| 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 |