Glossary

A

Adverse Event (AE)

Any medical or clinical occurrence that happens whilst the patient is in a clinical trial, e.g. a common cold, sore tummy or chickenpox. It need not to be related to the new medicine taken.

Adverse reaction

In a CTIMP, any untoward and unintended response in a subject to an IMP which is related to any dose administered to that subject. See also SSAR and SUSAR.

Arm

This is where the patient is allocated one of the treatments e.g. active drug or normal treatment or Placebo (3 arms). In a clinical trial there are usually two treatment arms but sometimes more.

Assent Form

A form that somebody who is under 16 years of age can sign to say they agree to take part in the study.