Active comparator drug (comparator)

A drug currently on the market, considered to be effective, that is used in a clinical trial to compare with

the study drug.

Investigator

A doctor who conducts and oversees a clinical trial at a study site (hospital/clinic). The investigator is

responsible for ensuring that the trial is conducted in accordance with the approved trial protocol and

ensures that the principles of ethics and good clinical practice are followed. It is also his/her

responsibility to take care of the rights and safety of the patient of the clinical trial participant.

The definition contained in the Act of 6 September 2001. Pharmaceutical Law (Dz.U. 2001 No. 126 item

1381 as amended):

An investigator is a doctor or a dentist, if the clinical trial concerns dentistry, who has the right to

practice his or her profession in the territory of the Republic of Poland and has appropriately high

professional qualifications, scientific knowledge and experience in working with patients, necessary for

the conduct of the clinical trial, and who is responsible for conducting this research at a given site; if the

clinical trial is conducted by a team of individuals, the investigator appointed by the sponsor, with the

consent of the head of the medical entity within the meaning of the provisions on medical activity in

which the clinical trial is conducted, is the team leader responsible for conducting this trial at a given

site.

Clinical trial

A scientific study conducted with human subjects to discover or confirm the efficacy and safety of

medicines.

Definition included in the Act of 6 September 2001. Pharmaceutical Law (Dz.U. 2001 No. 126 item 1381 as

amended):

‘a clinical trial is any study conducted with human subjects for the purpose of discovering or confirming

the clinical, pharmacological, including pharmacodynamic effects of one or more investigational medicinal

products, or to identify adverse reactions to one or more investigational medicinal products, or to follow

the absorption, distribution, metabolism and excretion of one or more investigational medicinal products

with a view to their safety and efficacy;’

Double-blind study

A study in which both the patient and the doctor do not know whether the patient is taking the medicine

(either the investigational medicine or the active comparator medicine) or a placebo. The study may also

be an open trial - in such a study, the doctor as well as the patient knows which drug the patient is taking.

Informed consent form

A document that allows the patient to make an informed decision about taking part in a clinical trial. It

outlines the purpose of the trial, the patient's rights and responsibilities, the procedures to be

performed during the trial and the possible benefits and risks of participating in the trial.

Bioethics Committee

A consultative body established in accordance with the applicable Polish Law. The composition and

functioning of the bioethics committee is set out in Article 29 of the Act of 5 December 1996 on the

professions of physician and dentist (consolidated text: Journal of Laws of 26 March 2018, item 617;) and

in the regulation of the Minister of Health of 11 May 1999 on the detailed regulations on the appointment

and financing and the mode of operation of the bioethics committee (Journal of Laws No. 47, item 480).

In addition, the activities of bioethics committees are based primarily on:

- Regulations of the Bioethics Committee

- Declaration of Helsinki Principles of Ethical Conduct in Medical Experimentation Involving Human

Subjects;

- the principle of Good Clinical Practice, as defined in the Regulation of the Minister of Health of 2 May

2012 on Detailed Requirements for Good Clinical Practice (Journal of Laws 2012, item 489).

Study coordinator

Where clinical trials are conducted by different investigators on the basis of a single protocol and at

multiple trial sites located within the territory of Poland or other countries (multi-centre clinical trials),

the sponsor shall select, from among all the investigators conducting the clinical trial, a clinical trial

coordinator.

Inclusion/exclusion criteria

A set of factors that help determine whether a person is eligible to participate in a clinical trial (and will

be included in the trial) or not (and will not be eligible for the trial).

Investigational medication

A substance or mixture of substances whose properties are being assessed in a clinical trial.

Study site

A healthcare facility, such as a hospital or clinic, where a clinical trial is conducted.

Placebo

A substance that looks the same as the study drug (has the same form e.g. identical tablets or ampoules),

but does not contain any drug (active substance). Clinical data collected from patients taking the

investigational drug are compared with data from patients taking a placebo, so that the efficacy and

safety of the investigational drug can be assessed.

Pharmaceutical drug

Definition contained in the Act of 6 September 2001. Pharmaceutical Law (Dz.U. 2001 No. 126 item 1381

as amended):

‘a substance or mixture of substances possessing properties by virtue of which it can be used for the

prevention of disease, treatment of diseases occurring in humans or animals, administered for the

purpose of making a diagnosis, restoring, improving or modifying physiological functions of the organism

through pharmacological, immunological or metabolic action.’

Clinical trial protocol

A document describing the plan of a clinical trial, its objectives and method of implementation. In Poland,

the trial protocol is approved by the Bioethics Committees and the President of the URPLWMiPB.

Randomization

Refers to randomized trials - the process of randomly assigning trial participants to a group with the

study drug or to a control group (with an active comparator drug or placebo).

Neither the patient nor the trial investigator can choose which group a patient will be allocated to.

Sponsor

Definition contained in the Act of 6 September 2001. Pharmaceutical Law (Dz.U. 2001 No. 126 item 1381

as amended):

‘an individual, a legal entity or an organizational unit without legal personality, responsible for the

initiation, conduct and financing of a clinical trial, which is established in the territory of one of the

Member States of the European Union or Member States of the European Free Trade Agreement (EFTA)

- a party to the Agreement on the European Economic Area, if the sponsor is not established in the

territory of one of the countries of the European Economic Area, may act only through its legal

representative established in that territory;’

Medical device

Definition contained in the Act of 6 September 2001. Pharmaceutical Law (Dz.U. 2001 No. 126 item 1381

as amended):

‘- A medical device is considered to be a tool, instrument, device, software, material or other article, used

alone or in combination, including software intended by its manufacturer for use for diagnostic or

therapeutic purposes and necessary for its proper use.

- a medical device intended by its manufacturer for human use may be used for diagnosing, preventing,

monitoring, treating or alleviating the course of a disease, compensating for an injury or handicap,

investigating, replacing or modifying an anatomical structure or a physiological process and regulating

conception.

Whereby, the essential intended action of a medical device in or on the human body is not achieved by

pharmacological, immunological or metabolic means, but whose action can only be assisted by such means.’