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CLINICAL TRIALS 2010
Словарь сокращений в клинических исследованиях. AACDM = Association for Clinical Data Management ACE = acetylcholinesterase ACH = Acetylcholine ACS = American Chemical Society ACTH = Adrenocorticotropic hormone ADH = Alcohol dehydrogenase ADH, vasopressin = Antidiuretic hormone ADME = absorption, distribution, metabolism and excretion ADMET = absorption, distribution, metabolism, excretion and toxicity ADR = adverse drug reaction AE = adverse event AEs = adverse events AIDS = Acquired Immune Deficiency Syndrome AIG = Active Ingredient Group ALS = amyotrophic lateral sclerosis ANDA = Abbreviated New Drug Application ANOVA = Analysis of variance AOQL = AVERAGE OUTGOING QUALITY LEVEL AQL = ACCEPTABLE QUALITY LEVEL AR = adverse reaction ASC = Advertising Standards Canada ASCII = American Standard Code for Information Interchange ASQ = American society for quality ATP = adenosine triphosphate ATP = Advanced Technology Program ATPE = Aqueous two-phase extraction AWG = Expert Working Groups BBAA = Broad Agency Announcements BBB = Blood Brain Barrier BGTD = Biologics and Genetic Therapies Directorate ?-End = ?-Endorphin BI = biological indicator BIMO = Bioresearch Monitoring BIs = biological indicators BL1-LS = Biosafety Level 1 large-scale BLA = Biologics License Application BODs = Boards of Directors BPR = Batch Production Records BPRs = Basic Research Plans CCADRMP = Canadian Adverse Drug Reaction Monitoring Program CAT = choline acetyltransferase CBER = Center for Biologics Evaluation and Research CCS = cell-cycle specific CDA = clinical data analyses CDC = clinical data coordinator CDC Centers for Disease Control CDER = Center of Drug Evaluation and Research CDISC = Clinical Data Interchange Standards Consortium CDM = Clinical Data Management CDS = clinical data specialist CED = Cause-Effect Diagram CFD = clean file declaration CFR = Code of Federal Regulations cGMP = current Good Manufacturing Process CHEM = Labs chemistry CIB = Clinical Investigator's Brochure CIS = Clintrial Integration Solution CL = clinical listing CMV = Cyto-Megalo Virus CO = cardiac output COPD = Chronic Obstructive Pulmonary Disease CONMEDS = Concomitant medications COSTART = Coding Symbols for a Thesaurus of Adverse Reaction Terms COX = cyclooxygenase CMA = Continuous Market Application Cp = Process Capability CPG = consumer packaged goods CPMP = Committee for Proprietary Medicinal Product CPR = emergency planning and response CRA = clinical research associate CRC = clinical research coordinator CRF = case report form CRO = Contract Research Organization CRS = clinical research scientist CS = clinical scientist CSF = Cerebrospinal Fluid CSO = Consumer Safety Officer CT = clinical trail CTAB = cetyltrimethylammonium bromide CTD = Common Technical Document CTQ = critical to quality CV = curriculum vitae CVA = Cardiovascular Accident DDA = Dopamine DBL = data base lock DBMS = database management system DCC = data change convention DCF = data clarification form DCI = Data Capture Interface DCFs = data clarification forms DCM = Data collection module DDAVP® = desmopressin acetate, 1-deamino-8- d -arginine vasopressin DEHP = diethylhexylphthalate DEMO = Demographics and subject characteristics DHHS = department of health and human services DHP = Data Handling Protocol DIA = Drug Information Association DISPOSIT = Disposition DIN = Drug Identification Number DIT = diiodotyrosine DMARD = disease-modifying antirheumatic drug DMAIC = process (define, measure, analyze, improve, control) DMADV methodology (define, measure, analyze, design, verify) DMF = drug master file DMID = Division of Microbiology and Infectious Diseases DMOP = data management operational plan DOB = date of birth DOD = date of death DOPA = 3,4-dihydroxyphenylalanine DPD = Drug Product Database DPMO = Defects per Million Opportunities DSMB = Data and Safety Monitoring Board DSMBs = Data and Safety Monitoring Boards DVGs = discrete value groups EECG = Electrocardiogram ECF = Extra Cellular Fluid e-CRF = Electronic Case Report Form ECs = ethics committees EDC = Electronic Data Capture EFPIA = European Federation of Pharmaceutical Industries and Associations EFTA = European Free Trade Are a EFTA = European Free Trade Association EIR = Establishment Inspection Report ELISA = enzyme-linked immunosorbent assay EMEA = European Agency for te Evaluation of Medical Products EMR = electronic medical record EPA = Environmental Protection Agency EPDM = ethylene propylene diene monomer ERISA = Employee Retirement Income Security Act 1974 ESA = EMISSION SPECTROGRAPHIC ANALYSIS EtO = Ethylene oxide EU = endotoxin units EWG = Expert Working Group EXPOSURE = Drug exposure FFDA = Food and Drug Administration FDM = Functional Deployment Matrix FOB = functional observation battery FOI = Freedom of Information FOIA = Freedom of Information Act FSH = Follicle Stimulating Hormone FU = fraction unbound GG6PD = Glucose-6-phosphate dehydrogenase GABA = Gamma-Aminobutyric acid GAMP = Good Automated Manufacturing Practice GC = gas chromatography GCP = Good Clinical practice GCDMP = Good Clinical Data Management Practice GDP = Good Distribution Practice GFR = glomerular filtration rate GH = Growth Hormone GHTF = Global Harmonization Task Force GI = Gastro Intestinal GIT = Gastro Intestinal Tract GLP = Good Laboratory Practices GMP = good manufacturing practice (cGMP) GTP = guanosine triphosphatE GUI = Graphical User Interface HHDL = high-density lipoproteins + HEMA = Labs hematology HHS = Health and Human Services HIPAA = Health Insurance Portability and Accountability Act HIV = human immune-deficiency virus HIV = Human Immunodeficiency Virus HLT = High level term HLGT = High level group term HMG-CoA = 3-hydroxy-3-methylglutaryl coenzyme A HMW = high-molecular-weight HPFB = Health Products and Food Branch HPFBI = Health Products and Food Branch Inspectorate HPLC = high-pressure liquid chromatography HTS = high throughput screening IIACUC = Institutional Animal Care and Use Committee IB = Investigator's Brochure IBCTs = Internet Based Clinical Trials IC = Institute and Center ICD-CM = International Classification of Diseases with Clinical Modification ICDRA = International Conference of Drug Regulatory Authorities ICH = International Conference on Harmonisation IDDM = Insulin-dependent diabetes mellitus IDE = independent development evaluation IDMC = Independent Data-Monitoring Committee IEC = independent ethics committee IFPMA = International Federation of Pharmaceutical Manufacturers Association IM = intramuscularly IME = important medical event IMPs = investigative medicinal products IND = investigational new drug IOL = intraocular lens IOM = Institute of Medicine IOM = Investigations Operations Manual IOP = Interim/Interface Operating Procedure IP = investigational product IPO = initial public offering IQ = INSTALLATION QUALIFICATION IQL = INDIFFERENCE QUALITY LEVEL IRB = institutional review board IRB/IEC = INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE IRR=internal rate of return IRS = Internal Revenue Service ISE = Information Systems Engineering ISM = Independent Safety Monitor ISS = Information System Services IV = intravenous IVD = in vitro diagnostic IVDs = in vitro diagnostics JJ-ART = Japanese Adverse Reaction Terminology JD = Doctor of Jurisprudence JGA = juxtaglomerular apparatus JPMA = Japan Pharmaceutical Manufacturers Association Back to Top KKPIs = Key Performance Indicators LLAL = limulus amebocyte lysate LAR - legally authorized representative LD50 = lethal dose for 50% of test subjects LDL = low-density lipoproteins LH = Luteinizing hormone LLOQ = lower limit of quantification LLT = Lowest level term LMW = low-molecular-weight LSL = Lower Spec Limit LTPD = LOT TOLERANCE PERCENT DEFECTIVE LVLP = last visit, last patient MMAb = monoclonal antibody MAC = Mycombacterium avium Complex MAO = monoamine oxidase MBI = mercapto-benzimidazole-sulfonic acid MC = membrane chromatography MCA = Medicines Control Agency MCO = managed-care organization MCOs = managed-care organizations MedDRA = Medical Dictionary for Regulatory Activities MEDHIST = Past medical history MEP = mercaptoethyl pyridine MHLW = Ministry of Health, Labor and Welfare, Japan MHW = Ministry of Health and Welfare MI = Myocardial Infarction MIT = monoiodotyrosine MMSE = Mini-Mental State Examination MRA = mutual recognition agreement MRSA = Methicillin-Resistant Staphylococcus aureus MS = mass spectrometric MSH = melanocyte stimulating hormone MSSO = Maintenance and Support Services Organization MWCB = MASTER WORKING CELL BANK NNAFTA = North American Free Trade Agreement NAI = No Action Indicated NAPA = N-acetylprocainamide NCCS = non-cell-cycle specific NCEs = Networks of Centres of Excellence NCI = National Cancer Institute NCR = no carbon required NDA = New Drug Application NDS = New Drug Submission in Canada NE = Norepinephrine NF = National Fonnulary NHS = Nation Health Service NIAID = National Institute of Allergy and Infectious Diseases NIDDM = Non-insulin-dependent diabetes mellitus NIEHS = National Institute of Environmental Health Sciences NIH = national institute of health NIHS = National Institute of Health Sciences (Japan) NIST = National Institute of Standards and Technologies NOC = Notice of Compliance NOC/c = Notice of Compliance with Conditions NPH = neutral protamine Hagedorn NPV= net present value NRC = National Research Council NSABP = National Surgical Adjuvant Breast and Bowel Project (NSABP) NSAIDs = non-steroidal anti-inflammatory drugs NTP = National Toxicology Program NTs = neurotransmitters OOAI = Official Action Indicated OCRA = Office of Clinical Research Affairs OCTs = Online Clinical Trials ODB = Ontario Drug Benefits ODM = Object Data Manager OECD = Organization for Economic Cooperation and Development OPRR = Office for Protection from Research Risks OQ = OPERATIONAL QUALIFICATION ORA = Office of Regulatory Affairs OTC = over the counter PPA = physician assistants PAAB = Pharmaceutical Advertising Advisory Board PAGE = poly-acrylamide gel electrophoresis PAR = Proven Acceptable Range PAT = Process Analytical Technology PBMS = pharmacy benefits management organizations PCs = Personal Computers PD = Parkinson's disease HD = Huntington's disease AD = Alzheimer's diseaseHSV = Herpes Simplex Virus PDC = paper data capture pdf = Portable Document Format PDL = POPULATION DOUBLING LEVEL PE = Physical examination PEG = polyethylene glycol PERT = program evaluation and review technique PGP ® = Pretty Good Privacy® PhRMA = Pharmaceutical Research and Manufacturers of America PI = Principal Investigator PIDA = Public Interest Disclosure Act 1998 PLOT = preclinical lead optimisation technologies PMA = Pre-Market Approval PO = Per oral PO = Project Officer Pp = Process Performance PPD = Purified Protein Derivative PLCs = Programmable logic controllers PQ = PERFORMANCE QUALIFICATION PRDA = Program Research and Development Announcements PRL = Prolactine PSA = Public Service Announcement PT = Preferred term PTT = Partial Thromboplastin Time (test) PUVA = Psoralen Ultra-Violet A PZI = protamine zinc insulin. QQAU = quality assurance units Back to Top RRCA = regional clinical associate RDE = remote data entry RN = registered nurse ROI= return on investment SSAEs = serious adverse events SAS = Statistical Analytical System+ SBOA = Summary Basis Of Approval SBR = styrene butadiene rubber SC = Steering Committee SCDM = Society for Clinical Data Management SDR = Source Document Review SDMB = safety data monitoring boards SDV = source data verification SIBR = Small Business Innovative Research SIC = STANDARD INDUSTRIAL CLASSIFICATION CODE SIC. = Spelled incorrectly SIP = steam-in-place SIADH = Syndrome of inappropriate Anti-diuretic Hormone SKAs = skills, knowledge, and abilities SKK = Seikagaku Corporation of Tokyo SLE = Systemic Lupus Erythematosus (aka Disseminated Lupus Erythematosus, D SLR = spore log reduction SMC = Safety Monitoring Committe SMO = site management organization SOC = System Organ Class SPC = Statistical process control SPOOS = significant payments of other sorts SQL = structured query language SVP = small volume parenteral TTC = total cholesterol TCO = total cost of ownership TEAVs = Treatment-emergent abnormal values TEM = Transmission Electron Microscopy TEM = Triethylenemelamine TGS = triglycerides TPD = Therapeutic Products Directorate TPR = total peripheral vascular resistance TRH = Thyrotropin Releasing Hormone TSB = trypticase soy broth TSH = thyroid stimulating hormone TPP = Therapeutic Products Panel UUNIX = Universal Network Information Exchange URINE = Labs urinalysis ULOQ = upper limit of quantification USL = Upper Spec Limit USP = United States Pharmacopoeia UWMC = University of Washington Medical Center VVAI = Voluntary Action Indicated VAMC = Vetrqans affairs Medical Center VEBs = ventricular ectopic beats VITAL = Vital signs VLDL = very low-density lipoproteins VOC = VOLATILE ORGANIC COMPOUND WWANs = Wide Area Networks WBC = white blood cell WHO-ART = World Health Organization Adverse Reaction Terminology WFI = water for injection
International Committee of Medical Journal Editors (ICMJE): June 2007 editorial
International Committee of Medical Journal Editors (ICMJE): May 2005 editorial
WHO International Clinical Trials Registry Platform (ICTRP)
The World Health Organization announces new standards for registration of all human medical research
WHO trial registration data set
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Good Clinical Practice (GCP) Certification Program Participants List
Approval of Procedure for Conducting Clinical Trials of Medicinal Products in Ukraine-2009
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