95 Clinical Research Acronyms Flashcards

Practice most common terms used Clinical Research teams. (95 cards)

1
Q

ADR

A

ADVERSE DRUG REACTION

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2
Q

ADR

A

ADVERSE EVENT

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3
Q

ALCOA

A

ATTRIBUTABLE, LEGIBLE, CONTEMPORANEOUS, ORIGINAL, ACCURATE

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4
Q

API

A

ACTIVE PHARMACEUTICAL INGREDIENT/APPLICATION PROGRAM INTERFACE (IT)

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5
Q

ARO

A

ACADEMIC RESEARCH ORGANIZATION

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6
Q

BA/BE

A

BIOAVAILABILITY/BIOEQUIVALENCE

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7
Q

BLA

A

BIOLOGICAL LICENSING APPLICATION

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8
Q

BSM

A

BIOSPECIMEN MANAGEMENT

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9
Q

CA

A

COMPETENT AUTHORITY

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10
Q

CAPA

A

CORRECTIVE AND PREVENTATIVE ACTION

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11
Q

CCEA

A

COMPLETE, CONSISTENT, ENDURING, AVAILABLE

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12
Q

CCTO/CTO

A

CENTRALISED CLINICAL TRIALS OFFICES/CLINICAL TRIALS OFFICE

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13
Q

CDM

A

CLINCAL DATA MANAGEMENT

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14
Q

CDP

A

CLINICAL DEVELOPMENT PLAN

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15
Q

CDS

A

CLINICAL DATA SYSTEM

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16
Q

CDUS

A

CLINICAL DATA UPDATE SYSTEM

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17
Q

CI

A

CONFIDENCE INTERVAL

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18
Q

CMO

A

CONTRACT MANUGACTURING ORGANIZATION

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19
Q

CNT

A

CONSENTED BUT NOT TREATED

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20
Q

CPM

A

CLINICAL PROJECT
MANAGER

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21
Q

CRA

A

CLINICAL RESEARCH ASSOCIATE

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22
Q

CRC

A

CLINICAL RESEARCH COORDINATOR

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23
Q

CRF

A

CASE REPORT FORM

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24
Q

CRO

A

CLINICAL RESEARCH ORGANISATION/ CONTRACT RESEARCH ORGANISATION

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25
CSR
CLINICAL STUDY REPORT
26
CSO
CONTRACT SAFETY ORGANISATION
27
CTA
CLINICAL TRIAL AUTHORISATION/AGREEMENT
28
CTCAE
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS
29
CTMS
CLINICAL TRIAL MANAGEMENT SYSTEM
30
CTRP
CLINICAL TRIALS REPORTING PROGRAMS
31
DDI
DRUG-DRUG INTERACTION
32
DM
DATA MANAGER
33
DMC
DATA MONITORING COMMITTEE
34
DMP
DATA MANAGEMENT PLAN
35
DSMB
DATA SAFETY MONITORING BOARD
36
EC
ETHICS COMMITTEE
37
eCOA
ELECTRONIC CLINICAL OUTCOME ASSESMENT
38
eCRF
ELECTRONIC CASE REPORT FORM
39
EDC
ELECTRONIC DATA CAPTURE
40
EHR
ELECTRONIC DATA CAPTURE
41
EMR
ELECTRONIC MEDICAL RECORD
42
eTMF
ELECTRONIC TRIAL MASTER FILE
43
FAIR
FINDABLE, ACCESSIBLE, INTEROPERABLE, REUSABLE
44
FDA
FOOD AND DRUG ADMINISTRATION
45
FIH
FIRST IN HUMAN
46
GCP
GOOD CLINICAL PRACTICE
47
GDPR
GENERAL DATA PROTECTION REGULATION
48
GLP
GOOD LABORATORY PRACTICE
49
GMP
GOOD MANUFACTURING PRACTICE
50
GVP
GOOD PHARMACOVIGILANCE PRACTICE
51
ICF
INFORMED CONSENT FORM
52
IDE
INVESTIGATIONAL DEVICE EXEMPTIONS
53
IEC
INDEPENDENT ETHICS COMMITTEEI
54
IHCRA
IN HOUSE CLINICAL TRIAL ASSOCIATE
55
IMP
INVESTIGATIONAL MEDICAL PRODUCT
56
IMPD
INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (EUDRA)
57
IND
INVESTIGATIONAL NEW DRUG APPLICATION (US FDA)
58
IRB
INSTITUTIONAL REVIEW BOARD
59
IP
INVESTIGATIONAL PRODUCT
60
ITT
INTENT TO TREAT
61
LTFU
LONG TERM FOLLOW UP
62
MAA
MARKETING AUTHORISATION APPLICATION (EUDRA)
63
MAD
MULTIPLE ASCENDING DOSE
64
MRN
MEDICAL RECORD NUMBER
65
MP
MONITORING PLAN
66
NDA
NEW DRUG APPLICATION (US FDA)
67
NHV
NORMAL HEALTHY VOLUNTEER
68
OSR
OUTSIDE SAFETY REPORT
69
PC
PROTOCOL COORDINATOR
70
PHI
PROTECTED HEALTH INFORMATION
71
PD
PROTOCOL DIRECTOR
72
PI
PRINCIPAL INVESTIGATOR
73
PRMS
PROTOCOL REVIEW AND MONITORING SYSTEM
74
PRO
PATIENT-REPORTED OUTCOMES
75
QC
QUALITY CONTROL
76
QCT
QAULIFYING CLINICAL TRIAL
77
QMS
QUALITY MANAGEMENT SYSTEM
78
QOL
QUALITY OF LIFE
79
RBM
RISK-BASED MONITORING
80
REC
RESEARH ETHICS COMMITTEE
81
SAD
SINGLE ASCENDING DOSE
82
SAE
SERIOUS ADVERSE EVENT
83
SAP
STATISTICAL ANALYSIS PLAN
84
SC
STUDY COORDINATOR
85
SDV
SOURCE DOCUMENT (DATA) VERIFICATION
86
SIF
SITE INVESTIGATOR FILE
87
SOC
STANDARD OF CARE
88
SOE
SHEDULE OF EVENTS
89
SOP
STANDARD OPERATIING PROCEDURES
90
SRB
SCIENTIFIC REVIEW BOARD
91
SUSAR
SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTION
92
TMF
TRIAL MASTER FILE
93
TMO
TRIAL MANAGEMENT ORGANISATION
94
UADE
UNANTICIPATED ADVERSE DEVICE EFFECT
95
UADR
UNEXPECTED ADVERSE DRUG REACTION