Patient’s rights

• The patient voluntarily gives his/her “informed consent”,
• The patient has the right to withdraw his/her “informed consent” and to stop participating in the trial at any time without giving any reason;
• The patient has the right to receive information about his or her health at any time;
• The patient has the right to receive a copy of the medical results obtained;
• The patient has the right to obtain information about the study drug;
• The patient has the right to a regular contact with a doctor;
• The patient has the right to protect his/her personal data;
• The patient  has the right to be informed of any new reports concerning the tested drug that may affect his/her further decision to participate in the trial.

What is expected from the patient?

To ensure patients’ safety and  effectiveness of a clinical trial, patients are expected to:

• comply with all recommendations of the attending physician;
• take medicines as recommended;
• participate in planned medical visits;
• inform the doctor about the diseases, injuries, surgeries, as well as the current state of health;
• inform the doctor about all adverse reactions, side effects and all phenomena that concern the patient that occurred during the trial.

Duties of the doctor and the KO-MED CK Study Sites

• Continuous supervision of the patient’s health;
• Making the results of laboratory tests available to the patients;
• Sharing information about the effect of the drug;
• Informing the patient about the course of the clinical trial;
• Making sure the doctor is available for the patients.

Legal regulations and control

Clinical trials in Poland must be conducted in accordance with legal regulations, which is subject to constant control. The conditions for conducting clinical trials on medicinal products are regulated by the Pharmaceutical Law Act of September 6, 2001. According to it, each clinical trial may be conducted only on the basis of a permit issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products as well as a positive opinion of the bioethics commission. [the text of the act]

Furthermore, a clinical trial of a medicinal product must be carried out in accordance with Good Clinical Practice (GCP), which provides a standard for the planning, conducting, monitoring, documenting and reporting of clinical trials conducted in humans. Good Clinical Practice is regulated by the Regulation of the Minister of Health of May 2, 2012 regarding Good Clinical Practice. This document specifies the responsibilities of the investigator and sponsor as part of the clinical trial. In addition, it defines the principles of creating a clinical trial protocol, an investigator’s brochure and a contract for conducting clinical trials. [the text of the regulation]

The control over the conduct of clinical trials is exercised by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products together with the Department of the Inspection of Medicinal Products. Inspections may be carried out on the national level and on behalf of the European Medicines Agency. The procedure and detailed scope of conducting clinical trial inspections are specified in the Regulation of the Minister of Health of 26 April 2012 on the Inspection of Clinical Trials. [the text of the regulation]

The Central Register of Clinical Trials (CEBK) is a data register kept in the form of an IT system by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products on each registered clinical trial. Entries in the register shall be made by the President of the Office. The CEBK register includes:

• the clinical trial title;
• the number of the clinical trial protocol;
• the number of the clinical trial in the European Clinical Trials Database (EudraCT);
• the names and addresses of the sites where the clinical trial is being conducted;
• the definition of the clinical trial phase;
• the name of the investigated medicinal product;
• the name of the active substance;
• the number of participants in the clinical trial;
• the characteristics of groups of participants in the clinical trial;
• the name, surname and place of residence or the name and registered office of the sponsor;
• the name, surname and title and academic degree of the investigator;
• the name, surname and title and academic degree of the clinical trial coordinator, if involved in the trial;
• the date of notification about the clinical trial
• the date of of completing the clinical trial;
• information about the decision regarding the clinical trial;
• the number of the clinical trial in the Central Register of Clinical Trials.