Glossary

Dictionary11

SEP
SEP is the Central Ethics Committee in Croatia which is an independent committee of 19 members, healthcare professionals and members of non-medical professions. The chair of the Central Ethics Committee, deputy chair and members are appointed by the minister of health and social welfare. Administrative support for the activities of the Central Ethics Committee is provided by the Agency for Medicinal Products and Medical Devices (HALMED).

HALMED
HALMED is Croatian Agency for Medicinal Products and Medical Devices which is a legal entity vested with public authority. The Agency was established on 1st October 2003 by the Republic of Croatia, and its legal compliance is supervised by the Ministry of Health and Social Welfare.

MZOS
Or MOH, is the Croatian Ministry of Health and Social Welfare in charge of health care and welfare. MZOS supervises the work of HALMED.

SPC and PIL
SPC stands for Summary of Product Characteristics, and PIL stands for Patient Leaflet Information, both of which you can find on HALMED webpages: http://www.almp.hr/?ln=en&w=lijekovi

IRB – Institutional Review Board /Croatian term: Vijeće za klinička ispitivanja                                                                          

The IRB is in charge of approving the clinical trial for conduct at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. In Croatia, the IRB is called Vijeće za klinička ispitivanja.

Approval (in relation to the IRB) / Croatian term: Odobrenje

The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, GCP, nd the applicable regulatory requirement(s)

Contract Research Organization (CRO) / Croatian term: Ugovorna istraživačka organizacija (UIO)

A person or an organization (commercial, academic, or other) contracted by thesponsor to perform one or more of a sponsor's trial-related duties and functions.

Investigator (Institution) / Croatian term: Ispitivač (Ustanova)

An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements".

Independent Ethics Committee (IEC) / Croatian term: Nezavisno etičko povjerenstvo

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical member whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Opinion (in relation to IEC) / Croatian term: Mišljenje

The judgement and/or the advice provided by an Independent Ethiccs Committee (IEC).