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acrp acronyms

acrp exam prep

QuestionAnswer
ADR Adverse Drug Reaction
AE Adverse Event
ALCOAC Accurate, legible, contemporaneous, original, attributable, and complete
ALT/AST Alanine transaminase (liver enzyme) Aspartate transaminase (liver enzyme)
BID twice a day (bis in die, latin)
BMI body mass index
BP blood pressure
BUN blood urea nitrogen (kidney function test)
C celsius
CAPA Corrective preventative action
CIOMS Council for International Organizations of Medical Sciences
CK Creatinine Kinase (muscle enzyme)
CRA Clinical Research Associate
CRC Clinical Research Coordinator
CRF Case Report Form
CRO Contract Research Organization
CSR Clinical Study Report
CTMS Clinical Trial Management System
CV Curriculum Vitae
DCF Data Clarification Form
IDMC Independent Data Monitoring Committee
DSMB Data and Safety Monitoring Board
EKG/ECG Electrocardiogram
eCRF Electronic Case Report Form
ePRO Electronic Patient Reported Outcomes
eTMF Electronic Trial Master File
EDC Electronic Data Capture
EMR/EHR Electronic medical record / electronic health record
F Farenheit
FEV1 Forced Expiratory Volume in 1 Second
GCP Good Clinical Practice
GI Gastrointestinal
GLP Good Laboratory Practices
GMP Good Manufacturing Practices
hCG Human Chorionic Gonadotrophin
HMO Health Maintenance Organization
IB Investigator’s Brochure
ICF Informed Consent Form
ICH International Conference on Harmonization
IP Investigational Product
IRB Institutional Review Board
IEC Independent Ethics Committee
IVRS Interactive Voice Response System
IWRS Interactive Web Response System
LAR Legally Acceptable Representative
MAOI Monoamine Oxidase Inhibitor
Mcg Microgram
mmHg Millimeters of mercury
NSAID(s) Non-Steroidal Anti-Inflammatory Drug(s)
PI Principal Investigator
PK Pharmacokinetics
PRO Patient Reported Outcomes
PM Project Manager
p.r.n. as needed (pro-re-nata, latin)
QA Quality Assurance
QC Quality Control
QD/OD Once a day (quaque die, latin)
QTc ECG/EKG QT interval corrected for heart rate
QID Four times a day (quater in die, latin)
RBCs Red Blood Cells
RBM Risk Based Monitoring
SAE Serious Adverse Event
SDV Source Document Verification
SMO Site Management Organization
SOP Standard Operating Procedure
SUSAR Suspected Unexpected Serious Adverse Reaction
TID Three times a day (ter in die, latin)
TMF Trial Master File
WBCs White Blood Cells, or leukocytes
Created by: wickerfurniture