Handbook for Clinical Investigators (2nd ed.)

Title Page......Page 2
Copyright Page......Page 3
Contents......Page 4
Introduction......Page 6
Some background facts......Page 8
Clinical trials – some definitions......Page 9
Clinical trials – why?......Page 11
Is there room for clinical trials within ordinary health care?......Page 13
Good Clinical Practice......Page 14
The investigator’s responsibility......Page 18
The sponsor’s responsibility......Page 20
SOP – “Standard Operating Procedure”......Page 22
The “Investigators Brochure”......Page 23
The clinical trial monitor......Page 24
The agreement with the sponsor......Page 26
IND studies......Page 29
Preparations – visits, planning......Page 30
The Study Protocol......Page 31
Ethical considerations......Page 46
The ethics committee......Page 49
Patient information and informed consent......Page 51
Approval from the regulatory authority......Page 54
Protecting the patient’s confidentiality......Page 56
Information for the staff......Page 58
The contract with the Principal......Page 59
Financial disclosure......Page 60
Multi-center trials......Page 61
Study documentation......Page 64
Finding suitable patients......Page 66
Monitoring......Page 67
Adverse events – Side-effects and other events......Page 69
Audits, inspections and quality assurance......Page 71
Carelessness and fraud in clinical trials......Page 73
Documentation and archiving......Page 74
Data and computer processing......Page 77
Analysis of results......Page 78
Publication......Page 79
Overview and time perspectives......Page 81
Conclusion......Page 84
Reference literature......Page 86
Appendix I – Suggestions for drawing up a protocol......Page 87
Appendix II – Glossary of common terms used in clinical research......Page 93
Appendix III – Declaration of Helsinki......Page 102
Useful addresses......Page 108
Index......Page 110