Acronyms of Clinical Trial Terms

For acronyms of clinical trial names, click here

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

AADA: Abbreviated Antibiotic Drug Application
AAFP: American Academy of Family Physicians
AAHRPP: The Association for the Accreditation of Human Research Protection Programs, Inc.,
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: 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)

Hari's Random Thoughts by Hariharan Ramamurthy

Saturday, July 04, 2020

new product(drug) development data Acronyms of Clinical Trial Terms

Acronyms of Clinical Trial Terms

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