Abbreviations

The Clinical Operations and Drug Development industry uses a wide range of abbreviations. Some key ones are shown below.

AbbreviationDefinition
ADRAdverse Drug Reaction
AEAdverse Event
APIActive Pharmaceutical Ingredient
BICBest In Class
CAPACorrective Action, Preventive Action
CMCChemistry Manufacturing and Control
COVClose-out Visit
CPMClinical Project Manager
CRAClinical Research Associate
CRFCase Report Form
CROClinical Research Organisation
CSRClinical Study Report
CTAClinical Trial Associate
CTAClinical Trial Application
ECEthics Committee
eCRFElectronic Case Record Form
EDCElectronic Data Capture
EMAEuropean Medicines Agency (EU)
ePROElectronic Patient Reported Outcome
eTMFElectronic Trial Master File
FDAFood and Drug Administration (US)
FICFirst In Class
FIHFirst In Human
FPFVFirst Participant First Visit
FPIFirst Participant In
GCPGood Clinical Practice
GDPRGeneral Data Protection Regulation
IBInvestigator Brochure
ICFInformed Consent Form
ICHInternational Council for Harmonisation (of Technical Requirements for Human Use)
ICOInformation Commissioner’s Office
IDMCIndependent Data Monitoring Committee
IECIndependent Ethics Committee
IMPDInvestigational Medicinal Product Dossier
IRBInstitutional Review Board
KOLKey Opinion Leader
LPFVLast Participant First Visit
LPILast Participant In
LPLVLast Participant Last Visit
LPOLast Participant Out
MHRAMedicines and Healthcare Products Regulatory Agency (UK)
PISParticipant Information Sheet
PROPatient-reported Outcome
QAQuality Assurance
QCQuality Control
QMSQuality Management System
RMVRoutine Monitoring Visit
RSIReference Safety Information
SAESerious Adverse Event
SIVSite Initiation Visit
SLAService Level Agreement
SOPStandard Operating Procedure
SQVSite Qualification Visit
SUSARSuspected unexpected serious adverse reaction
TMFTrial Master File
TPPTarget Product Profile
UATUser Acceptance Testing