Clinical Trials Risk Management 1st Edition by Martin Robinson ISBN 9781420037654 142003765X

Clinical Trials Risk Management 1st Edition by Martin Robinson – Ebook PDF Instant Download/Delivery:  9781420037654,142003765X
Full download Clinical Trials Risk Management 1st Edition after payment

Product details: 

ISBN 10:  142003765X

ISBN 13:  9781420037654

Author: Martin Robinson

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 Management explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to ‘real life’ clinical trial situations.

After building a foundation of basic principles, the authors lead you through specific methods for handling the risks characteristically encountered in clinical trials. Their combined years of experience in pharmaceutical research and development shine through the narrative, making the prose both lively and informative. They discuss concepts using worked examples and include a summary of the main points at the end of each chapter. In addition to diagrams and Risk and Precision Tree charts, the text is sprinkled with humorous line drawings that reinforce the concepts.

Table of contents: 

DEFINITIONS AND CONCEPTS
What is Risk?
The Principles of Risk Management
Drug R&D: A Risky Business
Why Risk Management in Important in Clinical Trials

DRUG SAFETY AND PHARMACOVIGILANCE
USA
Japan
European Union

TYPES OF RISK IN CLINICAL TRIALS
The Life Cycle of a Clinical Trial
Typical Risks that Clinical Trial Projects Face
Internal and External Risks

RISK IDENTIFICATION
Brainstorming a Risk Assessment
Compiling a Risk Register
Assessing Impact and Probability
Simulation Models

THREATS AND OPPORTUNITIES
Responding to Threats
Maximizing Opportunities
Stakeholder Needs and Risk Tolerance

PLANNING PREVENTATIVE STRATEGIES
Assessing Cause
Creating s Prevention Plan
Controlling the Critical Path

BACKUP PLANNING
Contingency Planning
Trigger Points

TRACKING RISKS
Detecting Symptoms
Responding to Deviations
Continuous Risk Management
Decision Milestones

INVESTIGATIONAL SITE RISK MANAGEMENT
The Role of the CRA in Individual Site Risk Assessment
Initial Risk Analysis Before and During the Prestudy Visit
Using the Initiation Visit for Risk Prevention
Ongoing Risk Management through Monitoring

POST PROJECTION EVALUATION
Reviewing Success of Risk Management Strategy
Learning Lessons for the Future

People also search for:

risk based quality management in clinical trials
    
risk management plan clinical trials
    
risk management in clinical trials ppt
    
risk based data management in clinical trials
    
reflection paper on risk based quality management in clinical trials

 

Tags:

Martin Robinson,Clinical Trials,Risk Management