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Collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.


The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.

Behavioral Research

The scope and diversity of research areas in the behavioral and social sciences is quite broad. Some research is readily applicable to human affairs; other studies may broaden understanding without any apparent or immediate application. Some research is designed to test hypotheses derived from theory; other research is primarily descriptive. Still other research may be directed at evaluating an intervention or social program. Behavioral research involving human subjects generates data by means of questionnaires, observation, studies of existing records, and experimental designs involving exposure to some type of stimulus or intervention.

Belmont Report

The Belmont Report is a document that is part of the Federal Register that sets forth fundamental ethical principles that form the foundation for rules for all government funded research involving human subjects. There are three basic ethical principles that are particularly relevant to the protection of human participants.  They are: Respect for persons, Beneficence, and Distributive Justice.


An 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: (l) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.


A valued or desired outcome; an advantage.


A type of 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.


Hospital Biomedical Engineering Unit


When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization. See Blind and Randomized Control Study.

Billing Grid

Billing Grid is the terminology that should be used instead of "UM Billing Calendar". This is the name of the calendar tab in OnCore. "Billing Grid" is also somteimes used interchangeably with "Specification" - which is the foundation calendar that Nimblify builds that CRAO imports into OnCore. The end result of CRAO's Michigan-ized calendar in OnCore is the Billing Grid


  • A biological product subject to licensure under the Public Health Service Act is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment or cure of diseases or injuries to humans. Examples include, but are not limited to, bacterial and viral vaccines, human blood and plasma and their derivatives, and certain products produced by biotechnology.
  • Any therapeutic serum, toxin, antitoxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.


  • Of or related to life or to living organisms
  • A drug derived from a biological source.

Biological product

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.  Biological products also include immunoglobulin products, monoclonal antibodies, products containing cells or microorganisms, and most proteins intended for therapeutic use.

Biomedical Research

Biomedical research employs many methods and research designs. Studies designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans or prenatal diagnosis through amniocentesis), and preventive measures (e.g., vaccines, diet, or fluoridated toothpaste). Research on normal human functioning and development can include studies of the human body while exercising, fasting, feeding, sleeping, or learning, or responding to such things as stress or sensory stimulation. Subjects of some biomedical studies engage in ordinary tasks while measurement of physiological and bodily functions are made. Some biomedical studies, particularly those conducted to evaluate new therapies or treatments, use such rigorous experimental methods as random assignment to treatment and control groups.


A randomized study is "Blind" if the participant is not told which arm of the study he is on. A clinical project is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. See Single Blind Study and Double Blind Study

Blinded Study Design

A study in which one party, either the investigator or participant, is unaware of what medication or study arm the participant is assigned to (Single-Blind study). A clinical study design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or another therapy (Double-Blind study). Double-blind studies are thought to produce more objective results, since the impact of expectations of the doctor and the participant about the experimental drug are minimized. Also referred to as a "masked" study.