Pharmaceutical inspectors, working within JAZMP, are competent to undertake inspections of the implementation of clinical trial of medicinal products intended for human use in the Republic of Slovenia. Inspections may be conducted before the beginning, during and/or after completion of a clinical trial. An inspection may also be performed as a part of the procedure for obtaining or maintaining a marketing authorization.
Good clinical practice (ICH GCP) is an international ethical and scientific quality standard for the planning, execution, recording, and reporting on testing involving human participation. The application of good clinical practice principles in the implementation of clinical trial of medicinal products for human use should provide for the security, protection of rights and well-being of participants, and the credibility of the testing results. This is ensured by pharmaceutical inspectors who supervise the compliance of conduction of clinical trials with good clinical practice.
Participants in clinical trials and their rights, obligations, and responsibilities in the clinical process of a medicinal product are also determined in the Rules on clinical testing of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 54/2006 and 17/2014 – ZZdr-2).
Inspections are performed:
– at the clinical trial site (of the investigator)*
– at the sponsor or their contractor**
– in a bioanalytical laboratory***
– at the manufacturer of a medicinal product
*These inspections are the most common. During the inspection, pharmaceutical inspectors review the documents that investigators are required to have in accordance with ICH GCP, and must be available to pharmaceutical inspectors for the inspection. Beside trial-related documentation, which is located in the dossier of the investigator (ISF, “Investigator Site File”), quality documents (SOPs, instructions, forms) are also reviewed, including records on training for personnel cooperating in clinical, trials and healthcare documentation of patients (”hospital charts”) who were included in the clinical, trials or have just signed an informed consent form (ICF), but were not suitable for inclusion in clinical trial. The focus is on data integrity of the raw data and its conformity with the reported data in the CRF (Case Report Form), inclusion and exclusion criteria for reporting on adverse effects, evidence regarding the monitoring of the clinical study, documentation storage, and storage and handling of medicinal products. The obligations and responsibilities of the investigator are provided in Chapter 4 of ICH GCP.
**Sponsor is a person liable or an individual with the responsibility for the initiation, management or financing the clinical trial of a medicinal product. Obligations and responsibilities of the sponsor are provided in Chapter 5 of ICH GCP.
***Bioanalytical laboratories perform analyses within bioavailability studies for demonstrating bioequivalence of generic medicinal products with originator medicinal products.