Addresses the practical details of organizing and conducting a clinical trial from large multicenter trials to small single-investigator studies. Coverage includes trial planning and resource assessment; developing a trial protocol and case report forms; selection and use of computers and software; eligibility checking and patient registration; data collection and data entry; quality control systems at the local and central levels; training and education of data management staff; the role of data management and implementing good clinical practice; and development of software tools. Annotation c. by Book News, Inc., Portland, Or.
Timely, authoritative, complete-a comprehensive guide to managing data in clinical trials
At some point during their training, virtually all health professionals are exposed to the theory of clinical trials, but few are taught about the practical details of organizing and conducting a clinical trial. This book fills that gap in training.
Management of Data in Clinical Trials is a valuable working resource for anyone involved in any type of clinical trial-from large multicenter trials to small single-investigator studies. The information is relevant to trials in all disease areas, done in any clinical setting, and is general enough to be applicable both within and outside the United States. This authoritative handbook offers in-depth coverage of accrual and follow-up phases of a clinical trial and provides valuable expert advice and step-by-step guidance on:
* Trial planning and resource assessment
* Developing a trial protocol and case report forms
* Selection and use of computers and software for clinical trials
* Eligibility checking and patient registration
* Data collection and data entry
* Quality control systems at the local and central levels
* Training and education of data management staff
* The role of data management in implementing good clinical practice (GCP)
* Development of software tools for trial management
