Guide for investigator initiated trials: [clinical trial before, during, after ; responsibilities, regulations, risks]
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Basel [u.a.]
Karger
2011
|
| Schlagworte: | |
| Online-Zugang: | Inhaltstext Inhaltsverzeichnis |
| Beschreibung: | V, 148 S. Ill., graph. Darst. |
| ISBN: | 9783805596848 |
Internformat
MARC
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Datensatz im Suchindex
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| adam_text |
IMAGE 1
CONTENTS
1 RISK-BENEFIT 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 QUALIFICATIONS, CVS OF SITE STAFF, TRAINING, DELEGATION OF AUTHORITY
26
8 EUDRACT 29
9 CONTRACTS 34
10 INFORMED CONSENT 38
11 INVESTIGATOR'S BROCHURE/SUMMARY OF PRODUCT CHARACTERISTICS 41
12 INSURANCE 43
13 HEALTH AUTHORITY APPROVAL 45
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 VERIFICATION 88
22 QUALITY 89
23 MONITORING 93
24 BIOMETRY 101
25 MULTICENTRE TRIALS 105
26 FINAL STUDY REPORT AND PUBLICATION 108
APPENDIX 1: COMMON ABBREVIATIONS 112
APPENDIX 2: GLOSSARY 113
APPENDIX 3: HEALTH AUTHORITY ADDRESSES IN THE EUROPEAN AREA 147
EXAMPLE DOCUMENTS, IN WORD OR PDF FORMAT, ARE AVAILABLE TO DOWNLOAD VIA
THE KARGER WEBSITE. PLEASE VISIT: WWW.KARGER.COM/GIIT
BIBLIOGRAFISCHE INFORMATIONEN HTTP://D-NB.INFO/1009520253
DIGITALISIERT DURCH |
| any_adam_object | 1 |
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| author_role | aut |
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| bvnumber | BV037387994 |
| ctrlnum | (OCoLC)723496142 (DE-599)DNB1009520253 |
| dewey-full | 615.580724 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-search | 615.580724 |
| dewey-sort | 3615.580724 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Book |
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| illustrated | Illustrated |
| indexdate | 2024-07-20T11:07:30Z |
| institution | BVB |
| isbn | 9783805596848 |
| language | English |
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| physical | V, 148 S. Ill., graph. Darst. |
| publishDate | 2011 |
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| publisher | Karger |
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| spelling | Fortwengel, Gerhard Verfasser aut Guide for investigator initiated trials [clinical trial before, during, after ; responsibilities, regulations, risks] Gerhard Fortwengel. Isabel Böckler ... Basel [u.a.] Karger 2011 V, 148 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier GCP-Regeln (DE-588)4281617-8 gnd rswk-swf Klinische Prüfung (DE-588)4031192-2 gnd rswk-swf Klinische Prüfung (DE-588)4031192-2 s GCP-Regeln (DE-588)4281617-8 s DE-604 Böckler, Isabel Sonstige oth X:MVB text/html http://deposit.dnb.de/cgi-bin/dokserv?id=3652328&prov=M&dok_var=1&dok_ext=htm Inhaltstext DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022540958&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Fortwengel, Gerhard Guide for investigator initiated trials [clinical trial before, during, after ; responsibilities, regulations, risks] GCP-Regeln (DE-588)4281617-8 gnd Klinische Prüfung (DE-588)4031192-2 gnd |
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| title | Guide for investigator initiated trials [clinical trial before, during, after ; responsibilities, regulations, risks] |
| title_auth | Guide for investigator initiated trials [clinical trial before, during, after ; responsibilities, regulations, risks] |
| title_exact_search | Guide for investigator initiated trials [clinical trial before, during, after ; responsibilities, regulations, risks] |
| title_full | Guide for investigator initiated trials [clinical trial before, during, after ; responsibilities, regulations, risks] Gerhard Fortwengel. Isabel Böckler ... |
| title_fullStr | Guide for investigator initiated trials [clinical trial before, during, after ; responsibilities, regulations, risks] Gerhard Fortwengel. Isabel Böckler ... |
| title_full_unstemmed | Guide for investigator initiated trials [clinical trial before, during, after ; responsibilities, regulations, risks] Gerhard Fortwengel. Isabel Böckler ... |
| title_short | Guide for investigator initiated trials |
| title_sort | guide for investigator initiated trials clinical trial before during after responsibilities regulations risks |
| title_sub | [clinical trial before, during, after ; responsibilities, regulations, risks] |
| topic | GCP-Regeln (DE-588)4281617-8 gnd Klinische Prüfung (DE-588)4031192-2 gnd |
| topic_facet | GCP-Regeln Klinische Prüfung |
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