Naslovna Articles/views Research Institutions, Principal Researcher and Research Team, Author, MSc.sci. Milorad Stamenović

Research Institutions, Principal Researcher and Research Team, Author, MSc.sci. Milorad Stamenović

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Milorad Stamenovic, Cambridge
Milorad Stamenovic, Cambridge

Research Institutions, Principal Researcher and Research Team, Author, MSc.sci. Milorad Stamenović

The sponsor of the clinical trial of the medicinal product has the right to choose within the feasibility study of a research institution that will deal with certain clinical trials. These research institutions represent the Clinical Centers and Clinical Hospital Centers in the Republic of Serbia that respond according to the given criteria to the sponsor in the sense that the clinical trial is performed in accordance with the time and human resources available. The sponsor is the one who performs a feasibility study in which a characteristic specification of research institutions is carried out and where those who meet certain standards gain the opportunity to participate in scientific and clinical trials of drugs.

After completing the feasibility study and analyzing the results obtained from the “field”, the sponsor of the clinical trial is selected by the research institutions. Selected research institutions have the role of carrying out clinical trials in their own space and according to standards that have to be adapted from one side to the international, and on the other by local standards, certain research institutions.

Within each research institution that wishes to deal with clinical trials in the Republic of Serbia, it is necessary that there be an Ethics Committee that will deal with ethical and certain functional issues before, during and after the clinical trial.

An investigator in a clinical trial is a medical doctor or a dentist who is involved in and responsible for the treatment and care of patients and is responsible for carrying out a clinical trial. [1] Depending on the clinical trial, the profile of the expert is required and the study plan should state which educational profile and how much experience and licenses and certificates should the researcher possess to legitimately participate in a clinical trial. Certificate of Knowledge of Standards Good clinical practice presents one of the important conditions for participation in a scientific project.

The main researcher is a person, expert and expert in a particular field who will have the role of a leader and coordinator of a clinical trial within a research center.

The lead researcher should have leadership qualities and in some cases be the coordinator of the study for the whole country in which the clinical trial is conducted. It should have a basic knowledge of project management and management by an expert and scientific team.

Prior to the commencement of a clinical trial, the principal investigator is required to: [2]

Send the sponsor his biography
signs the statement that he is familiar with the properties of the medicinal product being clinically examined
signs a contract with a sponsorship of clinical hysteria
delivers to the sponsor and keeps a list of researchers who will take part in a clinical trial
In addition to the above obligations to the sponsor, as well as the obligation during the clinical trial of the drug, the principal investigator is obliged to coordinate with the research team, to familiarize his team with the clinical trial protocol as well as with preclinical and clinical data on the drug. It is also obliged to notify them of all changes and amendments in the clinical trial. [3]

 

[1] Ordinance on the content of requests, ie documentation for the approval of a clinical trial of a medicinal product and a medical device, as well as the manner of conducting a clinical trial of a medicinal product and a medical device. Official Gazette RS no. 64/2011 of 31/08/2011 Article 2 <http://www.alims.gov.rs/download/regulativa/Pravilnici/Pravilnik%20o%20klinickom%20ispitanju/pravilnik%20klinicka_2011.pdf> Date 10. 08 2012.

[2] Ordinance on the content of requests, ie documentation for the approval of clinical trials of medicinal products and medical devices, as well as the manner of conducting clinical trials of medicinal products and medicinal products. Official Gazette RS no. 64/2011 from 31 August 2011 Article 29 <http://www.alims.gov.rs/download/regulativa/Pravilnici/Pravilnik%20o%20klinickom%20ispitanju/pravilnik%20klinicka_2011.pdf> Date 10. 08 2012.

[3] Ordinance on the content of requests and / or documentation for the approval of clinical trials of medicinal products and medical devices, as well as the manner of conducting a clinical trial of the medicinal product and medicinal product. Official Gazette RS no. 64/2011 of 31.8.2011. Article 29. <http://www.alims.gov.rs/download/regulativa/Pravilnici/Pravilnik%20o%20klinickom%20ispitanju/pravilnik%20klinicka_2011.pdf> Date 10. 08. 2012.