Clinical Study Glossary

ADVERSE EVENT:

An unexpected or undesirable symptom or illness which occurs during a study.

CONTRACT RESEARCH ORGANIZATION (CRO):

A commercial organization that conducts all or some of the activities involved in the drug or product development process. Parexel is one of the largest CROs in the world.

DOUBLE BLINDED STUDY:

A trial or study in which neither the research participants nor the study staff know which participants are receiving the study drug or placebo.

EUROPEAN MEDICINES AGENCY (EMA):

The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

FOOD AND DRUG ADMINISTRATION (FDA):

The FDA is a United States government agency with the power to authorize approval for new drugs.

INDEPENDENT REVIEW BOARD (IRB):

The IRB is a panel of experts and lay people representing a cross-section of society who are independent of the company and who have the responsibility of reviewing and approving all study protocols.

INFORMED CONSENT FORM (ICF):

A document that outlines the key facts about the trial including information on the potential risk associated with participating in the study and all available data on the drug being tested. Key information which must be included in an ICF include:

• Why the research is being carried out
• What will be done during the trial and for how long
• What risks are involved in the trial
• What the researchers want to achieve by carrying out the trial
• The fact that participants have the right to leave the trial at any time

PHARMACOKINETICS:

The study of absorption, distribution, metabolism and excretion of drugs from the body.

PHARMACODYNAMICS:

The study of drug action on the physiology of the body.

PLACEBO:

An inactive pill, liquid or powder that has no treatment value. In a placebo controlled trial, the study will be comparing the new drug against the placebo.

PRINCIPAL INVESTIGATOR (PI):

The doctor responsible for the performance of the trial and for the integrity, health and welfare of the participants during the trial. The PI must be a qualified doctor or dentist and someone who is trained and experienced in research.

PROTOCOL:

A formal written document that provides details about how a trial will be conducted. All study protocols must be reviewed and approved the Independent Review Board.

RANDOMIZATION:

A scientific method in which the participants or patients are assigned to investigational drug, comparator drug or placebo.

SPONSOR:

An individual, company, institution or organization which takes the responsibility for the initiation, management and/or financing of a trial - generally the manufacturer.

STUDY COORDINATOR:

A key member of the study team, study coordinators are often trained nurses. The study coordinator's name and contact telephone numbers are included in the study ICFs in order that participants may contact them if they have any queries about the study.