Acronyms of Clinical Trial Terms

A

AAAS: American Association for the Advancement of Science

AABB: American Association of Blood Banks

AADA: Abbreviated Antibiotic Drug Application (FDA) (used primarily for generics)

AAMC: Association of American Medical Colleges

• AAPP American Academy of Pharmaceutical Physicians
• AAPS American Association of Pharmaceutical Scientists
• ABPI Association of the British Pharmaceutical Industry
• ACC American College of Clinical Pharmacology
• ACDM Association of Clinical Data Management (UK)
• ACIL A national trade association representing independent, commercial scientific, and engineering firms (formerly the American Council of Independent Laboratories)
• ACPU Association of Clinical Pharmacology Units
• ACRA Associate Commissioner for Regulatory Affairs (FDA)
• ACRP Association of Clinical Research Professionals, formerly Associates in Clinical Pharmacology (ACP)
• ACRPI Changed its name to Institute of Clinical Research (UK)
• ACT Applied Clinical Trials magazine
• ACTG AIDS Clinical Trials Group (NIAID)
• ACTU AIDS Clinical Trials Unit (NIH)
• ADaM Analysis Dataset Model (CDISC)
• ADAMHA Alcohol, Drug Abuse, and Mental Health Administration (no longer exists)
• ADE adverse drug event; adverse drug effect
• ADME absorption, distribution, metabolism, and excretion (used to describe pharmacokinetic processes)
• ADR adverse drug reaction
• AE adverse event; adverse experience
• 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 See AFMR.

• AFMR American Federation for Medical Research, formerly the American Federation

for Clinical Research (AFCR)

• AHA American Heart Association
• AHCPR Agency for Health Care Policy Research (NIH)
• AICRC Association of Independent Clinical Research Contractors (UK)
• AIDS Acquired immune deficiency syndrome. See also SIDA and HIV in acronym glossary.

AIG = Active Ingredient Group

• ALCOA attributable, legible, contemporaneous, original, accurate (dimensions of data

quality)

• AMA American Medical Association
• AMC Antibody-mediated cytotoxicity
• AmFAR American Foundation for AIDS Research
• AMG Arzneimittelgesetz (German Drug Law)
• AMWA American Medical Writers Association
• ANDA Abbreviated New Drug Application (for a generic drug)
• ANOVA analysis of variance (statistics)
• ANSI American National Standards Institute
• AOAC Association of Official Analytical Chemists
• APB Association Pharmaceutique Belge (Belgium)
• APhA American Pharmacists Association
• API active pharmaceutical ingredient
• ARCS Association of Regulatory & Clinical Scientists (Australia)
• ARENA Applied Research Ethics National Association
• ARO academic research organization
• ASAP administrative systems automation project (FDA)
• ASCII American Standard Code for Information Interchange (computer files)
• ASCPT American Society for Clinical Pharmacology and Therapeutics
• ASQ American Society for Quality, formerly American Society for Quality Control
• AUC area under the curve (statistics)
• AZT zidovudine (HIV treatment)

B

BARQA British Association of Research Quality Assurance BCE beneficial clinical event Glossary Acronyms, Abbreviations, and Initials December 2003 actmagazine.com APPLIED CLINICAL TRIALS 25 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) BIO Biotechnology Industry Organization BIRA British Institute of Regulatory Affairs BLA Biologics License Application (FDA) BPI Bundesverband der Pharmazeutischen Industrie EV (Germany) BrAPP British Association of Pharmaceutical Physicians BSA body surface area

C

CA Competent Authority (regulatory body charged with monitoring compliance with European Union member state national statutes and regulations) CAPRA Canadian Association of Pharmaceutical Regulatory Affairs CAS Chemical Abstracts Service CBER Center for Biologics Evaluation and Research (FDA) CCI Committee on Clinical Investigations. See also Ethics Committee box. CCPPRB Comité Consultative pour la Protection des Personnes dans les Recherches Biomédicales (France). See also Ethics Committee box. CCRA Certified Clinical Research Associate. Certification issued to monitors by ACRP. CCRC Certified Clinical Research Coordinator. Certification issued to clinical coordinators by ACRP. CCRP Certified Clinical Research Professional. SOCRA certification of coordinators, monitors, and other research professionals. CDC Centers for Disease Control and Prevention CDER Center for Drug Evaluation and Research (FDA) CDISC Clinical Data Interchange Standards Consortium (formerly a DIA special interest group called the Clinical Data Interchange Standards Committee) CDM clinical data management CDRH Center for Devices and Radiological Health (FDA) CEN Comité Européen de Normalisation (European Committee for Standardization) CEU continuing education unit CF consent form 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) 26 APPLIED CLINICAL TRIALS actmagazine.com December 2003 cGMP current good manufacturing practices CHI Consolidated Health Initiative (eGov) CHR Committee on Human Research. See also Ethics Committee box. CIOMS Council for International Organisations of Medical Sciences (postapproval international ADR reporting, UK) CIP Certified IRB Professional CIS Commonwealth of Independent States CLIA Clinical Laboratory Improvements Amendments Cmax concentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug CMC chemistry, manufacturing, and control CME continuing medical education CNS central nervous system COP CDISC operating process/procedure COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms. See also MedDRA. CPHS Committee for the protection of human subjects CPMP Committee for Proprietary Medicinal Products (EU) CPSC Consumer Product Safety Commission (U.S.) CRA clinical research associate. See also CCRA CRADA cooperative research and development agreement (with NIH) CRB case record book CRB central review board CRC clinical research coordinator. See also CCRC, SC, SSC CRF case report form (sometimes case record form) CRO contract research organization. See also IPRO. CSDD Center for the Study of Drug Development CSF Collaborative Standards Forum (CDISC) CSM Committee on Safety of Medicines (UK) CSO Consumer Safety Officer (FDA) CSR clinical study report CSU clinical supply unit CT clinical trial CTC clinical trial certificate (UK) CTD common technical document 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181–182. Washington, D.C.: U.S. Government Printing Office, 1949. Nuremberg Code—Directives for Human Experimentation December 2003 actmagazine.com APPLIED CLINICAL TRIALS 27 CTEP Clinical Therapeutics Evaluation Program (NCI) CTM clinical trials materials CTX clinical trial exemption (MCA) CV curriculum vitae CVM Center for Veterinary Medicine (FDA)

D

DAWN Drug Abuse Warning Network DD Department of Drugs (Swedish regulatory agency) DEA Drug Enforcement Administration (U.S.) DEN Drug Experience Network DES Data Encryption Standard DESI Drug Efficacy Study Implementation notice (FDA, to evaluate drugs in use before 1962) DGPharMed Deutsche Gesellschaft für Pharmazeutische Medizin (German Society of Pharmaceutical Medicine), formerly FÄPI DHEW Department of Health, Education and Welfare (U.S., now split into DHHS and Department of Education) DHHS Department of Health and Human Services (U.S.) DHTML dynamic HTML (IT) DIA Drug Information Association DICOM Digital Imaging and Communications in Medicine DLT dose-limiting toxicity DMB Data Management Biomedical (France) DoD Department of Defense (U.S.) DPC-PTR Act Drug Price Competition and Patent Term Restoration Act of 1984 (also Waxman-Hatch or Hatch-Waxman bill) DSI Division of Scientific Investigations (FDA) DSM Diagnostic and Statistical Manual (of the American Psychiatric Association) DSMB Data and Safety Monitoring Board DSNP development of standardized nomenclature project (FDA) DTC direct-to-consumer (drug advertising) DTD document type definition (XML)

E

E3C European CDISC Coordinating Committee EAB Editorial Advisory Board (Applied Clinical Trials) EAB Ethical advisory board. See also Ethics Committee box. EC ethics committee. See also Ethics Committee box. EC European Commission (in documents older than the mid-1980s, EC may mean European Community) ECG electrocardiogram ECG European CDISC Group ECJ European Court of Justice ECOG Eastern Cooperative Oncology Group (U.S.) ECPHIN European Community Pharmaceutical Products Information Network eCRF electronic case report form EDC electronic data capture/collection EDI electronic data interchange EEC European Economic Community, now EU; some regulatory documents still have EEC document numbers EFGCP European Forum for Good Clinical Practice EFPIA European Federation of Pharmaceutical Industries and Associations EFTA European Free Trade Association EIR Establishment Inspection Report (FDA) ELA Establishment License Application (FDA) EMEA European Agency for the Evaluation of Medicinal Products EMS electronic mail service EMWA European Medical Writers Association EORTC European Organization for the Research and Treatment of Cancer EP European Parliament EPAR European Public Assessment Report EPO European Patent Office EPRG European Pharmacovigilance Research Group ER Essential Requirements (EMEA) ESRA European Society of Regulatory Affairs ESTRI Electronic Standards for the Transfor of Regulatory Information (ICH) EU European Union EUDRA European Union Drug Regulatory Authorities EUDRACT European Union clinical trials database EWG expert working group

F

FAQ frequently asked questions Farmindustria The Association of Italian Pharmaceutical Manufacturers FD&C Act Food, Drug, and Cosmetic Act (U.S.) FDA Food and Drug Administration (U.S.) FDAMA FDA Modernization Act FDLI Food and Drug Law Institute FFPM Fellow of the Faculty of Pharmaceutical Medicine (UK) FRCP Fellow of the Royal College of Physicians, sometimes followed by a place name—for example, FRCP (Edin.)—that indicates a university medical school FTC Federal Trade Commission (U.S.) FTP File Transfer Protocol FWA Federal-wide assurance

G

GAO General Accounting Office (U.S. government) GBP good business practice Gbps gigabits or billions of bits per second (data transmission) GCP good clinical practice GCRP good clinical research practice GLP good laboratory practice GMP good manufacturing practice GP general practitioner; general practice (UK) GPMS good postmarketing surveillance practice (Japan) GRAS generally regarded as safe (foods) GXP good [pharmaceutical] practice

H

HCFA Health Care Financing Administration; now renamed The Centers for Medicare & Medicaid Services. HEX human experimentation committee. See also Ethics Committee box. HHS Department of Health and Human Services (U.S., also called DHHS) HIMA Health Industry Manufacturers Association HIMSS Health Information and Management Systems Society HIPPA Health Insurance Portability and Accountability Act HL7 Health Level 7 (a not-forprofit ANSI-accredited standards developing organization (SDO) HPB Health Protection Branch, Laboratory Centre for Disease Control (Canada) HPLC high performance liquid chromatography HSRC human subjects review committee. See also Ethics Committee box. HTML Hypertext Markup Language HTTP Hypertext Transfer Protocol

I

I3C India CDISC Coordinating Committee IAB Industry Advisory Board (for CDISC) IB investigator’s brochure IC informed consent ICD9 International Classification of Diseases, 9th revision. See also MedDRA. ICG India CDISC Group ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICR Institute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK) ICSR individual case safety report ICTH International Committee on Thrombosis and Haemostases IEC independent ethics committee. See also Ethics Committee box. IEEE Institute of Electrical and Electronic Engineers, Inc. IFAPP International Federation of Associations of Pharmaceutical Physicians IFPMA International Federation of Pharmaceutical Manufacturers’ Associations IG Inspector General (HHS) IKS Interkantonale Kontrollstelle für Heilmittel (Switzerland) IMP investigational materials plan IND Investigational New Drug application (FDA). See also TIND IOM Institute of Medicine (National Academy of Science, U.S.) IPRO independent pharmaceutical research organization. See also CRO IRB institutional review board; independent review board. See also Ethics Committee box. IRD International Registration Document ISCB International Society for Clinical Biostatistics ISDN Integrated Services Digital Network ISO International Organization for Standardization ISP Internet service provider IT information technology ITU-T Telecommunication Standardization Sector of the International Telecommunications Union IVD in vitro diagnostics IVR interactive voice response (telephone technology) IVRS interactive voice response system

J

J3C Japan CDISC Coordinating Committee JCAHO Joint Commission on Accreditation of Healthcare Organizations JCG Japan CDISC Group JMA Japan Medical Association JPMA Japan Pharmaceutical Manufacturers Association Kbps kilobits or thousands of bits per second (data transmission)

L

LAB Laboratory Data Model (CDISC) LAN local area network LIF Swedish Pharmaceutical Industry Association LKP Leiter der klinischen Prüfung LOA letter of agreement LREC local research ethics committee (UK). See also Ethics Committee box.

M

MA marketing authorization MAA Marketing application (EU) Mbps millions of bits per second (data transmission) MCA Medicines Control Agency (UK) MDR Medical Device Reporting MedDRA 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) MEDLARS Medical Literature Analysis and Retrieval System MEFA Association of the Danish Pharmaceutical Industry MEP Member of the European Parliament MHLW Ministry of Health, Labor and Welfare (Japan) MIAME minimum information about a microarray experiment (standard for microarray data) MOH Ministry of Health (UK, Canada, others) MOPH Ministry of Public Health MOU Memorandum of Understanding (an MOU between FDA and a regulatory agency in another country allows mutual recognition of inspections) December 2003 actmagazine.com APPLIED CLINICAL TRIALS 29 MR medical representative (Japan) MRA medical research associate MREC multicentre research ethics committee(UK). See also Ethics Committee box. MRI magnetic resonance imaging MTD maximum tolerated dose MVP master validation plan

N

NABR National Association for Biomedical Research NAF Notice of Adverse Findings (FDA postaudit letter) NAI No Action Indicated (most favorable FDA postinspection classification) NAS new active substance (UK) NAS–NRC National Academy of Sciences–National Research Council (U.S.) NBAC National Bioethics Advisory Commission (U.S.) NCCAM National Center for Complementary and Alternative Medicine, formerly Office of Alternative Medicine (NIH) NCCTG North Central Cancer Treatment Group (U.S.) NCDM Nordic Clinical Data Management (Association) NCE new chemical entity NCHGR National Center for Human Genome Research (NIH) NCHS National Center for Health Statistics (in CDC) NCI National Cancer Institute (NIH) NCPDP National Council for Prescription Drug Programs NCPIE National Council on Patient Information and Education (Washington, DC) NCR no carbon [paper] required NCRR National Center for Research Resources (NIH) NCVIA National Childhood Vaccine Injury Act (1986) NDA New Drug Application (FDA) NDS New Drug Submission (Canada’s new drug application) NEFARMA Dutch Association of the Innovative Pharmaceutical Industry NEI National Eye Institute (NIH) NGO nongovernmental organization NHI National Health Insurance (Japan) NHLBI National Heart, Lung, and Blood Institute (NIH) NHS National Health Service (UK) NIA National Institute on Aging (NIH) NIAAA National Institute on Alcohol Abuse and Alcoholism (NIH) NIAID National Institute of Allergies and Infectious Diseases (NIH) NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH) NICHD National Institute of Child Health and Human Development (NIH) NIDA National Institute on Drug Abuse (NIH) NIDCD National Institute on Deafness and Other Communication Disorders (NIH) NIDDK National Institute of Diabetes and Digestive and Kidney Diseases (NIH) NIDR National Institute of Dental Research (NIH) NIEHS National Institute of Environmental Health Sciences (NIH) NIGMS National Institute of General Medical Sciences (NIH) NIH National Institutes of Health (DHHS) NIMH National Institute of Mental Health (NIH) NINDS National Institute of Neurological Disorders & Stroke (NIH) NINR National Institute of Nursing Research (NIH) NIRB noninstitutional review board. See also Ethics Committee box. NLM National Library of Medicine (NIH) NME new molecular entity NOEL No observable effect level [dose of an experimental drug given pre-clinically, that does not produce an observable toxicity] NRB noninstitutional review board, also known as an independent review board. See also Ethics Committee box. NSCLC non-small cell lung carcinoma NTP National Toxicology Program

O

OAI Official action indicated (serious FDA post-inspection classification) OAM See NCCAM ODAC Oncologic Drugs Advisory Committee (U.S.) ODE Office of Drug Evaluation (CDER now has five such offices: ODE I, II, III, IV, and V) ODM Operational Data Model [CDISC] OGD Office of Generic Drugs (CDER, formerly DGB) OGE Office of Government Ethics (formerly part of Office of Personnel Management, separate executive branch in 1989) OHRP Office for Human Research Protections OIG Office of the Inspector General OJC Office Journal of the European Union–C Series (Information) OJEC Official Journal of the European Communities OJL Office Journal of the European Union–L Series (Legislation) OMB Office of Management and Budget (U.S.) OPRR Office for Protection from Research Risks (predecessor to OHRP) OSHA Occupational Safety Health Administration (U.S.) OTA Office of Technology Assessment (U.S.; abolished by Congress, Fall 1995) OTC over-the-counter (refers to nonprescription drugs)

P

PAB Pharmaceutical Affairs Bureau (Japan) PAHO Pan American Health Organization 30 APPLIED CLINICAL TRIALS actmagazine.com December 2003 PCC Poison Control Center PCP Pneumocystis carinii pneumonia PD pharmacodynamics PDA personal digital assistant (Palm Pilot, for example) PDF Portable Document Format PDQ Physicians’ Data Query (NCI-sponsored cancer trial registry) PDR Physicians’ Desk Reference PDUFA Prescription Drug User Fee Act (1992, U.S.) PEM prescription event monitoring PERI Pharmaceutical Education & Research Institute (notfor- profit division of PhRMA) PFT pulmonary function tests PhRMA Pharmaceutical Research and Manufacturers of America (formerly PMA) PHS Public Health Service (U.S.) PI principal investigator PK pharmacokinetics PKI public key infrastructure PLA Product License Application (FDA) PMA Pre-Market Approval application (FDA) PMS postmarketing surveillance PPI patient package insert PPO preferred provider organization; policy and procedure order PR partial response; pulse rate PRIM&R Public Responsibility in Medicine and Research (Boston, MA) PROG peer-review oversight group (NIH) PSUR periodic safety update report PTC Points to Consider

Q

QA quality assurance QAU quality assurance unit QC quality control QL quality of life QOL quality of life

R

R&D research and development RADAR Risk Assessment of Drugs—Analysis and Response RAPS Regulatory Affairs Professionals Society RCRIM Regulated Clinical Research and Information Management (HL7) RCT randomized clinical trial RDE remote data entry RDRC Radioactive Drug Research Committee REB research ethics board (Canada) RIM Reference Information Model (HL7) RKI Robert-Koch-Institut, Bundesinstitut für Infektionskrankheiten und nich-übertragbare Krankheiten (Federal Institute for Infectious and Non-communicable Diseases, Germany) RL regulatory letter (FDA postaudit letter)

S

SAE serious adverse event SAS Statistical Analysis System (commonly used statistical analysis package) SATCM State Administration of Traditional Chinese Medicine (China) SBA summary basis of approval SC study coordinator. See also CRC, CCRC, SSC SCDM Society for Clinical Data Management (US) SCT Society for Clinical Trials SD standard deviation SDA State Drug Administration (China) SDM Submission Data Model (CDISC) SDO standards development organization SDS Submission Domain Standards (CDISC) SDS submissions data standard SE standard error (statistics) SEA Single European Act of 1987 SEER Surveillance, Epidemiology, and End Results program of the the National Cancer Institute that collects and publishes cancer incidence and survival data. SGML Standard Generalized Markup Language SIAC Special Interest Area Community (DIA) SIG Special Interest Group (HL7) SLA service level agreement SMART Submission Management and Review Tracking (FDA) SME significant medical event SMO site management organization SmPC Summary of Product Characteristics SNDA Supplemental New Drug Application SNIP Syndicat National de l’Industrie Pharmaceutique (France) SNOMED Systematized Nomenclature of Medicine (a dictionary) SOCRA Society of Clinical Research Associates SOP standard operating procedure SPAC State Pharmaceutical Administration of China SPM Society of Pharmaceutical Medicine (UK) SQA Society of Quality Assurance SQAP systems quality assurance plan SSC study site coordinator. See also CRC, CCRC, SC SSCT Swedish Society for Clinical Trials SSFA Società di Scienze Farmacologiche Applicate (Italy) STF study tagging file STT short term tests SC study coordinator. See clinical research coordinator. SUA serious unexpected adverse event SUD sudden unexpected death SWOG Southwest Oncology Group (U.S.)

T

TC Technical Committee (HL7) TCC Technical Coordinating Committee (CDISC) TCP/IP Transmission Control Protocol/Internet Protocol TESS treatment emergent signs and symptoms TIND Treatment IND. See also IND TK toxicokinetics Tmax the time after dosing when Cmax occurs TMO trial management organization

U

URL uniform resource locator (address of a Web site) USC United States Code (book of laws) USDA Department of Agriculture (U.S.) USP United States Pharmacopeia

V

VA Veterans Administration (officially, United States Department of Veterans Affairs) VAERS Vaccine Adverse Event Reporting System VAI Voluntary Action Indicated (FDA postaudit inspection classification) VGDS Voluntary Genomic Data Submission VPN virtual private network

W

WAN wide area network WHO World Health Organization WHOART World Health Organization Adverse Reaction Terminology WL Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days) WRAIR Walter Reed Army Institute of Research (DoD) WTO World Trade Organization www World Wide Web

X

XML Extensible Markup Language