ACORI | Dictionary: $A

Abbreviated Assessment

An abbreviated assessment is a less comprehensive assessment that focusses more specifically on the disease and treatments being studied.

Absorption

Absorption is the process of a medicine moving from the site of delivery into the bloodstream when not injected into a patient's veins (e.g., swallowed, inhaled, sprayed into nasal passages, applied to the skin, etc.).

Accelerated Approval

Accelerated approval is when regulatory groups (such as the Food and Drug Administration) speed up the process of making a treatment available to patients. This often happens for serious diseases (that either drastically reduce quality of life or are life-threatening) and when the treatment under study provides meaningful benefit that is superior to currently approved treatments or when no other approved treatment exists.

Accepts Healthy Volunteers

A clinical study that accepts healthy volunteers will enroll healthy people who do not have the condition/disease that the study is studying.

Accreditation

Accreditation refers to the process of ensuring that a healthcare organization meets regulatory requirements and standards established by a recognized accreditation organization. The Joint Commission (www.jointcommission.org) is an example of a recognized accreditation organization.

Accredited

A healthcare organization is accredited when it meets regulatory requirements and standards established by a recognized accreditation organization. The Joint Commission (www.jointcommission.org) is an example of a recognized accreditation organization.

Active Comparator Arm

The active-comparator arm refers to the group of participants in a clinical trial who receive a treatment that is considered effective and most often currently used in clinical care. Outcomes from the active-comparator arm are compared to the experimental arm to determine if the therapy or intervention being studied works better or is safer than the current treatment. (CTG)

Active Ingredient

An active ingredient is any ingredient in a medicine that has some kind of effect on a human or other animal. Effect means the ingredient in some way changes the status of a disease (diagnosis, cure, reduction, treatment, or prevention) or the structure or function of some part of a human or other animal.

Activities of Daily Living (ADLs)

Activities of daily living (ADL) refers to a person's daily self-care activities. In healthcare, a person's ability to perform ADLs provides essential information regarding their functional status. ADLs are especially helpful when assessing people post-injury, those with disabilities, and the elderly. Some common ADLs include a person's ability to bathe, dress, eat, groom, work, perform basic household tasks, enjoy leisure activities, etc.

Adjuvant Therapy

Adjuvant therapy is a secondary treatment patients can receive in addition to primary or initial treatments for cancer. An example would be chemotherapy and/or radiation treatment that follows the surgical removal of a cancerous tumor.

Administration

Administration refers to the process of introducing a medicine or treatment into or onto the body.

Adverse Drug Reaction

An adverse drug reaction is a unfavorable and unintended response to medical products, devices, or procedures.

Adverse Event

An adverse event is an unfavorable change in the health status of a clinical study participant, including any abnormal sign (e.g., abnormal physical exam or laboratory finding, symptom, or disease) that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by conditions of the study or the treatment being studied.

Adverse Events of Special Interest (AESI)

An adverse event of special interest (serious or non-serious) is any unfavorable change in the health status of a clinical study participant that is specifically related to the conditions of the study or the treatment being examined in the study.

Adverse Reaction

An adverse reaction is a unfavorable and unintended response to medical products, devices, or procedures.

Age

Age refers to the requirements some clinical study protocols have for enrolling participants. These protocols might require someone to be of a certain age or within a certain age range, such as: child (birth-17), adult (18-64), older adult (65+).

Age Group

Age groups refer to the age range designated in the protocol of some clinical studies regarding who is eligible for enrollment [e.g., child (birth-17), adult (18-64), older adult (65+)].

Algorithm

Algorithms are step-by-step procedures for making a series of choices or decisions regarding a patient's medical treatment based on disease, symptoms, and outcomes.

All-cause Mortality

All-cause mortality is the total number of deaths, due to any cause, that occur during a clinical study.

Allocation

Allocation is the process of assigning participants to various groups in a clinical study. Each of these groups is usually defined by the type of treatment they receive, (i.e., medicine A or medicine B, treatment or no treatment).

Anomaly

An anomaly is something that is unusual, unexpected, or different from what is normally expected.

Anonymization

Anonymization is a way of protecting privacy that makes it impossible to identify a participant in a clinical study.

Anticipated Adverse Events

"Anticipated adverse events are unfavorable events/reactions that one might expect could happen during the course of a clinical study. However, they are not events/reactions that are specifically being examined in the study. An example would be the known ""normal"""" negative affects a person would suffer as a result of the disease being studied."""

Arm

An arm is a group or subgroup of participants in a clinical study that receives a specific treatment, or no treatment, according to the study's design.

Arm Assignment

Arm assignment designates which group or subgroup of participants in a clinical study receives which type of treatment, or no treatment, as specified by the study's design.

Arm Type

Arm type simply describes what type of treatment group a clinical study participant is assigned to. For example one arm type might be the group that receives the treatment being tested and another arm type might be the group that receives no treatment.

Assessment

Assessments review and/or evaluate a clinical study participant's health status to better understand whether a treatment being studied is working. Examples of assessment include, blood tests, physical exams, x-rays, etc.

Association of Community Cancer Centers

The Association of Community Cancer Centers is a powerful community of more than 25,000 multidisciplinary practitioners and 2,100 cancer programs and practices nationwide.

Attributable

Attributable refers to when information can be traced back to the person to whom it pertains, as well as to those persons who were involved in collecting and recording the information.

Clinical Research Terms Glossary

Terms starting with A