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A&WCadequate and well-controlled
AABBAmerican Association of Blood Banks
AADAabbreviated antibiotic drug application (FDA) (used primarily for generics)
AAMCAssociation of American Medical Colleges
AAPSAmerican Association of Pharmaceutical Scientists
AASAmerican Association for the Advancement of Science
ABPIAssociation of the British Pharmaceutical Industry
ACDMAssociation for Clinical Data Management (UK)
ACEangiotensin-converting enzyme
ACILAmerican Council of Independent Laboratories. A national trade association representing independent, commercial scientific, and engineering firms.
ACPAmerican College of Clinical Pharmacology
ACPUAssociation of Clinical Pharmacology units
ACRAAssociate Commissioner for Regulatory Affairs (FDA)
ACRPAssociation of Clinical Research Professionals (formerly Associates in Clinical Pharmacology, ACP)
ACRPIChanged its name to ICR—Institute of Clinical Research (UK)
ACTApplied Clinical Trials magazine
ACTGAIDS Clinical Trials Group (NIAID)
ACTUAIDS Clinical Trials Unit (NIH)
ADaMAnalysis Data Model (a CDISC standard)
ADEadverse drug event; adverse drug effect
ADMEabsorption, distribution, metabolism, and excretion (used to describe pharmacokinetic processes)
ADRadverse drug reaction
AEAdverse Event
AEGISADROIT 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
AERSadverse event reporting system (FDA)
AFMRAmerican Federation for Medical Research, formerly the American Federation for Clinical Research (AFCR)
AHAAmerican Heart Association
AHCPRAgency for Healthcare Policy Research (NIH)
AHICAmerican Health Information Community. A US government-charted commission providing input and recommendations to HHS on how to make health records digital and interoperable, and assure the privacy and security of those records (HITSP)
AICRCAssociation of Independent Clinical Research Contractors (UK)
AIDSacquired immune deficiency syndrome, acquired immunodeficiency syndrome
ALCOAAttributable, Legible, Contemporaneous, Original, Accurate
amante meridian, morning (12:00 midnight thru 11:59:59)
AMAAmerican Medical Association
AMCantibody-mediated cytotoxicity
AmFARAmerican Foundation for AIDS Research
AMGArzneimittelgesetz (German Drug Law)
AMPauthorised medicinal product (ISO 11615:2017, 3.1.60)
AMWAAmerican Medical Writers Association
ANDAabbreviated new drug application (for a generic drug)
ANOVAanalysis of variance (statistics)
ANSIAmerican National Standards Institute
AOACAssociation of Official Analytical Chemists
APBAssociation Pharmaceutique Belge (Belgium)
APhAAmerican Pharmacists Association
APIActive Pharmaceutical Ingredient
APPIAcademy of Pharmaceutical Physicians and Investigators
ARCSAssociation of Regulatory & Clinical Scientists (Australia)
AROacademic research organization
ASAPadministrative systems automation project (FDA)
ASCIIAmerican Standard Code for Information Interchange (computer files)
ASCPTAmerican Society for Clinical Pharmacology and Therapeutics
ASPapplication service provider delivering a computer application via the www
ASQAmerican Society for Quality, formerly American Society for Quality Control
ATCAnatomic-Therapeutic-Chemical Coding dictionary
AUCArea Under the Curve
AxMPauxiliary medicinal product (ISO 11615:2017, 3.1.60)
BARQABritish Association of Research Quality Assurance
BCEbeneficial clinical event
BDPABureau of Drug Policy and Administration (China)
BEUCEuropean Bureau of Consumer Unions
BfArMBundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany)
BGABundesgesundheitsamt (Federal health office; former German public health agency)
BGVVBundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Health Protection of Consumers and Veterinary Medicine, Germany)
BIOBiotechnology Innovation Organization
BIRABritish Institute of Regulatory Affairs
BLAbiologics license application (FDA)
BPIBundesverband der Pharmazeutischen Industrie EV (Germany)
BrAPBritish Association of Pharmaceutical Physicians
BRIDGBiomedical Research Integrated Domain Group
BSAbody surface area
BUNBlood Urea Nitrogen
C3CChina CDISC Coordinating Committee
CACompetent Authority (regulatory body charged with monitoring compliance with European Union member state national member state national statutes and regulations)
caBIGcancer biomedical informatics grid
caCOREcancer common ontologic resource environment
caDSRcancer data standards registry and repository. A toolset maintained by NCI.
CAPACorrective and Preventive Action
CAPRACanadian Association of Professional Pharmaceutical Regulatory Affairs (also ACPR Association canadienne des professionnels en réglementation)
CASChemical Abstracts Service
CBERCenter for Biologics Evaluation and Research (FDA)
CBIITCenter for Biomedical Informatics and Information Technology (NCI)
CCIcommercially confidential information
CCIcommittee on clinical investigations
CCPRBComité Consultative pour la Protection des Personnes dans les Recherches Biomédicales (France)
CCRAcertified clinical research associate. certification issued to monitors by acrp.
CCRCcertified clinical research coordinator. certification issued to clinical coordinators by acrp.
CCRPcertified clinical research professional. socra certification of coordinators, monitors, and other research professionals.
CCSIcompany core safety information
CDAclinical document architecture (HL7)
CDASHClinical Data Acquisition Standards Harmonization (a 2006 CDISC initiative)
CDCCenters for Disease Control and Prevention
CDEcommon data element
CDERCenter for Drug Evaluation and Research (FDA)
CDISCClinical Data Interchange Standards Consortium
CDMclinical data management
CDMSclinical data management system
CDRHCenter for Devices and Radiological Health (FDA)
CENComité Européen de Normalisation (European Committee for Standardization)
CEUcontinuing education unit
CFconsent form
CFRcode of federal regulations (usually cited by title and part; for example, Title 21, Part 211 is shown as 21 CFR 211)
cGMPcurrent good manufacturing practices
CHIconsolidated health informatics. CHI began as an eGov initiative to establish a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to “speak the same language” based on common enterprise-wide business and information technology architectures. CHI is currently managed under the Office of the National Coordinator for Health Informational Technology’s (ONC) Federal Health Architecture (FHA) Program Management Office. Ref: The United States Health Information Knowledgebase [USHIK]. (HITSP)
CHRcommittee on human research
CIConfidence Interval
CICclinical imaging center
CIOMSCouncil for International Organizations of Medical Sciences (postapproval international ADR reporting, UK)
CIPcertified IRB professional
CISCommonwealth of Independent States
CLIAclinical laboratory improvement amendments
ClinROclinician-reported outcome
Cmaxconcentration maximum; used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug
CMCchemistry, manufacturing, and control
CMEcontinuing medical education
Cmin Minimum Plasma Concentration
CMSCenters for Medicare & Medicaid Services
CNScentral nervous system
CNT Consented but Not Treated
COAclinical outcome assessment
CONSORTconsolidated standards of reporting trials
COPCDISC operating process/procedure
CORECDISC operational roadmap environment (CDISC)
COSTARTCoding Symbols for a Thesaurus of Adverse Reaction Terms. See also MedDRA.
COUcontext of use
CPHSCommittee for the Protection of Human Subjects
CPMPCommittee for Proprietary Medicinal Products (EU)
CPSCConsumer Product Safety Commission (US)
Cr Serum Creatinine
CRA Clinical Research Associate
CRADACooperative Research And Development Agreement (with US Government entities such as FDA or NIH)
CRBcase record book
CRBcentral review board
CRC Clinical Research Coordinator
CRFcase report form (sometimes case record form)
CRIXclinical research information exchange
CROcontract research organization. See also IPRO.
CRTcase report tabulation
CSDDCenter for the Study of Drug Development (Tufts)
CSFcerebrospinal fluid
CSFcollaborative standards forum (CDISC)
CSFcolony stimulating factor
CSMCommittee on Safety of Medicines (UK)
CSOConsumer Safety Officer (FDA)
CSRclinical study report
CSUclinical supply unit
CSUICI(replaces CSUCT) Computerized Systems Used In Clinical Investigations. NOTE: usually pronounced “seesweecy.”
CTclinical trial
CTComputed Tomography
CTAclinical trial agreement
CTCclinical trial certificate (UK)
CTCCirculating Tumor Cell Count
CTCAECommon Terminology Criterion for Adverse Events. Standard terminology developed to report adverse events occurring in cancer clinical trials. CTCAE are used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. The CTCAE contain a grading scale for each adverse event term representing the severity of the event. (NCI)
CTDcommon technical document
CTEPCancer Therapy Evaluation Program
CTMclinical trial material
CTXclinical trial exemption (MCA)
CUIcommon unique identifier. A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms.
CVcurriculum vitae
CVMCenter for Veterinary Medicine (FDA)
CYPCytochrome P450
DARDrug or Device Accountability Records
DAWNDrug Abuse Warning Network
DCGIDrugs Controller General of India (Indian regulatory authority)
DDDepartment of Drugs (Swedish regulatory agency)
DDFdata definition file
DDIdrug–drug interaction
DDTdrug development tool (FDA-NIH BEST Resource)
DEADrug Enforcement Administration (US)
DENdrug experience network
DESdata encryption standard
DESIDrug Efficacy Study Implementation notice (FDA, to evaluate drugs in use before 1962)
DGPharMedDeutsche Gesellschaft für Pharmazeutische Medizin (German Society of Pharmaceutical Medicine), formerly FÄPI
DHHSDepartment of Health and Human Services (US)
DHTMLdynamic HTML (IT)
DIADrug Information Association
DIBDdevelopment international birth date. Analogous to the International Birth Date (IBD) for a PSUR, defined as the date of first marketing approval, worldwide. [Ref: ICH E2F – Development Safety Update Report]
DICOMDigital Imaging and Communications in Medicine
DIMsdomain information models
DITADarwin Information Typing Architecture
DLTdose-limiting toxicity
DLTDose Limiting Toxicity
DMBData Management Biomedical (France)
DNADeoxyribonucleic Acid
DPC-PTRDrug Price Competition and Patent Term Restoration Act of 1984 (also Waxman-Hatch or Hatch-Waxman bill)
DSIDivision of Scientific Investigations (FDA)
DSMDiagnostic and Statistical Manual (of the American Psychiatric Association)
DSMBData Safety Monitoring Board
DSMPData Safety Monitoring Plan
DSNPDevelopment of Standardized Nomenclature Project (FDA)
DSTdaylight saving time
DSTUdraft standard for trial use. See HL7 definition.
DSURdevelopment safety update report (ICH)
DTCdirect-to-consumer (drug advertising)
DTDdocument type definition coordinating committee
E3CEuropean CDISC coordinating committee
EABeditorial advisory board (Applied Clinical Trials)
ECEuropean Commission (in documents older than the mid-1980s, EC may mean European Community)
ECEthics Committee
ECGEuropean CDISC group
ECJEuropean Court of Justice
eCOAelectronic clinical outcome assessment
ECOGEastern Cooperative Oncology Group (Used to determine Performance Status )
ECPHINEuropean Community Pharmaceutical Information Network
eCRFelectronic case report form
ECRINEuropean Clinical Research Infrastructures Network
eCTDelectronic common technical document
EDCelectronic data capture/collection
EDIelectronic data interchange
eDMSelectronic data management system
EDRelectronic 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.
eDTelectronic data transfer
EECEuropean Economic Community, now EU; some regulatory documents still have EEC document numbers.
EFGCPEuropean Forum for Good Clinical Practice
EFPIAEuropean Federation of Pharmaceutical Industries and Associations
EFTAEuropean Free Trade Association
eHRelectronic health record
EIRestablishment inspection report (FDA)
ELAestablishment license application (FDA)
EMAEuropean Medicines Agency
EMEAEuropean Agency for the Evaluation of Medicinal Products
EMWAEuropean Medical Writers Association
EORTCEuropean Organization for Research and Treatment of Cancer
EPEuropean Parliament
EPAREuropean Public Assessment Report
EPOEuropean Patent Office; erythropoietin
EPRGEuropean Pharmacovigilance Research Group
ePROelectronic patient-reported outcome
ERessential requirements (EMA)
ERSRelectronic regulatory submissions and review (FDA’s e-Submissions processing group)
eRXelectronic prescribing
eSDIelectronic source data interchange
eSRelectronic source record. See eSource.
ESRAEuropean Society of Regulatory Affairs
eSRFelectronic source report form
ESTRIElectronic Standards for the Transfer of Regulatory Information (ICH)
EUEuropean Union
EU CTRClinical trials - Regulation EU No 536/2014
EUDRAEuropean Union Drug Regulatory Authorities
EudraCTEuropean Union clinical trials database
EVSEnterprise Vocabulary Services (National Cancer Institute)
EWGexpert working group
FAQfrequently asked questions
FarmindustriaThe Association of Italian Pharmaceutical Manufacturers
FD&C ActFood, Drug, and Cosmetic Act (US)
FDAFood and Drug Administration (US)
FDAAFood and Drug Administration Amendment Act (pronounced fedaahh or fedah-ah)
FDAMAFDA Modernization Act (pronounced fedahma)
FDLIFood and Drug Law Institute
FFPMFellow of the Faculty of Pharmaceutical Medicine (UK)
FIPSfederal information processing standards
FISMAFederal Information Security Management Act
FRCPFellow of the Royal College of Physicians, sometimes followed by a place name—for example, FRCP (Edin.)—that indicates a university medical school.
FTCFederal Trade Commission (US)
FTPfile transfer protocol
FWAfederalwide assurance
FWA number Federal Wide Assurance number (number assigned to IRB )
GAOGovernment Accountability Office (US government)
GBPgood business practice
Gbpsgigabits, or billions of bits per second (data transmission)
GCPGood Clinical Practices
GCRPgood clinical research practice
GLPGood Laboratory Practices
GMPGood Manufacturing Practices
GMTGreenwich mean time. See also UTC.
GPgeneral practitioner
GPMSgood postmarketing surveillance practice (Japan)
GPVPgood pharmacovigilance practice
GRASgenerally regarded as safe (foods)
GRPgood review practice (CDER)
GXPgood (pharmaceutical) practice
HAhealth authority (UK)
HAQHealth Assessment Questionnaire
HCFAHealthcare Financing Administration; now renamed The Centers for Medicare & Medicaid Services (CMS)
HDEHumanitarian Device Exemption (must be in place to use a HUD)
HEORhealth economics and outcomes research
HEXhuman experimentation committee
HHSDepartment of Health and Human Services (US, also called DHHS)
HIEHealth Information Exchange. The mobilization of healthcare information electronically across organizations within a region or community. HIE provides the capability to electronically move clinical information between disparate healthcare information systems, while maintaining the meaning of the information being exchanged. The goal of HIE is to facilitate access to, and retrieval of, clinical data to provide safer, more timely, efficient, effective, equitable, and patient-centered care. (HITSP)
HIMAHealth Industry Manufacturers Association
HIMSSHealthcare Information and Management Systems Society (pronounced hymns)
HIPAHealth Insurance Portability and Accountability Act
HIThealth information technology
HITSPHealth Information Technology Standards Panel (pronounced hitspee)
HL7Health Level 7 (a not-for-profit ANSI-accredited standards developing/development organization [SDO])
HPBHealth Protection Branch, Laboratory Centre for Disease Control (Canada); has been superseded by Health Canada
HPLChigh performance liquid chromatography
HRQoLhealth-related quality of life
HSRChuman subjects review committee
HTMLhypertext markup language
HTTPhypertext transfer protocol
HUDHumanitarian Use Device (for less than 4, 000 subjects)
I3CIndia CDISC Coordinating Committee
IABIndustry Advisory Board (for CDISC)
IBInvestigator's Brochure
IBDinternational birth date
ICinformed consent
IC50Inhibitory Concentration 50%
ICD9International Classification of Diseases, 9th revision. See also MedDRA.
ICFInformed Consent Form
ICGIndia CDISC Group
ICHInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
ICRInstitute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK)
ICSRindividual case safety report
ICTHInternational Committee on Thrombosis and Haemostasis
ICTRPInternational Clinical Trials Registry Platform (WHO)
IDEinvestigational device exemption application to CDRH to get permission for investigational device testing in clinical trials.
IDEInvestigational Device Exemption
IECindependent ethics committee
IECIndependent Ethics Committee
IEEEEInstitute of Electrical and Electronic Engineers, Inc.
IFAPInternational Federation of Associations of Pharmaceutical Physicians
IFPMAInternational Federation of Pharmaceutical Manufacturers and Associations
IGInspector General (HHS)
IHEIntegrating the Healthcare Enterprise (an international standards organization)
IHIInstitute for Healthcare Improvement
IKSInterkantonale Kontrollstelle für Heilmittel (Switzerland)
IMIInnovative Medicines Initiative (European Commission)
IMPinvestigational medicinal product; investigational materials plan
IMPDInvestigational Medicinal Product Dossier (EUDRA)
INDinvestigational new drug application (FDA). See also TIND.
INDInvestigational New drug
INNinternational nonproprietary name
IOMInstitute of Medicine (National Academy of Science, US)
IPROindependent pharmaceutical research organization. See also CRO.
IRBinstitutional review board; independent review board
IRBInstitutional Review Board
IRDinternational registration document
ISInternational System of Units (may also be referred to as SI—Systéme Internationale).
ISCBInternational Society for Clinical Biostatistics
ISDNintegrated services digital network
ISOInternational Organization for Standardization
ISOQOLInternational Society for Quality of Life Research
ISPinternet service provider
ISRInjection Site Reaction
ITinformation technology
ITU-TInternational Telecommunication Union—Telecommunication Standardization Sector
IUPACInternational Union of Pure and Applied Chemistry
IVDin vitro diagnostics
IVRSinteractive voice response system
IVRSInteractive Voice Recognition System
J3CJapan CDISC Coordinating Committee
JCAHOJoint Commission on Accreditation of Healthcare Organizations
JCGJapan CDISC Group
JMAJapan Medical Association
JPMAJapan Pharmaceutical Manufacturers Association
Kbpskilobits, or thousands of bits per second (data transmission); NOTE: KBps stands for kilobytes per second (an 8 fold difference)
KFDAKorean Food and Drug Administration
Ki Inhibition Constant
LABlaboratory data model (CDISC)
LANlocal area network
LDH Lactate Dehydrogenase
LIFSwedish Pharmaceutical Industry Association
LKPLeiter der Klinischen Prüfung
LOAletter of agreement
LOINClogical observations, identifiers, names, and codes
LREClocal research ethics committee (UK)
MAmarketing authorization
MAAmarketing authorisation application (EMA, EU)
MAHMarketing Authorisation Holder (EU)
MaPPManual of Policies and Procedures (CDER)
Mbpsmegabits, millions of bits per second (data transmission)
MDRmedical device reporting
MDRMedical Device Reporting
MedDRAMedical 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)
MedDRA Medical Dictionary for Regulatory Activities
MedIDmedicinal product identifier
MEDLARSmedical literature analysis and retrieval system
MEFAAssociation of the Danish Pharmaceutical Industry
MEPmember of the European Parliament
MHLWMinistry of Health, Labor and Welfare (Japan)
MHRAMedicines and Healthcare products Regulatory Agency (UK)
MIAMEminimum information about a microarray experiment (standard for microarray data)
mmHg Millimeters of Mercury
MOHMinistry of Health (UK, Canada, others)
MOPHMinistry of Public Health (Thailand, Yemen, others)
MOSMedical Outcomes Study
MOUmemorandum of understanding (an MOU between FDA and a regulatory agency in another country allows mutual recognition of inspections)
MPDTmedical product development tool (FDA-NIH BEST Resource)
MPIDmedicinal product identifier
MPRMedical Products Agency (Swedish Regulatory Agency)
MRMedical Representative (Japan)
MRAmedical research associate
MRECMulticentre Research Ethics Committee (UK). See also Ethics Committee in the Glossary.
MRImagnetic resonance imaging
MTDmaximum tolerated dose
MTD Maximum Tolerated Dose
MVPmaster validation plan
NABRNational Association for Biomedical Research
NAFnotice of adverse findings (FDA postaudit letter)
NAIno action indicated (most favorable FDA postinspection classification)
NASnew active substance (UK)
NAS–NRCNational Academy of Sciences–National Research Council (US)
NBACNational Bioethics Advisory Commission (US)
NCAnational competent authority
NCINational Cancer Institute (National Institutes of Health, USA)
NCICBNational Cancer Institute Center for Bioinformatics
NDANew Drug Application
NEFARMADutch Association of the Innovative Pharmaceutical Industry
NEINational Eye Institute (NIH)
NGOnongovernmental organization
NHINational Health Insurance (Japan)
NHINNational Health Information Network
NHLBINational Heart, Lung, and Blood Institute (NIH)
NHSNational Health Service (UK)
NIANational Institute on Aging (NIH)
NIAAANational Institute on Alcohol Abuse and Alcoholism (NIH)
NIAIDNational Institute of Allergies and Infectious Diseases (NIH)
NIAMSNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH)
NIBIBNational Institute of Biomedical Imaging and Bioengineering
NICHDNational Institute of Child Health and Human Development (NIH)
NIDANational Institute on Drug Abuse (NIH)
NIDCDNational Institute on Deafness and Other Communication Disorders (NIH)
NIDCRNational Institute of Dental and Craniofacial Research (NIH)
NIDDKNational Institute of Diabetes and Digestive and Kidney Diseases (NIH)
NIEHSNational Institute of Environmental Health Sciences (NIH)
NIGMSNational Institute of General Medical Sciences (NIH)
NIHNational Institutes of Health (DHHS)
NIMHNational Institute of Mental Health (NIH)
NINDSNational Institute of Neurological Disorders & Stroke (NIH)
NINRNational Institute of Nursing Research (NIH)
NIRBSee NRB. See also Ethics Committee, Independent.
NISTNational Institute of Standards and Technology
NLMNational Library of Medicine (NIH)
NMEnew molecular entity
NOAELno observed adverse effect level (IUPAC)
NOELno observable effect level (dose of an experimental drug given preclinically that does not produce an observable toxicity)
NRBnoninstitutional review board, also known as an independent review board. See also Ethics Committee in the Glossary, NIRB.
NSCLCnon-small cell lung carcinoma
NSRNon-Significant Risk ( usually refers to device research )
NTPNational Toxicology Program
OAIofficial action indicated (serious FDA postinspection classification)
OASISopen accessible space information system
ObsROobserver-reported outcome
ODACOncologic Drugs Advisory Committee (US)
ODEOffice of Drug Evaluation
ODMoperational data model (CDISC)
OGDOffice of Generic Drugs (CDER, formerly DGB)
OGEOffice of Government Ethics
OHITAOffice of Health Information Technology Adoption (ONCHIT)
OHRPOffice for Human Research Protections (pronounced O-harp)
OHRPOffice for Human Research Protection
OIGOffice of the Inspector General
OISOffice of Interoperability and Standards
OJCOfficial Journal of the European Union–C Series (Information)
OJECOfficial Journal of the European Communities
OJLOfficial Journal of the European Union–L Series (Legislation)
OMBOffice of Management and Budget (US)
ONCHITOffice of the National Coordinator for Health Information Technology (HIMSS)
OPROffice of Policy and Research
OPRROffice for Protection from Research Risks (predecessor to OHRP)
OSHAOccupational Safety & Health Administration (US)
OTAOffice of Technology Assessment (US, abolished 1995)
OTCover-the-counter (refers to nonprescription drugs)
PABPharmaceutical Affairs Bureau (Japan)
PADER/PAERperiodic adverse drug experience report
PAHOPan American Health Organization
PBRERperiodic benefit-risk evaluation report
PCCpoison control center
PCPpneumocystis carinii pneumonia. (The older name pneumocystis carinii—which now only applies to the pneumocystis variant that occurs in animals—is still in common usage. As a result, pneumocystis pneumonia (PCP) is also known as pneumocystis jiroveci[i] pneumonia.
PD Pharmacodynamics
PDApersonal digital assistant (Palm Pilot, for example)
PDFportable document format
PDQPhysicians’ Data Query (NCI-sponsored cancer trial registry)
PDRPhysicians’ Desk Reference
PDUFAPrescription Drug User Fee Act (1992, US)
PDUFA IVPrescription Drug User Fee Act (FDA)
PEMprescription event monitoring
PerfOperformance outcome
PERIPharmaceutical Education & Research Institute (not-for-profit division of PhRMA)
PFS Progression-Free Survival
PFTpulmonary function test
PHIprotected health information
PhPIDpharmaceutical product identifier
PhRMAPharmaceutical Research and Manufacturers of America
PHSPublic Health Service (US)
PIprincipal investigator
PI Principal Investigator
PIIpersonally identifiable information
PIMproduct information management (a system introduced by the EMA)
PK Pharmacokinetic
PKIpublic key infrastructure
PLAproduct license application (FDA)
pmpost meridian, evening (12 noon thru 23:59:59)
PMApremarket approval application (FDA)
PMAPre- Market Approval
PMDAPharmaceutical and Medical Devices Agency and Medical Devices Agency (Japanese regulatory authority)
PMSpostmarketing surveillance
PMS Post Marketing Surveillance
PPDprotected personal data
PPIpatient package insert
PPOpreferred provider organization; policy and procedure order
PRpartial response; pulse rate
PRGprotocol representation group (CDISC)
PRIM&RPublic Responsibility in Medicine and Research (Boston, MA)
PRMprotocol reference model
prn As Needed
PROpatient-reported outcome
PROGPeer-Review Oversight Group (NIH)
PROMISpatient reported outcomes measurement information systems (pronounced promise)
PSURperiodic safety update report
PTCpoints to consider
QAquality assurance
QAUquality assurance unit
QCquality control
QLquality of life
QOLquality of life (also QoL)
QOLQuality of Life
QRSquestionnaires, ratings and scales
QTcFQT Interval Corrected by the Fridericia Correction Formula
R&Dresearch and development
RADARrisk assessment of drugs–analysis and response
RAPSRegulatory Affairs Professionals Society
RBMrisk based monitoring
RCRIMRegulated 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).
RCTrandomized clinical trial
RDEremote data entry
RDFresource description framework
RDRCRadioactive Drug Research Committee (FDA)
REBresearch ethics board (Canada)
RECISTResponse Evaluation Criteria in Solid Tumors
REMSrisk evaluation and mitigation strategy
RFDretrieve form for data capture
RFPrequest for proposal
RHIORegional Health Information Organization. A group of organizations with a business stake in improving the quality, safety and efficiency of healthcare delivery. RHIOs are the building blocks of the proposed National Health Information Network (NHIN) initiative.
RIMreference information model (HL7)
RKIRobert-Koch-Institut, Bundesinstitut für Infektionskrankheiten und nichübertragbare Krankheiten (Federal Institute for Infectious and Noncommunicable Diseases, Germany)
RLRegulatory Letter (FDA—postaudit letter)
RMPrisk management plan
ROAroute of administration
RPSRegulated Product Submission (HL7 RCRIM)
RSIreference safety information
SAC HRPSecretary’s Advisory Committee on Human Protection. See also OHRP.
SADRsuspected adverse drug reaction (FDA)
SAEserious adverse event
SAE Serious Adverse Event
SAFEsecure access for everyone
SASstatistical analysis system
SATCMState Administration of Traditional Chinese Medicine (China)
SBAsummary basis of approval
SCstudy coordinator. See also CRC, CCRC, SSC.
SCDMSociety for Clinical Data Management
SCTSociety for Clinical Trials
SDstandard deviation (statistics)
SDStandard Deviation
SDAState Drug Administration (China)
SDMsubmission data model (CDISC)
SDOstandards development organization
SDSsubmission data standards (CDISC)
SDTMstudy data tabulation model (CDISC)
SDTMIGstudy data tabulation model implementation guide
SDVsource document (data) verification
SDVSource Document Verification
SEstandard error (statistics)
SEASingle European Act of 1987
SEERsurveillance, epidemiology, and end results program (National Cancer Institute)
SEMStandard Error for the Mean
SENDstandard for the exchange of nonclinical data. NOTE: The focus of the SEND Team is on data collected from animal toxicology studies. (CDISC)
SEVSite Evaluation Visit
SFDAState Food and Drug Administration (Chinese regulatory authority)
SGMLstandard generalized markup language
SHAREshared health and research electronic library (CDISC)
SIACSpecial Interest Area Community (DIA)
SIGSpecial Interest Group (HL7)
SIVSite Initiation Visit
SLAservice level agreement
SMARTsubmission management and review tracking (FDA)
SMEsignificant medical event
SMOsite management organization
SmPCsummary of product characteristics. See also SPC.
SNDAsupplemental new drug application
SNIPSyndicat National de l’Industrie Pharmaceutique (France)
SNOMEDSystematized Nomenclature of Medicine. A structured nomenclature and classification of the terminology used in human and veterinary medicine developed by the College of Pathologists and American Veterinary Medical Association. Terms are applied to one of eleven independent systematized modules.
SOAPsimple object access protocol (a W3C XML initiative)
SOCsystem organ class (MedDRA)
SoCRASociety of Clinical Research Associates
SOPstandard operating procedure
SPACState Pharmaceutical Administration of China
SPCsummary of product characteristics. See also SmPC.
SPIRITStandard Protocol Items for Randomized Trials (CONSORT for protocols)
SPLStructured Product Labeling (HL7, FDA)
SPMSociety of Pharmaceutical Medicine (UK)
SQASociety of Quality Assurance
SQAPsystems quality assurance plan
SRSignificant Risk (usually refers to device research)
SSCstudy site coordinator. See also CRC, CCRC, SC.
SSCTSwedish Society for Clinical Trials
SSFASocietà di Scienze Farmacologiche Applicate (Italy)
STFstudy tagging file
STTshort term test
SUAEserious unexpected adverse event
SUDsudden unexpected death
SUSARsuspected unexpected serious adverse reaction
SWOGSouthwest Oncology Group (US)
TACtechnical advisory committee (CDISC)
TbilTotal Bilirubin
TCtechnical committee (HL7)
TCCtechnical coordinating committee (CDISC)
TCP/IPtransmission control protocol/internet protocol
TermIDcontrolled vocabulary term identifier
TESStreatment-emergent signs and symptoms
TGATherapeutic Goods Administration (Australian regulatory authority)
TINDtreatment IND. See also IND.
Tmaxthe time after dosing when Cmax occurs
TMOtrial management organization
TTPTime To Progression
UMTuniversal mean time (also known as Greenwich mean time). See UTC.
URLuniform resource locator (address of a website)
USANUnited States adopted name
USCUnited States Code (book of laws)
USDAUS Department of Agriculture
USPUnited States Pharmacopeia
USTuser site testing (compare to UAT, user acceptance testing. See CDISC Glossary)
UTuniversal time (also known as Greenwich mean time). See UTC.
UTCcoordinated universal time (international standard since 1972)
UUIDuniversally unique identifier
VAVeterans Administration (officially, U.S. Department of Veterans Affairs)
VAERSVaccine Adverse Event Reporting System
VAIvoluntary action indicated (FDA postaudit inspection classification)
VCDEvocabularies and common data elements (caBIG)
VGDSvoluntary genomic data submission
VPNvirtual private network
W3CWorld Wide Web Consortium
WANwide area network
WBC White Blood Cell Count
WHOWorld Health Organization
WHOARTWorld Health Organization adverse reaction terminology
WHODRUG/WHO-DRLWorld Health Organization drug reference list
WLwarning letter (most serious FDA postaudit letter, demands immediate action within 15 days)
WMAWorld Medical Association
WRwritten request
WRAIRWalter Reed Army Institute of Research (DoD)
WTOWorld Trade Organization
WWWworld wide web
XMLextensible markup language