Acronyms of Clinical Trial Terms
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
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Acronym Definition AA Anaplastic Anaemia AAALAC Association for Assessment and Accreditation of Laboratory Animal Care AAALAC Assoc. for Assessment and Accreditation of Laboratory Animal Care International AAAS American Association for the Advancement of Science AABB American Association of Blood Banks AACR American Association for Cancer Research AACR American Association for Cancer Research AADA Abbreviated Antibiotic Drug Application AAFP American Academy of Family Physicians AAHRPP . AAI American Academy of Immunologists AALAS American Assoc. for Laboratory Animal Science AAMC Association of American Medical Colleges AAP American Association of Pathologists AAPS American Association of Pharmaceutical Scientists ABC Advanced Breast Cancer ABMT Autologous bone marrow transplant ABPI Association of the British Pharmaceutical Industry ABSL Animal Biosafety Level ABTA American Brain Tumour Association ACCP American College of Clinical Pharmacology Accrual the enrollment of qualified patients into clinical trials. Accrue to enroll qualified patients into clinical trials. ACDM Association for Clinical Data Management ACE Adverse Clinical Event ACIL American Council of Independent Laboratories ACIL A national trade association representing independent, commercial scientific, and engineering firms ACLAM American College of Laboratory Animal Medicine ACNP American College of Nuclear Physicians ACOR Association of Cancer Online Resources ACOSOG American College of Surgeons Oncology Group ACP Associates of Clinical Pharmacology ACPU Association of Clinical Pharmacology Units ACR American College of Radiology ACRA Associate Commissioner of Regulatory Affairs ACRP Association of Clinical Research Professionals ACRPI Association of Clinical Research for the Pharmaceutical Industry ACRPI Changed its name to Institute of Clinical Research (UK) ACS American Cancer Society ACS American Chemical Society ACT Applied Clinical Trials ACTG AIDS Clinical Trials Group (DAIDS) ACTG AIDS Clinical Trials Group (NIAID) ACTU AIDS Clinical Trials Unit (NIH) ACT UP AIDS Coalition to Unleash Power ACUC Animal Care and Use Committee ADaM Analysis Data Model (a CDISC standard) ADaM Analysis Dataset Model (CDISC) ADAMHA Alcohol, Drug Abuse and Mental Health Administration ADE Adverse Drug Event ADI Acceptable Daily Intake Adjuvant therapy medical treatment given in addition to a primary treatment. In the case of cancer, this can be chemotherapy, radiation, or hormone therapy given in addition to surgical removal of a tumor, for example. Adjuvant therapies are used to enhance the effect of primary treatment, and would not necessarily be expected to have therapeutic effect in the absence of the primary treatment. ADME Absorption, Distribution, Metabolism and Excretion ADP Automated Data Processing ADR Adverse Drug Reaction ADRS Adverse Drug Reporting System AE Adverse Event (any negative or unwanted effect from a drug, device, or medical test). AEGIS ADROIT Electronically Generated Information Service, a subscription service that provides subscribing organizations with access to adverse drug reaction data from the Medicines Control Agency’s ADROIT (Adverse Drug Reaction On line Information Tracking) database. AERS Adverse Event Reporting System (FDA) AFCR American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR) AFDO Association of Food and Drug Officials AFMR American Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR) AFP Alphafetoprotein eg. expressed by germ cell tumours and other cancers AHA American Heart Association AHCPR Agency for Health Care Policy and Research AHCPR Agency for Health Care Policy Research (NIH) AHRQ Agency for Healthcare Research and Quality AICRC Association of Independent Clinical Research Contractors (UK) AIDS Acquired immune deficiency syndrome AIG Active Ingredient Group AIM Active Ingredient Manufacturer AIOM Italian Association for Medical Oncology AIP Abbreviated Inspection Program AIRO Associazione Italiana di Radioterapia Oncologica AIUM American Institute of Ultrasound in Medicine AJCC American Joint Committee on Cancer ALARA As Low As Reasonably Achieved ALAT Alanine aminotransferase / alinine transaminase ALCL Anaplastic Large cell Lymphoma ALCOA attributable, legible, contemporaneous, original, accurate (dimensions of data quality) ALL Acute lymphoblastic leukaemia ALT Alanine Aminotransferase am ante meridian, morning (12:00 midnight thru 11:59:59) AMA American Medical Association AMA DE AMA Drug Evaluations AMC Antibody mediated cytotoxicity AMF Administrative Management of the Files AmFAR American Foundation for AIDS Research AMG West Germany Drug Law AMKL acute megakaryocytic leukemia AML Acute Myeloid leukemia AMWA American Medical Writers Association ANADA Abbreviated New Animal Drug Application ANC Absolute neutrophil count ANDA Abbreviated New Drug Application (for a generic drug) ANED Alive no evidence of disease ANLL Acute non lymphatic leukaemia ANOVA Analysis of variance ANSI American National Standards Institute AO Administrative Official AOAC Association of Official Analytical Chemists AOAC Association of Official Analytical Chemists APB Association Pharmaceutique Belge (Belgium) APhA American Pharmaceutical Association APHIS Animal and Plant Health Inspection Service APHIS Animal and Plant Health Inspection Service (USDA) API active pharmaceutical ingredient APPI Academy of Pharmaceutical Physicians and Investigators AQL Acceptable Quality Level ARCS Association of Regulatory & Clinical Scientists (Australia) ARENA Applied Research Ethics National Association ARMS Alveolar rhabdomyosarcoma ARO academic research organization ART Antiretroviral Therapy ASA American Statistical Association ASAP administrative systems automation project (FDA) ASCII American Standard Code for Information Interchange (computer files) ASCO American Society of Clinical Oncology ASCPT American Society for Clinical Pharmacology and Therapeutics ASCPT American Society for Clinical Pharmacology and Therapeutics ASH American Society for Hematology ASM American Society for Microbiology ASO AIDS Service Organization ASQ American Society for Quality, formerly American Society for Quality Control ASR Age Standardised Rate (Incidence) ASTRO American Society for Therapeutic Radiology and Oncology AT Active (COMIS term) ATC Anatomic Therapeutic Chemical Coding dictionary ATF Bureau of Alcohol, Tobacco, and Firearms AU Authorized User AUC Area Under the Curve (an expression of exposure) AV Attending Veterinarian AVAC AIDS Vaccine Advocacy Coalition AVEG AIDS Vaccine Evaluation Group AVMA American Veterinary Medical Association AVRC AIDS Vaccine Research Committee (also known as Baltimore Committee) AWA Animal Welfare Act (1966) AWAR Animal Welfare Act Regulations AWIS Animal Welfare Information Center AWRs Animal Welfare Regulations (USDA) BAA Broad Agency Announcement BACR British Association for Cancer Research BAER Brainstem Auditory Evoked Responce B ALL B cell Acute Lymphoblastic Leukaemia BARQA British Association of Research Quality Assurance BARQA British Association of Research Quality Assurance BASO British Association of Surgical Oncologists BCC Basal Cell Carcinoma BCE Beneficial Clinical Event BCE beneficial clinical event BCHD Baltimore City Health Department BDMC Biostatistics and Data Monitoring Center BDPA Bureau of Drug Policy and Administration (China) BEUC European Bureau of Consumer Unions BfArM Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany) BGA Bundesgesundheitsamt (Federal health office; former German public health agency) BGVV Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany) BID Two Times per Day BID / BD Twice a day (bis in die) BIND Biological Investigational New Drug BIO Biotechnology Industry Organization Biospecimen bank a facility that collects, catalogs, and stores samples of biological materials (such as urine, blood, tissue, cells, DNA, RNA, and protein) used for laboratory research. Biostatistics the use of statistics to analyze biological or health science data. BIP Biomedical Imaging Program BIRA British Institute of Regulatory Affairs BLA Biologics License Application (FDA) BM Bone Marrow BMA British Medical Association BMB Bioresearch Monitoring Branch BMI Body Mass Index BMJ British Medical Journal BMR Basal Metabolic Rate BMT Bone Marrow Transplant BNF British National Formulary BNLI British National Lymphoma Investigation BOA British Oncology Association BODMA British Oncology Data Managers Association (UK) BOV Board of Visitors BP Blood pressure BPI Bundesverband der Pharmazeutischen Industrie EV (Germany) BPM Beats Per Minute BrAPP British Association of Pharmaceutical Physicians BrAPP British Association of Pharmaceutical Physicians BRB Biomedical Research Branch BREF Baltimore Research and Education Foundation (at Baltimore VA) BRIDG Biomedical Research Integrated Domain Group BRM Biological Response Modifier BSA Body Surface Area BSE Breast Self Examination BSL Biosafety Level BVC British Veterinary Codex Bx Biopsy C & S Culture and Sensitivity C/O Complaining of C/W Continue With C1 C7 Cervical vertebrae (spine eg. C7 = seventh cervical vertebra) Ca Cancer; carcinoma CA Chemical Abstracts CA Competent Authority (regulatory body charged with monitoring compliance with European Union member state national statutes and regulations) CAAT Center for Alternatives to Animal Testing CAB Community Advisory Board CaBig Cancer Biomedical Informatics Grid CAC Carcinogenicity Assessment Committee CACE Committee for Advancement of Chemistry Education caDSR Cancer Data Standards Repository and toolset maintained by NCI CALGB Cancer and Leukemia Group B (USA) cALL Common ALL CANDA Computer Assisted New Drug Application CAP College of American Pathologists CAPLA Computer Assisted Product License Application CAPRA Canadian Association of Pharmaceutical Regulatory Affairs CAPRA Canadian Association of Professional Pharmaceutical Regulatory Affairs (also ACPR Association canadienne des professionnels en réglementation) CAQ Certificate of Added Qualifications CAS Chemical Abstracts Service CAS Chemical Abstracts Service CASB Cost Accounting Standards Board CAT Computerised axial tomography (scan) CBC Complete Blood Count CBCTN Community Based Clinical Trials Network CBER Center for Biologics Evaluation and Research CBO Community Based Organization cc Cubic centimeter CCASE Coordinating Committee for Advancement of Scientific Education CCC Compliance Coordinating Committee (CDER) CCF Congestive Cardiac Failure CCG Children's Cancer Group (USA) CCI Committee on Clinical Investigations. See also Ethics Committee box. CCM Center for Comparative Medicine CCOP Community Clinical Oncology Program CCPPRB Comité Consultative pour la Protection des Personnes dans les Recherches Biomédicales (France). See also Ethics Committee box in the Glossary. CCR Continuous complete remission CCRA Certified Clinical Research Associate. Certification issued to monitors by ACRP. CCRC Certified Clinical Research Coordinator CCRC CTSC Clinical Research Center CCRG Children's Cancer Research Group (Oxford, UK) CCRP Certified Clinical Research Professional (SoCRA) CCS Canadian Cancer Society CCSI Company Core Safety Information CCT Center for Clinical Trials, School of Medicine (UMB) CDA Confidential Disclosure Agreement CDA Clinical Document Architecture (HL7) CDASH Clinical Data Acquisition Standards Harmonization (a 2006 CDISC initiative) CDC Centers for Disease Control and Prevention CDE common data element CDER Center for Drug Evaluation and Research CDISC Clinical Data Interchange Standards Consortium(formerly a DIA special interest group called the Clinical Data Interchange Standards Committee) CDM clinical data management CDMS clinical data management system CDRH Center for Devices and Radiological Health CDUS Clinical Data Update System CEA Carcinoembryonic Antigen (tumour marker) CEN Comité Européen de Normalisation(European Committee for Standardization) CESS CDER Executive Secretariat Staff CEU continuing education unit CF Consent Form CFDA Catalog of Federal Domestic Assistance CFH Connecting for Health CFR Code of Federal Regulations (usually cited by title and part; for example, Title 21, Part 211 is shown as 21 CFR 211) CFSAN Center of Food Safety and Applied Nutrition CGH Comparative Genomic Hybridisation cytogenetics method CGMP Current Good Manufacturing Practice cGy Centi Gray (unit of radiation) CH Clinical Hold CHAVI Center for HIV/AIDS Vaccine Immunology CHF Congestive heart failure CHI Consolidated Health Initiative (eGov) CHR Committee on Human Research. See also Ethics Committee box. CIB Clinical Investigator's Brochure CIC clinical imaging center CID CTFA Cosmetic Ingredient Dictionary CIOMS Council for International Organizations of Medical Sciences CIP Cancer Imaging Program CIP Certified IRB Professional CIR Cosmetic Ingredient Review CIRA Center for Information on Research with Animals CIS Commonwealth of Independent States CITI Collaborative Institutional Training Initiative CLIA Clinical Laboratory Improvement Amendments CLL Chronic lymphocytic Leukaemia cm centimeter 0.01 meters Cmax concentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug CMC Chemistry and Manufacturing Controls CMC Contaminated Materials Container CMCCC Chemistry and Manufacturing Controls Coordinating Committee (CDER) CME Continuing Medical Education CMMS Centers for Medicare and Medicaid Services CMS Centers for Medicare & Medicaid Services CNS Central nervous system the brain and spine COE Code of Ethics COG Cooperative Oncology Group (USA) COI Conflict of Interest COLA Cost of Living Adjustment COMIS Center Office Management Information System CONSORT Consolidated Standards of Reporting Trials COP CDISC Operating Process/Procedure CORE CDISC Operational Roadmap Environment (CDISC) COS Canadian Oncology Society COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms. See also MedDRA. CP Compliance Program CP Community Partners CPCRA The Terry Beirn Community Programs for Clinical Research on AIDS (DAIDS) CPHS Committee for the protection of human subjects CPMP Committee for Proprietary Medicinal Products CPMP Committee for Proprietary Medicinal Products (EU) CPR Cardio pulmonary resuscitation CPSC Consumer Product Safety Commission CR Complete remission / complete response CR Cross Reference (COMIS term) CRA Clinical Research Associate CRADA Cooperative Research and Development Agreement CRB case record book CRB central review board CRC Cancer Research Campaign (UK) CRC Clinical Research Coordinator CRF Case Report Form CRIS Current Research Information Service CRISP Computer Retrieval of Information on Scientific Programs (NIH) CRIX Clinical Research Information Exchange CRO Contract Research Organisation CRS Clinical Research Site CS Clinically Significant CSA or CTA Clinical Study Agreement or Clinical Trial Agreement CSDD Center for the Study of Drug Development CSF Cerebro spinal fluid CSF Collaborative Standards Forum (CDISC) CSF colony stimulating factor CSI Consumer Safety Inspector CSM Committee on Safety of Medicines (UK) CSO Consumer Safety Officer (FDA) CSR clinical study report CSU clinical supply unit CSUICI (replaces CSUCT) Computerized Systems Used In Clinical Investigations. NOTE: usually pronounced "seesweecy." CT Computed tomography CT clinical trial CT(X) Clinical Trial Exemption CTA Clinical Trial Agreement CTC Computerized tomographic colonography CTC Clinical Trial Certificate CTC Clinical Trials Coordinator CTEP Clinical Therapeutics Evaluation Program (NCI) CTM Clinical Trials Manager CTM clinical trials materials CTO Clinical Trials Office CTP Clinical Trials Physician CTSC Clinical and Translational Science Center CTSC Clinical Research Training Program CTSU Clinical Trials Support Unit CTU Clinical Trials Unit CTWG Community Training Working Group CTX Clinical Trials Exemption CTX Clinical Trial Exemption Certification CUI common unique identifier. A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms. CV Curriculum Vitae CVA Cardiovascular Accident (stroke) CVC Central venous catheters CVM Center for Veterinary Medicine CVM Center for Veterinary Medicine (FDA) CVP Central Venous Pressure CXR Chest X Ray D/C Discharge D/H Drug History D/W Discussed With DAIDS Division of AIDS (NIAID) DAS Drug Abuse Staff DAWN Drug Abuse Warning Network DB Double Blind DC Direct Costs DCE MRI Dynamic contrast enhanced MRI DCF Data Correction Form / Data Clarification Form DCIS Ductal Carcinoma In Situ type of breast cancer DCTD Division of Cancer Treatment and Diagnosis at the NCI DD Department of Drugs(Swedish regulatory agency) DDF Data Definition File DDI drug–drug interaction DDIR Division of Drug Information Resources DDMAC Division of Drug Marketing, Advertising, and Communications DDx Differential diagnosis DEA Drug Enforcement Administration DEN Drug Experience Network DEN Drug Experience Network DEQ Department of Environmental Quality DES Division of Epidemiology and Surveillance DES Data Encryption Standard DESI Drug Efficacy Study Implementation notice (FDA, to evaluate drugs in use before 1962) DFI Disease Free Interval DFS Disease Free Survival time without disease prior to relapse or last follow up DGPharMed Deutsche Gesellschaft für Pharmazeutische Medizin (German Society of Pharmaceutical Medicine), formerly ÄPI DHEW Department of Health,Education and Welfare (U.S.,now split into DHHS and Department of Education) DHHS Department of Health and Human Services DHR Maryland Department of Human Resources DHTML dynamic HTML (IT) DI Diabetes Incipidus DIA Drug Information Association DICOM Digital imaging and communication in medicine DIS Decay in Storage DISD Division of Information Systems Design dl deciletre 0.01 litres DLBCL Diffuse Large B cell Lymphoma DLCL Diffuse large cell lymphoma DLT Dose limiting toxicity determined by phase 1 studies DLT dose limiting toxicity DM Data management DMB Data Management Biomedical (France) DMC Data Monitoring Committee DMF Drug Master File DMIST Digital Mammographic Imaging Screening Trial DNR Do Not Resusitate DOA Dead on Arrival DOD Department of Defense DOS Description of Study DPC PTR Act Drug Price Competition and Patent Term Restoration Act of 1984 (also Waxman Hatch or Hatch Waxman bill) DRG Diagnosis Related Groups DSI Division of Scientific Investigations DSM Diagnostic and Statistical Manual (of the American Psychiatric Association) DSMB Data and Safety Monitoring Board DSMC Data and Safety Monitoring Committee DSNP development of standardized nomenclature project (FDA) DSTU Draft Standard for Trial Use. See HL7 definition . DSUR Development Safety Update Report (ICH) DTC direct to consumer (drug advertising) DTD Document Type Definition (XML) DUR Drug Utilization Review DWI Diffusion weighted imaging Dx Diagnosis E3C European CDISC Coordinating Committee EA Environmental Assessment EAB Ethical Advisory Board EAB Editorial Advisory Board (Applied Clinical Trials ) EACR European Association for Cancer Research EANO European Association for NeuroOncology EBM Evidence Based Medicine EBMT European Group for Blood and Marrow Transplantation EC European Commission EC Ethics Committee ECG Electrocardiogram ECG European CDISC Group ECOG Eastern Cooperative Oncology Group ECPHIN European Community Pharmaceutical Information Network eCRF electronic case report form ECRIN European Clinical Research Infrastructures Network eCTD electronic common technical document ED Effective Dose EDC Electronic Data Capture EDC electronic data capture/collection EDI electronic data interchange eDMS electronic data management system EDR electronic document room. NOTE: The EDR is an extension of the e Submissions central document room. A check is performed on each submission sent to the EDR for file formats used and the integrity of bookmarks and hypertext links. EEG Electroencephalogram EER Establishment Evaluation Request EFGCP European Forum for Good Clinical Practice EFPIA European Federal of Pharmaceutical Industries Associations EFS Event Free Survival time from diagnosis to defined events (eg relapse or deat eHR electronic health record EHS Environmental Health and Safety EIA Establishment Inspection Reports EICESS European Intergroup Ewing's Sarcoma Study EIN Entity Identification Number EIR Establishment Inspection Report EJC European Journal of Cancer ELA Establishment License Application ELISA Enzyme Linked Immunosorbent Assay (test) ELISpot Enzyme Linked Immunospot (assay) EMEA European Medicines Agency EMERSE Electronic Medical Record Search Engine EMUO Early Morning Urine Osmolality (evaluating urine concentration) EMWA European Medical Writers Association ENSG European Neuroblastoma Study Group ENT Ear nose throat EO Executive Order EOI European Osteosarcoma Intergroup EOP1 End of phase 1 EOP2 End of phase 2 EORTC European Organisation for Research and Treatment of Cancer EOS End of Study EPA Environmental Protection Agency EPAR European Public Assessment Report EPL Effective Patent Life EPMS Employee Performance Management System EPO European Patent Office; erythropoietin EPRG European Pharmacovigilance Research Group ER Essential Requirements (EMEA) ERA Electronic Research Administration ERISA Employee Retirement Insurance Security Act Erlotinib (Tarceva) (Tarceva) a drug used to treat locally advanced or metastatic non small cell lung cancer and other cancers. Like gefitinib, it targets epidermal growth factor receptor tyrosine kinase, and specific genetic mutations correlate to patients’ response to the drug. ERSR electronic regulatory submissions and review (FDA's e Submissions processing group) eRX electronic prescribing eSDI electronic Source Data Interchange ESO European School of Oncology ESR Erythrocyte Sedimentation rate ESRA European Society of Regulatory Affairs ESS Executive Secretary and Staff ESTRI Electronic Standards for the Transfer of Regulatory Information (ICH) ESTRO European Society for Therapeutic Radiation and Oncology ETS Environmental Tobacco Smoke ETT Exercise Tolerance Test EUDRA European Union Drug Regulatory Authorities EudraCT European Union clinical trials database EUP Experimental Use Permit EUROVAC European Vaccine Effort Against HIV/AIDS EVS Enterprise Vocabulary Services (National Cancer Institute) EWG expert working group F&A Costs Facilities and Administrative Costs F/H Family history FAB French American and British classification scheme for leukaemia FACA Federal Advisory Committee Act 1972 FAR Federal Acquisition Regulation FBC Full Blood Count FCCSET Federal Coordinating Council for Science, Engineering and Technology FD & C Act Federal Food, Drug and Cosmetic Act FDA Food and Drug Administration (USA) FDA 1572 FDA Form for Statement of Investigator FDA 482 Notice of Inspection FDA 483 Notice of Adverse Findings in an Inspection FDAAA Food and Drug Administration Amendment Act (pronounced fedaahh or fedah ah) FDAMA FDA Modernization Act FDA SRS Spontaneous Reporting System of the Food and Drug Administration FDCA Food, Drug, and Cosmetic Act FDG PET Fluorodeoxyglucose PET FDLI Food and Drug Law Institute FDP Federal Demonstration Partnership FECS Federation of European Cancer Societies FEV Forced expectorant volume (a lung test) FFA For Further Appointment FFDCA Federal Food, Drug, and Cosmetic Act FFPM Fellow of the Faculty of Pharmaceutical Medicine (UK) FHCRC Fred Hutchinson Cancer Research Center FHI Family Health International FIC Fogarty International Center, NIH FIGO International Federation of Gynecology and Obstetrics FIPS Federal Information Processing Standards FISH Flourescence in situ Hybridisation FMD Field Management Directives FMTC Familial Medullary Thyroid Carcinoma FNA Fine Needle Aspiration a type of biposy using a thin needle (or FNAB) FOI Freedom of Information FOIA Freedom of Information Act FONSI Finding of No Significant Impact FPL Final Printed Labeling FPR Final Proposal Revision FRC Federal Records Center (Suitland) FRCP Fellow of the Royal College of Physicians, sometimes followed by a place name for example, FRCP (Edin.) that indicates a university medical school FSIS Food Safety and Inspection Service FTE Full Time Equivalent FU Follow up FUR Follow up Request FVC Forced Vital Capacity FWA Federalwide Assurance g gram unit of weight GA General Anaesthetic GAO General Accounting Office GATT General Agreement of Tariffs and Trade GBP good business practice Gbps gigabits, or billions of bits per second (data transmission) GC General Counsel (FDA) GCAB Global Community Advisory Board GCP Good clinical practice GCRC General Clinical Research Center GCRP good clinical research practice GDA Global Disclosure Agreement GFR Gromerular filtration rate GI Gastrointestinal GI Gastrointestinal GLP Good Laboratory Practice GMC General Medical Council (UK) GMO Grants Management Officer GMP Good Manufacturing Practice GOG Gynecology Oncology Group GP general practitioner; general practice (UK) GPMS good postmarketing surveillance practice (Japan) GPOH Gesellschaft fur Padiatrische Onkologie und Hamatologie (German Paed. Onc Group) GPR Good Partial Remission GPRA Government Performance and Results Act GQA General Qualifying Application Grade 1 toxicities mild adverse events. Grade 3 toxicities severe adverse events. Grade 4 toxicities life threatening or disabling adverse events. GRAS Generally Recognized as Safe GRASE Generally Recognized as Safe and Effective GRP Good Review Practice GU Genito urinary GXP good (pharmaceutical) practice Gy Grays (units of radiation) H&E Hematoxylin and Eosin (stain) H/O History of HA health authority (UK) HAACP Hazard Analysis and Critical Control Point (inspection technique) HAART Highly Active Antiretroviral Therapy HAI Health Action International HANC HIV/AIDS Network Coordination Hb Haemoglobin HCFA Health Care Financing Administration; now renamed The Centers for Medicare & Medicaid Services (CMS). HCPCS modifier An HCPCS code descriptor utilized to provide additional information regarding the service or item identified by the HCPCS code, including specific circumstances that may apply to the service or item. HDC High Dose Chemotherapy HEPA High Efficiency Particulate Air Filter HEX Human Experimentation Committee. See also Ethics Committee box in the Glossary. HF Routing code for mail to the Office of the Commissioner of the FDA HFD Routing code for mail to CDER HFM Routing code for mail to CBER HFS Routing code for mail to CFSAN HFT Routing code for mail to NCTR HFV Routing code for mail to CVM HFZ Routing code for mail to CDRH HHS Health and Human Services (Department of) HHS Department of Health and Human Services (U.S., also called DHHS) HIC Human Investigation Committee(former name of HSR) HIE health information exchange HIMA Health Industry Manufacturers Association HIMSS Healthcare Information and Management Systems Society (pronounced hymns) HIPAA Health Insurance Portability and Accountability Act HIRE Human Investigations Involving Radiation Exposure (subcommittee of RSC) HIT health information technology HITSP Health Information Technology Standards (pronounced hitspee) HIV Human Immunodeficiency Virus HIVNET HIV Network for Prevention Trials – United States (Closed October 1999) HL7 Health Level 7 (a not for profit ANSI accredited standards developing/development organization [SDO]) HL A Human Leukocyte Associated antigens (HL A matching for BMT) HLA Human Leucocyte Antigen HMO Health Maintenance Organization HNPCC Hereditary NonPolyposis Colorectal Cancer HP Health Physicist HPA Human Protections Administration HPB Health Protection Branch, Laboratory Centre for Disease Control (Canada); has been superseded by Health Canada HPLC high performance liquid chromatography HPTN HIV Prevention Trials Network HPTU HIV Prevention Trials Unit HPV Human Papilloma Virus implicated in some gynacological cancers HR High risk HRG Health Research Group HRRC Human Research Review Committee HRSA Health Resources and Services Administration HRT Hormone replacement therapy HRW High Risk Women HSRC Human Subjects Review Committee. See also Ethics Committee box in the Glossary . HTLV Human T cell leukemia lymphoma virus HTML Hypertext Markup Language HTTP Hypertext Transfer Protocol HVTN HIV Vaccine Trials Network HVTU HIV Vaccine Trials Unit HX History I3C India CDISC Coordinating Committee IAB Industry Advisory Board (for CDISC) IACR International Association of Cancer Registries IACUC Institutional Animal Care and Use Committee IARC International Agency for Research on Cancer IASLC International Association for the Study of Lung Cancer IAVI International AIDS Vaccine Initiative IB Investigator’s Brochure IBC Institutional Biosafety Committee IC Informed consent IC Chemistry Information Amendment (COMIS term) IC informed consent ICARE International Cancer Alliance for Research and Education (ICARE) ICASO International Council of AIDS Service Organizations ICCCPO International Confederation of Childhood Cancer Parent Organisations ICCG International Collaborative Cancer Group ICCPO Icelandic Childhood Cancer Parent Organisation ICD International Classification of Diseases (coding system) ICD Informed Consent Document ICD9 International Classification of Diseases, 9th revision. See also MedDRA. ICD 9 CM International Classification of Disease Codes, 9th revision Clinical Modification ICDO International Classification of Diseases for Oncology (coding system) ICF Intercellular fluid ICF informed consent form ICG India CDISC Group ICH International Conference on Harmonization (GCP) ICH GCP ICH Harmonised Tripartite Guideline for Good Clinical Practices ICLAS International Council for Laboratory Animal Sciences ICMJE International Committee of Medical Journal Editors ICPEMC International Commission for Protection Against Mutagens and Carcinogens ICR Institute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK) ICRF Imperial Cancer Research Fund (UK) ICSR individual case safety report ICTH International Committee on Thrombosis and Hemostases ICTRP International Clinical Trials Registry Platform (WHO) ICU Intensive Care Unit IDB Investigational Drug Brochure IDC Indirect costs IDE Investigational Device Exemption Application to CDRH to get permission for investigational device testing in clinical trials IDR Idiosyncratic Drug Reaction IDS Investigational Drug Service (pharmacy) IDSMB Independent Data Safety Monitoring Board IDU Injecting Drug User IEC Independent Ethics Committee IEEE Institute of Electrical and Electronic Engineers, Inc. IESS Intergroup Ewing's Sarcoma Study (USA) IFAPP International Federation of Associations of Pharmaceutical Physicians IFN Interferon IFPMA International Federation of Pharmaceutical Manufacturers and Associations IG Inspector General IG Immunoglobulin IHE Integrating the Healthcare Enterprise (an international standards organization) IHI Institute for Healthcare Improvement IHS Indian Health Service IKS Interkantonale Kontrollstelle für Heilmittel (Switzerland) IL Interleukin IL2 Interleukin2 ILAR Institute for Laboratory Animal Research IM Intramuscular into a muscle IM Clinical Information Amendment (COMIS term) IMI Innovative Medicines Initiative (European Commission) IMP investigational medicinal product; investigational materials plan IMPAACT International Maternal Pediatric Adolescent AIDS Clinical Trial Group IMPD Investigational Medicinal Product Dossier (EUDRA) IMRT Intensity Modulated Radiotherapy INAD Investigational New Animal Drug IND Investigational new drug INDA Investigational New Drug Application INDC Investigational New Drug Committee INFA International Neurofibromatosis Association INN International Nonproprietary Name INSS International Neuroblastoma Staging System Investigational New Drug (IND) A new molecular, antibiotic, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes. IO Institutional Official IOM Institute of Medicine (National Academy of Science, U.S.) IOM Institute of Medicine IPC Institutional Participants Committee IPCS International Program for Chemical Safety IPRA International Product Registration Document IPRO Independent Pharmaceutical Research Organization IPRO independent pharmaceutical research organization. See also CRO. IPSO International Society of Pediatric Surgical Oncology IRB Institutional Review Board IRB HSR Institutional Review Board Health Sciences Research IRC Institutes Review Committee IRD international registration document IRG Integrated Review Group (NIH peer review) IRG Initial Review Groups IRS Identical, Related, or Similar IS International System of Units (may also be referred to as SI Systéme Internationale) ISCB International Society for Clinical Biostatistics ISDN Integrated Services Digital Network ISNCC International Society of Nurses in Cancer Care ISO International Organization for Standardization ISOQOL International Society for Quality of Life Research ISP Internet service provider ISPE International Society for Pharmacoepidemiology IT Information Technology ITCC Information Technology Coordinating Committee (CDER) ITU Intensive Therapy Unit ITU T International Telecommunication Union Telecommunication Standardization Sector IU International units IUPAC International Union of Pure and Applied Chemistry IV Intravenous into a vein IVD In Vitro Diagnostics IVP Intravenous Pyelogram type of Xray after injection with iodine dye J3C Japan CDISC Coordinating Committee JCAH Joint Commission for the Accreditation of Hospitals JCAHO Joint Commission on Accreditation of Health Care Organizations JCG Japan CDISC Group JCO Journal of Clinical Oncology J Code An HCPCS code used to bill payors (such as CMS or insurance companies) for drugs. A J code, as opposed to another letter code (i.e., A code or B code), generally signifies an injectable drug that cannot be self administered. JCPT Journal of Clinical Pharmacology and Therapeutics JCRDD Journal of Clinical Research and Drug Development JCRP Journal of Clinical Research and Pharmacoepidemiology JMA Japan Medical Association JPA Joint Personnel Agreement JPMA Japan Pharmaceutical Manufacturers Association K+ Potassium Kbps kilobits, or thousands of bits per second (data transmission) kg Kilogram a thousand grams LAB Laboratory Data Model (CDISC) LATA Laboratory Animal Training Association LCH Langerhans cell histiocytocis LCIS Lobular Carcinoma In Situ type of breast cancer LD Lethal Dose LD50 Lethal Dose (50%) LDH Lactic dehydrogenase high levels correlate with tumour volume in some cancers LEAA Law Enforcement Assistance Administration LERN Library Electronic Reference Network LIF Swedish Pharmaceutical Industry Association LKP Leiter der Klinischen Prüfung LMP Low Malignant Potential (context: ovarian tumours) LN Lymph Node LNC Labeling and Nomenclature Committee LOC Level of Concern LOCF Last Observation Carried Forward LOINC logical observations, identifiers, names, and codes LP Lumbar puncture LPP Local Partnership Project LRC Lipid Research Clinic LREC Local Research Ethics Committee (UK) LRF Leukaemia Research Fund (UK) LRFA Lymphoma Research Foundation of America LRI Lower Respiratory Infection LTE Less Than Effective LVEF Left Ventricular Fjection Fraction a heart function test Lx Lumpectomy m meter (unit of length) M/H Medical history MA marketing authorization MAA Marketing Authorisation Application (EMEA, EU) MAB mAb Monoclonal antibody MACS Multi center AIDS Cohort Studies MAH Marketing Authorisation Holder (EU) MAPP Manual of Policy and Procedures MBC Minimum Bactericidal Concentration MBE Minority Business Enterprise Mbps megabits, millions of bits per second (data transmission) MCA Medicines Control Agency (UK) MDI Metered Dose Inhaler MDR Multi drug resistant MDR Medical Device Reporting MDS Myelo dysplastic syndrome MedDRA M Medical Dictionary for Regulatory Activities (new global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others) MedID Medicinal Product Identifier MEDLARS Medical Literature Analysis and Retrieval System MEDWATCH MEFA Association of the Danish Pharmaceutical Industry MEN Multiple Endocrine Neoplasia (familial) a.k.a. FMEN mEq/l milliequivalent per liter MERIT Method to Extend Research in Time award (NIH) mets Metastases (where the tumour has spread to secondary sites) Mg Magnesium MHC Major Histocompatibility Complex MHLW Ministry of Health, Labor and Welfare (Japan) MHRA Medicines and Healthcare products Regulatory Agency (UK) MHW Ministry of Health and Welfare (Japan's equivalent to the FDA) MI Miocardial Infarction MI Myocardial Infarction MIAME minimum information about a microarray experiment (standard for microarray data) mIBG Radioactive Iodine Metaidobenzoguanidine (mIBG scans or mIBG therapy). MIC Minimum Inhibitory Concentration ml millilitre 0.001 liter MM Malignant Melanoma MMR Minor Modification Review MO Medical Officer MOH Ministry of Health (UK, Canada, others) MOP Manual of Operations MOPH Ministry of Public Health (Thailand, Yemen, others) mOsm milliosmole MPCC Medical Policy Coordinating Committee (CDER) MPNST Malignant Peripheral Nerve Sheath Tumour MPR Medical Products Agency (Swedish Regulatory Agency) MQSA Mammography Quality Standards Act MR Medical Representative (Japan) MRA Magnetic resonance angiography MRA Medical Research Associate MRC Medical Research Council (UK) MREC Multi centre Research Ethics Committee (UK) MRgFUS MR guided focused ultrasound MRI Magnetic resonance imaging MRSI Magnetic resonance spectroscopic imaging MRT Malignant Rhabdoid Tumour MSM Men who have Sex with Men MSSU Mid stream specimen urine MTA Material Transfer Agreement MTD Maximum Tolerated Dose MTDC Modified Total Direct Costs MTN Microbicide Trials Network MTPCI Multidisciplinary Training Program in Clinical Investigations MUD Matched Urelated Donor for bone marrow transplant MVP master validation plan Mx Mastectomy N/V Nausea and vomiting NA Not Approvable Na+ Sodium NAACCR North American Association of Central Cancer Registries NABCO National Alliance of Breast Cancer Organizations NABR National Association for Biomedical Research NABTT New Approaches to Brain Tumor Therapy NAD No Abnormality Detected NADA New Animal Drug Application NAF Notice of Adverse Findings NAHC National Advisory Health Council NAI No Action Indicated NAS National Academy of Sciences NAS new active substance (UK) NAS National Academy of Sciences –National Research Council (U.S.) NBAC NRC National Bioethics Advisory Commission NBAC National Bioethics Advisory Commission (U.S.) NBCCS Nevoid basal cell carcinoma syndrome NBM Nil by mouth NCA national competent authority NCCAM National Center for Complementary and Alternative Medicine, NIH NCCF National Childhood Cancer Foundation (USA) NCCLS National Committee for Clinical Laboratory Standards NCCTG North Central Cancer Treatment Group NCE No Cost Extension NCE New Chemical Entity NCHS National Center for Health Statistics NCI National Cancer Institue (USA) NCI LSS National Cancer Institute Lung Screening Study NCIA National Cancer Imaging Archive NCIC National Cancer Institute of Canada NCI CIRB National Cancer Institute Central Institutional Review Board NCI National Cancer Institute NCI PCIRB Nat. Cancer Inst.. Pediatric Central Inst. Review Board NCMHD National Center for Minority Health and Health Disparities, NIH NCPF National Cancer Policy Forum NCRA National Cancer Registrars Association (USA) NCRN National Cancer Research Network NCRR National Center for Research Resources, NIH NCS Networking and Communications Subcommittee NCS Not Clinically Significant NCTR National Center for Toxicological Research NCVIA National Childhood Vaccine Injury Act (1986) NDA New Drug Application NDE New Drug Evaluation NDS New Drug Study NECCR North of England Children's Cancer Research Unit NED No evidence of disease NEFARMA Dutch Association of the Innovative Pharmaceutical Industry NEI National Eye Institute, NIH NEJM New England Journal of Medicine NF National Formulary ng nanogram 0.000000001 gram NGA Notice of Grant Award NGO Non Governmental Organization NHGRI National Human Genome Research Institute, NIH NHI National Health Insurance (Japan) NHIN National Health Information Network NHL Non Hodgkin's Lymphoma NHLBI National Heart, Lung, and Blood Institute NHS National Health Service (UK) NHVREI NIAID HIV Vaccine Research Education Initiative NHW National Health and Welfare Department (Canada's equivalent of DHHS) NIA National Institute on Aging, NIH NIAAA National Institute on Alcohol Abuse and Alcoholism, NIH NIAID National Institute of Allergy and Infectious Diseases, NIH NIAID National Institute of Allergies and Infectious Diseases (NIH) NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH) NIAMSD National Institute of Arthritis and Musculoskeletal and Skin Diseases NIBIB National Institute of Biomedical Imaging and Bioengineering, NIH NICHD National Institute of Child Health and Human Development, NIH NICHD National Institute of Child Health and Human Development (NIH) NIDA National Institute of Drug Abuse, NIH NIDCD National Institute on Deafness and Other Communication Disorders, NIH NIDCD National Institute of Deafness and other Communication Disorders NIDCD National Institute on Deafness and Other Communication Disorders (NIH) NIDCR National Institute of Dental and Craniofacial Research, NIH NIDCR National Institute of Dental and Craniofacial Research (NIH) NIDDK National Institute of Diabetes and Digestive and Kidney Diseases, NIH NIDDK National Institute of Diabetes and Digestive and Kidney Diseases (NIH) NIDDKD National Institute of Diabetes And Digestive And Kidney Diseases NIDR National Institute of Dental Research NIEHS National Institute of Environmental Health Services, NIH NIGMS National Institute of General Medical Sciences, NIH NIH National Institutes of Health NIH NRSA National Research Service Award NIMH National Institute of Mental Health, NIH NINDS National Institute of Neurological Disorders and Stroke, NIH NINR National Institute of Nursing Research (NIH) NIOSH National Institute for Occupational Safety and Health, CDC NIRB noninstitutional review board, also known as an independent review board. See also Ethics Committee in the Glossary, NIRB. NK Natural Killer cells (large lymphocytes, part of the immune system) NKA No Known Allergies NKCA National Kidney Cancer Association (USA) NLEA Nutrition Labeling and Education Act (1990) NLM National Library of Medicine, NIH NLST National Lung Screening Trial NME New Molecular Entity NMR Nuclear Magnetic Resonance NMSC Non Melanoma Skin Cancer NNFF National Neurofibromatosis Foundation (USA) NOAEL no observed adverse effect level (IUPAC) NOEL No Observed Effect Level Non Mem Non linear Nixed Effect Model NORD National Organization for Rare Disorders (USA) NOS Not otherwise specified (see ICDO) NPC Nasopharyngeal Carcinoma NR No Reply Necessary (COMIS term) NRB noninstitutional review board, also known as an independent review board NRC Nuclear Regulatory Commission NRC National Research Council NRCT National Registry of Childhood Tumours (UK) held by the CCRG at Oxford NRSA National Research Service Award (NIH) NRSTS Non Rhabdomyosarcoma Soft Tissue Sarcoma NSABP National Surgical Adjuvant Breast and Bowel Project NSAID Nonsteroidal Anti inflammatory Drug NSCLC Non–small cell lung cancer NSE Neuron Specific Enolase a neural marker NSF National Science Foundation NSR Non significant result NSR Nonsignificant Risk NTP National Toxicology Program O/E On Examination OAI Official Action Indicated (serious FDA postinspection classification) OAR Office of AIDS Research (NIH) OARAC Office of AIDS Research Advisory Committee OASH Office of the Assistant Secretary for Health OB GYN Obstetrics Gynecology OC Office of Compliance (CDER) OCD Office of the Center Director (CDER) OCGR Office of Communications and Government Relations (NIAID) OCPB Office of Clinical Pharmacology and Biopharmaceutics (CDER) OD Right Eye ODAC Oncologic Drugs Advisory Committee (U.S.) ODB Observational Database ODE Office of Drug Evaluation (CDER) ODM Operational Data Model (CDISC) OEB Office of Epidemiology and Biostatistics (CDER) OECI Organization of European Cancer Institutes OEHS Office of Environmental Health and Safety OGA Office of Grants and Contracts Administration OGD Office of Generic Drugs (CDER) OHA Office of Health Affairs OHITA Office of Health Information Technology Adoption (ONCHIT) OHRM Office of Human Resource Management OHRP Office for Human Research Protections OIG Office of the Inspector General OIS Office of Interoperability and Standards OJC Official Journal of the European Union–C Series (Information) OJEC Official Journal of the European Communities OJL Official Journal of the European Union–L Series (Legislation) OLAW Office of Laboratory Animal Welfare (NIH) OM Office of Management (CDER) OMB Office of Management and Budget ONB Olfactory Neuroblastoma ONCHIT Office of the National Coordinator for Health Information Technology (HHS) ONDC Office of New Drug Chemistry (CDER) ONR Office of Naval Research ONS Oncology Nursing Society (USA) OPCRO Office for Policy in Clinical Research Operations OPERA Office of Policy for Extramural Research Administration (NIH) OPR Office of Policy and Research OPRR Office of Protection for Research Risks OPS Office of Pharmaceutical Science (CDER) ORA Office of Regulatory Affairs ORAGS Office of Research and Graduate Studies, UMB School of Medicine ORI Office of Research Integrity ORM Office of Review Management (CDER) ORO Office of Regional Operations ORWH Office of Research on Women’s Health (NIH) OS Overall Survival OS Left Eye OSHA Occupational Safety Health Administration OSP U.Va. Office of Sponsored Programs OTA Office of Technology Assessment OTA Office of Technology Assessment (U.S., abolished 1995) OTC Over the Counter Drugs OTC Over the counter (non prescription drugs) OTC over the counter (refers to nonprescription drugs) OTCOM Office of Training and Communications (CDER) OTR Office of Testing and Research (CDER) OU Both Eyes OVCR Office of the Vice Chancellor for Research PA Program Announcement (in context of funding searches) PAB Pharmaceutical Affairs Branch PAHO Pan American Health Organization PAIR Patient Advocates in Research PAITS Pre Approval Inspection Tracking System PAR Postapproval Research PAVE Partners for AIDS Vaccine Evaluation PBSC Peripheral Blood Stem Cell (see PBSCT) PBSCH Peripheral Blood Stem Cell Harvest PBSCR Peripheral Blood Stem Cell Rescue (transplant) PBSCT Peripheral Blood Stem Cell Transplant PBTC Pedi Brain Tumor Consortium PC Personal Computer PCC Parklawn Computer Center PCC Poison Control Center PCP Pneumocystis carinii pneumonia PCR Polymerase Chain Reaction PD Progressive disease PD Pharmacodynamics PDA Parenteral Drug Association PDA personal digital assistant (Palm Pilot, for example) PDC Protocol Development Coordinator PDF portable document format PDQ Physician's Data Query (CancerNet) PDR Physician's Desk Reference PDRC Protocol Development and Regulatory Compliance PDUFA Prescription Drug User Fee Act of 1992 PE Physical Examination PEM prescription event monitoring PEP Performance Evaluation Plan PERI Pharmaceutical Education & Research Institute (not for profit division of PhRMA) PET Positron Emmission Tomography a scan after a small radioactive injection. PFS Progression Free Survival PFT Pulmonary Function Tests PFT pulmonary function test pg picogram 0.000000000001 gram PGT pharmacogenetics PGX pharmacogenomics pH hydrogen ion concentration acid / alkaline Phase I trial A clinical trial in a small number of patients in which the toxicity and dosing of an intervention are assessed. Phase II trial A clinical trial in which the safety and preliminary efficacy of an intervention are assessed. Phase III trial A large scale clinical trial in which the safety and efficacy of an intervention are assessed in a large number of patients. The Food and Drug Administration generally requires new drugs to be tested in Phase III trials before they can be put on the market. Phase IV trial A large scale trial undertaken after FDA approval for safety surveillance to detect rare or long term adverse events. Also known as a post marketing surveillance trial. PHI Protected health information PHI Protected Health Information PHI Protected Health Information PhPID pharmaceutical product identifier PhRMA Pharmaceutical Research and Manufacturers of America PhRMA Pharmaceutical Research and Manufacturers of America PHRP Partnership for Human Research Protection, Inc. PHS Public Health Service PHS Public Health Service PHS2590 Refers to the form used for noncompeting continuation applications to the NIH PHS398 Refers to the form used for new and competing renewal applications to the NIH PI Principal Investigator PI Package Insert (approved product labeling) PIM product information management (a system introduced by the EMEA) PK Pharmacokinetics PLA Patent License Agreement PLA Product License Application (when seeking commercialization of a biologic) PLA/ELA Product License Application/Establishment License Application PLWA Person Living With AIDS PM Project Manager PMA Pre Market Approval (when seeking commercialization of a device) PMCC Project Management Coordinating Committee (CDER) PMDIT Project Management PMS Postmarketing Surveillance PN Protocol Amendment New Protocol (or Pending Review) (COMIS term) PNET Primitive neuroectodermal tumour Context: CNS tumours PNS Peripheral nervous system nervous system outside the brain and spine. PO Purchase Order PO Per Os (by mouth) POG Pediatric Oncology Group (USA) PONF Paediatric Oncology Nurses Forum (UK) PPA Poison Prevention Act PPE Personal Protective Equipment PPI Patient Package Insert PPO Policy and Procedure Order PPO Preferred Provider Organization PR Partial Responce / Partial Remission PR Pulse Rate PRC Protocol Review Committee U.Va. Cancer Center PRG Protocol Representation Group (CDISC) PRIM & R Public Responsibility in Medicine and Research prn as required PRN As Needed PRO patient reported outcome Process map A visual representation of a workflow comprising a stream of activities that transforms a well defined input or set of inputs into a pre defined set of outputs. PROG Peer Review Oversight Group (NIH) PROMIS Patient Reported Outcomes Measurement Information Systems (pronounced promise) Protocol A study plan on which a clinical trial is based. The plan is designed to safeguard the health of participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. PRT Primary Review Team PSA Protocol specific Application PSRC Prevention Sciences Review Committee PSUR periodic safety update report PTAO/PTAEO Project Task Award Office PTC points to consider PTCC Pharmacology/Toxicology Coordinating Committee (CDER) PTN (see HPTN) PTV Primary tumor volume PV pharmacovigilance PWA Person With AIDS QA Quality Assurance QALY Quality Adjusted Life Year QARC Quality Assurance Review Center QAU Quality Assurance Unit QC Quality Control QD Once Daily qid Four times a day (quater in die) QL Quality of Life QNS Quantity Not Sufficient QOD Every Other Day QoL Quality of Life QOL quality of life (also QoL) R & D Research and Development RA Research Associate RAB Regulatory Affairs Branch (DAIDS) RAC Reviewer Affairs Committee (CDER) RADAR Risk Assessment of Drugs Analysis and Response RAPS Regulatory Affairs Professionals Society RBC Red blood cell / red blood count RC Research Coordinator RCC Research Coordinating Committee (CDER) RCC Regulatory Compliance Center (DAIDS) RCH Remove Clinical Hold RCR Responsible Conduct of Research RCRA Regional Clinical Research Associate RCRIM Regulated Clinical Research Information Management, a technical committee of HL7 with responsibility for developing technical standards for the exchange and management of health research information to be submitted to regulatory authority(ies) RCT Randomized Clinical Trial RD Response to Request for Information (COMIS term) RDE Remote Data Entry RDRC Radioactive Drug Research Committee RDT Rising dose tolerance REB research ethics board (Canada) REMS Risk Evaluation and Mitigation Strategy (FDA, in FDAAA) RFA Radiofrequency ablation RFD retrieve form for data capture RFP Request for Proposals (Contracts) RFQ Request for Quote RHIO regional health information organization RIF Reduction In Force RIGS Radioimmunoguided surgery RIM Reference Information Model (HL7) RKI Robert Koch Institut, Bundesinstitut für Infektionskrankheiten und nich übertragbare Krankheiten (Federal Institute for Infectious and Noncommunicable Diseases, Germany) RL Regulatory Letter RMO Regulatory Management Officer RMS Rhabdomyosarcoma RMW Regulated Medical Waste ROC Receiver operating characteristic ROE Report of Expenditures RPE Radiation Producing Equipment RPS Regulated Product Submission (HL7 RCRIM) RSC Radiation Safety Committee RSO Radiation Safety Officer RT Radiotherapy RTF Refuse To File RTOG Radiation Therapy Oncology Group RTPCR Reverse transcriptase polymerase chain reaction RUG Resource Utilization Group Rx Treatment S Standard SA Surface area (see BSA) SAAVI South African AIDS Vaccine Initiative SACHRP Secretary's Advisory Committee on Human Protection. See also OHRP . SADR suspected adverse drug reaction (FDA) SAE Serious adverse event SAG Science Administration Group SAL Sterility Assurance Level SAS Statistical Analysis System (commonly used statistical analysis package) SATCM State Administration of Traditional Chinese Medicine (China) SBA Summary Basis of Approval SBIR Small Business Innovation Research Grant SBS IRB Social and Behavioral Sciences Institutional Review Board SC Subcutaneous SC Study Coordinator SCAW Scientists Center for Animal Welfare SCDM Society for Clinical Data Management SCHARP Statistical Center for HIV AIDS Research and Prevention SCLC Small cell lung cancer SCSO Supervisory Consumer Safety Officer SCT Society for Clinical Trials SCTN Scottish Cancer Therapy Network SD Stable Disease SD Standard Deviation SD Source Document SDA State Drug Administration (China) SDM Submission Data Model (CDISC) SDMC Statistical and Data Management Center SDO standards development organization SDS Submission Data Standards (CDISC) SDTM Study Data Tabulation Model (CDISC) SDV Source Data Verification SDV source document (data) verification SE Standard Error SE standard error (statistics) SEA Single European Act of 1987 SEER Surveillance, Epidemiology, and End Results (Registry of NCI) SEG Special Emphasis Group (Laboratory) SEND Standard for the Exchange of Nonclinical Data. NOTE: The focus of the SEND Team is on data collected from animal toxicology studies. [CDISC] SES Senior Executive Service SF Standard Form (Federal) SFOP French Paediatric Oncology Scociety SGDM Study Group on Data Management (EORTC) SGML Standard Generalized Markup Language SGO Society of Gynecologic Oncologists SGOT Serum glutamic oxalacetic transaminase a liver function test SGPT Serum glutamic pyruvic transaminase a liver function test SHIV Simian Human Immunodeficiency Virus SHO Senior House Officer SIAC Special Interest Area Community (DIA) SIG Special Interest Group (HL7) SIOP International Society of Paediatric Oncology SIV Simian Immunodeficiency Virus SLA service level agreement SMART Submission Management and Review Tracking SMDA Safe Medical Devices Act (1990) SME Significant Medical Event SMO Site Management Organization SmPC summary of product characteristics. See also SPC. SNAP Streamlined Noncompeting Award Process (NIH) SNDA Supplemental New Drug Application SNIP Syndicat National de l'Industrie Pharmaceutique (France) SNLG Scottish and Newcastle Lymphoma Group SNOMED Systematized Nomenclature of Medicine (a dictionary) SNP Single Nucleotide Polymorphism SOAP simple object access protocol (a W3C XML initiative) SOB Short of breath SoCRA Society of Clinical Research Associates SOM School of Medicine SOMCTO School of Medicine Clinical Trials Office SOMOGC School of Medicine Office of Grants and Contracts Administration SON School of Nursing SOP Standard operating procedure SOW Scope of Work SPAC State Pharmaceutical Administration of China SPC summary of product characteristics. See also SmPC. SPL Structured Product Labeling (HL7, FDA) SPM Society of Pharmaceutical Medicine (UK) SPOHNC Support for People with Oral and Head and Neck Cancer SPORE Specialized Programs of Research Excellence SQ Subcutaneous SQA Society of Quality Assurance SQAP systems quality assurance plan SRA Society of Research Administrators SRA Staff Research Associate SRS Spontaneous Reporting System SSC Scientific Steering Committee (HVTN) SSC study site coordinator. See also CRC, CCRC, SC. SSCT Swedish Society for Clinical Trials SSFA Società di Scienze Farmacologiche Applicate (Italy) SSM Superficial Spreading Melanoma SSM Skin Surface Microscopy STD Sexually Transmitted Disease STF study tagging file STI Sexually Transmitted Infection STT Short Term Tests STTR Small Business Technology Transfer Grant SUAE serious unexpected adverse event SUD sudden unexpected death SUPAC Scale up and post approval changes SWG Strategic Working Group SWOG Southwest Oncology Group SX Symptoms TAC Technical Advisory Committee (CDISC) TAMs tumour associated macrophages TBI Total body irradiation TC Technical Committee (HL7) TCC Transitional Cell Carcinoma (usually bladder cancer) TCP Thrombocytopenia TCP/IP Transmission Control Protocol/Internet Protocol TDC Total Direct Costs tds / tid Three times a day (ter in die) TESS treatment emergent signs and symptoms TID Three Times A Day TIND Treatment IND TK Toxicokinetics Tmax the time after dosing when Cmax occurs TMO trial management organization TNF Tumour Necrosis Factor TNM Staging system primary tumour TOP Topical TPN total parenteral nutrition TRK Transketolase TSH Thyroid Stimulating Hormone UA Urinalysis ug microgram 0.000001 gram UICC Union Internationale Contre le Cancer International Union Against Cancer UKACR UK Association of Cancer Registeries UKCCCR UK Coordinating Committee for Cancer Research UKCCR United Kingdom Coordinating Committee on Cancer Research UKCCRG UK Children's Cancer Research Group (Oxford) UKCCSG UK Children's Cancer Study Group (UK) ULN Upper Limits of Normal UMMS University of Maryland Medical System UMT universal mean time (also known as Greenwich mean time). See UTC. UNAIDS Joint United Nations Programme on HIV/AIDS UNESCO United Nations Educational Science and Cultural Organization UNK Unknown URL uniform resource locator (address of a Web site) URTI Upper respiratory tract infection US Ultrasound (scan) USAN United States Adopted Name USDA United States Department of Agriculture USMHRP U.S. Military HIV Research Project USP U.S. Pharmacopeia USPC U.S. Pharmacopeial Convention USP DI United States Pharmacopeia Drug Information USPIO Ultrasmall particle superparamagnetic iron oxide USP NF United States Pharmacopeia National Formulary UST user site testing. Synonym for UAT (user acceptance testing) USUHS Uniformed Services University of the Health Sciences UTI Urinary Tract Infection UVR Ultra Violet Radiation VA Department of Veteran’s Affairs (Federal) VAERS Vaccine Adverse Event Reporting System VAI Voluntary Action Indicated VAI Voluntary Action Indicated (FDA postaudit inspection classification) VAI Voluntary Action Indicated (post FDA audit inspection classification) Value stream mapping a lean process visualization technique used to analyze the flow of materials and information through a system. The goal of value stream mapping is to understand and streamline the work processes by reducing waste, or activities that do not add value. VCDE vocabularies and common data elements (caBIG) VDGIF Virginia Dept. of Game and Inland Fisheries VEF Ventricular ejection fraction (tests lung function) VGDS voluntary genomic data submission VIEW Virtual Imaging Evaluation Workspace VM 26 Teniposide (anti cancer drug) VMA Vanillylmandelic Acid VP 16 Etoposide (anti cancer drug) VPRP Vaccine and Prevention Research Program (DAIDS) VRC Dale and Betty Bumpers Vaccine Research Center (NIAID/NIH) VS Vital Signs VTN (see HVTN) WBC White blood cell count WCC White cell count WD Withdrawn (COMIS term) WHO World Health Organization WHOART World Health Organization Adverse Reaction Terminology WI Inactive (COMIS term) WIHS Women's Interagency HIV Study (DAIDS) WITS Women and Infants Transmission Study (DAIDS) WL Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days) WNL Within Normal Limits WOCBP Women of Child Bearing Potential WR written request WRAIR Walter Reed Army Institute of Research WTO World Trade Organization WVA World Veterinary Association WWW World Wide Web XIP EXtensible Imaging Platform XML eXtensible Markup Language XRT Radiotherapy (external) YST Yolk sac tumour (aka. germ cell tumour)