Abbreviations ACRP Association of Clinical Research Associates ADR Adverse Drug Reaction AE Adverse Event AMA American Medical Association CCRC Certified Clinical Research Coordinator CCRP Certified Clinical Research Professional CDC Center for Disease Control CDER Center for Drug Evaluation and Research CEU Continuing Education Unit COI Conflict of Interest CRC Clinical Research Coordinator CFR US Code of Federal Regulations CLIA Clinical Laboratory Improvement Amendment CRA Clinical Research Associate (监视器) CRF Case Report Form CRO Contract Research Organization CRSC Clinical Research Staff Council CTC Clinical Trials Center CTSS Clinical Trials Support Services DCF Data Clarification Form DGR Dangerous Goods Regulation D & H Doctor and Hospital Account DHHS US Department of Health and Human Services DOD US Department of Defense DSMB Data Safety Monitoring Board EDC Electronic Data Capture EMR Electronic Medical Record FDA US Food & Drug Administration FWA Federal Wide Assurance GCP Good Clinical Practice GCRC General Clinical Research Center (通常称为 CRC) GLP Good Lab Practice GMP Good Manufacturing Practice HIPAA Health Insurance Portability and Accessibility Act HSRC Human Subjects Radiation Committee IATA International Air Transport Association IB Investigator’s Brochure IBC ICD or ICF Informed Consent Form ICH International Conference of Harmonization IDE Investigational Device Exemption IND Investigational New Drug IRB Institutional Review Board LAN Local Area Network MAB Medical Arts Building MCN Medical Center North MOP Manual of Operations MPA Multiple Project Assurances MTD Maximum Tolerated Dose NAI No Action Indicated NCS Not Clinically Significant NDA New Drug Application NIH National Institute of Health OAI Official Action Indicated OHRP Office of Human Research Protections ORI Office of Research Integrity OTC Over the Counter PHI Protected Health Information PHS Public Health Service PCRO Pediatric Clinical Research Office PI Principle Investigator PM Project Manager PMS Post Marketing Surveillance PRB Preston Research Building RCR Responsible Conduct of Research RRB Robinson Research Building RDE Remote Data Entry RSS Research Support Services QA Quality Assurance QC Quality Control SAE Serious Adverse Event SD Source Document SI Sub Investigator SIV Site Initiation Visit SMO Site Management Organization SoCRA Society of Clinical Research Associates SOP Standard Operating Procedures VAI Voluntary Action Indicated VTEU Vaccine Trial Evaluation Unit WHO World Health Organization
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