Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Save to My Library
Look up keyword or section
Like this
2Activity

Table Of Contents

Preface
Contributors
Comments from the Contributors
Terms of Use
Abbreviations
Chapter 1. Introduction 15
Chapter 1. Introduction
1.1 Ethics and Bioethics
Ethical Codes – The Declaration of Helsinki
Ethical Codes – The ICH GCP Guideline
Ethical Codes – Ethics Committee
No Universal Ethical Code for Ethics Committees
Ethics Committee Definition
1.2 Clinical Trials in the Context of Biomedical Research
Clinical Trials on Medicinal Products
Low and High Risk Clinical Trials
Sponsors of Clinical Trials
1.3 Clinical Trial Players and Their Responsibilities
Drug Regulatory Authority
Sponsor
Investigator
Ethics Committee
Trial Participant
Clinical Trial Services Provider
Site Supporting Organisation
Data Safety and Monitoring Committee
Chapter 2. Features of Clinical Trials 29
Chapter 2. Features of Clinical Trials
2.1 Objectives of Clinical Trials
2.2 Clinical Trial Design
The Importance of Clinical Trial Design
Clinical Equipoise
Superiority, Non-inferiority and Equivalence Clinical Trials
Types of Clinical Trial Designs
Adaptive Clinical Trial Design
2.3 Controls of Clinical Trials
Placebo Treatment
2.4 Clinical Trial Outcome/Endpoint
Defining Clinical Trial Outcome/Endpoint
Primary and Secondary Outcome/Endpoint
Surrogate or Clinical Outcome/Endpoint
Disadvantages of Using Surrogate Outcome/Endpoint
Example: Surrogate Outcome/Endpoint in the Cardiovascular Area
2.5 Randomisation
2.6 Blinding
2.7 Sample Size
2.8 Trial Phases
Drug Development at Large
The Basics of Trial Phases
Phase 0 Trials
Human Pharmacology/Phase I Clinical Trials
Risk Assessment/Management of Human Pharmacology/Phase I Trials
Therapeutic Exploratory/Phase II Clinical Trials
Therapeutic Confirmatory/Phase III Clinical Trials
Therapeutic Use/Phase IV Clinical Trials
2.9 Multicentre Trials
Uninterrupted Globalisation of Industry-Sponsored Clinical Trials
Chapter 3. Science, Ethics and Quality Assurance of Clinical Trials 61
Chapter 3. Science, Ethics and Quality Assurance of Clinical Trials
3.1 Research in Humans
Essential Clinical Trial EC Review Topics
Human Research Protection Assurance
Clinical Trials of Today – Only One Standard
3.2 Science of Clinical Trials
3.3 Issues of Ethics of Clinical Trials
Risk-Benefit Balance
Scientific Evaluation of a Clinical Trial Protocol
Informed Consent Process
Vulnerable Participants
Privacy and Confidentiality
Safety Monitoring
Qualification of Investigator and Research Staff
Financial Conflict of Interest
Clinical Trial Insurance and Indemnity
Essential Clinical Trial Documents
Clinical Trial Registration
Dissemination of Trial Results
Operation of an EC
3.4 Issues of EC Procedures
Local Laws and Institutional Guidelines
Proportionate EC Review: Expedited/Full
Acceptability of Trial
Continuing Review
Trial Amendments
Unanticipated Problems
Complaints
Appeals
Non-compliance
Suspension or Termination of a Trial
Pre-clinical and Clinical Quality Assurance
Monitoring of Site Performance
3.6 Human Research Protection Programme Accreditation
3.7 The AAHRPP Accreditation Standards
Organisation
Investigator and Staff
Quality Assurance and Quality Control
Risk-Benefit Balance - Scenario 3
Informed Consent Process – Scenarios
Vulnerable Participants – Scenarios
Vulnerable Participants - Scenario 1
Vulnerable Participants - Scenario 2
Privacy and Confidentiality – Scenarios
Privacy and Confidentiality – Scenario 1
Comments to Privacy and Confidentiality – Scenario 1
Data Safety Monitoring – Scenarios
Data Safety Monitoring - Scenario 1
Participant Recruitment Procedures – Scenarios
Participant Recruitment Procedures - Scenario 1
Participant Recruitment Procedures - Scenario 2
Qualification of Investigator – Scenarios
Qualification of Investigator - Scenario 1
Qualification of Investigator - Scenario 2
Conflict of Interest – Scenarios
Conflict of Interest - Scenario 1
Conflict of Interest - Scenario 2
Conflict of Interest - Scenario 3
Clinical Trial Insurance and Indemnity - Scenario 3
Essential Clinical Trial Documents – Scenarios
Clinical Trial Registration – Scenarios
Clinical Trial Registration - Scenario 1
Clinical Trial Registration - Scenario 2
Dissemination of Trial Results – Scenarios
Dissemination of Trial Results - Scenario 1
Local Laws and Institutional Guidelines – Scenarios
Local Laws and Institutional Guidelines - Scenario 1
Proportionate EC Review: Expedited/Full – Scenarios
Proportionate EC Review: Expedited/Full - Scenario 1
Proportionate EC Review: Expedited/Full - Scenario 2
Continuing Review – Scenarios
Continuing Review - Scenario 1
Acceptability of Trial – Scenarios
Acceptability of Trial - Scenario 1
Acceptability of Trial - Scenario 2
Trial Amendments – Scenarios
Adverse Event Reporting – Scenarios
Adverse Event Reporting - Scenario 1
Adverse Event Reporting - Scenario 2
Unanticipated Problems – Scenarios
Unanticipated Problems - Scenario 1
Unanticipated Problems - Scenario 2
Unanticipated Problems - Scenario 3
Suspension or Termination of a Trial – Scenarios
Suspension or Termination of a Trial - Scenario 1
Complaints – Scenarios
Appeals – Scenarios
Non-compliance – Scenarios
0 of .
Results for:
No results containing your search query
P. 1
null

null

Ratings: (0)|Views: 13 |Likes:
Published by crabby12

More info:

Published by: crabby12 on Dec 16, 2010
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less

04/09/2012

pdf

text

original

You're Reading a Free Preview
Pages 4 to 75 are not shown in this preview.
You're Reading a Free Preview
Pages 79 to 95 are not shown in this preview.
You're Reading a Free Preview
Pages 99 to 107 are not shown in this preview.
You're Reading a Free Preview
Pages 111 to 132 are not shown in this preview.
You're Reading a Free Preview
Pages 136 to 160 are not shown in this preview.

You're Reading a Free Preview

Download
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->