https:\/\/learnexams.com\/search\/study?query=<\/a><\/em><\/li>\n<\/ul>\n\n\n\n\u00a0
ADR Adverse Drug Reaction- Pre-approval – all noxious, unintended responses to a medicinal product at any dose.- marketed – all noxious, unintended responses to a medicinal product at any dose normally used.- causal or cannot be ruled out. – eg rash, jaundice, anemia, decreased WBC.- can be dose related, non-dose (bizarre), dose related and time (Chronic), time related (delayed), withdrawal, and failure. not all ADRs are known. UNEXPECTED ADR- an ADR not consistent with product info (IB or risk info). – or at the specificity or severity that has been observed.
AE Adverse Event (experience)- untoward\/unfavorable medical occurrence in a patient\/clinical investigation subject administered a pharmaceutical product and does not necessarily have a causal relationship with treatment- any unfavorable\/unintended sign, lab finding, symptom, disease temporarily associated- may or may not be considered related to the medical product
ALCOAC Good documentation practices in clinical trials – trial records and source documents for site trial subjects. Accurate (error-free – double check)legible (easy to read)contemporaneous (recorded when observed – signatures and dates)original (not a copy)attributable (who did what, when, and why)complete (source documentation)
ALT Alanine Transaminase (liver enzyme)- When liver cells are damaged, they release ALT into the bloodstream. – High levels of ALT in your blood may be a sign of a liver injury or disease.
AST Aspartate Transaminase (liver enzyme)Found mostly in the liver, but also in muscles and other organs in your body. When cells that contain AST are damaged, they release the AST into your blood. Commonly used to help diagnose liver damage or disease
BID 2 x day (bid in die)
BMI Body Mass Index- WT divided by HT
BP Blood Pressure
BUN Blood Urea Nitrogen – a waste product that your kidneys remove from your blood- kidney function test
CAPA Corrective and Preventive Action- Noncompliance with the protocol, SOPs, GCP, and\/or applicable regulatory requirement(s) by an investigator\/institution, or by member(s) of the sponsor’s staff should lead to prompt action by the sponsor to secure compliance. – If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions (CAPA).
CIOMS Council for International Organizations of Medical Sciences-CIOMS mission is to advance public health through guidance on health research and policy including ethics, medical product development, and safety. CIOMS is in official relations with WHO and is an associate partner of UNESCO.
CK Creatinine Kinase (muscle enzyme)- type of protein (enzyme) and if high levels in blood, could mean damage or disease to skeletal muscles, heart or brain.
CRA Clinical Research Associate
CRC Clinical Research Coordinator
CRF Case Report Form-record all of the protocol required information to be reported to the sponsor on each trial subject.
CRO Contract Research Organization- A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality\/integrity of the trial data always resides with the sponsor. – The CRO should implement quality assurance and quality control.
CSR Clinical Study Report- To document results and interpretation of trial (methods, results, key findings)- similar to an academic paper structure
CTMS Clinical Trial Management System
CV Curriculum Vitae
DCF Data Clarification Form- also called data query – official communication to the site to question discrepant data on CRF, with changes to the data signed off
IDMC Independent Data Monitoring Committee (interchangeable with DSMB\/DSMC)
DSMB Data and Safety Monitoring Board – assess at intervals progress of a trial, safety data, and critical efficacy endpoints- recommend to sponsor whether to continue, modify, or stop a trial.
ECG Electrocardiogram
eCRF Electronic Case Report Form
ePRO Electronic Patient Reported Outcomes
eTMF Electronic Trial Master File
EDC Electronic Data Capture
EKG Electrocardiogram
EMR Electronic Medical Record
EHR Electronic Health Record
C Celcius
F Fahrenheit
FEV1 Forced Expiratory Volume in 1 Second
GCP Good Clinical Practices- international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
GI Gastrointestinal
GLP Good Laboratory Practices- apply to nonclinical laboratory studies supporting research or marketing applications for FDA-regulated products (21 CFR 58.1)
GMP Good Manufacturing Practices – ensuring that products are consistently produced and controlled according to quality standards
hCG Human Chorionic Gonadotrophin- hormone produced by the placenta during pregnancy
HMO Health Maintenance Organization
IB Investigator’s Brochure – dose frequency\/interval, methods of administration, safety monitoring procedures
ICF Informed Consent Form- non-technical, practical, understandable to the subject or the subject’s legally acceptable representative, and an impartial witness, where applicable.
ICH International Conference on Harmonization
IP Investigational Product
IRB Institutional Review Board- Ethics- rights, safety and wellbeing of subjects- review consent, protocol, AMDs, recruitment (ads), written info provided to subjects, IB, safety info, payments, PI CV etc
IEC Independent Ethics Committee
IVRS Interactive Voice Response System
IWRS Interactive Web Response System
LAR Legally Acceptable Representative- individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.
MAOI Monoamine Oxidase Inhibitor
Mcg Microgram
mmHg Millimeters of mercury
NSAID(s) Non-Steroidal Anti-Inflammatory Drugs(s)
PI Principal Investigator- A person responsible for the conduct of the clinical trial at a trial site
PK Pharmacokinetics- metabolism, as appropriate, and absorption, plasma protein binding, distribution, and elimination
PRO Patient Reported Outcomes
PM Project Manager
p.r.n. as needed- pro re nata
QA Quality Assurance- QA involves the design of processes, such as documenting standard operating procedures (SOPs) according to ISO 9000 standards
QC Quality Control- QC involves the testing of products to ensure they meet standards for safety and efficacy
QD or OD Once daily – quaque die
QTc ECG\/EKG QT interval corrected for heart rate
QID Four times a day- quater in die
RBCs Red Blood Cells
RBM Risk Based Monitoring
SAE Serious Adverse Event: – An adverse event that results in any of the following:DeathLife-threatening situationInpatient hospitalizationProlongation of existing hospitalizationPersistent or significant disability\/incapacityCongenital anomaly\/birth defect
SDV Source Document Verification- the comparison of reported trial data with information from primary health records of trial subjects
SMO Site management organization – Companies contracted with by the sponsor to find and manage the sites conducting the study.
SOP Standard Operating Procedure
SUSAR Suspected Unexpected Serious Adverse Reaction- unexpected SAR
TID three times a day -ter in die
TMF Trial Master File
WBCs White Blood Cells, or leukocytes<\/p>\n","protected":false},"excerpt":{"rendered":"
ACRP Abbreviations with Verified Explanations (Latest 2024\/ 2025 Update) 100% Correct ACRP Abbreviations with VerifiedExplanations (Latest 2024\/ 2025 Update)100% CorrectV: BIDAnswer:2 x day (bid in die)V: BMIAnswer:Body Mass Index V: CAPAAnswer:Corrective and Preventive Action V: CRCAnswer:Clinical Research CoordinatorV: CRFAnswer:Case Report Form-record all of the protocol required information to be reported to the sponsor on each […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[25],"tags":[],"class_list":["post-131807","post","type-post","status-publish","format-standard","hentry","category-exams-certification"],"_links":{"self":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/131807","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/comments?post=131807"}],"version-history":[{"count":0,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/131807\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/media?parent=131807"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/categories?post=131807"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/tags?post=131807"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}