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El. knyga: Quick Guide to Good Clinical Practice: How to Meet International Quality Standard in Clinical Research

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  • Formatas: EPUB+DRM
  • Išleidimo metai: 15-Nov-2016
  • Leidėjas: Springer International Publishing AG
  • Kalba: eng
  • ISBN-13: 9783319443447
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Quick Guide to Good Clinical Practice: How to Meet International Quality Standard in Clinical ResearchDidesnis paveikslėlis
  • Formatas: EPUB+DRM
  • Išleidimo metai: 15-Nov-2016
  • Leidėjas: Springer International Publishing AG
  • Kalba: eng
  • ISBN-13: 9783319443447
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This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard - Good Clinical Practice - provided by the International Conference on Harmonization (ICH).The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols.Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applica

tions to the ethic committees, whose approval is required for new clinical studies.

1 Clinical Trials: Historical Aspects and Importance and New Drug Developments.- 2 The Definition of GCP.- 3 The Principles of GCP.- 4 The Drug Development Process and Evolution of Regulations.- 5 Planning Clinical Research.- 6 Preparation of Ethics Committee (IRB) Proposal.- 7 Preparation of Informed Consent.- 8 Preparation of Findings Tables.- 9 Setting the Ideal Statistical Methods.- 10 The Duties of a Clinical Research Coordinator.- 11 The Duties of Clinical Researchers.- 12 The Phases of Clinical Studies.- 13 Safety in Clinical Trials.- 14 Setting the Size.- 15 Setting the Ideal Method.- 16 Ethics of Clinical Research.- 17 Recruitment and Enrolment.- 18 Why we need Clinical Consent and Other Documentation.- 19 Monitoring the Trial.- 20 Inspection.- 21 Ethics - Institutional Review Board/Independent Ethics Committee(IRB/IEC).- 22 Responsibilities of the Investigator .- 23 Responsibilities of the Sponsor.- 24.Clinical Trial Protocols.
1 Clinical Trials: Historical Aspects and Importance and New Drug Developments
1(16)
1.1 Introduction
1(1)
1.2 Clinical Trials
1(3)
1.2.1 Why Are Clinical Studies Conducted?
2(1)
1.2.2 Participating in Clinical Studies
3(1)
1.2.3 How Are Participants Protected?
3(1)
1.3 Historical Aspects of Clinical Trials
4(11)
1.3.1 562 BC--1537: Pre-James Lind Era
5(1)
1.3.2 1747: James Lind and Scurvy Trial
6(1)
1.3.3 1800: Arrival of Placebo
7(1)
1.3.4 1943: The First Double-Blind Controlled Trial (Patulin for Common Cold)
7(1)
1.3.5 1946: The First Randomised Curative Trial (The Randomised Controlled Trial of Streptomycin)
8(1)
1.3.6 Evolution of Ethical and Regulatory Framework
9(2)
1.3.7 The Food and Drug Administration (FDA) in the USA
11(2)
1.3.8 European Medicines Agency (EMEA)
13(1)
1.3.9 Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
14(1)
1.4 Evolution of the Drugs
15(2)
References
15(2)
2 The Definition of GCP
17(12)
2.1 Introduction
17(1)
2.2 Definitions
18(11)
References
27(2)
3 The Principles of GCP
29(4)
3.1 The Principles of ICH GCP
29(1)
3.2 WHO Principles of GCP
30(3)
References
32(1)
4 The Drug Development Process and Evolution of Regulations
33(12)
4.1 Introduction
33(2)
4.2 Drug Development
35(4)
4.3 Recent Developments in Drug Approval
39(1)
4.4 Emergence of a New Drug System
40(5)
References
42(3)
5 Planning Clinical Research
45(12)
5.1 Introduction
45(1)
5.2 Methodology
45(12)
5.2.1 Considerations for the Plan
45(4)
5.2.2 Planning a Study
49(6)
References
55(2)
6 Preparation of Ethics Committee (IRB) Proposal
57(6)
6.1 ICH GCP Requirements for the Composition of the Ethics Committee (IRB)
57(1)
6.2 What Documents Must Be Submitted to the Ethics Committee (IRB)?
58(1)
6.3 Communication with an IRB/IEC
59(1)
6.4 Compliance with Protocol
60(3)
References
61(2)
7 Preparation of Informed Consent
63(10)
7.1 The Steps for Preparation of Informed Consent
63(5)
7.2 Obtaining Informed Consent
68(1)
7.3 Delegation of Consent Process
69(1)
7.4 Checklist for Obtaining Informed Consent
70(3)
References
72(1)
8 Preparation of Findings Tables
73(6)
8.1 Planning Your Paper: When to Use Tables and Figures
73(1)
8.2 When to Choose Tables
74(1)
8.3 Best Practices for Presentation of Tables and Figures
74(1)
8.4 Completion of Record Forms in Research Facilities
75(4)
References
77(2)
9 Setting the Ideal Statistical Methods
79(8)
9.1 Introduction
79(1)
9.2 Randomisation Plan
79(1)
9.3 Blinding
80(1)
9.4 Sample Selection/Allocation Procedures
81(2)
9.5 Statistical Analysis Methodology
83(4)
9.5.1 Statistical Analysis Example for a Randomised Study
84(1)
9.5.2 Statistical Analysis Example for a Longitudinal Cohort Study
84(1)
References
85(2)
10 The Duties of a Clinical Research Coordinator
87(10)
10.1 Introduction
87(1)
10.2 Job Duties and Tasks of a Clinical Research Coordinator
88(2)
10.3 Job Activities Associated with Being a Clinical Research Coordinator
90(3)
10.4 Skills Needed for a Clinical Research Coordinator
93(1)
10.5 Abilities Needed to Be a Clinical Research Coordinator
94(2)
10.6 Knowledge, Experience and Education Required to Be a Clinical Research Coordinator
96(1)
References
96(1)
11 The Duties of Clinical Researchers
97(8)
11.1 Conducting Ethical Research
98(1)
11.2 Informed Consent Process
98(1)
11.3 Statement of Investigator
99(1)
11.4 Reporting Adverse Events
100(1)
11.5 Maintaining Accurate Records
100(1)
11.6 Steps to Becoming a Clinical Trial Investigator
101(4)
References
103(2)
12 The Phases of Clinical Studies
105(10)
12.1 Introduction
105(1)
12.2 Preclinical Studies
106(1)
12.3 Phase 0
106(1)
12.4 Phase 1
107(1)
12.5 Phase II
108(1)
12.6 Phase III
109(2)
12.7 Phase IV
111(1)
12.8 Summary of Clinical Trial Phases
112(3)
References
114(1)
13 Safety in Clinical Trials
115(6)
13.1 Introduction
115(1)
13.2 Safety Monitoring
116(5)
13.2.1 Sponsor
116(1)
13.2.2 Subjects
116(1)
13.2.3 Investigators
117(1)
13.2.4 Institutional Review Board/Ethics Committee
117(1)
13.2.5 Data and Safety Monitoring Board
118(1)
13.2.6 Regulatory Authorities
119(1)
13.2.7 Medical Community and Patients
119(1)
References
120(1)
14 Setting the Size
121(8)
14.1 Sample Size
121(2)
14.2 What Information Is Needed to Calculate Power and Sample Size?
123(1)
14.3 Clinical Outcome Measures
123(1)
14.4 Effect Size
124(1)
14.5 How Is the Effect Size Determined?
124(1)
14.6 Variation Estimates for Sample Size Calculations
125(4)
References
127(2)
15 Setting the Ideal Method
129(8)
15.1 Introduction
129(1)
15.2 Setting
129(1)
15.3 Validity (Precision) and Reliability (Consistency)
130(1)
15.4 Types of Study Design
131(2)
15.5 Identifying Risk Factors
133(1)
15.6 Compliance
134(1)
15.7 Data Storage and Collection
134(1)
15.8 Analysis
134(3)
References
135(2)
16 Ethics of Clinical Research
137(12)
16.1 Introduction
137(1)
16.2 Research Ethics' Declarations
138(2)
16.2.1 Nuremberg Code (1947)
138(1)
16.2.2 Declaration of Helsinki
139(1)
16.3 Research Ethics Committees (RECs) or Institutional Review Boards (IRBs)
140(1)
16.4 Data Safety Monitoring Boards (DSMBs)
140(1)
16.5 Good Clinical Practice
141(1)
16.6 Important Topics for Research Ethics
142(3)
16.6.1 Informed Consent
142(1)
16.6.2 Patient Information Sheet
143(1)
16.6.3 Confidentiality
143(1)
16.6.4 Privacy
143(1)
16.6.5 Privileged Communication
144(1)
16.6.6 Respect and Responsibility
144(1)
16.7 Ethics for the Paediatric Population
145(4)
16.7.1 Informed Consent from a Legal Representative
145(1)
References
146(3)
17 Recruitment and Enrolment
149(8)
17.1 Introduction
149(1)
17.2 Patient Recruitment
150(2)
17.3 Patient Enrolment
152(5)
17.3.1 The Patient Population
153(1)
17.3.2 Enrolment Planning
153(1)
17.3.3 Take the Time to Research and Understand the Potential Participant
154(1)
17.3.4 Engage with Sponsors
154(1)
References
155(2)
18 Why We Need Clinical Consent and Other Documentation
157(16)
18.1 Introduction
157(1)
18.2 Investigator's Brochure (IB)
157(9)
18.2.1 Introduction
159(1)
18.2.2 General Considerations
160(6)
18.3 Clinical Study Protocol
166(2)
18.3.1 Protocol Amendment
168(1)
18.4 Informed Consent
168(1)
18.4.1 The Main Principles of Informed Consent
169(1)
18.5 Study Progress Reports
169(1)
18.6 Case Record Form (CRF)
170(3)
References
171(2)
19 Monitoring the Trial
173(6)
19.1 Purpose
173(1)
19.2 Selection and Qualifications of Monitors
173(1)
19.3 Extent and Nature of Monitoring
174(1)
19.4 Monitor's Responsibilities
174(3)
19.5 Monitoring Procedures
177(1)
19.6 Monitoring Report
177(2)
References
178(1)
20 Inspection
179(10)
20.1 Introduction
179(1)
20.2 The Types of Inspections
180(4)
20.3 Pre-inspection Activities
184(1)
20.4 Inspection Process
184(2)
20.5 Communication of Results
186(1)
20.6 Common Findings
187(2)
References
188(1)
21 Ethics: Institutional Review Board/Independent Ethics Committee (IRB/IEC)
189(6)
21.1 Responsibilities
189(2)
21.2 Composition, Functions and Operations
191(1)
21.3 Procedures
192(1)
21.4 Records
193(2)
References
193(2)
22 Responsibilities of the Investigator
195(16)
22.1 Investigator's Qualifications and Agreements
195(1)
22.2 Adequate Resources
196(1)
22.3 Medical Care of Trial Subjects
196(1)
22.4 Communication with IRB/IEC
197(1)
22.5 Compliance with Protocol
197(1)
22.6 Investigational Product(s)
198(1)
22.7 Randomisation Procedures and Unblinding
199(1)
22.8 Informed Consent of Trial Subjects
200(5)
22.9 Records and Reports
205(1)
22.10 Progress Reports
206(1)
22.11 Safety Reporting
207(1)
22.12 Premature Termination or Suspension of a Trial
207(1)
22.13 Final Report(s) by Investigator/Institution
208(3)
References
209(2)
23 Responsibilities of the Sponsor
211(20)
23.1 Quality Assurance and Quality Control
211(1)
23.2 Contract Research Organisation (CRO)
212(1)
23.3 Medical Expertise
212(1)
23.4 Trial Design
212(1)
23.5 Trial Management, Data Handling, Record-Keeping and Independent Data Monitoring Committee
213(2)
23.6 Investigator Selection
215(1)
23.7 Allocation of Duties and Functions
216(1)
23.8 Compensation to Subjects and Investigators
216(1)
23.9 Financing
217(1)
23.10 Notification/Submission to Regulatory Authority(ies)
217(1)
23.11 Confirmation of Review by IRB/IEC
217(1)
23.12 Information on Investigational Product(s)
218(1)
23.13 Manufacturing, Packaging, Labelling and Coding Investigational Product(s)
219(1)
23.14 Supplying and Handling Investigational Product(s)
220(1)
23.15 Record Access
221(1)
23.16 Safety Information
221(1)
23.17 Adverse Drug Reaction Reporting
222(1)
23.18 Monitoring
222(5)
23.18.1 Purpose
222(1)
23.18.2 Selection and Qualifications of Monitors
223(1)
23.18.3 Extent and Nature of Monitoring
223(1)
23.18.4 Monitor's Responsibilities
223(3)
23.18.5 Monitoring Procedures
226(1)
23.18.6 Monitoring Report
226(1)
23.19 Audit
227(1)
23.19.1 Purpose
227(1)
23.19.2 Selection and Qualifications of Auditors
227(1)
23.19.3 Auditing Procedures
228(1)
23.20 Noncompliance
228(1)
23.21 Premature Termination or Suspension of a Trial
229(1)
23.22 Clinical Trial/Study Reports
229(1)
23.23 Multicentre Trials
230(1)
References
230(1)
24 Clinical Trial Protocols
231
24.1 General Information
231(1)
24.2 Background Information
232(1)
24.3 Trial Objectives and Purpose
232(1)
24.4 Trial Design
233(1)
24.5 Selection and Withdrawal of Subjects
234(1)
24.6 Treatment of Subjects
234(1)
24.7 Assessment of Efficacy
234(1)
24.8 Assessment of Safety
235(1)
24.9 Statistics
235(1)
24.10 Direct Access to Source Data/Documents
236(1)
24.11 Quality Control and Quality Assurance
236(1)
24.12 Ethics
236(1)
24.13 Data Handling and Record-Keeping
236(1)
24.14 Financing and Insurance
236(1)
24.15 Publication Policy
237(1)
24.16 Supplements
237
References
237
Cemal Cingi, MD, is a Professor in the Otorhinolaryngology Department at Eskisehir Osmangazi University, Medical Faculty, Eskisehir, Turkey. He graduated from the School of Medicine, Istanbul University in 1984 and then entered the Otorhinolaryngology Residency Programme at Anadolu University, Eskisehir, becoming a Specialist in ORL & HNS in 1990. He was appointed as an Associate Professor in 1995 and as a Professor in 2001. In 2013 he became an accredited Specialist in Mouth, Face, and Chin Surgery. Dr. Cingi is Chair of the ENT Section of the European Academy of Allergy and Clinical Immunology (EAACI) and President of the Asian Facial Plastic Surgery Society (AFPSS). He is editor of Journal of Medical Updates and an editorial board member for several other journals. Dr. Cingi is the author or editor of seven previous books.

Dr. Nuray Bayar Muluk is currently professor of Ear, Nose and Throat at Kirikkale University, Medical Faculty in Turkey. Author of12 book chapters and more than 120 published papers, She is working on many different fields of ENT such as Head and Neck Cancer, Tinnitus, Laryngology, Rhinology, Aesthetic Surgery.
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