Akronimy w badaniach klinicznych/ Acronyms & Abbreviations in Clinical Research

Data: 2019-01-13

Każdy kto zaczyna swoją przygodę w badaniach klinicznych, czy zmienia pracę spotyka się z problemem zrozumienia, o czym Ci wszyscy ludzie mówią. Skróty, akronimy, wyrażenia bardzo często są trudne do zrozumienia dla osób nawet biegle mówiących po angielsku. Dlatego powstał pomysł, aby przygotować taką listę i aktualizować ją regularnie. Kolejne wyrażenia będą pojawiały się regularnie, a propozycję nowych pozycji umieszczajcie proszę na naszej stronie FB tutaj.

Below list of the Acronyms & Abbreviations in Clinical Research (updated every 2 weeks):

AACI: Association of American Cancer Institutes

ABM Agencja Badań Medycznych

ADR: Adverse Drug Reaction

AE: Adverse Event

AHA American Heart Association

ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate, Complete

AMC: Academic Medical Center

AOTMiT: Agencja Oceny Technologii Medycznych i Taryfikacji

API: Active Pharmaceutical Ingredient

ARO: Academic Research Organization

ASAP: as soon as possible

ATC Anatomic-Therapeutic-Chemical Coding dictionary

AUC area under the curve (statistics)

BID Twice daily

BSA body surface area

CA: Competent Authority

CA: Confidentiallity Agreement

CAPA: Corrective and Preventive Action

CCEA: Complete, Consistent, Enduring, Available

CCM Concomitant Medication

CCR: Center for Cancer Research

CDA Confidential Disclosure Agreement

CDASH: Clinical Data Acquisition Standards Harmonization

CDER: Center for Drug Evaluation and Research

CDM: Clinical Data Management

CDMS Clinical Data Management System

CDS: Clinical Data System

CDUS: Clinical Data Update System

CEBK Centralna Ewidencja Badań Klinicznych (obecnie rejestr, dawniej nazwa urzędu)

CEC Central Ethics Committee

CFR: Code of Federal Regulations

CIOMS Council for International Organization od medical Sciences

Cmax: Maximum Plasma Concentration

Cmin: Minimum Plasma Concentration

CMO: Contract Manufacturing Organization

CNS: Central Nervous System

COA: Clinical Outcome Assesment

COV Close Out Visit

CR Complete Response

CRA: Clinical Research Associate

CRC: Clinical Research Coordinator

CRF: Case Report Form

CRMS: Clinical Research Management System

CRO: Contract Research Organizaction

CS: Clinically Significant

CSO: Contract Safety Organization

CSR: Clinical Study Report

CSR: Corporate Social Responsibility

CSR: Clinical Study Report

CT: Computed Tomography

CTA Clinical Trial Agreement

CTA Clinical Trial Application

CTA Clinical Trial Assistant

CTCAE: Common Terminology Criteria for Adverse Events

CTIS: Clinical Trial Information(al) System

CTMS: Clinical Trial Management System

CTRP: Clinical Trials Reporting Program

CTSA: Clinical and Translational Science Award

CV: Curriculum Vitae

CYP Cytochrome P450

DAR Drug or Device Accountability Records

DB Double Blinded

DBL Database Lock

DCF: Data Clarification Form

DCO: Data Cut Off

DHHS: Department of Health and Human Services

DM: Data Manager

DMC: Data Monitoring Committee

DOA Delegaton of Authority

DP: Disease Progression

DSMB Data Safety Monitoring Board

DSMB: Data and Safety Monitoring Board

DSMP Data Safety Monitoring Plan

EC: Ethics Committee

ECG: Electrocardiogram

ECOG Eastern Cooperative Oncology Group (Used to determine Performance Status )

eCRF: Electronic Case Report Form

ECTIS: lub European Clinical Trial Information(al) System 

EDC: Electronic Data Capture

EDV Early Discontinuation Visit

EHR: Electronic Health Record

EMA European Medicines Agency

EMEA European Agency for the Evaluation of Medicinal Products

EMR: Electronic Medical Record

EORTC European Organization for Research and Treatment of Cancer

EOS End of Study

ePRO: Electronic Patient-Reported Outcomes

ET Early Termination

eTMF: Electronic Trial Master File

EUDRA European Union Drug Regulatory Authorities

EudraCT European Union clinical trials database

FAIR: Findable, Accessible, Interoperable, Reusable

FDA 1572 A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial

FDA 483 (Form FDA 483) "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during these inspections

FDA: Food and Drug Administration

FDF: Financial Desclosure Form

FPFV First Patient First Visit

FPLV: First Patient Last Visit

FSR: First Site Ready

FU Follow-up

GCP: Good Clinical Practice

GCRC: General Clinical Research Center

GDP: Good Documentation Practice

GLP Good Labaratory Practice

GMP Good Manufacturing Practice

GP general practitioner

HAQ Health Assessment Questionnaire

HC- Health Canada

HIPAA: Health Insurance Portability and Accountability Act

IB: Investigator’s Brochure

ICD 9 International Classification of Diseases, 9th revision

ICF: Informed Consent Form

ICH: International Council for Harmonization

ICR Institute of Clinical Research (formerly ACRPI, Association for Clinical Research in the Pharmaceutical Industry, UK)

ICSR individual case safety report

IDE: Investigational Device Exemptions

IEC: Independent Ethics Committee

IHCRA: In House Clinical Research Associate

IIT: Investigator Initiated Trial

IMP - investigational medicinal procuct

IND: Investigational New Drug (Application)

IP - investigational procuct

IRB: Institutional Review Board

IRT: Interactive Response Technology

ISF Investigator's Study File

ITT: Intent to Treat

IVRS: Interactive Voice Response System

IVRS: Interactive Voice Response System

IWRS: Interactive Web Response System

IWRS: Interactive Web Response System

JMA Japan Medical Association

LEC: Local ethics committee

LOA Letter of Agreement

LoA: letter of authorization

LPLV - last patient last visit

LRAA: Local Regulatory Affairs Associate

LTFU: Long Term Follow Up

MedDRA Medical Dictionary for Regulatory Activities

MHRA: The Medicines and Healthcare products Regulatory Agency

mmHg Millimeters of Mercury

MOH Ministry of Health

MP- Monitoring Plan

MRI: Magnetic Resonsnce Imaging

MRN: Medical Record Number

MTD maximum tolerated dose

MV: Monitoring Visit

NA: Not applicable

NCI: National Cancer Institute

NCS Not Clinically Significant

ND: Not Done

NDA non disclosure agreement

NDA: New Drug Application

NHS National Health Service

NHV: Normal Healthy Volunteer

NIH: National Institutes of Health

NIMP non-investigational medicinal product

NIS: Non-Interventional Study

NLM: National Library of Medicine

OCT: Office of Clinical Trials

OHRP: Office for Human Research Protections

OSR: Outside Safety Report

OTC over-the-counter

PA- Protocol Amendment

PA: Project Assistant

PASS: Post-Authorisation Safety Study

PC: Protocol Coordinator

PD Pharmacodynamics

PD Protocol Deviation

PD: Protocol Director

PFS Progression-Free Survival

PFT pulmonary function test

PGT pharmacogenetics

PGX pharmacogenomics

PHI: Protected Health Information

PI: Principal Investigator

PIP: Paediatric Investigation Plan

PK Pharmacokinetic

PL: Project Lead

PM project manager (i inne stanowiska)

PMA Pre- Market Approval

PMS Post Marketing Surveillance

PMS postmarketing surveillance

PoA: Power of Attorney

PP -Per Protocol

PR partial response

PR  pulse rate

PRMC: Protocol Review and Monitoring Committee

PRMS: Protocol Review and Monitoring System

PRO Patient reported outcome

PSUR periodic safety update report

PV pharmacovigilance

QA quality assurance

QC: Quality Control

QCT: Qualifying Clinical Trial

QD (once daily)

QL quality of life

QOL Quality of Life

QTcF QT Interval Corrected by the Fridericia Correction Formula

QUID four times a day

R&D Research and Development

RA Regulatory Authority

RBM Risk Based Monitoring

RCA Root Cause Analysis

RCT: Randomized Clinical Trial

RDC Remote Data Capture

RDE Remote Data Entry

RECIST Response Evaluation Criteria in Solid Tumors (Oncology )

RFP request for proposal

RMV: Remote Monitoring Visit

RTSM Randomization and Trial Supply Management

SADR suspected adverse drug reaction

SAE: Serious Adverse Event

SAFE Secure Access for Everyone

SAS Statistical Analysis System (commonly used statistical analysis package)

SC study coordinator. See also CRC, CCRC, SSC.

SCR: Screeing

SD Source Data

SDR: Source Document Review (Also Source Data Review)

SDV Source Data Verification

SEV: Site Evaluation Visit

SI Sub-investigator

SIF: Site Investigator File

SIV: Site Initiation Visit

SM: Substantial Modification

SME: Subject Matter Expert

SMO: Site Management Organization

SmPC summary of product characteristics

SMV: Site Monitoring Visit

SOC: Standard of Care

SOE: Schedule of Events

SOP: Standard Operating Procedure

SPOREs: Specialized Programs for Research Excellence

SR Significant Risk (usually refers to device research)

SRB: Scientific Review Board

SRC: Scientific Review Committee

SUAE serious unexpected adverse event

SUSAR: Suspected Unexpected Serious Adverse Reaction

SVT: Subject Visit Template

T 1/2 Half-Life

TC Tele-Conference

TID (tree time daily)

Tmax the time after dosing when Cmax occurs

TMF: Trial Master File

TMO: Trial Management Organization

TTP Time To Progression

UADE: Unanticipated Adverse Device Effect

UADR: Unexpected Adverse Drug Reaction

URPL URPLWiPB Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

VHP: Voluntary Harmonization Procedure

WBC White Blood Cell Count

WHO World Health Organization

WL Warning Letter (most serious FDA postaudit letter, demands immediate action within 15 days)

WOCBP: Woman of child bearing potential


Modyfikacja / Last update: 18.01.2019