Translation glossary: Clinical trial abbreviations

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