20.500.12556/DKUM-97256 Dobra klinična praksa za raziskovalce, ki izvajajo klinična preskušanja zdravil Good Clinical Practice for Investigators Conducting Clinical Trials Razvoj zdravila je dolgotrajen in drag proces. Preden zdravilo dobi ustrezno dovoljenje za promet, je potrebno poleg njegove kakovosti dokazati tudi njegovo učinkovitost in varnost. Za dokazovanje učinkovitost in varnost zdravila so nujna klinična preskušanja. Klinično preskušanje zdravila je raziskava na zdravih posameznikih in pacientih, pri kateri je potrebno upoštevati načela dobre klinične prakse (GCP; Good clinical practice). Skladnost s tem standardom daje javno zagotovilo, da so pravice, varnost in dobrobit udeležencev v preskušanju zaščiteni ter da so podatki kliničnih preskušanj verodostojni. V kliničnem preskušanju zdravila sodelujejo raziskovalci, sponzorji in udeleženci. V prispevku se osredotočamo na raziskovalca v kliničnem preskušanju zdravila, ki mora dobro poznati načela GCP, da lahko svoje obveznosti in odgovornosti tudi upošteva. S prikazom primerov ugotovljenih pomanjkljivosti med inšpekcijo na mestu preskušanja (pri raziskovalcu) želimo raziskovalcem pomagati pri doseganju skladnosti z dobro klinično prakso. Drug development is a long and expensive process. Before a particular drug receives the appropriate marketing authorization, it is necessary to prove its efficacy and safety in addition to its quality. Clinical trials are necessary to prove the effectiveness and safety of the drug. A clinical trial of a drug is research conducted on healthy individuals and patients, in which the principles of good clinical practice (GCP) must be followed. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible. A clinical trial of a drug involves investigators, sponsors, and participants. In this paper, we focus on the investigator in the clinical trial of a drug, who must be well aware of the principles of GCP in order to be able to comply with his obligations and responsibilities. By showing examples of deficiencies identified during clinical trial site inspection (at the investigator), we aim to help investigators to achieve compliance with good clinical practice. klinično preskušanje zdravila dobra klinična praksa (GCP) raziskovalec mesto preskušanja inšpekcija clinical drug trial good clinical practice investigator clinical trial site inspection true false true Univerza v Mariboru, Univerzitetna založba Slovenski jezik Angleški jezik Znanstveno delo 2026-02-25 12:14:15 2026-02-25 12:14:15 2026-03-30 07:39:25 0000-00-00 00:00:00 2023 0 Maribor 0 17 št.2 Letn.13 nov. 2023 0000-00-00 Zaloznikova Objavljeno NiDoloceno 2023-03-01 0000-00-00 2023-11-07 615.07(497.4) 187898115 10.18690/analipazu.13.2.17-33.2023 2820-364X Dobra_klinicna_praksa-Tivadar-2023.pdf Dobra_klinicna_praksa-Tivadar-2023.pdf 1 F9590BB8547D4599F47120D79C799C7A 2c2bd2ed78d936dfa720fe5f83163629f4ddfc0d490062e0a71f723bd9e44dd3 1c81e20e-123c-11f1-a540-00155d580e1a https://dk.um.si/Dokument.php?lang=slv&id=203841 https://journals.um.si/index.php/anali-pazu/article/view/3289 1 1f3b22b9-123b-11f1-a540-00155d580e1a https://dk.um.si/Dokument.php?lang=slv&id=203839 Univerzitetna založba Univerze v Mariboru Anali PAZU 0 0 0