Glossary

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An adverse event for which there is adequate evidence of an association with the use of the medicinal product of interest.

A reaction that occurs rarely and unpredictably in a small percentage of the population in response to a treatment or medicine. These reactions frequently occur with exposure to new medicines and cannot be explained by the known mechanisms of action of the medicine, do not occur at any dose in most patients, and develop mostly unpredictably in susceptible individuals only. Based on the underlying mechanisms, idiosyncratic reactions can be differentiated into (1) immune-mediated hypersensitivity reactions such as skin rashes to serious systemic symptoms (2) reactions involving non-immune individual susceptibility, often related to abnormal production or detoxification of cytotoxic metabolites

The ability of a substance to produce an immune response.

Immunotoxicity is harm occurring to the immune system caused by exposure to chemical substances. Testing for immunotoxicity is a standard part of developing substances as potential new medicines. Symptoms of immunotoxicity can include increased rates or severity of infectious diseases or cancer. Toxic agents can also cause autoimmune diseases, in which healthy tissue is attacked by the body™s own immune system. Allergy is another form of immunotoxicity, and many chemicals are known to induce allergic reactions in some people.

The role of an impartial witness is to attend the informed consent process if the patient/participant or their legally authorised representative (LAR) cannot read. The impartial witness reads the relevant documentation supplied to the participant (for instance, the consent form). The witness must be independent of the research and may not be unfairly influenced by those involved in the trial. They may, for example, be a non-research member of staff or the patient's relative.

Inactivated vaccines use the killed version of the pathogen that causes a disease.

The number of new cases of a health event (such as development of a disease, or reaction to a medicine) that occur during a specific time period, usually a year, in a specified population. Incidence is therefore also a measure of the risk of experiencing the health event during a certain period of time.

Inclusion criteria are the characteristics that potential participants must have in order to be considered for participation in a trial. They describe the patient population and patient selection criteria.

Inclusion criteria should specify the type of testing used to make the patients' diagnosis, as well as specific disease requirements (for example, how severe the disease is, failure or success with previous treatments, plus any other factors that might affect prognosis such as age, sex, or ethnicity).

The inclusion criteria (and exclusion criteria) are important parts of a trial protocol. If they are properly defined, inclusion and exclusion criteria will increase the chances that the trial produces reliable results. They also protect participants from harm and minimise the risks.