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Data and Safety Monitoring Board (DSMB): An independent committee composed of community representatives and clinical research experts that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.
Data and Safety Monitoring Plan: A Data and Safety Monitoring Plan (DSMP) for a clinical study is an outline set out in advance for the routine review and evaluation of enrollment, data, outcomes, and adverse events.
Data Sharing: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing/). Investigators should seek guidance from their institutions on issues related to institutional policies, local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data-sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Deferral: 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.
DHHS: U.S. Department of Health and Human Services. Federal executive department of which the U.S. Public Health Service (PHS) is a component. The NIH is an agency of the PHS.
Direct Costs: Costs that can be specifically identified with a particular project(s) or activity. Examples of research project-specific expenses include expenses for equipment, personnel, travel, and others necessary to carry out a research project.
Double-Blind Study: A clinical trial design in which neither the subject participants nor the study staff know which patients are receiving the experimental drug and which are receiving a placebo or another therapy.
Draft Review Report: A preliminary compilation of reviewer critiques used by Scientific Review Groups to guide final discussion and assignment of overall priority scores to applications.
DSMB: See Data and Safety Monitoring Board.
Dual Assignments: Applications that are simultaneously assigned to two Institutes, Centers, or Divisions. The primary Institute has complete responsibility for administering and funding the application; the secondary assumes this responsibility only if the primary is unable or unwilling to support it.
Dual Review Process: The peer review approach used by NIH. The first level of review provides a judgment of scientific merit. The second level of review, usually conducted by an Institute/Center/Division’s Advisory Council, assesses the quality of the first review, sets program priorities, and makes funding recommendations.
Data Universal Numbering System (DUNS) number: Identifier government vendors need to register in the Central Contractor Registration database so they can apply for a federal grant. Go to CCR.
