Clinical trials risk management. (2006)

• Record Type: Book
• Further Information: Note: Martin Robinson, Simon Cook.
• Other Names: Robinson, Martin, 1949-; Cook, Simon, 1959-
• 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
• Publisher Details: Boca Raton : CRC/Taylor & Francis Sue Horwood Pub
• Publication Date: 2006
• Extent: 1 online resource (xv, 211 pages), illustrations
• Subjects: 615/.19; Drugs -- Testing -- Risk assessment; Clinical trials -- Risk assessment; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Clinical Trials -- methods; Drug Evaluation -- methods; Risk Management; Electronic books
• Languages: English
• ISBNs: 9781420037654; 0849333237; 9780849333231
• Related ISBNs: 142003765X
• Notes: Note: Includes bibliographical references (pages 201-203) and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.