|Adverse event (AE)
|Any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
|See adverse event
|The process through which one or more parties to a clinical trial are unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware. “Blinded” studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known.
|Chief investigator, the person who takes overall responsibility for the design, conduct and reporting of a study.
|Clinical Research Associate (CRA)
|Person employed by the study sponsor or CRO to monitor a clinical study at all participating sites.
|Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent’s safety and efficacy.
|Clinical Trial Protocol (CTP)
|See Study Protocol
|A list of drugs in the study protocol that are prohibited or allowed to be taken by the study subject during the study period.
|Contract Research Organisation (CRO)
|An organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may conduct a clinical trial on behalf of the Sponsor.
|A comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.
|Clinical Trial Investigator – see Investigator
|The design of a study in which neither the investigator nor the subject knows which medication (or placebo) the subject is receiving.
|Summary criteria for participant selection; includes Inclusion and Exclusion criteria.
|Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
|Health Care Professional
|A doctor, dentist, nurse, pharmacist or registered ophthalmic optician or other officially registered health professional.
|see Investigator’s brochure
|Investigational medicinal product
|A list of criteria that must be met by all study subjects.
|Informed Consent Form (ICF)
|A document that requires a participant’s signature upon participating in a clinical trial, to confirm that the patient consents to participate and has been informed of the nature, significance, implications and risks of the trial (see Patient Information Sheet)
|A medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.