Badania Kliniczne

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AACI
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association of american cancer issues
abm
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agencja badań medycznych
adr
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adverse drug reaction
ae
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adverse event
aha
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american heart association
alcoa
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attributable legible contemporaneous orginal accurate complete
amc
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academic medical center
aotmit
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agencja oceny technologii medycznych i taryfikacji
api
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active pharmaceutical ingredient
aro
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academic research organization
asap
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as soon as possible
atc
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anatomic therapeutic chemicsl coding dictionary
auc
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Area under the curve
bid
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twice daily
bsa
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body surface area
ca
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competent authority
ca
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comfidentiallity agreement
capa
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corrective and preventive action
ccea
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complete consistent endurong available
ccm
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concomitant medication
ccr
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center for cancer research
cda
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confidential disclosure agreement
cdash
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clinical data acquisition standards harmonization
cder
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center for drug evaluation and research
cdm
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clinical data management
cdms
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clinical data management system
cds
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clinical data system
cdus
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clinical data updated system
cebk
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centralna ewidencja badań klinicznych
cec
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central ethics committee
cfr
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code of federal regulations
cioms
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council for international organization of medical sciences
cmax
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maximum plazma concentration
cmin
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minimum plazma concentration
cmo
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contract manufacturing organization
cns
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central nervous system
coa
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clinical outcome assesment
cov
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close out visit
cr
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complete response
cra
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clinical research associate
crc
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clinical research associate
crf
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case report form
crms
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clinical research management system
cro
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clinical research organization cro
cs
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clinical significant
cso
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contract safety organization
csr
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clinical study report
ct
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computer tomography
cta
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clinical trial agreement
cta1
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clinical trial application
cta2
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clinical trial assistant
ctcae
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common terminology criteria for adverse events
ctis
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clinical trial information system
ctms
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clinical trial management system
ctrp
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clinical and translational science award
cv
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curriculum vitae
cyp
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cytochrome p450
dar
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drug or device accountability records
db
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double blindeddb
dbl
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database lock
dcf
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data clarification form
dco
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data cut off
dhhs
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department of health and human services
dm
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data management
dmc
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data monitoring committee
doa
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delegation of authority
dp
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disease progression
dsmb
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data safety monitoring board
dsmp
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data safety monitoring plan
ec
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ethics committee
ecg
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electrocardiogram
ecog
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eastern cooperative oncology group
ecrf
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electronic case report form
ectis
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European clinical trial information
edc
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electronic data capture
edv
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early discontinuation visit
ehc
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electronic health record
ema
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European medicines agency
emea
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European agency for the evaluation of medicinal products
emr
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electronic medical record
eortc
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European organization for research and treatment of cancer
eos
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end of study
ePRO
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electronic patient reported outcomes
et
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early termination
eTMF
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electronic trial master file
eudra
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European Union drug regulatory authorities
EudraCT
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European Union clinical trials database
fair
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findable accessible interoperable reusable
fda
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food and drug administration
fdf
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financial desclosure form
fpfv
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first patient first visit
fplv
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first patient last visit
fsr
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first site ready
fu
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follow up
gcp
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good clinical practice
gcrc
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general clinical research center
gdp
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good documentation practice
glp
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good laboratory practice
gmp
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good manufacturing practice
gp
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general practicioner
haq
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health assessment questionnaire
hc
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health canada
hipaa
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health insurance portability and accountability act
ib
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investigators brochure
ICD 9
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international classification of disease 9th
icf
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informed consent form
ich
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international council for harmonization
icr
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institute of clinical research
icsr
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individual case safety
ide
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investigational device exemptions
iec
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independent ethics committee
ihcra
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in house clinical associste
iit
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investigator initiated trial
imp
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investigational medicinal product
ind
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investigational new drug
ip
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investigational product
irb
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institutional review board
irt
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interactive response technology
isf
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investigator study file
itt
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intent to treat
ivrs
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interactive voice response system
iwrs
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interactive web response system
jma
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Japan medical association
lec
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local ethics committee
loa
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letter of agreement
loa
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letter of authorization
lplv
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last patient last visit
lraa
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local regulatory affairs associate
ltfu
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long term follow up
meddra
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medical dictionary for regulatory activities
mhra
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medicines and health products regulatory agency
mmHg
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millimeters of mercury
moh
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ministry of health
mp
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monitoring plan
mri
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magnetic resonance imaging
mrn
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medical record number
mtd
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maximum tolerated dose
mv
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monitoring visit
na
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not applicable
nci
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national Cancer institute
ncs
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not clinically significant
nd
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not done
nda
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non disclosure agreement
nda
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new drug application
nhs
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national health service
nhv
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Normal healthy volunteer
nih
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national institutes of health
nimp
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non investigational medicinal product
nis
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non interventional study
nlm
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national library of medicine
oct
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office of clinical trials
ohrp
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office for human research protections
osr
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outside safety report
otc
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over the counter
pa
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protocol amendment
pa
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project assistant
pass
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post authorisation safety study
pc
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protocol coordinator
pd
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pharmacodynamics
pd
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protocol deviation
pd
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protocol director
pfs
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progression free survival
pft
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pulmonary function test
pgt
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pharmacogenetics
pgx
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pharmacogenomics
phi
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protected health information
pi
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principal investigator
pip
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paediatric investigation plan
pk
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pharmacokinetic
pl
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project lead
pm
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project manager
pma
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pre market approval
pms
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t marketing surveillance
poa
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power of attorney
pp
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per protocol
pr
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partial response
pr
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pulse rate
prmc
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protocol review and monitoring committee
prms
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otocol review and monitoring system
pro
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patient reported outcome
psur
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periodic safety update report
pv
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pharmacovigilance
qa
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quality assurance
qc
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quality control
qct
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qualifying clinical trial
ql
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quality of life
r&d
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research and development
ra
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research authority
rbm
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risk based monitoring
rca
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root cause analysis
rct
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randomised clinical trial
RDC
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emote data capture
rde
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remote data entry
recist
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response evaluation criteria in solid timors
rfp
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request for proposal
rmv
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remote monitoring visit
rtms
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randomization and trial supply management
sadr
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suspected adverse drug reaction
sae
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serious adverse event
safe
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statistical acess for everyone
sas
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statisticsl analysis system
sc
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study coordinator
scr
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screening
sd
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source data
sdr
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sourve document review
SDV
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Source data verification
sev
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ite evaluation list
sif
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site investigator file
siv
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site initiation visit
sm
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substantial modification
sme
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ssibject matter expert
smo
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site management organization
SmPC
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summary of product characteristics
smv
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site monitoring visit
soc
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standard of care
soe
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schedule of events
sop
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standard operating procedure
spores
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specialized programs for research excellence
sr
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significant risk
srb
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scientific review board
SRC
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scientific review committee
suae
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serious unaxpected adverse event
susar
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suspected unexpexted serious adverse reaction
svt
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subject visit template
tc
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tele conference
tmf
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trial master file
tmo
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trial management organization
ttp
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time to progression
uade
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unanticipated adverse device effect
uadr
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unexpected adverse drug reaction
urlp
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urząd rejestracji produktów leczniczych wyrobów medycznych i produktów biobójczych
vhp
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voluntary harmonization procedure
wbc
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White blood cell count
who
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world health organization
wl
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warning letter
wocbp
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woman of child bearing potential

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