Data Collection and Quality Control

Abstract

To achieve a reliable data set for analysis that complies with the protocol, a system of clinical data management (CDM) is critical. CDM is the planning and process of data collection, integration and validation. This chapter provides a synopsis of the key components of CDM which need to be considered during the design phase of any trial. Topics addressed include the roles and responsibilities of research staff, the design of case report forms for collecting data; the design and development of a clinical database management system, subject enrolment and data entry, data validation, medical coding, database close-out, data lock and archiving. An additional section discusses the rationale behind trial registration.