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AE Adverse Event
ADE Adverse Device Effect
ADR Adverse Drug Reaction
AGEK Arbeitsgemeinschaft der Ethikkommissionen
ASR Annual Safety Report
BAG Bundesamt für Gesundheit
CAPA Corrective and Preventive Actions
CEO Chief Executive Officer
CIOMS Council for International Organizations of Medical Sciences
CRF Case Report Form
CRO Contract Research Organisation
CTC Clinical Trials Center
CV Curriculum Vitae
EDC Electronic Data Capture
EK Ethikkommission
FDA Food and Drug Administration
FO Related Forms (Formulare, Vorlagen)
GCP Good Clinical Practice
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
HFG Humanforschungsgesetz
HFV Humanforschungsverordnung
IB Investigator`s Brochure (Prüfarztbroschüre)
ICH International Conference of Harmonisation
IEC Independent Ethical Committee
IT Information Technology
IIT Investigator Initiated Trial
IMD Investigational Medical Device
IMP Investigational Medicinal Product (Prüfpräparat)
IMPD Investigational Medicinal Product Dossier
IRO Implementation Revision Outdating
ISF Investigator Site File (Prüferordner)
ISO International Standardisation Organisation
KEK Kantonale Ethikkommission Zürich
KlinV Verordnung Klinische Forschung
MedDRA Medical Dictionary for Regulatory Activities
NA Not Applicable
OV-HFG Organisationsverordnung Humanforschungsgesetz
PD Process Description
PHIU Phase-I-Unit
PI Principal Investigator
PIC Patient Informed Consent
PIL Patient Information Leaflet
QA Quality Assurance
QC Quality Control
QM Quality Management
QMS Quality Management System
RMV Regular Monitoring Visit
RRB Regierungsratsbeschluss
RUS Read Understand Sign
SAE Serious Adverse Event
SADE Serious Adverse Device Effect
SAMW Schweizerische Akademie der Medizinischen Wissenschaften
SAR Serious Adverse Reaction
SCTO Swiss Clinical Trial Organisation
SDV Source Data Verification
SIV Site Initiation Visite
SOP Standard Operating Procedure
SUSAR Suspected Unexpected Serious Adverse Reaction
SwAPP Swiss Association of Pharmaceutical Professionals
TMF Trial Master File
TxG Transplantationsgesetz
TxP Transplantationsprodukt
USZ UniversitätsSpital Zürich
UZH Universität Zürich
USADE Unanticipated Serious Adverse Device Effect
WHO World Health Organization
WI Working Instruction
ZKF (obsolet) Zentrum für Klinische Forschung; Center for Clinical Research