The management of clinical data, from its collection to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially
Practical Guide to Clinical Data Management
β Scribed by Susanne Prokscha
- Publisher
- CRC Press
- Year
- 2006
- Tongue
- English
- Leaves
- 254
- Edition
- 2
- Category
- Library
No coin nor oath required. For personal study only.
β¦ Synopsis
Introducing professionals to the role of data management in clinical trials, Practical Guide to Clinical Data Management highlights current thinking about data management, focusing on responsibilities that typical data managers have today. This second edition includes detailed requirements of 21CFR11, the standard for electronic records and signatures. It features new chapters on training of data collection staff as well as controlling access and security. It explores software applications for CDM and explains how to use computerized data collection software. It addresses clinical data for drug and medical device trials. It also presents overviews of various documents for use as templates.
β¦ Subjects
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