Practical Guide to Clinical Data Management

by Susanne Prokscha

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 clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.

Practical Guide to Clinical Data Management, Second Edition provides a solid introduction to the key process elements of clinical data management. Offering specific references to regulations and other FDA documents, it gives guidance on what is required in data handling.

Updates to the Second Edition include -

252 pages, Hardcover

First published January 1, 1999

Reviews

[Meharjit Dhage · Rating 5 out of 5]

excellent book !

[Manali]

nice

[Nitesh Sharma · Rating 5 out of 5]

jhg