Conducting GCP compliant clinical research:
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Chichester [u.a.]
Wiley
1999
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XIV, 211 S. |
| ISBN: | 0471988243 |
Internformat
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Datensatz im Suchindex
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| adam_text | CONDUCTING GCP-COMPLIANT CLINICAL RESEARCH WENDY BOHAYCHUK AND GRAHAM
BALL GOOD,CLINICAL RESEARCH PRACTICES, UK AND CANADA JOHN WILEY & SONS
CHICHESTER * NEW YORK * WEINHEIM * BRISBANE* SINGAPORE * TORONTO
CONTENTS ABBREVIATIONS IX INTRODUCTION XI 1. THE CURRENT RULES FOR
CONDUCTING CLINICAL RESEARCH 1 1.1 THE BASIC TENETS OF GCP 2 CHECKLIST
1.1-1. GENERAL SYSTEMS AND PROCEDURES FOR IMPLEMENTATION OF GCP 3 1.2
THE GENERAL REGULATORY FRAMEWORK FOR GCP 4 1.3 STANDARD OPERATING
PROCEDURES 5 CHECKLIST 1.3-1. SUGGESTIONS FOR THE FORMAT AND CONTENTS OF
SOPS 8 CHECKLIST 1.3-2. TOPICS FOR SOPS FOR SPONSORS/CROS 8 CHECKLIST
1.3-3. TOPICS FOR SOPS FOR INVESTIGATORS 9 1.4 CLINICAL RESEARCH
AUDITING 10 CHECKLIST 1.4-1. TYPES OF AUDITS WHICH MAY BE UNDERTAKEN TO
ASSESS GCP COMPLIANCE 12 CHECKLIST 1.4-2. ACTIVITIES DURING INVESTIGATOR
SITE AUDITS 14 1.5 REGULATORY INSPECTIONS 15 CHECKLIST 1.5-1. CONDUCT
DURING REGULATORY INSPECTIONS OF STUDY SITES 17 1.6 FRAUD. THE ULTIMATE
NON-COMPLIANCE IN GCP 17 CHECKLIST 1.6-1. POSSIBLE INDICATIONS OF FRAUD
18 CASE STUDY ONE 19 2. SETTING UP CLINICAL STUDIES 25 2.1 PROTOCOLS 26
VI CONTENTS 2.2 CRFS AND OTHER DATA COLLECTION FORMS 29 CHECKLIST 2.2-1.
INFORMATION TO BE COLLECTED IN CRFS 31 CHECKLIST 2.2-2. BASIC DESIGN
FEATURES OF CRFS 32 2.3 INVESTIGATOR BROCHURES 33 2.4 REGULATORY
REQUIREMENTS 36 CHECKLIST 2.4-1. ITEMS TO BE SUBMITTED TO REGULATORY
AUTHORITIES 36 2.5 SELECTION OF INVESTIGATORS AND STUDY SITES 37
CHECKLIST 2.5-1. ITEMS TO CONSIDER AT PRE-STUDY ASSESSMENT VISITS 40
CHECKLIST 2.5-2. ADDITIONAL CONSIDERATIONS FOR ASSESSMENT OF PHASE I
FACILITIES 42 2.6 QUALIFICATIONS OF CLINICAL RESEARCH PERSONNEL 42 2.7
STUDY AGREEMENTS 44 CHECKLIST 2.7-1. INVESTIGATOR RESPONSIBILITIES 47
CHECKLIST 2.7-2. SPONSOR/CRO RESPONSIBILITIES 49 CHECKLIST 2.7-3. ITEMS
IN FINANCIAL AGREEMENTS 50 2.8 SELECTION OF CROS 50 CHECKLIST 2.8-1.
ITEMS TO REVIEW IN SELECTING CROS 51 CHECKLIST 2.8-2. CONTRACTS WITH
CROS 52 2.9 SELECTING CLINICAL LABORATORIES 52 CHECKLIST 2.9-1.
SELECTING CLINICAL LABORATORIES 53 2.10 INITIATION VISITS 54 CHECKLIST
2.10-1. ITEMS TO BE ADDRESSED AT STUDY INITIATION VISITS 56 CHECKLIST
2.10-2. ITEMS TO BE PROVIDED TO THE STUDY SITE BEFORE THE STUDY BEGINS
56 CASE STUDY TWO 57 3. ETHICAL CONSIDERATIONS 65 3.1 ETHICS
COMMITTEE/IRB REVIEW AND APPROVAL 66 CHECKLIST 3.1-1. REVIEW BY ETHICS
COMMITTEES/IRBS BEFORE CLINICAL STUDIES BEGIN 72 CHECKLIST 3.1-2. REVIEW
BY ETHICS COMMITTEES/IRBS DURING AND AFTER CLINICAL STUDIES 74 3.2
DOCUMENTATION OF SAFE ETHICS COMMITTEE/IRB APPROVAL 75 CONTENTS VII
CHECKLIST 3.2-1. DOCUMENTATION OF ETHICS COMMITTEES /IRB REVIEW AND
APPROVAL 79 CHECKLIST 3.2-2. MEMBERSHIP OF ETHICS COMMITTEES/IRBS 79
CHECKLIST 3.2-3. WORKING PROCEDURES OF ETHICS COMMITTEES/IRBS 80 3.3
CONDUCT OF INFORMED CONSENT 81 CHECKLIST 3.3-1. PRINCIPLES FOR THE
CONDUCT OF INFORMED CONSENT 85 3.4 INFORMATION TO BE PROVIDED TO STUDY
SUBJECTS IN CLINICAL STUDIES 86 CHECKLIST 3.4-1. ITEMS FOR INFORMED
CONSENT 88 CASE STUDY THREE 91 4. MONITORING AND SAFETY REPORTING 97 4.1
MONITORING 98 CHECKLIST 4.1-1. THE MAJOR OBJECTIVES OF MONITORING VISITS
102 CHECKLIST 4.1-2. MANAGEMENT OF CROS AND CLINICAL LABORATORIES DURING
STUDIES 104 4.2 PROTOCOL VIOLATIONS AND PROTOCOL AMENDMENTS 105
CHECKLIST 4.2-1. CONTENTS OF PROTOCOL AMENDMENTS 109 4.3 REPORTING AND
RECORDING SAFETY EVENTS 109 CHECKLIST 4.3-1. ADVERSE EVENT TERMINOLOGY
115 CHECKLIST 4.3-2. ITEMS OF INFORMATION TO INCLUDE ON AE PAGES IN CRFS
117 CASE STUDY FOUR 117 5. COLLECTING DATA WITH INTEGRITY 127 5.1 THE
DIFFERENCE BETWEEN SOURCE DOCUMENTS AND CRFS 128 5.2 ACCESS TO SOURCE
DOCUMENTS 130 5.3 SOURCE DATA VERIFICATION 133 CHECKLIST 5.3-1. INITIAL
MONITOR REVIEW AND RETRIEVAL OF CRFS AT THE INVESTIGATOR SITE 138
CHECKLIST 5.3-2. EXTENT OF SOURCE DATA VERIFICATION 139 5.4 DATA QUERIES
141 CHECKLIST 5.4-1. INITIAL INTERNAL CRF REVIEW 144 VIII CONTENTS 5.5
GENERAL INTERNAL DATA PROCESSING 145 5.6 GENERAL STATISTICAL PROCEDURES
146 CASE STUDY FIVE 148 6. MANAGING STUDY MEDICATIONS/DEVICES 159 6.1
PREPARATION OF STUDY MEDICATIONS/DEVICES 160 CHECKLIST 6.1-1. GENERAL
LABELLING REQUIREMENTS 163 6.2 SHIPMENT OF STUDY MEDICATIONS/DEVICES 164
6.3 CONTROL OF STUDY MEDICATIONS /DEVICES AT STUDY SITES 168 CHECKLIST
6.3-1. STUDY MEDICATIONS /DEVICES INVENTORY 171 CHECKLIST 6.3-2. STUDY
MEDICATIONS/DEVICES DISPENSING RECORDS 171 6.4 OVERALL ACCOUNTABILITY OF
STUDY MEDICATIONS/DEVICES 172 CHECKLIST 6.4-1. ITEMS TO CONSIDER FOR 6.5
6.6 RE-ALLOCATION OF STUDY MEDICATIONS/DEVICES RANDOMISATION AND
BLINDING CHECKLIST 6.5-1. INFORMATION TO CONSIDER IN REQUESTS FOR
RANDOMISATION SCHEDULES MANAGEMENT OF CLINICAL LABORATORY SAMPLES
CHECKLIST 6.6-1. STUDY SITE PERSONNEL BRIEFING FOR MANAGEMENT OF
CLINICAL LABORATORY SAMPLES CHECKLIST 6.6-2. BIOLOGICAL SAMPLE ANALYSIS
REQUEST FORMS CASE STUDY SIX 7. FINAL STAGES IN CLINICAL STUDIES 7.1 7.2
7.3 READING INDEX CLOSURE OF CLINICAL STUDIES CHECKLIST 7.1-1.
PROCEDURES AT STUDY CLOSURE VISITS FINAL CLINICAL REPORTS ARCHIVING
CHECKLIST 7.3-1. TYPICAL DOCUMENTS IN SPONSOR/CRO ARCHIVES CHECKLIST
7.3-2. TYPICAL DOCUMENTS IN INVESTIGATOR ARCHIVES CASE STUDY 7 LIST 177
177 181 182 183 184 184 189 190 192 193 194 195 196 197 202 207
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| illustrated | Not Illustrated |
| indexdate | 2024-07-09T18:43:36Z |
| institution | BVB |
| isbn | 0471988243 |
| language | English |
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| physical | XIV, 211 S. |
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| spelling | Bohaychuk, Wendy Verfasser aut Conducting GCP compliant clinical research Wendy Bohaychuk and Graham Ball Conducting GCP-compliant clinical research Chichester [u.a.] Wiley 1999 XIV, 211 S. txt rdacontent n rdamedia nc rdacarrier Geneeskunde gtt Onderzoek gtt Medizin Clinical Trials as Topic standards Clinical trials Standards Drug Evaluation standards Drug Evaluation, Preclinical Drugs Testing Standards Ball, Graham Verfasser aut GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009076927&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Bohaychuk, Wendy Ball, Graham Conducting GCP compliant clinical research Geneeskunde gtt Onderzoek gtt Medizin Clinical Trials as Topic standards Clinical trials Standards Drug Evaluation standards Drug Evaluation, Preclinical Drugs Testing Standards |
| title | Conducting GCP compliant clinical research |
| title_alt | Conducting GCP-compliant clinical research |
| title_auth | Conducting GCP compliant clinical research |
| title_exact_search | Conducting GCP compliant clinical research |
| title_full | Conducting GCP compliant clinical research Wendy Bohaychuk and Graham Ball |
| title_fullStr | Conducting GCP compliant clinical research Wendy Bohaychuk and Graham Ball |
| title_full_unstemmed | Conducting GCP compliant clinical research Wendy Bohaychuk and Graham Ball |
| title_short | Conducting GCP compliant clinical research |
| title_sort | conducting gcp compliant clinical research |
| topic | Geneeskunde gtt Onderzoek gtt Medizin Clinical Trials as Topic standards Clinical trials Standards Drug Evaluation standards Drug Evaluation, Preclinical Drugs Testing Standards |
| topic_facet | Geneeskunde Onderzoek Medizin Clinical Trials as Topic standards Clinical trials Standards Drug Evaluation standards Drug Evaluation, Preclinical Drugs Testing Standards |
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