Guide for Investigator Initiated Trials

Front Cover
Gerhard Fortwengel
Karger Medical and Scientific Publishers, 2011 - Medical - 148 pages
An essential manual for beginners and senior researchers alike For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the International Conference on Harmonization and Good Clinical Practice'. This makes the publication at hand an essential cookbook' for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.
 

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Contents

1 RiskBenefi t Analysis
1
2 Study Types and Study Design
4
3 Investigational Medicinal Products
8
4 Study Protocol
13
5 Case Report Forms
17
6 Financing
23
7 Qualifi cations CVs of Site Staff Training Delegation of Authority
26
8 EudraCT
29
14 Ethics
56
15 Trial Master File Updating and Archiving
60
16 Documentation
67
17 Data Management
69
18 Screening
74
19 Pharmacovigilance
77
20 Patient Compliance
83
21 Source Data Verifi cation
88

9 Contracts
34
10 Informed Consent
38
11 Investigators BrochureSummary of Product Characteristics
41
12 Insurance
43
13 Health Authority Approval
45
Declaration Of The End Of Trial
55
Requirements CA
55
Substantial Amendments Form
55
Synopsis Form
55
22 Quality
89
23 Monitoring
93
24 Biometry
101
25 Multicentre Trials
105
26 Final Study Report and Publication
108
Common Abbreviations
112
Glossary
113
Health Authority Addresses in the European Area
147
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