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.

NCI's Division of Cancer Biology (DCB) encourages and facilitates continued support of basic research in all areas of cancer biology to provide the research foundation which enables improved understanding of the disease and may lead to new approaches for prevention, diagnosis, and treatment.

NCI's Division of Cancer Control and Population Sciences (DCCPS) conducts and supports an integrated program of genetic, epidemiological, behavioral, social, applied, and surveillance cancer research to reduce risk, incidence, and deaths from cancer as well as enhance the quality of life for cancer survivors.

NCI's Division of Cancer Epidemiology and Genetics (DCEG) conducts population and multidisciplinary research to discover the genetic and environmental causes of cancer and ways to prevent it.

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.

NCI's Division of Cancer Prevention (DCP) conducts and supports research to find ways to prevent and detect cancer, and to prevent or relieve symptoms from cancer and its treatments.

NCI's Division of Cancer Treatment and Diagnosis (DCTD) supports the translation of promising research into clinical applications to improve the diagnosis and treatment of cancer in areas of unmet need that are often too risky or difficult for industry or academia to develop alone.

NCI's Division of Extramural Activities (DEA) coordinates the scientific review of extramural research before funding and provides systematic surveillance of that research after awards are made to assist the NCI in achieving its goal of a balanced research portfolio.

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.

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

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.

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.

NIH's Division of Program Coordination, Planning, and Strategic Initiatives' (DPCPSI) mission includes identifying emerging scientific opportunities, rising public health challenges, and scientific knowledge gaps that merit further research. The Division plans and implements trans-NIH initiatives supported by the Common Fund and coordinates research related to AIDS, behavioral and social sciences, women's health, disease prevention, and research infrastructure.

The Division of Receipt and Referral (DRR) within the Center for Scientific Review (CSR) serves as the central receiving point for all competing applications, whether solicited or unsolicited. Upon receipt of a competing application, DRR:

• Checks for completeness
• Determines area of research
• Assigns application to specific NIH Institute or Center for possible funding
• Assigns an identification number
• Assigns application to a Integrated Review Group (IRG) - Applications are assigned to a specific study section, also known as a Scientific Review Group (SRG) or review committee, within the IRG that has the expertise to evaluate the scientific and technical merit.

CSR reviews most R01s, fellowships, and small business applications and some PAs, PARs, & RFA's. IC review groups handle applications that have Institute-specific features such as program projects, training grants, career development awards, and responses to Requests for Applications.

Quoted from the NIH CSR Peer Review Glossary of Terms and Acronyms.

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.

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.

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.

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.