Translation glossary: Clinical trial abbreviations

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BLLblinded line listing 
English
CIOMSCouncil for International Organizations of Medical Sciences 
English
CROcontract research organisation 
English
CTCAECommon Terminology Criteria for Adverse Events 
English
CTCAECommon Terminology Criteria for Adverse Events 
English
DSURdevelopment safety update report 
English
eCOAelectronic clinical outcome assessment 
English
eCRFelectronic case report form 
English
EUCTREuropean Union Clinical Trials Register 
English
FAERSUS Food and Drug Administration Adverse Event Reporting System 
English
GCPGood Clinical Practice 
English
IBInvestigator\'s Brochure 
English
ICHInternational Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use 
English
ICRindependent central review 
English
IMPinvestigational medicinal product 
English
IRBInstitutional Review Board 
English
ISFInvestigator Site File 
English
IWRSinteractive web response system 
English
PGAPhysician Global Assessment [sometimes \'Patient Global Assessment\'] 
English
PIPrincipal Investigator [responsible for each research site; distinguish from Chief Investigator] 
English
PIS/ICFParticipant Information Sheet and Informed Consent Form 
English
pMCSpartial Mayo Clinic Score 
English
SCStudy Coordinator 
English
SFscreen failure [patient who did not pass screening] 
English
SIVsite initiation visit 
English
SOPsStandard Operating Procedures 
English
Sub-ISub-Investigator 
English
UVunscheduled visit 
English
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