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Status:
Available5.0
40 reviews
ISBN 10: 0429129823
ISBN 13: 9780429129827
Author: Martin Robinson, Simon Cook
Drug development is risky business. It is against the backdrop of huge financial, scientific, technical and medical risks that a clinical trials manager is expected to function, effectively identifying and managing all project risks, to deliver a successful outcome. Focusing on the day-to-day needs of a clinical trials manager, Clinical Trials Risk
Chapter 1 Definitions and Concepts
What is Risk?
The Principles of Risk Management
Definition Setting
Project Planning
Risk Identification
Quantitative Assessment
Contingency Allocation
Action
Measurement
Outcome Assessment
Post-Project Review
Drug R&D: A Risky Business
The Drug Safety Staircase
The Commercial Stakes
Why Risk Management is Important in Clinical Trials
Quality
Costs And Resources
Time
Chapter 2 Assessing Drug Safety
Nonclinical Safety Studies
Hazard Identification And Characterization
Exposure Assessment
Risk Characterization
Clinical Safety
Chapter 3 International Regulatory Perspectives
European Union
Us
Japan
Chapter 4 Types of Risk in Clinical Trials
Clinical Trials
Phase I
Phase II
Phase III
Phase IV
The Clinical Trial Life Cycle
1. Start Up
2. Clinical Monitoring
3. Biometrics/Reporting
4. Completion Activities
5. Quality Assurance
Typical Risks That Clinical Trial Projects Face
Definition Risks
Timeline
Budget
Regulatory Authorities
Dose Selection
Market Potential
Study Design
Subject Recruitment Rate
Planning Risks
Investigator Selection
Drug Supplies
Stafing
Implementation Risks
Site Set-Up
Ich Gcp Compliance
Product Safety And Stability
Close-Out Risks
Data Quality
Experimental Results
Internal And External Risks
Chapter 5 Risk Identification and Quantification
Brainstorming A Risk Assessment
Compiling A Risk Register
Assessing Impact And Probability
Simulation Models
Chapter 6 Threats and Opportunities
Responding To Threats
Maximizing Opportunities
Stakeholder Needs And Risk Tolerance
Chapter 7 Planning Preventative Strategies
Assessing Cause
Logic-Based Methods For Risk Analysis
Analyzing The Critical Path For Risks
Creative Techniques For Risk Analysis
Creating A Risk Prevention Plan
Chapter 8 Backup Planning
The Contingency Concept
Finding The Weakest Link
Insurance And Indemnification
Chapter 9 Project Tracking and Decision-Making
Project Tracking
Detecting Symptoms
Quality
Time
Cost/Resource
Responding To Deviations
Continuous Risk Management
Project Decisions
Decision Trees
Decision-Making
Chapter 10 Investigational Site Risk Management
The Role of The Cra in Individual Site Risk Assessment
Initial Risk Analysis During Site Selection
Preventing Threats To Patient Recruitment
Using The Initiation Visit For Risk Prevention
Ongoing Risk Management Through Monitoring
Managing Investigator Fraud
Chapter 11 Post-Project Evaluation
Reviewing The Success of Risk Management Strategy
Introductory Team Meeting
Review of Project Plan
Analysis of Project Metrics
Identify Issues And Key Decisions
One-To-One Interviews
Observations Feedback
Report Preparation
Learning Lessons For The Future
Conclusions
References
Index
Tags: Martin Robinson, Simon Cook, Clinical, Trials
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