Читать книгу Guide for Investigator Initiated Trials - Группа авторов - Страница 5
Contents
Оглавление2 Study Types and Study Design
3 Investigational Medicinal Products
7 Qualifications, CVs of Site Staff, Training, Delegation of Authority
11 Investigator’s Brochure/Summary of Product Characteristics
12 Insurance
13 Health Authority Approval
14 Ethics
15 Trial Master File, Updating and Archiving
16 Documentation
17 Data Management
18 Screening
19 Pharmacovigilance
20 Patient Compliance
21 Source Data Verification
22 Quality
23 Monitoring
24 Biometry
25 Multicentre Trials
26 Final Study Report and Publication
Appendix 1: Common Abbreviations
Appendix 2: Glossary
Appendix 3: Health Authority Addresses in the European Area
Example documents, in Word or PDF format, are available to download via the Karger website. Please visit: www.karger.com/giit
