Management of Data in Clinical TrialsJohn Wiley & Sons, 14/12/2007 - 208 من الصفحات A valuable new edition of the trusted, practical guide to managing data in clinical trials Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided. While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements. Newly featured topics include:
Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels. |
المحتوى
1 Introduction | 1 |
2 Study Design and Planning | 12 |
3 Data Definition Forms and Database Design | 33 |
4 Computer Systems for Data Management and Data Entry | 56 |
5 Patient Registration | 76 |
6 Local Data Management Systems | 94 |
7 Central Quality Control of Data | 106 |
8 Data Management and Good Clinical Practice | 121 |
9 Software Tools for Trials Management | 140 |
10 FollowUp and CloseOut Phase | 155 |
11 Training Education and Documentation | 163 |
12 Clinical Trials Collaboration Models | 175 |
Bibliography | 180 |
181 | |
طبعات أخرى - عرض جميع المقتطفات
عبارات ومصطلحات مألوفة
accrual adverse events allow analysis answer assessment audit backup Chapter Clinical Practice Clinical Research Associate clinical trials Coding Conventions complete compliance computer system consent form Coordinating Center copies correct CRFs criteria data collection Data Coordinator data entry data items data management Data Monitoring Committee defined developed drug electronic eligibility checklist endpoints ensure error example field files follow-up format important institution investigator involved logical checks maintained manual medical record ment multicenter trial participating sites Patient ID patient identifier patients entered Phase III trials physician possible prior procedures protocol document protocol treatment quality control queries questions randomization Reference Center registration regulatory relevant report forms responsible schedule screen side effects specific sponsor staff statistical statistician submitted tests tion treatment assignment trial data trial database update usually values