Unwanted harmful or potentially harmful effects that occur as a result of a drug administered at a normal dosage. This includes any change in symptoms, physical examination, or laboratory or other types of monitoring tests (e.g., ECG). These reactions can be further classified according to severity (mild to severe) or to expected versus unexpected, and are a key part of any safety testing for an IND.
Any unfavorable change in health status that occurs in an individual enrolled in a clinical trial. Adverse events can be classified according to severity (mild to life-threatening) and according to likelihood that they are related to an investigational drug, device, or procedure.
Administrative Official. The individual in an institution’s grants and contracts or research administration office who has the responsibility for reviewing grants for accuracy and compliance prior to submission. This individual may or may not be the same as the Signing Official (SO) who authorizes submission.
A standardized form which the NIH and many other granting agencies use as an abbreviated surrogate (2-4 pages) for a full curriculum vitae. Components include education history, positions and appointments, honors/awards, bibliography, and funding history. See the NIH biosketch template.
The increments of time (typically 12 months) that a project is divided into for budgeting and funding. The start date of a budget period from certain funding agencies (e.g., American Heart Association) is fixed, whereas the start date for other agencies such as the NIH varies and may not necessarily match the applicant’s requested start date due to budget cycles.
Center Core Grant
Also known as the NIH P-30 “shared equipment” grant. This grant is intended to fund shared equipment, resources, or facilities for a group of investigators from different disciplines. A center core can be part of a PPG award or can be a stand-alone award. The primary aim is to ensure greater productivity of established research programs. These awards can be used to purchase shared ultrasound resources.
A prospective biological or behavioral research study of human subjects that is designed to answer specific questions about biological or behavioral interventions (such as new drugs, treatments, or devices, or new ways of using known drugs, treatments, or devices). Trials may be interventional and/or observational. Clinical trials are conducted in phases. See Phase 0, Phase 1, Phase 2, Phase 3, and Phase 4.
A written arrangement made between the primary grantee of a research award and an individual or entity at a separate legal institution. Commonly, these agreements involve contractual services or co-investigators at a separate academic institution. For NIH grant applications, consortium agreements generally require additional budgetary information and must be approved by the research administration office for the consortium institution. See the NIH policy for grants that include consortium agreements.
A central laboratory that provides specialized or standardized services as part of a pre-clinical or clinical trial, or application to regulatory agency. For core echo labs, activities can include trial design, training of personnel, acquisition of images, image interpretation, measurements, data storage, and preparation of reports. Regulatory agencies require a core lab to demonstrate detailed operational procedures and quality assurance measures with adherence to good clinical practice (see GCP). See the ASE Standards for Echocardiography Core Labs for a complete description of the components of an echo core lab. See also ASE’s Reference Guide for Academic Imaging Core Labs.
Contract Research Organization. A commercial contracted service organization or company that provides “outsourced” support to either individual investigators or to pharmaceutical or biotechnology industries. CROs often coordinate clinical trials or perform pharmacology/toxicology services as part of an IND application to regulatory agencies. Academic Research Organizations also exist and reside within universities to perform similar functions for non-commercial purposes.
Case report form. Forms that contain data obtained for each subject enrolled in a clinical trial. CRF content includes clinical data and questions that are important for testing a hypothesis or efficacy and safety of a new drug, device, or clinical strategy.
Center for Scientific Review. The NIH component responsible for the receipt and referral of grant applications to the PHS, as well as the initial review for scientific merit of most applications submitted to the NIH. The different CSR “study sections” are now known as SRGs.
Clinical and Translational Science Award. This term applies to a large institutional NIH grant awarded by the National Center for Research Resources (NCRR) to fund clinical and translational research centers. The CTSA term is also used to denote the multidisciplinary research facilities that receive this funding. These facilities represent the latest phase of what was originally ter a General Clinical Research Center (GCRC). They fund facilities, equipment, and technical expertise needed for innovative clinical-oriented research. See the CTSA web site for information on the CTSA program, academic institutions that have a CTSA, and how to find CTSAs that can be contracted for specific services.
Data Safety and Monitoring Board or Plan. An IRB requires investigators to submit a plan (DSMP) and sometimes join a group of experts (DSMB) that ensures safety and monitoring for subjects who are enrolled in clinical trials, and reviews treatment efficacy data. The details of the DSMP and the level of monitoring are commensurate with the risk involved with participation in clinical research. A DSMB is essential for trials that may lead to an IND.
The Department of Health and Human Services (DHHS) assurance number assigned to an institution that denotes that it complies with the terms of the CTSA web site. This number is required for many grants that involve human subjects.
Data Universal Numbering System number. A unique nine digit identification number assigned by Dun & Bradstreet (D&B) to any business world-wide for reporting practice. This number is required for certain grant applications.
Electronic Research Administration Commons. An NIH web site that allows grant applicants/awardees to send and receive information regarding grant applications or to perform grant-related administrative duties such as non-competing renewal.
Facilities and administration costs. Also commonly known as “indirect costs” or “overhead,” these are costs that are often added to the grant budget after the “direct costs” (those imediately required to perform a research project). F&A rates for Federal grants are negotiated and are different between different academic institutions. These rates are usually provided by the Office of Sponsored Programs (Research Grant office) in the course of developing budgets for a grant application.
U.S. Food and Drug Administration. The FDA is an agency within the U.S. Department of Health and Human Services. With regard to medical responsibilities, it is responsible for protecting public health by assuring that human and veterinary drugs, vaccines, and other biological products and medical devices intended for human use are safe and effective, and for promoting public access to accurate science-based information they need to use medicines, devices, and foods to improve their health. See IND for information on submitting a new device, drug, or indication.
Good Clinical Practice. GCP is the broad term for acceptable standards for conducting clinical research. GCP includes regulations enforceable by law, guidelines that are generally accepted but not legally enforceable, and local city or state laws. See the FDA guidelines for clinical trials including GCP.
Good Manufacturing Practice. Practices, systems, and guidelines that are required in the manufacture of pharmaceutical agents, diagnostics, and ical devices. These practices ensure quality control in the process of manufacturing, testing, and labeling. GMP requirements are enforced by the FDA as well as the European regulatory agencies, and must be fulfilled in order to apply for an IND. See the FDA regulations for GMP.
Good Laboratory Practice. A set of principles and a framework of management controls and regulations for research or commercial laboratories that ensures laboratory procedures and safety and efficacy testing are perform in an appropriate manner. Key aspects of GLP are practices that ensure uniformity, consistency, reliability, and quality of safety and efficacy tests. See guidelines on GLP.
Grants Management Specialist
A NIH staff member who oversees all business aspects of a grant. These individuals usually do not have a major role in the scientific or programmatic oversight of grant applications or management. That oversight is instead under the auspices of a Program Officer (PO).
Institutional Animal Care and Use Committee. The institutional committee that approves and monitors research protocols involving animal subjects and conducts evaluations of the institution’s animal care, and carries out facility inspections by law. See the guide for the care and use of laboratory animals (8th edition), which forms the basis for many of the IACUC compliance statements.
Investigational Device Exemption. A designation by the FDA that allows an investigational device to be used in a clinical study. An IDE is often used to collect safety and efficacy data in preparation for a Premarket Approval from the FDA for a new product. See FDA device advice for information and criteria for determining whether a study is IDE exempt.
Investigational New Drug. A designation by the FDA for any experimental drug that has not yet been approved for marketing, for an approved drug that is being investigated for a new indication, or for a new dosing method. See IND exemption guidance. Also see a FDA checklist for determining whether an IND is needed for IRB submissions.
Institutional Review Board. The committee at an institution that is designated to approve, monitor, and review medical research. The aim of the committee is to protect the rights and welfare of research subjects and to ensure research is conducted in an ethical manner that conforms to regulatory standards.
A research project or grant application that originates scientifically with an individual investigator. When referring to grant applications, these are also frequently referred to as “unsolicited applications,” as opposed to those that are submitted in response to a RFA or that are solicited by a commercial entity.
Just-in-time. A process whereby certain key components of a competing grant application to the NIH are uploaded through eRA Commons once the application has been favorably reviewed but prior to funding. Components of the JIT include investigator Other Support and IACUC and/or IRB approval information. See NIH grants policy on JIT.
NIH grants that support early career scientists. These grants are awarded to individuals who are transitioning from fellowship to faculty, or are at early faculty stage, and primarily fund salary support with a small amount of operating costs. K-08 (Mentored Clinical Scientist Research Career Development Award) is for those engaged in bioical and transitional research. K-23 (Mentored Patient-oriented Research Career Development Award) is targeted to those engaged in clinical research. See the K Kiosk for more information about NIH Career Development Awards.
Grant applications to the NIH whereby monetary support is requested in specified increments up to a limit (normally $25,000 modules up to $250,000). A modular application simplifies the budget process since it requires less details. See the NIH Modular Grant Application.
Materials Transfer Agreement. A legal document that defines the terms and conditions under which research or other materials can be transferred and used among research laboratories. For academic researchers, these agreement are often made with different academic laboratories or with commercial entities and are negotiated through an institution’s technology transfer or grants and contracts office.
In an effort to encourage young investigators and new ideas in biological research, the NIH places special emphasis on funding new investigators. These are investigators who have not previously been awarded a major independent research award (R01). Previous awardees of T-32 or K-Awards can still qualify as new investigators. See the NIH’s New Investigator Policies for a full definition of new investigator.
A request to a funding agency for an extension of an award period in order to complete the work specified in the grant. These are time extensions only; no further funds can be requested.
Ruth L. Kirschstein National Research Service Awards. Also known as a T-32 grant, these are large institutional research training grants that are awarded by the NIH to institutions in order to support pre-doctoral and post-doctoral (PhD and MD) research programs. They require an organized and strong academic environment and generally fund several years of dedicated research training. See the T Kiosk for more information about NRSA funding opportunities.
National Science Foundation Grants. The NSF is an independent Federal agency founded and funded by Congress to promote basic science. Their self-described purpose is to support investigators in the frontiers of science, making the agency a source of grant funding for both established and beginning investigators in engineering and basic biological research. See NSF funding opportunities.
Office of Laboratory Animal Welfare.OLAW is a section of the NIH Office of Extramural Research that provides guidance and interpretation on the humane care and use of animals in research. The IACUC at each institution must report annually to OLAW and ensure AAALAC accreditation status.
Information requested by the NIH and other granting agencies regarding an investigator’s current and anticipated sources of research funding. For NIH applications, this information is often requested after initial review and is part of the JIT submission. The format for Other Support differs from the Funding History portion of the NIH Biosketch. See a sample NIH Other Support template.
Program Announcement. A formal statement from a granting agency about a new, ongoing, or modification to an extramural activity or program. Applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes.
Phase 0 Clinical Trial
Also known as a micro dosing trial. This classification was added by the FDA in order to accelerate development of promising drugs by providing pilot data on pharmacokinetics and/or pharmacodynamics for candidate drugs in a small number of individuals. This type of clinical trial gives no data on safety or efficacy, being by definition a dose too low to cause any effect.
Phase 1 Clinical Trial
Clinical trials that generally represent the first major step in approval for a new drug or approach by testing safety, tolerability, pharmacodynamics, and/or pharmacokinetics. Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range (dose escalation), and identify side effects.
Phase 2 Clinical Trial
Clinical trials that generally test the efficacy of a new drug at different doses or the efficacy of a new treatment approach. The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase 3 Clinical Trial
Large clinical trials that test the clinical impact of a new drug or treatment approach. These are generally randomized trials that compare efficacy of the new drug or approach to an established drug or approach. The experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Phase 4 Clinical Trial
A clinical trial or process to monitor safety or efficacy of a drug or treatment after it has been approved for use. Also known as post-marketing surveillance. Often, these trials examine safety in specific populations.
PubMed Central Identification number. PubMed Central (PMC) is the NIH digital archive of scientific publications. The PMCID is the unique identifier that must be included for citations that are provided in an investigator’s Biosketch or Progress Report. PMCID lookup is available here.
Program Officer. A NIH official who is responsible for the scientific and/or programmatic aspects of a grant and is often present at the initial SRG peer-review meeting. This individual is a good source for questions regarding strategic planning or changes to a grant.
Program Project Grant, or P01 award. A large grant from the NIH that supports integrated, multiproject proposals that involve several independent investigators whose individual projects contribute to a common theme. These grants often fund not only salary support and operating costs for the research, but also core services that are shared between the investigators.
The score provided by the SRG for NIH grants or by other grant peer-review committees that reflects the scientific impact and strength of a proposal. These scores are the major mechanism by which an SRG makes a recommendation for funding. Currently, the NIH priority scores range from 10 to 90 (10 being highest).
A periodic report submitted by the grantee and used by a funding agency to assess scientific progress to date. These reports are often used to determine whether to provide funding for the budget period subsequent to that covered by the report. Many grants use annual progress reports. For NIH grants, these are also commonly referred to as non-competing renewal.
NIH Research Project Grant. The R01 funds a discrete, specified project from an investigator or several co-investigators. These awards are generally for 3-5 years. While there is no monetary limit, permission is required to apply for annual direct costs of greater than $500,000. R01s can be investigator initiated or in response to a PA or RFA. See the NIH Research Project Grant Program (R01) for more information.
Randomized Controlled Trial. A clinical trial of a drug, device, or care strategy that assigns interventions on a random basis in order to create the highest level of evidence. This approach removes many possible biases in treatment selection through the randomized assignment of the study group.
Request for Application. Funding agencies such as the NIH, Doris Duke Foundation, etc. often earmark portions of their budget towards specific topics. A RFA is the posted announcement for these specific opportunities. RFAs for the NIH are posted by the NIH Office of Extramural Research. At this website it is also possible to sign up to receive periodic emails summarizing all new RFAs.
Request for Proposals. Announcements that a granting agency wishes to award a contract to meet a specified need. Often this involves either technical or bioical development.
Small Business Innovation Research and Small Business Technology Transfer awards. These are programs funded by the U.S. government and administered by the NIH, Department of Defense, Department of Education, etc. With respect to bioical research, they fund technology-based research projects that are innovative and have a future potential for commercialization. In particular, the STTR grants are targeted for public/private sector partnerships. RFAs for small business grants are posted by the NIH Office of Extramural Research.
Biologic or toxic agents that require special consideration when applying for grants. The National Select Agent Registry (NSAR) maintains a list of select agents. In general, use of a select agent must be approved by the U.S. Department of Agriculture or Centers for Disease Control.
An individual selected by a sponsor to oversee the progress of a clinical investigation. Activities often include site visits to ensure protocol and regulatory compliance, appropriate consent and patient selection, accuracy of data collection, and appropriate adverse event reporting.
Signing Official. The official at an academic institution that has been assigned the authority to legally bind the institution in grants administration. All grant proposals must be approved by the SO. This individual may also fulfill the role of Administrative Official (AO).
Original documents, data, and records from which patient case report forms are compiled. Source documents include hospital records, clinical and office charts, laboratory and procedural reports, patient diaries, pharmacy dispensing records, and x-rays.
Scientific Review Group. A committee composed of non-government experts in a particular field that provide peer review for NIH grant applications; informally known as “study sections.” SRG members evaluate and provide critique for grant applications, and assign scores according to scientific and technical merit. See criteria for NIH peer review and scoring. See also a list of SRGs and their acronyms.
Scientific Review Officer. The NIH official who serves as the designated Federal official having legal responsibility for managing the SRG peer-review meeting. The SRO aids in SRG member selection, assignment of grant applications to reviewers, and all pre- and post-meeting details. The SRO also works in partnership with members of the SRG to identify the most meritorious science.
The individual at the study site typically responsible for the day-to-day conduct of study activities using good clinical practice (see GCP). Responsibilities include case report form completion, study file maintenance, investigator assistance, study drug administration, and communicating with the sponsor.