ABSTRACT
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 t
TABLE OF CONTENTS
part |2 pages
part one. Elements of the process
part |2 pages
part two. Necessary infrastructure
part |2 pages
part three. CDM systems