behalf) creates a submission and sends it to the PRMC for review.

Describes existence of a research opportunity. It may describe new or expanded interest in a particular extramural program or be a reminder of a continuing interest in an extramural program.

Periodic, scheduled reports required by the sponsor summarizing research progress to date. Technical, fiscal, and invention reports may be required.  For the IRB, details of the study activity during the last approval period.  Often requested when submitting for continuation or closure of your active IRB research study.

NIH official responsible for the programmatic, scientific, and/or technical aspects of a grant.

Total time for which support of a project has been programmatically approved. A project period may consist of one or more budget periods. (Also see Budget Period.)

Application for funding that contains all information necessary to describe project plans, staff capabilities, and funds requested. Formal proposals are officially approved and submitted by an organization in the name of a principal investigator.

Individually identifiable health information transmitted or maintained by a covered entity or its business associate [45 CFR 160.103].  PHI and its potential uses in research are described in more detail in the Health Insurance Portability and Accountability Act (HIPAA).  See also identifiable information.

Programs and activities of a State educational agency (SEA), local educational agency (LEA), or other recipient of funds under any program funded by the U.S. Department of Education.  It governs the administration to students of a survey, analysis, or evaluation that concerns one or more of the following eight protected areas:

1. Political affiliations or beliefs of the student or the student’s parent;
2. Mental or psychological problems of the student or the student’s family;
3. Sex behavior or attitudes;
4. Illegal, anti-social, self-incriminating, or demeaning behavior;
5. Critical appraisals of other individuals with whom respondents have close family relationships;
6. Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers;
7. Religious practices, affiliations, or beliefs of the student or student’s parent; or,
8. Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program).

Written description of a research study.  It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.  For IRB review, a protocol should include detailed information about the study population and components of human subjects’ protections (risks, benefits, recruitment, consent, etc.).

Defined by a “Protocol Specification,” the protocol calendar is protocol-specific and is populated with “milestones” (e.g. Consent Date, On Study Date, On Follow-Up Date, etc.), which are based upon offsets and used to trigger study visit dates.  The protocol calendar is accessed via the eCRFs/Calendars horizontal tab.

Access and research staff role designating the lead person responsible assigned to the protocol.  This person provides oversight to the study team, and has important editing and signoff privileges within OnCore.

Divergence (unintentional or intentional) from the IRB-approved protocol without significant consequences.  A deviation generally (a) does not increase risk or decrease benefit, (b) does not have a significant effect on the subject's rights, safety, or welfare, and (c) does not impact the integrity of the data.  Deviations may result from the action of the subject or the researcher.  May also be non-compliance.  See protocol violation.

Divergence (unintentional or intentional) from the IRB-approved protocol that (a) increases risk or decreases benefit, (b) affects the subject's rights, safety, or welfare, or (c) impacts the integrity of the data.  May also be non-compliance.  See protocol deviation.  (Note: Deviation and violation may be used synonymously, but violation tends to be more serious.)

Operating division of the Health and Human Services Department (HHS) responsible for promoting the protection and advancement of the American population's physical and mental well-being.

Commercial document and first official offer issued by a buyer to a seller, indicating types, quantities, and agreed prices for products or services. It is used to control the purchasing of products and services from external suppliers

Majority of voting members are present.

Act of amending the budget buy moving funds from one category or line item to another. Certain sponsors may require prior approval before rebudgeting.

Process of notifying research subjects of changes (or new risks, problems, events, etc.) in the research, including documentation of the subject's continued informed consent through signature on a revised written consent form.

Recruitment, a component of the consent process, is the process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment.

Reference codes are codes and definitions that are used throughout OnCore, often to define lists of choices when entering data.  Some Reference Codes are industry standard, some are defined by Forte, and others are defined by Augusta University.  Reference Codes may be added or modified.  Due to the consequences to the system that may be associated with changes to reference codes, adding or modifying reference codes will only take place after consultation with Forte.

Short for "regulations."

Contractual rules and procedures governing sponsored research projects.

Event or issue (e.g., unanticipated problem, side effect, etc.) is "related" if in the opinion of the investigator it is likely to have resulted from participation in the research study.

Organization that has entered into an IRB Authorization Agreement with another organization's IRB.

Applicable to grants and cooperative agreements only. A competitively reviewed proposal requesting additional funds extending the scope of work beyond the current project period.

Categories of information that require immediate or timely reporting to the IRB for review and determination.  Includes, but is not limited to, information that indicates a new or increased risk to subjects or others, non-compliance, audits, unresolved complaints, and other unanticipated problems, events, acts, or omissions.  See also unanticipated problem involving risks to subjects or others.

Announcements that indicate the availability of funds for a topic of specific interest to a sponsor. Proposals submitted in response to RFAs generally result in the award of a grant. Specific grant announcements may be published in the Federal Register and/or specific sponsor publications. 

Announcements that specify a topic of research, methods to be used, product to be delivered, and appropriate applicants sought. Proposals submitted in response to RFPs generally result in the award of a contract. Notices of federal RFPs are published in the Commerce Business Daily.

Formal request from to vendors for a price quotation on equipment or supplies to be purchased.

Systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]

Experiment that involves a test article and one or more human subjects, and that meets any one of the following:

• Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;
• Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR
• Any activity the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

Note: FDA-regulation of research is not dependent on funding or funding sources.

Conducting research administration by utilizing electronic resources such as the internet, the World Wide Web, form templates, databases, and other electronic tools.

Account established for the purpose of receiving the transfer of an unrestricted residual balance at the closeout of a sponsored account.

Unobligated balance of funds remaining in a sponsored account at termination of the project and closeout of the account.

Ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

For purposes of time and effort reporting, an individual having firsthand knowledge or using a suitable means of verification of the work performed toward specific sponsored activities. Normally, this is the employee or Principal Investigator for whom the University effort report has been generated. In the event that the employee/Principal Investigator is unable to certify the effort report, a surrogate who having firsthand knowledge or using a suitable means of verification of the work performed may certify the report (e.g., the Department Chair, a Co-Investigator).

Interface used to facilitate the sharing of clinical research data with Electronic Medical Record (EMR) systems (PowerTrials/PowerChart) and OnCore.  The RPE Interface allows users to send basic protocol and subject status information from OnCore to an EMR, increasing patient safety and reducing the need for duplicate data entry.

Modified and resubmitted request for funding for a project that was previously not funded either because it was denied by the sponsor or withdrawn by the principal investigator.

Probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.  Both the probability and magnitude of possible harm may vary from minimal to significant.  Federal regulations define only "minimal risk."  See also minimal risk.

All direct salaries, wages, and fringes.

Description of the work to be performed and completed on a research project.

The Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.

Individual who contributes to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation.  Note that Principal Investigator/Project Directors are always considered key personnel.

Failure to adhere to laws, regulations, or policies governing research involving human participants that might reasonably be regarded as:

• Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human research participants, research staff, or others

• If studies conducted at the Charlie Norwood VA Medical Center, it includes substantively compromising the effectiveness of a VA facility’s human research protection program.

Refers to diseases or conditions that cause major irreversible morbidity (e.g., blindness, loss of limb, loss of hearing, paralysis, or stroke). This does not include “pre-existing” (e.g., chronic) diseases or conditions with major morbidity.

Used with IRB approval when a subject or the subject’s legally authorized representative cannot read the standard written consent form.  The short form consent document states the elements of consent that are presented orally and is translated into the appropriate language.  The short form consent process requires a witness (and in some cases an interpreter or translator) and has specific requirements for documentation of consent.

Individual who has been delegated the authority to bind Augusta University/Augusta University Research Institute, Inc. in grant and contract administrative activities.

Agency administered programs supported by ear-marked federal funds, making grants to small business entities.

Grant applications and/or programs to fund small business "teamed" with research institutions.

Special type of grant, often limited to a beginning researcher. Typically, such an award may be obtained for one year only.

Research management society providing education, professional development and the latest comprehensive information about research management.

Documents in which data collected for a clinical trial is first recorded. These data are usually later entered in the data collection form or case report form. The ICH-GCP guidelines define source documents as "original documents, data, and records." Source documents contain source data, which is defined as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. These include medical records, x-rays, labs, etc. These documents are used to verify inclusion/exclusion criteria, collected data points, etc.

Organization that funds a research project.

Sponsors means a person/entity that takes responsibility for and initiates a clinical investigation.  The sponsor type in OnCore are industry, institutional, externally peer reviewed, national group, or other.  The sponsor type list can be updated by since it is used for Cancer Center reporting, Forte does not recommend changing it as NCI reports will be impacted. 

Salary caps are limitations, sponsor-imposed ceilings, on the amount of an individual’s salary that a sponsor will directly support. When an employee’s institutional base salary (IBS) exceeds the effective salary cap the University must fund the difference from non-federal sources. This difference is considered cost sharing thus the associated effort is expected to be captured on the effort report for certification purposes.

Account Established for the receipt and expensing of funds from a source external to the institution for project-specific purposes.

Externally funded programs under which the University is obligated to perform a defined scope of work according to specific terms and conditions and within budgetary limitations. These programs are to be budgeted and accounted for separately from other activities. Sponsored activities include grants, contracts, cooperative agreements, clinical trial agreements, Intergovernmental Personnel Agreements and other awarding instruments supporting research, instruction, public service, and clinical trials.

Serves as the principal interface between Augusta University and external agencies providing sponsored program support, including the Augusta University Research Institute (AURI).

Externally funded activities in which a written agreement (e.g. grant, contract or cooperative agreement) is entered into or issued on behalf of Augusta University Research Institute, Inc. or Augusta University.

Computer database with detailed and up-to-the minute information about thousands of government and private funding opportunities.

In a contract proposal, the detailed description of the work to be performed under the contract.

Stewardship Report (including a general financial report, a brief summary of how the funding was used, and/or the impact of the gift) states how funds were used. A stewardship report may not be a detailed technical report. However, if publications result, copies of such publications may be shared with the donor. In addition, confirmation of proper utilization of funds is allowed.

Payment made to an individual under a fellowship or training grant in accordance with pre-established levels to provide for the individual's living expenses during the period of training.

Program to simplify the requirements of the non-competing application and financial reporting processes for the National Institutes of Health.

Schematic that shows study procedures, codes, prices, location and billing designation (study, patient, insurance).

Document written under the authority of, and consistent with the terms and conditions of an award (a grant, cooperative agreement, or contract) that transfers a portion of the research or substantive effort of the prime award to another institution or organization.

May also be referred to as participants. See human subjects.

Follows the guidelines defined in the Protocol Calendar to create a personalized visit schedule with actual dates automatically populated based upon milestones.  The Subject Calendar is accessible via the Subject Console.

Process through which one receives assurance that work was performed to provide a certification of effort on the periodic effort reports. This process must take into consideration other institutional records and provide for the documented review of such records in support of work performed. Some examples of these records might include: calendars, teaching schedules, logbooks, or sponsor budgets. Other means of verification may also suffice, including e-mails attesting to effort devoted based upon firsthand knowledge. Oral verification from the employee/Principal Investigator or others fulfilling the role of a responsible person to an administrator will not suffice as a suitable means of verification.

Typically responsible for the actual management of day-to-day operations.  They may be mid-level management staff and other team members who will complete post go-live new employee and other ongoing training.  Super Users may be key contributors to creating the detailed process and other end user documentation.

Request to the sponsor for additional funds for an ongoing project during the previously approved performance period. A supplemental proposal may result from increased costs, modifications in design, or a desire to add a closely related component to the ongoing project.

Directive of the fully convened IRB, or IRB designee either to stop temporarily some or all previously approved research activities, or to stop permanently some previously approved research activities. Suspended protocols remove open and require continuing review.

Generally one of the primary users of an application.  They should be conversant with the application and should play an integral role in the coordination of application changes (e.g. version upgrades, software patch, etc.) and conducting change control assessments.  The System Administrator typically has full access rights.  The OnCore Coordinator, Specialist, and/or Trainer may function as the System Administrator.

Activity that involves a prospective research plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question.

Legally binding document authorizing work and appropriating funds as a supplement to a basic contract.

Identifying number used for tax purposes in the United States. It is also known as a Tax Identification Number or Federal Taxpayer Identification Number. A TIN may be assigned by the Social Security Administration or by the Internal Revenue Service (IRS).

Agreement between two or more parties to participate in a research project or teaching activity.

Recorded information, regardless of form or characteristic, of a scientific or technical nature. Often referred to as the "science" of a proposal.

Action of the IRB, IRB designee, Organizational Official, or designee of the Organizational Official to permanently withdraw IRB approval of all research procedures.  Terminated studies are permanently closed and no longer require continuing review.

Legal requirements imposed on an agreement by the sponsor, whether by statute, regulation(s), or terms in the award document. The terms of an agreement may include both standard and special provisions that are considered necessary to protect the sponsor's interests.

Property or services which benefit a federally assisted project or program and which are contributed by non-federal third parties without charge to the grantee, or sub grantee, under the grant agreement.

Method for genotyping and/or identification of small rodents; the practice of removing the toe from the most distal joint to the tip of the toe; removal of the last phalangeal (toe) bone of a digit from one or more limbs corresponding to a predetermined numbering code.

Cost that can be specifically identified with a particular project, program, or activity or that can be directly assigned to such activities relatively easily and with a high degree of accuracy. Direct costs include, but are not limited to, salaries, travel, equipment, and supplies directly benefiting the grant-supported project or activity.

Professional activity for which the Augusta University Enterprise employs an individual, whether on a full or part time basis.

Includes all activities performed by a faculty or staff member regardless of how (or whether) the individual receives compensation. All such activities are comprised of both inclusions and exclusions in defining 100% ‘University effort.’

Total allowable direct and indirect costs incurred by the institution to carry out an approved project or activity.

Use of an investigational drug, vitamin, biologic, or nutraceutical with a person or group of persons with a serious or debilitating condition where there are no other treatment options available.

Expenditures in excess of the budget or that are not allowable according to the regulatory guidelines. Unallowable expenditures also include expenditures in excess of the total payments received (this could occur on milestone and/or clinical trial based awards). While there may be programmatic and specific circumstances which justify the costs outlined below, these costs are generally questioned, and specific approval from DSPA and/or the federal agency may be necessary before the cost is incurred.

Any incident, experience, or outcome in any study involving human subjects that meets ALL of the following criteria:

• Is new or greater than previously known in terms of nature, severity, or frequency given the research procedures that are described in the protocol related documents, such as the IRB approved research protocol, informed consent document, and the PI brochure;  and the characteristics of the subject population being studies using the terms “unanticipated” and “unexpected”; AND
• Is related or possibly related to participation in the research (“possibly related” means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); AND
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

A device used for a purpose or condition for which the device would require but does not have premarket approval or an approved investigational device exemption (IDE) from FDA.

Provides awarding agencies and grantees a standardized set of financial management procedures and definitions. State agencies are required to adhere to these standards when administering grants and other financial assistance agreements with cities, counties and other political subdivisions of the state.

Regulations published by the Federal Office of Management and Budget (OMB) that establish principles for determining administrative requirements, cost principles, and audit requirements applicable to grants, contracts, and other government agreements.  The Regulation is codified in 2 CFR Part 200.

• NIH
• NSF
• HRSA

Award made by a sponsor to an organization without considering competitive proposals. Unilateral awards are most often made when unsolicited proposals receive favorable treatment.

Provides leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on public policy, the best available science, and effective management.

Vertebrate animals used for research or teaching must be assigned to a USDA pain and distress category on the protocol under which they are used.

Federal agency for granting U.S. patents and registering trademarks.

Portion of ‘total professional effort’ that comprises one's professional/professorial workload at Augusta University, including the Medical Center for which the employee is compensated [through Augusta University Research Institute (AURI) and/or Augusta University Medical Associates (AUMA)]. (See definition of Institutional Base Salary). This includes research, instruction, other sponsored activities, administration, non-sponsored/departmental research, university service, competitive proposal preparation and clinical activities. For the purpose of effort certification, ‘university effort’ totals 100%, regardless of the number of hours worked or the individual’s appointment percentage.

Difference between the amount of indirect costs charged to the award versus the amount which could have been charged had the applicable Augusta University Federally approved negotiated indirect cost rate been applied. Unrecovered indirect costs, including indirect costs on cost sharing or matching expenditures may be included as part of cost sharing or matching only with the prior approval of the awarding agency. In accordance with the Uniform Guidance 200.306, prior agency approval is required if Unrecovered Indirect Costs are to be used as part of the cost sharing/matching.

Monies with no requirements or restrictions as to use or disposition. Grants, contracts, and cooperative agreements are considered to be restricted funds, while gifts are usually considered unrestricted funds.

Residual that is not required to be returned to the external funding source.

Proposals submitted to a sponsor that are not in response to an RFP, RFA, or program announcement. (See also Investigator-Initiated Proposal.)

With respect to individually identifiable health information, the sharing, employment, application, utilization, examination, or analysis of such information within the entity or health care component (for hybrid entities) that maintains such information.

Venture capital (VC) is a type of private equity, a form of financing that is provided by firms or funds to small, early-stage, emerging firms that are deemed to have high growth potential, or which have demonstrated high growth (in terms of number of employees, annual revenue, or both). A venture capitalist is an investor who either provides capital to startup ventures or supports small companies that wish to expand but do not have access to equities markets. 

See oral consent.

Newborn being able after delivery to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.

Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.

University expenses committed in a proposal to a sponsor, when it was not required. The university must track VCCS in accordance with federal regulations.

University expenses, such as faculty salaries, that is over and above that which is committed and budgeted for in a sponsored agreement. The university does not have to track VUCS in accordance with federal regulations.

The documentation that the covered entity obtains from a researcher or an IRB or a Privacy Board that states that the IRB or Privacy Board has waived or altered the Privacy Rule's requirement that an individual must authorize a covered entity to use or disclose the individual's PHI for research purposes.

Waiver of some or all required elements of informed consent for research that meets certain criteria and are not regulated by the FDA. The IRB will make the determination if the research meets criteria for granting the waiver.

Waiver of the requirement for the investigator to obtain a signed consent form from participants if the research meets certain criteria. The IRB will make the determination if the research meets criteria for granting the waiver and may require an information sheet be given to participants informing them of the research.

Waiver of research participants’ authorization for use/disclosure of protected health information about them for research purposes (i.e.: chart reviews). The IRB will make the determination if the research meets criteria for granting the waiver.

Child who is placed in the legal custody of the state or other agency, institution or entity, consistent with applicable federal, state or local law.

Subject who enrolled (i.e., consented to participate) but later withdrew from (i.e., discontinued his or her participation in) a study, either before, during, or after completing research procedures.  For a variety of reasons, a subject enrolled in a research study may decide to withdraw from the research, or an investigator may decide to terminate a subject’s participation in research regardless of whether the subject wishes to continue participating (e.g., for non-compliance with research procedures). 

A person who is independent of the research team and cannot be unfairly influenced by people involved with the research, who does not have a coercive relationship with the participant, who attends the informed consent process when the participant or the participant’s legally authorized representative is illiterate or legally blind. A witness is required when using a translated consent.