MANAGEMENT OF DATA IN CLINICAL TRIALS
- ÜRÜNÜN BULUNDUĞU ŞUBELERİMİZ
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
Table of Contents:
Study Design and Planning.
Data Definition, Forms, and Database Design.
Computers in Clinical Trials: Hardware, Operating Systems, and Database Management Systems.
Data Entry and Distributed Computing.
Local Data Management Systems.
Central Quality Control of Data.
Data Management and Good Clinical Practice.
Software Tools for Trials Management.
Follow-Up and Closeout Phase.
Training and Education.