Adverse Drug Reaction (ADR)

Neeljena reakcija na lek

ICH E6

Adverse event

Neeljeni dogaaj
Dir. 2001/20

Adverse Event (AE)

Neeljeni dogaaj
ICH E6

Adverse reaction

Neeljena reakcija
Dir. 2001/20

Amendment (to the protocol)

Amandman protokola, vidi Protokol - amandman

ICH E6

Applicable Regulatory Requirement(s)

Zakonsko / upravni propisi

ICH E6
Approval (in relation to Institutional Review Boards)
Saglasnost nadzonog ili etikogi odbora ustanove
ICH E6
Audit
Nadzor nad podacima i postupcima (Odit)
ICH E6
Audit Certificate

Potvrda o izvrenom nadzoru

ICH E6

Audit Certificate

Izvetaj o nadzoru
ICH E6

Audit Trail
Putanja nadzora
Documentation that allows reconstruction of the course of Dokumentacija koja omoguava rekonstrukciju tok
events.
dogaaja.
ICH E6
Bias (statistical & operational)
Statistiki i operacioni bias
ICH E9
Blind review

Ocena maskiranja klinikog ispitivanja

ICH E9

Blinding/Masking

Slepost/maskiranje
ICH E6

Case Report Form (CRF)

Individualna test lista

ICH E6

Clinical trial

Kliniko ispitivanje
Dir. 2001/20

Clinical Trial/Study

Kliniko ispitivanje/studija

ICH E6
Clinical Trial/Study Report

Izvetaj o klinikog ispitivanju/studiji

ICH E6

Comparability Bridging Study:

Studija premoavanja rezultata

ICH Q5E

Comparability Exercise:

Uporedjivanje
ICH Q5E

Comparable:

Uporedljivo
ICH Q5E

Comparator (Product)

Komparator ( proizvod za poreenje)

ICH E6

Compliance (in relation to trials)

Confidentiality
Content validity
Contract
Contract Research Organization (CRO)
Coordinating Committee
Coordinating Investigator
Direct Access
Documentation
Double-Dummy
Dropout
Equivalence Trial
Essential Documents

Potovanje usvojenog plana klinikog ispitivanja

ICH E6(komplijansa)
Poverljivost
ICH E6
Opseg valjanosti
ICH E9
Ugovor
ICH E6
Ugovorna istraivaka organizacija
ICH E6
Koordinacioni komitet (odbor)
ICH E6
Istraiva koordinator
ICH E6
Neposredan pristup
ICH E6
Dokumentacija
ICH E6
Dvostruku placebo
ICH E9
Osoba koja odustaje od klinkog ispitivanja
ICH E9
Ispitivanje ekvivalentnosti
ICH E9
Osnovni dokumenti
ICH E6

Frequentist Methods
Metodi sa frekvencijama
Statistical methods, such as significance tests and
Statistiki metodi, poput testova signifikantnosti i
confidence intervals, which can be interpreted in terms of intervala poverenja, koji se mogu tumaiti u smislu
the frequency of certain outcomes occurring in
frekvencije odredenih ishoda, nastalih prilikom
hypothetical repeated realisations of the same
hipotetiki ponavljanih izvodjenja iste ogledne
experimental situation.
situacije.
ICH E9
Good Clinical Practice (GCP)
Dobra klinika praksa (GCP)
A standard for the design, conduct, performance,
GCP je meunarodno prihvaen standard klinikih
monitoring, auditing, recording, analyses, and reporting ispitivanja za planiranje, sprovoenje, monitoring,
of clinical trials that provides assurance that the data and nadzor nad podacima i postupcima (odit),
reported results are credible and accurate, and that the
registrovanje, analiziranje i izvetavanje, kojim se
rights, integrity, and confidentiality of trial subjects are obezbeuje verodostojnost i tanost prijavljenih
protected.
podataka i rezultata, kao i to da su zatieni prava,
ICH E6integritet i tajnost identiteta ispitanika.
Impartial Witness
Nepristrasan svedok
A person, who is independent of the trial, who cannot be Osoba, nezavisna od ispitivanja, koja ne moe biti
unfairly influenced by people
podlona neispravnim uticajima osoba ukljuenih u
involved with the trial, who attends the informed consent kliniko ispitivanje, koja prisustvuje procesu
process if the subject or the
potpisivanja informacije za pacijenta ukoliko
subjects legally acceptable representative cannot read, ispitanik ili njegov zakonski zastupnik ne mogu da
and who reads the informed
itaju, i koja ita bilo koju pisanu informaciju
consent form and any other written information supplied podnetu ispitaniku.
to the subject.
.
ICH E6
Independent Data-Monitoring Committee (IDMC) (Data Nezavisni komitet za monitoring podataka (Odbor
and Safety
monitorovanje podataka i bezbednosti, Komitet za
Monitoring Board, Monitoring Committee, Data
monitoring, Komitet za monitoring podataka)
Monitoring Committee)
An independent data-monitoring committee that may be Nezavisan komitet za monitoring podataka koji mo
established by the sponsor to assess at intervals the
da formira sponzor, za periodinu procenu toka
progress of a clinical trial, the safety data, and the critical klinikog ispitivanja, podataka o bezbednosti,
efficacy endpoints, and to recommend to the sponsor
kljunih zakljuaka o delotvornosnosti i koji
whether to continue, modify, or
preporuuje sponzoru nastavak, modifikaciju ili
stop a trial.
prekid ispitivanja.
ICH E6
Independent Ethics Committee (IEC)
Nezavisni etiki odbor
An independent body (a review board or a committee,
Nezavisno telo (jedne ustanove, regije, zemlje ili
institutional, regional, national, or supranational),
nadnecionalno) sastavljeno od medicinskih, nauni
constituted of medical professionals and non-medical
ne-naunih lanova ija je dunost da obezbedi
members, whose responsibility it is to ensure the
zatitu prava, bezbednost i dobrobit ispitanika
protection of the rights, safety and well-being of human ukljuenih u kliniko ispitivanje, izmeu ostalog,
subjects involved in a trial and to provide public
nadzorom, odobravanjem, obezbeivanjem stalnog
assurance of that
uvida u protokol ispitivanja i amandmane, pogodno
protection, by, among other things, reviewing and
ispitivaa, mogunosti ustanove, kao i metoda i

approving / providing favourable opinion on, the trial

materijala namenjenog za dokumetovanje i dobijan
protocol, the suitability of the investigator(s), facilities, pristanka ispitanika.
and the methods and material to be used in obtaining and Pravni status, sastav, funkcija, operativni i nadleni
documenting informed consent of the trial subjects.
propisi koji se odnose na nezavisni etiki odbor
The legal status, composition, function, operations and mogu razlikovati se meu dravama, ali treba da
regulatory requirements pertaining to Independent Ethics omogui nezavisnom etikom odboru da deluje u
Committees may differ among countries, but should allowskladu sa Dobrom klinikom praksom opisanom u
the Independent Ethics Committee to act in agreement
ovim smernicama.
with GCP as described
in this guideline
ICH E6
Informed Consent
Pristanak ispitanika uz punu obavetenost (pristan
A process by which a subject voluntarily confirms his or ispitanika)
her willingness to participate
Proces kojim ispitanik dobrovoljno potvruje svoju
in a particular trial, after having been informed of all
spremnost da uestvuje u odreenom ispitivanju,
aspects of the trial that are
poto je prethodno informisan o svim aspektima
relevant to the subject's decision to participate. Informed ispitivanja koji su od znaaja za donoenje odluke
consent is documented by
ispitanika o ueu. Pristanak ispitanika uz punu
means of a written, signed and dated informed consent obavetenost se dokumentuje pomou pisanog,
form.
potpisanog i datiranog obrasca za pristanak
ICH E6informisanog pacijenta (u daljem: pristanak
ispitanika).

Inspection
Inspekcija
The act by a regulatory authority(ies) of conducting an in nadlenih vlasti kojim sprovodi zvanini pregle
official review of documents,
dokumenata, ustanova, dosijea, i bilo kojih drugih
facilities, records, and any other resources that are
podataka za koje vlasti ocene da su u vezi sa
deemed by the authority(ies) to be
klinikim ispitivanjem i koji se mogu nalaziti u cen
related to the clinical trial and that may be located at the tru ispitivanja, prostorijama sponzora ili ugovorne
site of the trial, at the
istraivake organizacije, ili ostalim ustanovama ko
sponsor's and/or contract research organizations (CROs) nadlene vlasti smatraju pogodnim za procenu.
facilities, or at other
establishments deemed appropriate by the regulatory
authority(ies).
ICH E6
Institution (medical)
Ustanova (medicinska)
Any public or private entity or agency or medical or
Bilo koje drutveno ili privatno preduzee, agencija
dental facility where clinical trials are conducted.
medicinska ili stomatoloka ustanova u kojoj se
sprovodi kliniko ispitivanje.
Institutional Review Board (IRB)
An independent body constituted of medical, scientific,
and non-scientific members, whose responsibility is to
ensure the protection of the rights, safety and well-being
of human subjects involved in a trial by, among other

Nadzorni odbor ustanove

Nezavisno telo sastavljeno od medicinskih, naunih
ne-naunih lanova ija je dunost da obezbedi
zatitu prava, bezbednost i dobrobit ispitanika
ukljuenih u kliniko ispitivanje, izmeu ostalog,

things, reviewing, approving, and providing continuing nadzorom, odobravanjem, obezbeivanjem stalnog
review of trial protocol and amendments and of the
uvida u protokol ispitivanja i amandmane, kao i
methods and material to be used in obtaining and
metoda i materijala namenjenog za dokumetovanje
documenting informed consent of the trial
dobijanje pristanka ispitanika.
subjects.
Napomena prev.: Po nadlenostima Nadzorni odbo
ICH E6ustanove ( upotreba izraza u SAD i Nezavisni etik
odbor (Evropski termin) su izjednaeni
Interim Clinical Trial/Study Report
Fazni izvetaj klinikog ispitivanja
A report of intermediate results and their evaluation based Izvetaj o rezultatima u toku ispitivanja i njihova
on analyses performed
procena na osnovu analiza sprovedenih u toku
during the course of a trial.
ispitivanja
ICH E6
Investigational Product
Ispitivani proizvod
A pharmaceutical form of an active ingredient or placebo Farmaceutski oblik aktivne supstancije ili placeba
being tested or used as a reference in a clinical trial,
koji se ispituje ili koristi kao referentan u klinikom
including a product with a marketing authorization when ispitivanju, ukljuujui i proizvod odobren za
used or assembled (formulated or packaged) in a way
prodaju kada se koristi ili je sastavljen (formulisan
different from the approved
pakovan) na drugaiji nain od odobrenog oblika, i
form, or when used for an unapproved indication, or
kada se ispituje za indikacije koje nisu odobrene, il
when used to gain further
kada se koristi za dobijanje daljih informacija o
information about an approved use.
odobrenoj upotrebi.
ICH E6
Investigator
Istraiva
A person responsible for the conduct of the clinical trial at Osoba odgovorna za sprovoenje klinikog
a trial site. If a trial is conducted by a team of individuals ispitivanja u centru ispitivanja. Ako kliniko
at a trial site, the investigator is the responsible leader of ispitivanje sprovodi tim pojedinaca u centru
the team and may be called the principal investigator. See ispitivanja, ispitiva je odgovornan rukovodiocu tim
also Subinvestigator
i moe se zvati glavni ispitiva. Videti takoe
ICH E6Ispitiva saradnik.
.

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

Istraiva / ustanova
Izraz kojim se eli obuhvatititi Ispitiva i/ili
ustanova ve prema zahtevima vaeih zakonskih
propisa
ICH E6

Investigator's Brochure
Broura za ispitivaa
A compilation of the clinical and nonclinical data on the Kompilacija klinikih i ne-klinikih podataka o
investigational product(s)
ispitivanom proizvodu ili proizvodima, znaajnih z
which is relevant to the study of the investigational
ispitivanje ispitivanog/ispitivanih proizvoda na
product(s) in human subjects (see
ispitanicima. (videti 7. Broura za ispitivaa).
ICH E6
Legally Acceptable Representative
Pravni zastupnik
An individual or juridical or other body authorized under Pojedinac ili pravno ili drugo telo ovlaeno po

applicable law to consent, on behalf of a prospective

vaeem zakonu da, u ime mogunog uesnika
subject, to the subject's participation in the clinical trial. ispitivanja, da pristanak na njegovo/njeno uee u
ICH E6datom ispitivanju.

Monitoring
Monitoring
The act of overseeing the progress of a clinical trial, and in nadgledanja toka klinikog ispitivanja i
of ensuring that it is conducted, recorded, and reported in potvrivanja da se to kliniko ispitivanje sprovodi,
accordance with the protocol, Standard Operating
dokumentuje i prijavljuje u skladu sa protokolom,
Procedures (SOPs), Good Clinical Practice (GCP), and Standardnim operativnim postupcima, Dobrom
the applicable
klinikom praksom i vaeim nadlenim propisima
regulatory requirement(s).
ICH E6
Monitoring Report
Izvetaj monitora
A written report from the monitor to the sponsor after
Pismeni izvetaj monitora sponzoru posle svake
each site visit and/or other trial-related communication posete centru ispitivanja i/ili drugog naina
according to the sponsors SOPs.
komunikacije vezanog za kliniko ispitivanje, u
ICH E6skladu sa standardnim operativnim postupcima
(SOP) sponzora.

Multicentre Trial
Multicentrino kliniko ispitivanje
A clinical trial conducted according to a single protocol Kliniko ispitivanje koje se sprovodi prema
but at more than one site, and
jedinstvenom protokolu u vie centara, tako da ga
therefore, carried out by more than one investigator.
sprovodi vie od jednog ispitivaa.
ICH E6
Nonclinical Study
Ne-kliniko ispitivanje
Biomedical studies not performed on human subjects.
Biomedicinske studije koje se ne sprovode na
ljudima.

Opinion (in relation to Independent Ethics Committee) Miljenje Nezavisnog etikog komiteta
The judgement and/or the advice provided by an
Ocena i / ili savet koji daje Nezavisni etiki komite
Independent Ethics Committee
(IEC).
ICH E6
Original Medical Record
Izvorni medicinski nalazi
See Source Documents
Vidi Izvorni podaci
ICH E6
Protocol
Protokol
A document that describes the objective(s), design,
Dokument koji opisuje cilj (ciljeve), plan,
methodology, statistical considerations, and organization metodologiju, statistiku analizu i organizaciju
of a trial. The protocol usually also gives the background ispitivanja. Protokol obino sadri uvod i racionaln
and rationale for the trial, but these could be provided in osnovu za kliniko ispitivanje, ali se oni mogu
other protocol referenced documents. Throughout the
obezbediti u drugim referentnim dokumentima
ICH GCP Guideline the term protocol refers to protocol protokola. Kroz naela ICH GCP termin protokol se
and protocol amendments.
odnosi na protokol i amandmane protokola.

ICH E6
Protocol Amendment
A written description of a change(s) to or formal
clarification of a protocol.

Amandman(i) protokola
Pisan opis promene (promena) protokola ili formal
objanjenje protokola.
ICH E6

Quality Assurance (QA)

Obezbeivanje/osiguravanje kvaliteta
All those planned and systematic actions that are
Sve planirane i sistematske aktivnosti ustanovljene
established to ensure that the trial is performed and the da se obezbede sprovoenje ispitivanja, stvaranje,
data are generated, documented (recorded), and reported dokumentovanje (uvanje) i prijavljivanje podataka
in compliance with Good Clinical Practice (GCP) and the u skladu sa Dobrom klinikom praksom i vaeim
applicable regulatory
nadlenim propisima.
requirement(s).
.
ICH E6
Quality Control (QC)
Kontrola kvaliteta
The operational techniques and activities undertaken
Operacionalizovane tehnike i aktivnosti preduzete
within the quality assurance system to verify that the
okviru sistema obezbeenja kvaliteta radi potvrde d
requirements for quality of the trial-related activities have su u preduzetim aktivnostima u ispitivanju ispunjen
been fulfilled.
svi zahtevi za kvalitet.
ICH E6
Randomization
Randomizacija
The process of assigning trial subjects to treatment or
Proces ukljuivanja ispitanika terapijskoj ili
control groups using an element of chance to determine kontrolnoj grupi korienjem elementa sluajnosti
the assignments in order to reduce bias.
izbora pri ukljuivanju, sa ciljem da se smanji
ICH E6pristrasnost.

Regulatory Authorities
Nadlene vlasti
Bodies having the power to regulate. In the ICH GCP
Tela sa ingerencijama dravne uprave. Naela GCP
guideline the expression Regulatory Authorities includes izraz nadlene vlasti ukljuuju organe vlasti koje
the authorities that review submitted clinical data
razmatraju predoene podatke o ispitivanjima i on
and those that conduct inspections . These bodies are
koje sprovode sprovode nadzor.
sometimes referred to as competent authorities.
ICH E6
Serious Adverse Event (SAE) or Serious Adverse Drug
Reaction
(Serious ADR)
Any untoward medical occurrence that at any dose:
-results in death,
-is life-threatening,
- requires inpatient hospitalization or prolongation of
existing hospitalization,
-results in persistent or significant disability/incapacity,
or
-is a congenital anomaly/birth defect (see the ICH

Ozbiljan neeljeni dogaaj ili teka neeljena

reakcija na lek
Bilo koja neprijatna medicinska pojava koja, bez
obzira na dozu:
za posledicu ima smrtni ishod
ugroava ivot
zahteva hospitalizaciju ili produava postojeu
hospitalizaciju
daje trajnu ili znaajnu nesposobnost ili
invalidnost ili
je pojava kongenitalne anomalije ili uroenog

Guideline for Clinical Safety Data Management:

oteenja (vidi ICH: Rukovanje podacima o klinik
Definitions and Standards for Expedited Reporting).
bezbednosti: Definicije i Standardi za hitno
ICH E6izvetavanje o neeljenim dogaajima).
Prim. prev. Od tekog neeljenog dogaaja ili teke
neeljene reakcije na lek treba razlikovati dogaaje
koji se burno odvijaju ali nemaju za posledicu napr
navedene pojave. (engl. serious prema severe)

Source Data
Izvorni podaci
All information in original records and certified copies of Svi podaci iz izvornih dokumenata i overene kopije
original records of clinical
originalnih klinikih nalaza, opservacija ili drugih
findings, observations, or other activities in a clinical trial aktivnosti u klinikom ispitinecessary for the
vanju koje su neophodne za rekonstrukciju i procen
reconstruction and evaluation of the trial. Source data are rezultata ispitivanja. Izvorni podaci se nalaze u
contained in source
izvornim dokumentima (kao originali ili overene
documents (original records or certified copies
kopije).
ICH E6

Source Documents
Izvorni dokumenti
Original documents, data, and records (e.g., hospital
Originali dokumenata, podataka i dosijea (npr.
records, clinical and office charts,
istorija bolesti, klinika i kancelarijska dokumenta,
laboratory notes, memoranda, subjects' diaries or
laboratorijske beleke, memorandumi, dnevnici
evaluation checklists, pharmacy
ispitanika ili njihove kotrolne liste, dnevnik izdadispensing records, recorded data from automated
vanja lekova, automatski zapisi, kopije ili prepisi
instruments, copies or
overeni posle pro-vere ispravnosti, negativi
transcriptions certified after verification as being accurate fotografija, mikrofilmovi ili magnetni zapisi,
copies, microfiches,
rentgenski snimci, dosijei koji se uvaju u apoteci,
photographic negatives, microfilm or magnetic media, x- laboratoriji i medicinsko-tehnikim slubama
rays, subject files, and records kept at the pharmacy, at ukljuenim u kliniko ispitivanje).
the laboratories and at medico-technical departments
involved in the clinical trial).
ICH E6
Sponsor
Sponzor
An individual, company, institution, or organization
Pojedinac, kompanija, ustanova ili organizacija koj
which takes responsibility for the initiation, management, preuzima odgovornost za pokretanje, rukovoenje
and/or financing of a clinical trial.
i/ili finansiranje klinikog ispitivanja.
ICH E6
Sponsor-Investigator
Sponzor-ispitiva
An individual who both initiates and conducts, alone or Pojedinac koji i pokree i vodi kliniko ispitivanje,
with others, a clinical trial, and under whose immediate sam ili sa drugima, i pod ijim neposrednim
direction the investigational product is administered to, nadzorom se ispitivani proizvod primenjuje i izdaje
dispensed to, or used by a subject. The term does not
ispitaniku ili koristi od strane ispitanika. Ovaj term
include any person other than
podrazumeva samo pojedinca (npr. ne ukljuuje
an individual (e.g., it does not include a corporation or an korporaciju ili agenciju). U odgovornosti sponzoraagency). The obligations of a sponsor-investigator include ispitivaa spojene su odgovornosti i sponzora i

both those of a sponsor and those of an investigator.

ispitivaa.
ICH E6

Standard Operating Procedures (SOPs)

Standardni operativni postupci (SOP)
Detailed, written instructions to achieve uniformity of the Detaljna, pisana uputstva za postizanje uniformnos
performance of a specific
pri izvoenju specifinih funkcija. (procedura =
function.
stalan red postupaka
ICH E6

Subinvestigator
Istraiva-saradnik
Any individual member of the clinical trial team
Bilo koji pojedinac, lan tima klinikog ispitivanja
designated and supervised by the
imenovan i nadziran od strane istraivaa u centru
investigator at a trial site to perform critical trial-related ispitivanja koji sprovodi kljune aktivnosti u
procedures and/or to make
ispitivanju i/ili donosi vane odluke vezane za
important trial-related decisions (e.g., associates,
kliniko ispitivanje (npr. saradnici, specijalizanti,
residents, research fellows). See also Investigator.
istraivai-saradnici).
ICH E6
Subject Identification Code
Identifikaciona ifra/kod ispitanika
A unique identifier assigned by the investigator to each Jedinstvena odrednica koju istraiva dodeljuje
trial subject to protect the
svakom ispitaniku umesto imena, radi zatite
subject's identity and used in lieu of the subject's name identiteta ispitanika pri prijavljivanju neeljenih
when the investigator reports
dogaaja i/ili drugih podataka iz klinikog
adverse events and/or other trial related data.
ispitivanja.
ICH E6
Subject/Trial Subject
Ispitanik/subjekt ispitivanja
An individual who participates in a clinical trial, either as Pojedinac koji uestvuje u klinikom ispitivanju, b
a recipient of the investigational product(s) or as a
da prima ispitivani (ispitivane) lek ili kontrolni
control.
proizvod.

Trial Site
Istraivaka ustanova
The location(s) where trial-related activities are actually Lokacija/ustanova gde se sprovode aktivnosti veza
conducted.
za ispitivanje
ICH E6

Unexpected Adverse Drug Reaction

Neoekivana nepovoljna reakcija na lek
An adverse reaction, the nature or severity of which is not Neeljena reakcija takve prirode ili intenziteta kakv
consistent with the applicable product information (e.g., nisu u skladu sa navedenim u postojeoj informacij
Investigator's Brochure for an unapproved
o proizvodu (npr. u brouri za ispitivaa za
investigational product or package insert/summary of
neregistrovan proizvod ili uputstvu za primenu leka
product characteristics for an approved product) (see the ili saetku karakteristika proizvoda za registrovan
ICH Guideline for Clinical Safety Data Management:
proizvod).
Definitions and Standards for Expedited Reporting).
Za medicinske proizvode koji su u prometu: tetan
ICH E6nenameravan odgovor na lek koji se javlja pri
dozama koje se normalno upotrebljavaju kod ovek
u profilaksi, dijagnostici ili terapiji oboljenja ili rad

promene fizioloke funkcije.

Vulnerable Subjects
Vulnerabilni ispitanici
Individuals whose willingness to volunteer in a clinical Pojedinci na iju odluku da pristupe klinikom
trial may be unduly influenced by the expectation,
ispitivanju kao dobrovoljci mogu preterano da utiu
whether justified or not, of benefits associated with
oekivanja, opravdana ili ne, ili koristi od uea u
participation, or of a retaliatory response from senior
ispitivanju ili pretnja konsekvencama od strane
members of a hierarchy in case of refusal to participate. nadreenih osoba u sluaju da odbiju uee. Prime
Examples are members of a group with a hierarchical
su lanovi grupe sa hijerarhijskom stukturom, kao
structure, such as medical, pharmacy, dental, and nursing to su studenti medicine, farmacije, stomatologije i
students, subordinate hospital and laboratory personnel, vie medicinske kole, osoblje bolnice i
employees of the pharmaceutical industry, members of laboratorijsko osovblje, zaposleni u farmaceutskoj
the armed forces, and persons kept in detention. Other
industriji, pripadnici vojnih i policijskih snaga i
vulnerable subjects include patients with incurable
zatvorenici. Ostale vulnerabilne ispitanike ine pac
diseases, persons in nursing homes, unemployed or
jenti sa neizleivim bolestima, osobe u domovima z
impoverished persons, patients in emergency situations, nemone, nezaposleni ili siromane osobe, pacijent
ethnic minority groups, homeless persons, nomads,
u urgentnim stanjima, pripadnici etnikih manjina,
refugees, minors, and those incapable of giving consent. beskunici, nomadi, izbeglice, maloletnici i osobe
ICH E6nesposobne da daju pristanak.
Well-being (of the trial subjects)
The physical and mental integrity of the subjects
participating in a clinical trial.

Dobrobit (ispitanika u studiji)

Fiziki i mentalni integritet osoba koje uestvuju u
studiji kao ispitanici
ICH E6

Adverse Drug Reaction (ADR) - Neeljena reakcija na lek