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Best Practice for … Clinical Monitoring
Gerald Van Roey
Verlag PharmImage GmbH, 2011
ISBN 9783862500024 , 145 Seiten
Format PDF, OL
Kopierschutz DRM
Geräte
1 An Introduction to Medicine andClinical Research
12
1.1 PRECLINICAL RESEARCH
14
1.2 CLINICAL RESEARCH
15
1.2.1 THE FUNDAMENTAL ELEMENTSOF A CLINICAL TRIAL
16
1.2.2 THE DIFFERENT PARTIES INVOLVED
19
1.2.3 PHASE I
21
1.2.4 PHASE II
22
1.2.5 PHASE III
23
1.2.6 PHASE IV
23
1.2.7 REGULATIONS GUIDING CLINICALRESEARCH
24
1.2.7.1 History
24
1.2.7.2 DeclaraQon of Helsinki
28
1.2.7.3 ICH-GCP
28
1.2.7.4 European legislaQon
30
1.2.7.5 Food & Drug AdministraQon
31
1.2.7.6 WHO
32
1.2.7.7 Other regulaQons
32
2 What Makes a GoodMonitor?
38
2.1 CHARACTERISTICS
38
2.2 RELATIONSHIP WITH THE INVESTIGATOR
39
2.3 TOOLS OF A MONITOR
40
3 Key Documents in ClinicalTrials / Documents to Know
46
3.1 PROTOCOL
46
3.2 INFORMED CONSENT FORM
48
3.3 CRF
50
3.4 INVESTIGATOR BROCHURE
52
3.5 SOURCE DOCUMENTS
53
4 Investigator Selection
56
4.1 SOURCES
57
4.2 COLD CALL
57
4.3 CONFIDENTIALITY
58
5 How to Prepare a Visit
62
6 Pre-Study Visit
66
6.1 WHAT TO CHECK
66
6.2 HOW TO CHECK
68
6.3 PROTOCOL READINESS
68
6.4 WHAT TO DO AFTER A VISIT
69
6.4.1 FOLLOW-UP LETTER
69
6.4.2 DOCUMENTATION
69
7 The Initiation Visit
76
7.1 TRAINING
76
7.2 HOW TO ...
77
7.3 WHAT TO DO AFTER AN INITIATION VISIT
78
7.3.1 FOLLOW-UP LETTER
78
7.3.2 DOCUMENTATION
79
8 Monitoring Visits
84
8.1 SOURCE DATA VERIFICATION
85
8.1.1 ELECTRONIC CRF
86
8.1.2 PAPER CRF
86
8.2 INVESTIGATIONAL MEDICINAL PRODUCT
87
8.2.1 DEFINITIONS
87
8.2.1.1 Inves7ga7onal medicinal product
87
8.2.1.2 Medical device
87
8.2.1.3 Accessory
88
8.2.1.4 AcYve implantable medical device
88
8.2.1.5 In vitro diagnosYc devices (IVD):
88
8.2.2 IMPORT AND EXPORT
88
8.2.3 IMP DISTRIBUTION
89
8.2.4 TRACKING OF IMP: SHIPMENTS
90
8.2.5 RETURN OF USED/UNUSED IMP
91
8.2.6 TRANSFER
91
8.2.7 CERTIFICATE OF ANALYSIS
91
8.2.8 INVESTIGATIONAL PRODUCT
91
8.2.9 LABELING
92
8.2.10 SITE INVENTORY &PATIENT ACCOUNTABILITY FORM
92
8.2.11 STORAGE CONDITIONS
93
8.2.12 IMP DESTRUCTION
94
8.3 FILING
94
8.4 SITE MANAGEMENT
95
8.5 RECRUITMENT ISSUES
96
8.5.1 THE RIGHT PROTOCOL
96
8.5.2 SELECTION AND SUPPORT OF STUDY SITES
96
8.5.3 HOW TO HELP SITES?
99
8.5.4 KEEPING TRACK
100
8.6 SAFETY
102
8.6.1 ADVERSE EVENT (AE)
102
8.6.2 ADVERSE DRUG REACTION (ADR)
104
8.6.3 SERIOUS ADVERSE EVENT (SAE)
105
8.6.4 SUSPECTED UNEXPECTED SERIOUSADVERSE REACTION (SUSAR)
106
8.6.5 NOTIFICATION TO EC AND THEAUTHORITIES (EUROPEAN LEGISLATION)
107
8.7 REPORTING BY THE MONITORS
108
8.8 WHAT TO DO AFTER A MONITORING VISIT
109
8.8.1 FOLLOW-UP LETTER
109
9 The Close-Out Visit
114
9.1 WHAT TO DO AFTER A CLOSE-OUT VISIT
115
9.1.1 FOLLOW-UP LETTER
115
9.1.2 DOCUMENTATION
117
10 Audits & Inspections
120
10.1 HOW TO PREPARE
121
10.2 DURING AN AUDIT OR INSPECTION
121
10.3 AFTER AN AUDIT
123
11 Reporting & Archiving
128
11.1 COMMUNICATION REPORTS
128
11.1.1 EXTERNAL
128
11.1.2 INTERNAL
129
11.2 SAFETY REPORTING
129
11.2.1 CIOMS REPORTS
129
11.2.2 LINE LISTINGS
129
11.2.3 ANNUAL SAFETY REPORT
130
11.2.4 CLINICAL STUDY REPORT
130
11.3 GOOD DOCUMENTATION
132
11.4 ARCHIVING
133
Appendix1 Answers to Self Study
136
Appendix2 List of Abbreviaions
140
Appendix3 Index
144
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