Introduction:
Over the past 50 years, eminent trialists have written persuasively and repeatedly of the need for large, randomized, controlled trials, and such trials are considered the highest level of evidence for guiding clinical practice. However, how to manage these important trials has had little mention in most commentaries. Many clinical trials fail to deliver because of the lack of a structured, practical, businesslike approach to trial management. The human and financial resources for conducting a randomized trial is finite, so it is crucial that every effort is made to ensure that a trial is implemented simply and managed efficiently. A randomized trial involves a huge investment of time, money and people; therefore, it warrants expert management and needs to be managed from its inception like any other business. To review the literature, develop a protocol, apply for funding and design data collection forms requires lengthy consultations and a considered approach. Rarely is this essential depth of thinking applied to how the trial will actually be managed. Trial management is essential amongst the key competencies that are needed to deliver high-quality trials. It is recognized that well designed trials are the basis for addressing important clinical questions, but science alone will not be sufficient to successfully deliver a trial. Once the science is determined and the trial accepted through the peer review process, the challenge is quite different. The key challenge is then to establish and implement management systems and techniques that are effective and responsive to the needs of the trial and the trialist. Clinical trials all require the same coordinated processes and systems, regardless of the size, scope, costs or duration.
Number of Pages of Project Report: 60
Package Includes: Synopsis/Project Proposal + Project Report
Project Format: Document (.doc)
Table of Contents of Project Report:
CHAPTER 1: INTRODUCTION
CHAPTER 2: RESEARCH METHODOLOGY
RESEARCH PARADIGM
RESEARCH DESIGN
DATA SOURCE
TOOLS OF ANALYSIS
CHAPTER 3: COMPANY PROFILE
FINDINGS
CONCLUSION
PRODUCT SAFETY
MEDICAL MONITORING
CLINICAL MONITORING
PROJECT MANAGEMENT
QUESTIONNAIRE
REFERENCES
