232 Pages
by
CRC Press
232 Pages
by
CRC Press
Also available as eBook on:
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... Read more
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
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
Biography
Martin Robinson, Simon Cook
"…fills a key niche as there are few concise books offering a practical, readable guide to risk management."
-Institute of Clinical Research
"A practical, readable guide, the book is packed with information that can be put to immediate use to improve current or planned clinical trials."
--Anticancer Research
"…a welcome addition to the clinical researcher's essential reading list…The book is well organized and, for a technical subject, easy to read, helped enormously by the use of humourous illustrations that gently emphasize the points being made…I can recommend this book to everyone working at the sharp end of clinical drug development."
-Good Clinical Practice Journal
