Nella nostra vita da Clinical Research Associate ci sono alcuni acronimi che indispensabilmente bisogna conoscere per poter sopravvivere. Ecco qui in basso le principali abbreviazioni utilizzate nell’ambito della Ricerca Clinica.
Puoi scaricare il file PDF per la stampa direttamente qui o nella sezione link utili.
ADR: Adverse Drug Reaction.
AE: Adverse Event
AR: Adverse Reaction
BD: Business Development
CA: Competent Authority
CDMS: Clinical Data Management System
CO: Clinical Operations
COV: Close Out Visit
CPM: Clinical Project Manager
CRA: Clinical Research Associate
CRF: Case Report Form
CTA: Clinical Trial Assistant
CTD: Clinical Trials Directive
CTMS: Clinical Trial Management System.
DAF: Data Amendment Form
DBA: Database Administrator
DCF: Data Clarification Form
DM: Data Management
DMPM: Data Management Project Manager
DQF: Data Query Form
DSMB: Data Safety Monitoring Board
EC: European Commission
ECG: electrocardiogram
eCRF: electronic case report form
EDC: Electronic Data Capture
EMEA: European Medicines Evaluation Agency
EU: European Union.
EudraCT: European Clinical Trials Database
Eudravigilance: European Union Pharmacovigilance Database
EVCTM: Eudravigilance Clinical Trials Module
FDA: Food & Drug Administration (USA)
FL: Functional Lead.
GCP: Good Clinical Practice
GLP: Good Laboratory Practices
GMP: Good Manufacturing Practice
HMA: Head of Medical Affairs
IATA: International Air Transport Association
IB: Investigator’s Brochure
ICF: Informed Consent Form
ICH: International Conference on Harmonisation
ICMJE: International Committee of Medical Journal Editors
IDB: Investigator’s Drug Brochure
IDPCF: Investigator Data Protection Consent Form
IEC: Independent Ethics Committee
IMP: Investigational Medicinal Product
IND: Investigational New Drug
IP: Investigational Product
IRB: Institutional Review Board
ISF: Informatore Scientifico del Farmaco
IVRS: Interactive Voice Response System
KOM: Kick-Off Meeting
MA: Medical Affairs
MM: Medical Monitor
MW: Medical Writing
PI: Principal Investigator
PM: Project Manager
PRA: Pharmaceutical Research Associate
PSV: Pre-Study Visit
QA: Quality Assurance
QC: Quality Control
QP: Qualified Person
QR: Quality Review
SAE: Serious Adverse Event
SDV: Source Data Verification
SDR: Source Document Review
SIS: Subject Information Sheet
SIV: Site Initiation Visit
SMV: Site Monitoring Visit
SOP: Standard Operating Procedure
SOW: Scope of Work
SSAR: Suspected Serious Adverse Reaction
SSP: Study Specific Procedure
SUSAR: Suspected Unexpected Serious Adverse Reaction
WP: Working Procedure
