Test subject

A person who participates in a clinical trial, either as a recipient of the investigational medicinal product or as a control.

Sub-study

A study that is part of the clinical trial but may or may not be related to the main objective of the clinical trial, in which some of the persons included in the clinical trial participate on a voluntary basis and for which additional informed consent is sought, e.g. pharmacokinetic or pharmacogenetic substudies.

Spanish Register of Clinical Trials

Database owned by the Spanish Agency of Medicines and Health Products, accessible from its website, free and open to all users, whose objective is to serve as a source of information on clinical studies for citizens.

Promoter

The individual, company, institution or organisation responsible for initiating, managing and organising the financing of a clinical trial.

Active ingredient

A substance or mixture of substances intended for the manufacture of a medicinal product and which, when used in its production, becomes an active constituent of that medicinal product intended to exert a pharmacological, immunological or metabolic action with the aim of restoring, correcting or modifying physiological functions, or of making a diagnosis.

Prevalence

Proportion of people suffering from a disease in relation to the total study population.

Posology

Part of pharmacology that deals with the administration of drug doses: quantity and time interval between successive administrations.

Prescription gazetteer

Medicines database designed to provide basic prescribing information to healthcare information systems.

Medicines

Any substance or combination of substances presented as having properties for treating or preventing disease in human beings or which may be used in human beings or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to ... Read more