Clinical Trials Acronyms Search Acronyms AACI Association of American Cancer Institutes Read full definition → AAHRPP Association for the Accreditation of Human Research Protection Programs Read full definition → ABM Affiliated Board Member Read full definition → ABSA The Association for Biosafety and Biosecurity Read full definition → ACH Automated Clearing House Read full definition → ACRP Association of Clinical Research Professionals Read full definition → ACSoMP Advisory Committee for Medicinal Products Read full definition → ACT Artemisinin-Based Combination Therapy Read full definition → ACTS Association for Clinical and Translational Science Read full definition → ADME Absorption, Distribution, Metabolism, and Elimination Read full definition → ADR Adverse Drug Reaction Read full definition → AE Adverse Event Read full definition → AEFI Adverse Event Following Immunization Read full definition → AEMPS Agencia Española de Medicamentos y Productos Sanitarios Read full definition → ALCOA Attributable, Legible, Contemporaneous, Original, Accurate Read full definition → AMA American Medical Association Read full definition → AMC Academic Medical Center Read full definition → ANSM Agence Nationale de Sécurité du Médicament Read full definition → API Active Pharmaceutical Ingredient Read full definition → ARO Academic Research Organization Read full definition → ART Antiretroviral Therapy Read full definition → ARV Antiretrovirals Read full definition → ASCO American Society of Clinical Oncology Read full definition → ASCPT American Society for Clinical Pharmacology and Therapeutics Read full definition → ASGCT American Society of Gene and Cell Therapy Read full definition → ATC Anatomical Therapeutic Chemical Classification Read full definition → BA / BE Bioavailability / Bioequivalence Read full definition → BAA Business Associate Agreement Read full definition → BCPNN Bayesian Confidence Propagation Neural Network Read full definition → BfArM Bundesinstitut für Arzneimittel und Medizinprodukte Read full definition → BIND Biological Investigational New Drug Read full definition → BLA Biological License Application Read full definition → BSM Biospecimen Management Read full definition → CA Coverage Analysis Read full definition → caBIG Cancer Biomedical Informatics Grid Read full definition → CAPA Corrective and Preventive Action Read full definition → CBCTN Community-Based Clinical Trials Network Read full definition → CBER Center for Biologics Evaluation and Research Read full definition → CCEA Complete, Consistent, Enduring, and Available Read full definition → CCOP Community Clinical Oncology Program Read full definition → CCR Center for Cancer Research Read full definition → CCRA Certified Clinical Research Associate Read full definition → CCRC Certified Clinical Research Coordinator Read full definition → CCRP Certified Clinical Research Professional Read full definition → CCRT Center for Clinical Research Technology Read full definition → CCSG Cancer Center Support Grant Read full definition → CCTO Centralized Clinical Trials Office Read full definition → CDA Confidential Disclosure Agreement Read full definition → CDASH Clinical Data Acquisition Standards Harmonization Read full definition → CDC Centers for Disease Control and Prevention Read full definition → CDER Center for Drug Evaluation and Research Read full definition → CDISC Clinical Data Interchange Standards Consortium Read full definition → CDM Clinical Data Management Read full definition → CDMS Clinical Data Management System Read full definition → CDP Clinical Development Plan Read full definition → CDRH Center for Devices and Radiological Health Read full definition → CEM Cohort Event Monitoring Read full definition → CFR Code of Federal Regulations Read full definition → CHMP Committee for Medicinal Products for Human Use Read full definition → CI Confidence Interval Read full definition → CIOMS Council for International Organizations of Medical Sciences Read full definition → CITI Collaborative Institutional Training Initiative Read full definition → CLIA Clinical Laboratory Improvement Amendments Read full definition → CMC Chemistry, Manufacturing, and Controls Read full definition → CME Continuing Medical Education Read full definition → CMO Contract Manufacturing Organization Read full definition → CMR Center for Medicines Research Read full definition → CMS Centers for Medicare & Medicaid Services Read full definition → CMS Central Management System Read full definition → CN Consent Navigator Read full definition → CNT Consented But Not Treated Read full definition → CPIB Capital Project Investment Board Read full definition → CPM Clinical Project Manager Read full definition → CR Continuing Review Read full definition → CRA Clinical Research Associate Read full definition → CRC Clinical Research Coordinator Read full definition → CRF Case Report Form Read full definition → CRM Clinical Research Management Read full definition → CRMS Clinical Research Management System Read full definition → CRO Clinical Research Organization / Contract Research Organization Read full definition → CRPC Clinical Research Process Content Read full definition → CSC Client Services Coordinator Read full definition → CSO Contract Safety Organization Read full definition → CSR Clinical Study Report Read full definition → CTA Clinical Trial Authorization Agreement Read full definition → CTA Clinical Trial Agreement Read full definition → CTCAE Common Terminology Criteria for Adverse Events Read full definition → CTEP Cancer Therapy Evaluation Program Read full definition → CTMS Clinical Trial Management System Read full definition → CTO Clinical Trials Office Read full definition → CTRP Clinical Reporting Program Read full definition → CTSA Clinical and Translational Science Award Read full definition → CTSC Clinical and Translational Science Collaborative Read full definition → CTSC Clinical and Translational Science Collaborative Read full definition → CTSI Clinical and Translational Sciences Institute Read full definition → DCCPS Division of Cancer Control and Population Sciences Read full definition → DCEG Division of Cancer Epidemiology and Genetics Read full definition → DCF Data Correction Form / Data Clarification Form Read full definition → DCTD Division of Cancer Treatment and Diagnosis Read full definition → DDD Defined Daily Dose Read full definition → DDI Drug-Drug Interaction Read full definition → DHHS / HHS Department of Health and Human Services Read full definition → DIA Drug Information Association Read full definition → DM Data Manager Read full definition → DMC Data Monitoring Committee Read full definition → DMP Data Management Plan Read full definition → DOS Date of Service Read full definition → DSMB Data and Safety Monitoring Board Read full definition → DSRU Drug Safety Research Unit (UK) Read full definition → DTP Direct to Patient Read full definition → E2B (R3) E2B (R3) Electronic Transmission of Individual Case Safety Reports Read full definition → EAB Ethical Advisory Board Read full definition → EAC Endpoint Adjudication Committee Read full definition → EC Ethics Committee Read full definition → eCOA Electronic Clinical Outcome Assessment Read full definition → eCRF Electronic Case Report Form Read full definition → EDC Electronic Data Capture Read full definition → EHR Electronic Health Record Read full definition → EMA European Medicines Agency Read full definition → EMR Electronic Medical Record Read full definition → ENCePP European Network of Centres for Pharmacoepidemiology and Pharmacovigilance Read full definition → EP Ethics Pack Read full definition → ePRMS Electronic Protocol Review Management System Read full definition → ePRO Electronic Patient-Reported Outcomes Read full definition → eReg Electronic Regulatory System Read full definition → eTMF Electronic Trial Master File Read full definition → EVAL Research Evaluation System Read full definition → FAIR Findable, Accessible, Interoperable, Reusable Read full definition → FDA-1571 FDA Form 1571 – IND Application Form Read full definition → FDA-1572 FDA Form 1572 – Statement of Investigator Read full definition → FDA-482 FDA Form 482 – Notice of Inspection Read full definition → FDA-483 FDA Form 483 – Inspectional Observations Read full definition → FIH First-in-Human Read full definition → FIP International Pharmaceutical Federation Read full definition → FPI First Patient In Read full definition → FWA Federalwide Assurance Read full definition → GACVS Global Advisory Committee on Vaccine Safety (WHO) Read full definition → GAP-Net Global Alzheimer’s Platform Foundation Network Read full definition → GCP Good Clinical Practice Read full definition → GCRC General Clinical Research Center Read full definition → GDP Good Documentation Practice Read full definition → GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria Read full definition → GLP Good Laboratory Practice Read full definition → GMP Good Manufacturing Practice Read full definition → GVP Good Pharmacovigilance Practice Read full definition → GVSI WHO Global Vaccine Safety Initiative Read full definition → GxP / GXP Good Practice Read full definition → HATC Herbalists / Herbal Therapy Considerations in Clinical Research Read full definition → HHS Department of Health and Human Services Read full definition → HIC High-Income Countries Read full definition → HIPAA Health Insurance Portability and Accountability Act Read full definition → HITECH Health Information Technology for Economic and Clinical Health Act Read full definition → HITRUST CSF Health Information Trust Alliance Common Security Framework Read full definition → HRPP Human Research Protection Program Read full definition → HSP Human Subjects Protections Read full definition → IACUC Institutional Animal Care and Use Committee Read full definition → IAR Independent Asset Review Read full definition → IB Investigator Brochure Read full definition → IBC Institutional Biosafety Committee Read full definition → IC Information Component of Informed Consent Read full definition → ICD International Classification of Diseases Read full definition → ICD-9 International Classification of Diseases, Ninth Revision Read full definition → ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification Read full definition → ICDRA International Conference of Drug Regulatory Authorities Read full definition → ICF Informed Consent Form Read full definition → ICH International Council for Harmonisation Read full definition → ICSR Individual Case Safety Report Read full definition → IDB Investigational Drug Branch Read full definition → IDE Investigational Device Exemption Read full definition → IDS Investigational Drug Services (pharmacy) Read full definition → IEC Independent Ethics Committee Read full definition → IHCRA In-House Clinical Research Associate Read full definition → IIT Investigator-Initiated Trials Read full definition → IMB Irish Medicines Board (now HPRA) Read full definition → IMMP Intensive Medicines Monitoring Programme (New Zealand) Read full definition → IMP Investigational Medicinal Product Read full definition → IMPD Investigational Medicinal Product Dossier Read full definition → IND Investigational New Drug Application Read full definition → INN International Nonproprietary Name Read full definition → IOC Inter-Office Communicator Read full definition → IP Investigational Product Read full definition → IPCS International Programme on Chemical Safety Read full definition → IRB Institutional Review Board Read full definition → iRIS Integrated Research Information System Read full definition → IRT Interactive Response Technology Read full definition → ISF Investigator Site File Read full definition → ISL Institutional Service Line Read full definition → ISMS Information Security Management System Read full definition → ISN Investigative Site Network Read full definition → ISO International Organization for Standardization Read full definition → ISO 9001 ISO Quality Management Standard Read full definition → ISO/IEC 27001 ISO Information Security Standard Read full definition → ISoP International Society of Pharmacovigilance Read full definition → ISPE International Society for Pharmacoepidemiology Read full definition → ITT Intent-to-Treat Read full definition → IVRS Interactive Voice Response System Read full definition → IWRS Interactive Web Response System Read full definition → JCAHO Joint Commission (formerly JCAHO) Read full definition → JPMA Japan Pharmaceutical Manufacturers Association Read full definition → LOA Letter of Agreement Read full definition → LRAA Local Regulatory Affairs Associate Read full definition → LTFU Long-Term Follow-Up Read full definition → LTM Last Twelve Months Read full definition → MAA Marketing Authorisation Application Read full definition → MAC Medicare Administrative Contractor Read full definition → MAD Multiple Ascending Dose Read full definition → MAH Marketing Authorization Holder Read full definition → MCA Medicare Coverage Analysis Read full definition → MCTA Master Clinical Trial Agreement Read full definition → MDR Medical Device Reporting Read full definition → MedDRA Medical Dictionary for Regulatory Activities Read full definition → MHRA Medicines and Healthcare products Regulatory Agency (UK) Read full definition → MOOP Maximum Out-of-Pocket Read full definition → MOP Manual Operation Read full definition → MOU Memorandum of Understanding Read full definition → MP Monitoring Plan Read full definition → MRN Medical Record Number Read full definition → MSA Master Services Agreement Read full definition → MSF Médecins Sans Frontières Read full definition → MSH Management Sciences for Health Read full definition → MSSO Maintenance and Support Services Organization Read full definition → MTA Material Transfer Agreement Read full definition → MTT Multi-Tenant Tier Read full definition → MU Maintenance Update Read full definition → NCE New Chemical Entity Read full definition → NCI National Cancer Institute Read full definition → NCIP National Cancer Informatics Program Read full definition → NCS Not Clinically Significant Read full definition → NDA New Drug Application Read full definition → NGO Non-Governmental Organization Read full definition → NHV Normal Healthy Volunteer Read full definition → NIH National Institutes of Health Read full definition → NIST SP 800-53 NIST Special Publication 800-53 Read full definition → NLM National Library of Medicine Read full definition → NME New Molecular Entity Read full definition → NRA National Regulatory Authority Read full definition → NSAID Nonsteroidal Anti-Inflammatory Drug Read full definition → NWABR Northwest Association for Biomedical Research Read full definition → OAI Official Action Indicated Read full definition → OHRP Office for Human Research Protections Read full definition → ORI Office of Research Integrity Read full definition → OSR Outside Safety Report Read full definition → OTS Off-the-Shelf Read full definition → PAC Post-Approval Commitments Read full definition → PC Protocol Coordinator Read full definition → PCC Poison Control Centre Read full definition → PCIDSS Payment Card Industry Data Security Standard Read full definition → PD Protocol Deviation Read full definition → PD Pharmacodynamic Read full definition → PDQ Physician Data Query Read full definition → PDQ Physician Data Query (NCI-Sponsored Resource) Read full definition → PDR Physicians’ Desk Reference Read full definition → PDS Pharmacoepidemiology and Drug Safety (Journal) Read full definition → PE Protocol Essentials Read full definition → PEM Prescription Event Monitoring Read full definition → PHI Protected Health Information Read full definition → PHRMA Pharmaceutical Research and Manufacturers of America Read full definition → PI Principal Investigator Read full definition → PII Personally Identifiable Information Read full definition → PIL Package Insert Leaflet Read full definition → PK Pharmacokinetic Read full definition → PMA Pre-Market Approval (Device) Read full definition → PMDA Pharmaceuticals and Medical Devices Agency (Japan) Read full definition → PMS Post-Marketing Surveillance Read full definition → POM Prescription-Only Medicine Read full definition → PP Patient Portal Read full definition → PPI Patient Package Inserts Read full definition → PRAC Pharmacovigilance Risk Assessment Committee (EMA) Read full definition → PRE Prompt Reporting Event Read full definition → PRIM&R Public Responsibility in Medicine and Research Read full definition → PRMC Protocol Review and Monitoring Committee Read full definition → PRMS Protocol Review and Monitoring System Read full definition → PRO Patient-Reported Outcomes Read full definition → PRW Patient Recruitment Website Read full definition → PSM Procurement and Supply Management Read full definition → PSN Pre-Screen Navigator Read full definition → PSUR Periodic Safety Update Report Read full definition → PTA Post-Training Assessment Read full definition → PTAEO Project-Task-Award Expenditure (Oracle/finance structure) Read full definition → PV Pharmacovigilance Read full definition → QA Quality Assurance Read full definition → QC Quality Control Read full definition → QCT Quality Clinical Trial Read full definition → QE/QI Quality Event / Quality Incident Read full definition → QI Quality Improvement Read full definition → QMP Quality Management Plan Read full definition → QMS Quality Management System Read full definition → QOL Quality of Life Read full definition → R&D Research and Development Read full definition → RBM Risk-Based Monitoring Read full definition → RBNF Research Billing Notification Form Read full definition → RC RingCentral Read full definition → RCA Root Cause Analysis Read full definition → RDE Remote Data Entry Read full definition → REB Research Ethics Board Read full definition → REC Research Ethics Committee Read full definition → RES Rater Evaluation Survey Read full definition → RFS Research Finance Specialist Read full definition → RL Regulatory Letter (FDA audit/inspection letter) Read full definition → RPE Retrieve Process for Execution Read full definition → RQA Research Quality Association Read full definition → RWE Real-World Evidence Read full definition → SAD Single Ascending Dose Read full definition → SAE Serious Adverse Event Read full definition → SAP Statistical Analysis Plan Read full definition → SC Study Coordinator Read full definition → SCDM Society for Clinical Data Management Read full definition → SCRS Society for Clinical Research Sites Read full definition → SD Source Document Read full definition → SDLC Software Development Life Cycle Read full definition → SDR Source Data Review / Source Document Review Read full definition → SDTM Study Data Tabulation Model Read full definition → SDV Source Data Verification Read full definition → SEF Screening Eligibility Form Read full definition → SFDA State Food and Drug Administration (China) Read full definition → SG&A Selling, General, and Administrative Read full definition → SIF Site Investigator File Read full definition → SIP Study Information Portal Read full definition → SME Subject Matter Expert Read full definition → SMO Site Management Organization Read full definition → SMQ Standardized MedDRA Query Read full definition → SOC Standard of Care Read full definition → SOC System Organ Class Read full definition → SOC 1 Report SOC for Service Organizations: ICFR Read full definition → SOC 2 Report SOC for Service Organizations: Trust Services Criteria Read full definition → SOC 3 Report SOC for Service Organizations: General Use Report Read full definition → SoCRA Society of Clinical Research Associates Read full definition → SOE Schedule of Events Read full definition → SOM School of Medicine Read full definition → SOP Standard Operating Procedure Read full definition → SOW Statement of Work Read full definition → SPC Summary of Product Characteristics Read full definition → SPOREs Specialized Programs of Research Excellence Read full definition → SQA Software Quality Assurance Read full definition → SRAI Society of Research Administrators International Read full definition → SRB Scientific Review Board Read full definition → SRC Scientific Review Committee Read full definition → SSU Study Start-Up Read full definition → SUSAR Suspected Unexpected Serious Adverse Reaction Read full definition → TMF Trial Master File Read full definition → TMF (or eTMF) Trial Master File (Electronic) Read full definition → TMO Trial Management Organization Read full definition → UADE Unanticipated Adverse Device Effect Read full definition → UADR Unexpected Adverse Drug Reaction Read full definition → UAP Unanticipated Problem Read full definition → URM Unified Registries Management Read full definition → VA United States Department of Veterans Affairs Read full definition → VAI Voluntary Action Indicated Read full definition → VE Visit Essentials Read full definition → VIM Virtual Investigator Meeting Read full definition → WHO World Health Organization Read full definition → WL Warning Letter Read full definition →
