Clinical Studies Management —— A Practical Guide to Success

----- 临床研究管理

ISBN: 9780849320842 出版年：2004 页码：120 Cook, Simon CRC Press

DRUG DEVELOPMENT AND INDUSTRY TRENDS From Concept to Market Industry Trends CONTRACT RESEARCH ORGANIZATIONS Outsourcing to CROs THE ROLE OF THE CLINICAL STUDY PROJECT MANAGER The Project Team The Function of the Manager High-Rise vs Hands-Off GOALS AND STANDARDS Objectives and Milestones Clinical Research Standards Writing a Study Protocol BUDGETS Where the Money Goes TIME The Cost of Time Finding the Critical Path The Proactive Approach RESOURCES Manpower Drug Supplies MEASUREMENT Quality Tracking Taking the Project Pulse COMMUNICATIONS Efficient Signalling Team Meetings Presentations TRAINING In Pursuit of Error-Free Work Organizing an Investigators' Meeting SURVIVING QUALITY ASSURANCE AUDITS Quality Assurance in Clinical Research TROUBLESHOOTING: A CASE HISTORY Introduction Problems Prioritising Actions Recruitment Enhancement Getting Back on Track CONCLUSIONS References Index