Complications or drug side effects that may occur during the research study.  An anticipated adverse event is known to occur from past experience with the treatment.  An unanticipated adverse event is an unexpected complication.  These events may or may not be related to your participation in the research study, and will be closely monitored and recorded by the PI.

Factors, such as human choice or opinion, affecting the results of the study when, in reality, these factors are not related to the treatment under study.

An approach to avoid bias, when a researcher and/or study participant is not aware of whether the study participant is on the active study drug or the placebo.

A carefully controlled and developed study or research study designed to test and evaluate new drugs or treatment plans.

A federally (NIH/NCRR) funded hospital unit that provides support to investigators who want to participate in clinical research.

The predetermined criteria that are established in order to select the correct participants for the study.These include the presence or absence of certain conditions, the medications, or physical characteristics.

The communication between the study investigator and interested individual, in which the individual learns key facts about the research study they are being asked to participate in.  The individual then agrees voluntarily to take part or decide against participation in the study.  This process includes signing an Informed Consent Form that describes the risks and benefits that may occur if the person decides to take part in the study.

A patient or research subject who stays overnight in a hospital bed for treatment.

A patient or research subject who does not stay overnight in a hospital bed for treatment.

The steps of a clinical trial.  Usually describes the type of study and is an indication of the degree of knowledge that has been obtained on the drug.

A study that includes a small number of individuals to evaluate the safety, dosage and side effects of a new drug, treatment or procedure

A study that includes a larger number of individuals to determine if the new drug or treatment is effective and to further evaluate safety.

A study that includes an even larger number of individuals to confirm effectiveness, monitor safety, compare it to other commonly used treatments and collect information needed to market the new treatment.   

A study conducted after the new treatment has been FDA- approved and marketed to continue testing the study treatment.

An inactive substance which may resemble an active agent but has no medical value.

Health professional responsible for a study.

An action plan for a research study.  The plan states why and how the research will be done and who may take part.

A place that provides an environment for the conduct of research studies.

Developed to help to answer a question regarding medical care for a condition.  Can be designed to answer a basic question, to test a new drug or treatment, or to compare commonly used interventions.

The participants in a clinical research study.  These individuals voluntarily agree to participate in the study.

An individual who is independent of the CTSI who is responsible for insuring that the clinical research conducted on the CTSI is safely conducted, especially in regards to research subject safety.

A comparison of the risks involved for the Research Subjects and whether the expected benefits justify that risks.

The agency responsible for overseeing and financing the research study.  The sponsor may be the federal government, a private industry, or other organization with a stake in the research information obtained.