DEA Extramural Glossary: 'D' Terms

DEA Extramural Glossary

'D' Terms

Data and Safety Monitoring DSM

Principles of monitoring data and safety:

All clinical trials require monitoring — Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III); etc.

Monitoring should be commensurate with risks — The method and degree of monitoring needed is related to the degree of risk involved. A monitoring committee is usually required to determine safe and effective conduct and to recommend conclusion of the trial when significant benefits or risks have developed or the trial is unlikely to be concluded successfully. Risk associated with participation in research must be minimized to the extent practical.

Monitoring should be commensurate with size and complexity. Monitoring may be conducted in various ways or by various individuals or groups, depending on the size and scope of the research effort. These exist on a continuum from monitoring by the principal investigator or NIH program staff in a small phase I study to the establishment of an independent data and safety monitoring board for a large phase III clinical trial.

Quoted from NIH Guide Notice NOT-98-084 — NIH Policy for Data and Safety Monitoring.

Data and Safety Monitoring Board DSMB: A DSMB is a group of doctors, statisticians, and others who are independent of the people, organizations, and institutions that are sponsoring, organizing, and conducting the clinical trial. DSMB members are experts in clinical research and clinical trials. They ensure that trial data are complete, and they can stop a trial early if safety concerns arise or if an answer to the main research question is obtained earlier than expected. Stopping a trial early because the main research question has been answered may make it possible for people who are not in the trial to get access to an effective intervention sooner. DSMBs have scheduled meetings to review clinical data, and their meeting minutes or recommendations are forwarded to the IRBs.
Quoted from the NCI Clinical Trials Information — Patient Safety — Scientific Review webpage.

Data and Safety Monitoring Plan DSMP: Prior to award, this plan must be approved by the applicant's IRB and the NIH awarding IC prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the DSMB (if applicable) or other monitoring entity, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.
Quoted from the NIH OER Glossary & Acronym List.

Data Sharing: It is NIH policy that the results and accomplishments of the activities that it funds should be made available to the public. PIs and funding recipient institutions are expected to make the results and accomplishments of their activities available to the research community and to the public at large.
For additional information, visit the NIH Data Sharing Policies and Related Guidance on NIH-Funded Research Resources webpage.

Data Universal Numbering System DUNS: A nine-digit number established and assigned by Dun and Bradstreet to uniquely identify a business entity.
Quoted from the NIH OER Glossary & Acronym List.

Debarment and Suspension: The actions taken by a debarring official in accordance with OMB guidance at 2 CFR 180, "Non-procurement Debarment and Suspension," as implemented by HHS in 2 CFR 376, to exclude a person or organization from participating in grants and other non-procurement awards government-wide. If debarred or suspended, the person or organization may not receive financial assistance (under a grant, cooperative agreement, or subaward, or contract under a grant) for a specified period of time. Debarments and suspensions carried out pursuant to 2 CFR 376 are distinct from post-award suspension action by an awarding agency. (See NIH Grants Policy Statement: 4 Public Policy Requirements, Objectives and Other Appropriation Mandates 4.1.6 Debarment and Suspension).
Quoted from the NIH OER Glossary & Acronym List.

Debriefing: Debriefings provide many benefits to contractors who compete for a Government contract. Debriefings give unsuccessful offerors insight into the contracting officer's decision making and evaluation process, and help contractors better compete in future solicitations. Additionally, a properly conducted debriefing can clear up an offeror's misunderstandings and greatly minimize the risk of protests being filed.
There are two types of debriefings, preaward and postaward, governed by Federal Acquisition Regulation (FAR) 15.505 and 15.506, respectively.

A contractor can request a preaward debriefing if the contracting officer excluded the contractor before awarding the contract to any other offeror.

A contractor may request a postaward debriefing when the contracting officer decides to which offeror to award the contract.

Quoted from the GSA's Debriefings Deconstructed webpage.

Defense Advanced Research Projects Agency DARPA: The Defense Advanced Research Projects Agency of the U.S. Department of Defense responsible for the development of new technologies for use by the military.

Deferral: Deferral is the process by which a recommendation on an application under review is delayed because specific information is needed to complete the review, or because the review has been otherwise compromised.

Deferred DF: Refers to the delay in the review of an application by a scientific review group, usually to the next review cycle, due to insufficient information.
Quoted from the NIH OER Glossary & Acronym List.

Deliverable: A report or product that must be delivered to the government by the contractor to satisfy contractual requirements.
Quoted from the NSF Glossary of Procurement Terms.

Delivery Order: "Delivery order" means an order for supplies placed against an established contract or with Government sources.
Quoted from §2.101 of the Federal Acquisition Regulation.

Delivery-Order Contract: "Delivery-order contract" means a contract for supplies that does not procure or specify a firm quantity of supplies (other than a minimum or maximum quantity) and that provides for the issuance of orders for the delivery of supplies during the period of the contract.
Quoted from the §16.501 of the Federal Acquisition Regulation.

Demonstration Project: A project, supported through a grant or a cooperative agreement, generally to establish or demonstrate the feasibility of new methods or new types of services.; See Also: Research Demonstration and Dissemination Project ; Research and Development Demonstration Contract

Department of Health and Human Services DHHS: It is the mission of the U.S. Department of Health & Human Services (HHS) to enhance and protect the health and well-being of all Americans. We fulfill that mission by providing for effective health and human services and fostering advances in medicine, public health, and social services.

Designated Federal Officer DFO: Per 41 CFR §102-3.25, Designated Federal Officer ("DFO"), means an individual designated by the agency head, for each advisory committee for which the agency head is responsible, to implement the provisions of sections §10(e) and (f) of 5 U.S.C. app. – the Federal Advisory Committee Act (FACA) and any advisory committee procedures of the agency under the control and supervision of the Committee Management Officer (CMO).
The terms Executive Secretary, Designated Federal Official and Scientific Review Officer are used at NIH to denote the Designated Federal Officer role.
For information about NIH Advisory Committees, see the NIH Office of Federal Advisory Committee Policy (OFACP) website.

Designated Federal Official DFO: Designated Federal Official (DFO) is a term used at NIH to denote the Designated Federal Officer (DFO) role.; See: Designated Federal Officer

Detailed Budget for Initial Budget Period Form: PHS 398 Fillable Form Page 4 — These forms are to be used only with paper submissions using the PHS 398. Do not use the PDF samples provided below in an SF424 (R&R) application. These are fillable PDF forms which will cause an error in the electronic submission of an SF424 (R&R) application. See the SF424 (R&R) application page for appropriate formats to be used for electronic submission.
Note: The terms "detailed budget" and "R&R Budget" are used interchangeably.

Development: "Development" is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes.
Quoted from 45 CFR §75.2.

Development Contracts: See: Research and Development Contract Proposal

Deviation: A departure on a single-case or class basis from a regulatory or policy requirement. A single-case deviation represents a request for waiver or exception sought for one grant only that arises on a case-by-case basis. A class deviation involves more than one grant for which the same type of deviation action is being requested.
Quoted from the NIH OER Glossary & Acronym List.

Direct Cost/Direct Costs: Grants: Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. (See NIH Grants Policy Statement 7.3 Direct Costs and Facilities and Administrative Costs)
Quoted from the NIH OER Glossary & Acronym List.
Contracts: "Direct cost" means any cost that is identified specifically with a particular final cost objective. Direct costs are not limited to items that are incorporated in the end product as material or labor. Costs identified specifically with a contract are direct costs of that contract. All costs identified specifically with other final cost objectives of the contractor are direct costs of those cost objectives.
Quoted from §2.101 of the Federal Acquisition Regulation.; See Also: Indirect Cost

Direct Operations: Funds for salary and other administrative costs.

Director's Consumer Liaison Group DCLG: Now known as the NCI Council of Research Advocates (NCRA).
Information on past NCRA/DCLG meetings, including agendas and summaries, can be on the NCI Division of Extramural Activities website.; See: NCI Council of Research Advocates

Disaggregation Application: An application with a portion (or subproject) funded as a separate grant.
Quoted from the NIH OER Glossary & Acronym List.

Disallowed costs: Disallowed costs means those charges to a Federal award that the Federal awarding agency or pass-through entity determines to be unallowable, in accordance with the applicable Federal statutes, regulations, or the terms and conditions of the Federal award.
Quoted from 45 CFR §75.2.

Discretionary Grant: A grant (or cooperative agreement) for which the federal awarding agency generally may select the recipient from among all eligible recipients, may decide to make or not make an award based on the programmatic, technical, or scientific content of an application, and can decide the amount of funding to be awarded.
Quoted from Grants.gov Grant Terminology.

Discussant

In the first level of review, a Discussant is a reviewer assigned to an application who:

reads and understands the critiques of the assigned application;
may provide a short written review if the SRO asks for one;
provides additional information or illustration during the review discussion; and
is not expected to submit a written critique.

Also known as a Reader.

For additional information, visit the NIH OER Attendees Roles and the NIH OER Know Assignment Role webpages.