A total anonymity and strict protection of patients’ data are measures of patient’s legal protection while taking part in clinical tests of medicines. Participation in such test is completely free for the patient. Moreover, she is entitled to reimbursement of the additional costs borne connected to the participation in the test. Over the course of tests she may obtain information from her doctor with respect to the state of her health as well as report changes in her condition observed during tests. The patient is also entitled to access the medical documentation of her case. The doctors’ responsibility to inform patient of all new data which may influence patient’s decision on further participation in tests is correlated with patients’ rights. A patient may, at any given moment, resign from further participation in tests without any consequences.

In order to guarantee the safety of patients participating in tests, the researcher is obliged to ensure medical care for the patients and to monitor the accuracy of the tests with the rules of Good Clinical Practice. The sponsor is obliged to observe the course of the tests in all research plants both during and after conducting clinical tests. The protection of interest and rights of tests’ participants, the proper course and documentation of tests are subjected to the sponsors’ supervision. In the event of justified suspicion that the conditions stipulated in the permit for conducting clinical tests are no longer observed or if information obtained raises concerns about the safety or scientific validity of the conducted tests, the Ministry of Health – depending on the situation – may issue a decision suspending the clinical tests, withdraw the permit or indicate actions to be performed in order to continue with the test. The fulfillment of sponsor and researcher obligations with respect to the requirements of Good Clinical Practice as well as the correctness of conducted tests is subjected to the supervision of Clinical Tests Inspection.

dr Agata Marcinowska