COMMONLY-USED ABBREVIATIONS AND ACRONYMS FOR RESEARCH COORDINATORS

AABB AADA AAPS Ab ABEP ABPI AC ACE ACIL ACRA ACRP ACRPI ACT AD AD ADAMHA ADAS ADE ADME ADR AE AED AHRQ AIDS

American Association of Blood Banks Abbreviated Antibiotic Drug Application American Association of Pharmaceutical Scientists Antibody Auditory Brainstem-Evoked Potential Association of British Pharmaceutical Industries Before Meals Adverse Clinical Event American Council of Independent Laboratories Associate Commissioner of Regulatory Affairs (FDA) Association of Clinical Research Professionals Association for Clinical Research in the Pharmaceutical Industry (United Kingdom) Applied Clinical Trials (industry journal) Alzheimer's Disease Antidepressant Alcohol, Drug Abuse and Mental Health Administration Alzheimer's Disease Assessment Scale Adverse Drug Event Absorption, Distribution, Metabolism, and Excretion (criteria affecting activity of a drug within an organism) Adverse Drug Reaction Adverse Event Antiepileptic Drugs Agency for Healthcare Research and Quality Acquired Immunodeficiency Syndrome

Research Coordinator Orientation, University of Pittsburgh, 2011

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AKA ALT AMA AmFAR AMG AMI ANDA AOACI APHIS ARC ARDS ASCPT AST ATF AZT BAER BCE BEUC BGA BID BIND BKA BMI BMR BP BPAD

Above-the-Knee Amputation Alanine Aminotransferase (formerly SGPT, liver enzyme) American Medical Association, American Management Association, against medical advice American Foundation for AIDS Research West Germany Drug Law (Germany's equivalent to Food, Drug and Cosmetic Act) Acute Myocardial Infarction Abbreviated New Drug Application (used for generics) Association of Official Analytical Chemists International Animal and Plant Health Inspection Service (USDA) AIDS-Related Complex Adult Respiratory Distress Syndrome American Society for Clinical Pharmacology and Therapeutics Aspartate Aminotransferase (also known as SGOT, liver enzyme) Bureau of Alcohol, Tobacco and Firearms (US Department of Justice) Zidovudine (HIV treatment) Brainstem Auditory-Evoked Potential Beneficial Clinical Event European Consumers Organisation Bundesgesundheitsamt (Germany's equivalent to FDA) Twice a Day Biological IND Below-the-Knee Amputation Body Mass Index Basil metabolic rate Blood Pressure Bipolar Affective Disorder

Research Coordinator Orientation, University of Pittsburgh, 2011

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BPM BSA BSN BUN C&S Ca CA CAD CANDA CAPLA CAPRA CBC CBCTN CBER CBF CC CDD CCRA CCRC CDC CDER CDRH CEN CEU CFR CFSAN CHD

Beats per Minute Body Surface Area Bachelor of Science in Nursing Blood Urea Nitrogen Culture and Sensitivity Test (for bacteria) Calcium Carcinoma Coronary Artery Disease Computer-Assisted New Drug Application Computer-Assisted Product License Application Canadian Association of Pharmaceutical Regulatory Affairs Complete Blood Count Community-Based Clinical Trials Network Center for Biologics Evaluation and Research (FDA) Cerebral Blood Flow Chief Complaint Canadian Drugs Directorate Certified Clinical Research Associate Certified Clinical Research Coordinator Centers for Disease Control Center for Drug Evaluation and Research (FDA) Center for Devices and Radiological Health (FDA) Committee for European Normalization Continuing Education Units Code of Federal Regulations Center of Food Safety and Applied Nutrition (FDA) Coronary Heart Disease

Research Coordinator Orientation, University of Pittsburgh, 2011

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CHF CHI CIOMS CIR CK or CPK Cl CLIA CMC CMDRH CME CMG CNS COSTART CP CPMP CPR CPSC CRA CRADA CRC CRF CRO CSDD CSF CSM CT

Congestive Heart Failure Closed Head Injury Council for International Organizations of Medical Sciences (postapproval international ADR) Cosmetic Ingredient Review (FDA) Serum Creatine Kinase or Creatine Phosphokinase Serum or Plasma Chloride Clinical Laboratory Improvement Amendments Chemistry and Manufacturing Controls (FDA) Center for Medical Devices and Radiological Health (FDA) Continuing Medical Education Cystometrogram Central Nervous System Coding Symbols for Thesaurus of Adverse Reaction Terms (FDA) Compliance Program (FDA) Committee for Proprietary Medicinal Products Cardiopulmonary Resuscitation Consumer Product Safety Commission Clinical Research Associate Cooperative Research and Development Agreements (between government agencies and industry) Clinical Research Coordinator Case Report Form Clinical Research Organization Center for the Study of Drug Development Cerebral Spinal Fluid Commission on Safety of Medicines (United Kingdom) Clinical Trial

Research Coordinator Orientation, University of Pittsburgh, 2011

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CT CTM CV CVA CVM CXR DAWN DB DBM DCF DD DEA DEN DHHS DIA DJD dl. DNR DOD DOT DPC-PTR DRG DSI DSM DUR Dx. EAB

Computed Tomography Clinical Trail Material Curriculum Vitae Cerebrovascular Accident Center for Veterinary Medicine (FDA) Chest X-Ray Drug Abuse Warning Network Double Blind Division of Bioresearch Monitoring, CDRH, FDA Data Correction Form/Data Clarification Form Department of Drugs (Sweden's equivalent to the FDA) Drug Enforcement Administration (law enforcement division of FDA) Drug Experience Network Department of Health & Human Services Drug Information Association Degenerative Joint Disease Deciliter Do Not Resuscitate Department of Defense Department of Transportation Drug Price Competition and Patent Term Restoration Act of 1984 Diagnosis-Related Groups Division of Scientific Investigations (FDA) Diagnostic and Statistical Manual Drug Use Review Diagnosis Ethical Advisory Board (similar to IRB, used by other nations)

Research Coordinator Orientation, University of Pittsburgh, 2011

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ECG ECU ED EEC EEG EFPIA EFTA EIR EKG ELA EMG EMS ENDA ENT EO EORTC EOS EPA EPI EPL ETT EUP EURODIAB FACA FAX FBS

Electrocardiogram European Currency Unit Erectile Dysfunction European Economic Community Electroencephalogram European Federation of Pharmaceutical Industries and Associations European Free Trade Association Establishment Inspection Report (provides a detailed account of the FDA inspection) Electrocardiogram Establishment License Application Electromyogram Electronic Mail Service Electronic NDA Ear, Nose, and Throat Executive Order European Organization for Research and Treatment of Cancer End of Study Environmental Protection Agency Expanded Programme in Immunization (WHO program) Effective Patent Life Exercise Tolerance Test Experimental Use Permit (for animal research, obtained from EPA) European Concerted Action on the Epidemiology of Diabetes Federal Advisory Committee Act, 1972 Facsimile Fasting Blood Sugar

Research Coordinator Orientation, University of Pittsburgh, 2011

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FCC FCCSET FDA FDA-482 FDA-483 FDA-1572 FDA-SRS FDCA FDLI FMD FOIA FP FR FSIS FTC

Federal Communications Commission Federal Coordinating Council for Science, Engineering and Technology Food and Drug Administration Notice of Inspection Notice of Adverse Findings in an Inspection FDA Form for Statement of Investigator Spontaneous Reporting System of the FDA Food, Drug, and Cosmetic Act Food and Drug Law Institute Field Management Directives (FDA) Freedom of Information Act Family Practice Federal Register Food Safety and Inspection Service (USDA) Federal Trade Commission (has primary responsibility for nonprescription advertising while the FDA has responsibility for prescription drug advertising) Fever of unknown origin Fracture Gram General Accounting Office General Agreement of Tariffs and Trade Good Clinical Practices Glomerular Filtration Rate Gastrointestinal Gastrointestinal Bleed Good Laboratory Practice Good Manufacturing Practice

FUO Fx. g GAO GATT GCP GFR GI GIB GLP GMP

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GP GRAS GRE GTN GU HAI HAZCOM HAZMAT Hb HCFA HCO3 Hct Hg Hgb HHS HIV HMO HPB HRG HRRC HRSA HS HTN Hx. IACUC IB ICD9

General Practice Physician Generally Recognized as Safe (salt, hydrogen peroxide, etc.) Generally Recognized as Effective Nitroglycerin Genitourinary Health Action International Hazardous Communication (EPA) Hazardous Materials (EPA) Hemoglobin Health Care Financing Administration Serum or Plasma Bicarbonate Hematocrit Mercury Hemoglobin Health and Human Services (Department of ) Human Immunodeficiency Virus Health Maintenance Organization Health Protection Branch (Canada's equivalent to the FDA) Health Research Group Human Research Review Committee Health Resources and Services Administration At Hour of Sleep Hypertension History Institutional Animal Care and Use Committee (IRB for animal research) Investigator's Brochure International Classification of Disease Codes, 9th Revision

Research Coordinator Orientation, University of Pittsburgh, 2011

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ICD-9-CM ICH ICTH ID IDB IDE IDR IM INAD IND IPCS IPEMC IPRA IPRD IRB IRG ISO ISPE IT IV IVD IVDA IVF IVF/ET IVP JCAHO

International Classification of Disease Codes, 9th Revision-Clinical Modification International Conference on Harmonisation International Committee on Thrombosis and Haemostases Identification or Intradermal Investigational Drug Brochure Investigational Device Exemption Idiosyncratic Drug Reaction Internal Medicine or Intramuscular Investigational New Animal Drug (FDA) Investigational New Drug (Application) International Program for Chemical Safety International Commission for Protection Against Mutagens and Carcinogens International Product Registration Application International Product Registration Document Institutional Review Board Initial Review Groups International Organization for Standardization International Society for Pharmacoepidemiology Information Technology Intravenous In Vitro Diagnostic (test that works on a body fluid sample) Intravenous Drug Abuse In Vitro Fertilization In Vitro Fertilization/Embryo Transfer Intravenous Pyelography Joint Commission on Accreditation of Healthcare Organizations

Research Coordinator Orientation, University of Pittsburgh, 2011

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JCPT JCRDD JCRP JPMA K kg Kilo KS LASER lb LD LDH LOA LOC LTF MCA MCV MD MDD MDI MDR MEDLARS MHW ml mm MMSE

Journal of Clinical Pharmacology and Therapeutics Journal of Clinical Research and Drug Development Journal of Clinical Research and Pharmacoepidemiology Japan Pharmaceutical Manufacturers Association Serum or Plasma Potassium Kilogram Kilogram Kaposi's sarcoma Light Amplification by Stimulated Emission of Radiation Pound Linked Databases Lactate Dehydrogenase Letter of Agreement Level of Concern Liver Function Tests Medicines Control Agency (a division of United Kingdom's equivalent to the FDA) Mean Corpuscular Volume Medicines Division (United Kingdom's equivalent to the FDA) Manic Depressive Disorder Metered Dose Inhaler Medical Device Reporting Medical Literature Analysis and Retrieval System Ministry of Health and Welfare (Japan's equivalent to the FDA) Milliliter Millimeter Mini-Mental Status Exam (Folstein Test)

Research Coordinator Orientation, University of Pittsburgh, 2011

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MOU MRA MRI MS MTD MVP Na NA NACH NAF NAI NAS-NRC NCE NCHS NCI NCS NCTR NCV NCVIA ND NDA NDS NHLBI NHW NIAID NIDA NIH

Memoranda of Understanding Medical Research Associate Magnetic Resonance Imaging Multiple Sclerosis Maximum Tolerated Dose Mitral Valve Prolapse Serum or Plasma Sodium Not Available, Not Applicable National Advisory Health Council Notice of Adverse Findings (post-FDA audit letter) No Action Indication (most favorable post-FDA inspection classification) National Academy of Sciences - National Research Council New Chemical Entity National Center for Health Statistics (part of CDC) National Cancer Institute Not Clinically Significant National Center for Toxicological Research (FDA) Nerve Conduction Velocities National Childhood Vaccine Injury Act (1986) Not Done New Drug Application New Drug Study (Canada's equivalent of NDA) National Heart, Lung, and Blood Institute National Health and Welfare Department (Canada's equivalent of DHHS) National Institute of Allergy and Infections Disease National Institute of Drug Abuse National Institutes of Health

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NKA NLEA NME NMR NPI NPO NRB NRC NS NSAID NSR NTP OAI OB-GYN OBRR

No Known Allergies Nutrition Labeling and Education Act (1990) New Molecular Entity Nuclear Magnetic Resonance Neuropsychiatric Inventory Nothing By Mouth Non-Institutional Review Board Nuclear Regulatory Commission Not Clinically Significant Nonsteroidal Anti-Inflammatory Drug Normal Sinus Rhythm National Toxicology Program Official Action Indicated (serious post-FDA inspection classification) Obstetrics-Gynecology Office of Blood Research and Review (FDA) Temperature in Centigrade Right Eye Observational Database Office of Drug Evaluation (in FDA's CDER) Office of Enforcement (FDA) Organization for Economic Cooperation and Development (international) Temperature in Fahrenheit Office of Generic Drugs (FDA) Office of Health Affairs (FDA) Office for Human Research Protections Office of Management and Budget Office of Professional Development and Staff College (FDA)

OD ODB ODE OE OECD

OGD OHA OHRP OMB OPD/SC

Research Coordinator Orientation, University of Pittsburgh, 2011

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ORA ORO OS Os OSHA OTA OTC OU Oz PA PaCO2 PaO2 PAR PCC PCP PD PD PDQ PDR PE PET PFT PhRMA PHS PI PI PID

Office of Regulatory Affairs (FDA) Office of Regional Operations (FDA) Left Eye Opening Occupational Safety and Health Administration Office of Technology Assessment (part of Patents and Trademarks) Over-the-Counter (nonprescription drugs) Both Eyes Ounce Posterior-Anterior Arterial CO2 Arterial O2 Post-Approval Research (significant for approval of AIDS drugs) Poison Control Center Pneumocystis Carinii Pneumonia Parkinsons Disease Pharmacodynamics Physician's Data Query (NCI-sponsored cancer trial registry) Physician's Desk Reference Physical Examination or Pulmonary Embolus Positron Emission Topography Pulmonary Function Tests Pharmaceutical Research and Manufacturers of America Public Health Service Package Insert Principal Investigator Pelvic Inflammatory Disease

Research Coordinator Orientation, University of Pittsburgh, 2011

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PK PLA PMA PMI PMS PMS PO PPE PPI PPO PPO PR PR interval PRIM & R PRN PT PTT PUD PVD QA QAU QC QD QI QID

Pharmacokinetics Product License Application (when seeking commercialization of a biologic) Pre-Market Approval (when seeking commercialization of a device) Point of Maximum Impulse Premenstrual Syndrome Post-Marketing Surveillance By Mouth Personal Protective Equipment (EPA) Patient Package Inserts Policy and Procedure Order Preferred Provider Organization Pulse Rate An ECG interval Public Responsibility in Medicine and Research (nonprofit agency) As Needed Prothrombin Time Partial Thromboplastin Time Peptic Ulcer Disease Peripheral Vascular Disease Quality Assurance Quality Assurance Unit Quality Control Every Day Quality Improvement Four Times a Day

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QNS QOD QOL R&D RADAR RAPS RBC RCT RDE RDRC RIND RL RUG Rx SAE SAH SC or SQ SC SD SD SDAT SE SEA SEER SMDA SME SMO

Quantity Not Sufficient Every Other Day Quality of Life Research and Development Risk Assessment of Drugs - Analysis and Response Regulatory Affairs Professional Society Red Blood Count Randomized Controlled Trial Remote Data Entry Radioactive Drug Research Committee Reversible Inschemic Neurological Deficit Regulatory Letter (post-FDA audit letter) Resource Utilization Group Prescription Serious Adverse Event Subarchnoid Hemorrhage Subcutaneous Study Coordinator Source Document Standard Deviation Senile Dementia of the Alzheimer's Type Standard Error Single European Act of 1987 Surveillance, Epidemiology, and End Results (Registry of NCI) Safe Medical Devices Act (1990) Significant Medical Event Site Management Organization

Research Coordinator Orientation, University of Pittsburgh, 2011

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SNDA SOB SOP SSM STD STT SUD Sx. TIA TID TIND TK TMO TNG TQM UA UKCCR UNESCO UNK URI USDA USP UTI VA VAI VER VS

Supplemental NDA Shortness of Breath Standard Operating Procedure Skin Surface Microscopy Sexually Transmitted Disease Short Term Tests Sudden Unexpected Death Symptom Transient Ischemic Attack Three Times a Day Treatment IND Toxicokinetics Trial Management Organization Nitroglycerin Total Quality Management Urinalysis United Kingdom Coordinating Committee on Cancer Research United Nations Educational Science and Cultural Organization Unknown Upper Respiratory Infection United States Department of Agriculture U.S. Pharmacopeia Urinary Tract Infection United States Department of Veterans Affairs Voluntary Action Indicated (post-FDA audit inspection classification) Visual Evoked Response Vital Signs

Research Coordinator Orientation, University of Pittsburgh, 2011

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WBC WHO WL WNL

White Blood Count World Health Organization Warning Letter (most serious of post-FDA audit letter, demands immediate action within 15 days) Within Normal Limits

Research Coordinator Orientation, University of Pittsburgh, 2011

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