Glossary

Anamnesis
An anamnesis is a methodical survey of the subject done by the treating physician with the aim of obtaining as much information as possible about his/her current state of health, e.g. medically relevant complaints, previous illnesses or genetic risks of the subject.

Control group
A group of participants in a clinical trial that receives an inactive substance, also called placebo under the same conditions that has no intervention value. Subjects are randomly (i.e., by chance) assigned to one of the treatment arms of a clinical trial.

CRO
A Contract Research Organization, also called Clinical Research Organization is a service organization which supports pharmaceutical and medical device companies in the planning, conducting and evaluation of clinical trials or non-interventional studies.

Declaration of Helsinki
The Declaration of Helsinki was adopted in 1964 by the 18th General Assembly of World Medical Association, in Helsinki and addresses the ethical principles for medical research involving human subjects.

Double blind study
A clinical trial design in which neither the subject nor the investigator knows whether the subject is receiving the experimental drug or a placebo. To achieve double-blinding, random numbers are assigned to the subject and the test preparations and the classification into the respective group is performed. In addition, the packaging and dosage forms are kept identical.

Double-dummy
The double-dummy technique is used to compare drugs with very different appearance (for example, different dosage forms). For this purpose, subjects take two types of drug, one of which is a placebo. For example, a tablet is to be compared to a juice, a study group receives the tablet with active drug and a placebo juice and the comparison group receives a juice with active ingredient and a placebo tablet.

Ethics Committee
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure that a clinical trial is ethical and that the rights of study participants are protected and that the benefits and potential risks are clear. A clinical trial may be initiated only if the responsible Ethics Committee has given a positive vote for the clinical trial.

Experimental group
The group of participants in a clinical trial that receives the experimental drug to be tested under the same conditions as the control group. Subjects are randomly (i.e., by chance) assigned to one of the treatment arms of a clinical trial.

GCP
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, recording and analyses of clinical trials involving human subjects that provides assurance that the rights, integrity, and confidentiality of trial subjects are protected during a trial and that the data and reported results are credible and accurate.

Human subject
A patient or healthy person, who participates in a clinical trial without any known physiological or behavioural problems to examine new drugs, medical devices or interventions. Phase I studies (see "what are clincial trials") are usually conducted on small populations of healthy humans to specifically determine a drug's toxicity, absorption, distribution and metabolism.

ICH
International Conference on Harmonization (ICH) is an international council for harmonization of technical requirements for registration of Pharmaceuticals for human use which brings together the regulatory authorities of Japan, the United States and Europe to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for drug registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

Inclusion criteria
A limited list of criteria in a protocol, those a prospective subject must meet to be eligible for participation in a clinical trial. These criteria are based on such factors as age, gender, the type and stage of the disease, medical conditions and will be reviewed by the investigator before the start of the study.

Informed Consent
Prior to enrollment into a clinical trial a participant has to give consent, usually in writing, based upon adequate knowledge and understanding of relevant study details enlightened by the investigator or the research team. The consent may be withdrawn at any time without giving reasons.

Investigational Medicinal Product
A pharmaceutical dosage form of an active ingredient or placebo being tested or used as a reference or used to excite a reaction in a subject in a clinical trial is called investigational medicinal product. Thus, products could be authorized or unauthorized active substances, as well as provocative substances or placebos.

Investigator
A physician, who is responsible for the conduct of the clinical trial at a site, has to prove according to legal requirements his scientific qualifications and the adequacy of the facilities of his clinic or practice. Clinical trials can only be performed by those physicians who have the appropriate experience so that all important scientific aspects are considered. The physician informs the subject in detail about the study including its procedures, potential benefits, purpose, risks and scope. The subject must also be informed that he/she has the right to leave the study at any time without giving any reasons and their questions be answered throughout the study. All unexpected adverse events reported by the subject, or observed by the investigator must be followed-up, if necessary, (in the case of serious adverse events) reported immediately to the sponsor and to the authorities.

Multi centre trial
A clinical trial is conducted according to a single protocol at multiple sites, often more than one country at the same time. Thus, the highest possible number of participants can be ensured in order to obtain reliable results from the study.

Placebo
A placebo is a dummy treatment in a placebo controlled trial, in which at least two different products are compared. One group of subjects will receive the new drug being tested; while the other group will receive an inactive substance designed to resemble the actual drug. Not in every clinical trial a placebo is used as a reference. By comparing people's responses to the drug being tested and to the placebo, the real benefit of the new drug is measured and not the normal course of the disease or the psychological response. In the case of life-threatening diseases, placebos are usually not used.

Protocol
A protocol or study protocol describes the objectives, design, methods and statistical considerations of a clinical trial. A study protocol must be approved by the competent authorities and the ethics committee before the start of each clinical trial and shall ensure that all investigators work by the same methods to achieve comparable results.

Randomization
The process of assigning trial subjects to treatment or control groups is not done by the investigator or the patient. Each participant is randomly assigned to a treatment group. For example, a new investigational medicinal product is compared with a drug already approved on the market, the subjects are assigned randomly to one of two groups of studies that are as identical as possible. While one group receives the already approved drug, the other group receives the investigational product. Randomization should ensure the most equal distribution of participants with particular characteristics and possible influencing factors, thereby avoiding the influence of the deliberate allocation by the investigator.

Site
A physician, who is responsible for the conduct of the clinical trial at a site, has to prove according to legal requirements his scientific qualifications and the adequacy of the facilities of his clinic or practice. Clinical trials can only be performed by those physicians who have the appropriate experience so that all important scientific aspects are considered. The physician informs the subject in detail about the study including its procedures, potential benefits, purpose, risks and scope. The subject must also be informed that he/she has the right to leave the study at any time without giving any reasons and their questions be answered throughout the study. All unexpected adverse events reported by the subject, or observed by the investigator must be followed-up, if necessary, (in the case of serious adverse events) reported immediately to the sponsor and to the authorities.

Sponsor
The sponsor is the client of the clinical trial. In most cases, the sponsor is a company committed to the development of the active substance or medical device to be tested. The sponsor takes responsibility for the initiation and management of a clinical trial.

Study Nurse
Study Nurse or Study Assistant who supports the site investigator by carrying out most of the administrative responsibilities of a clinical trial. These are typically members of medical specialists, such as, Nurses or medical assistants.