Overview of Clinical Data Management Systems (CDMS)
A Clinical Data Management System (CDMS) is a generic name for a tool or set of tools for electronic capture and management of patient data generated during the conduct of a clinical trial. A CDMS can be part of a suite of clinical trials management tools or used as a stand-alone component.
A CDMS is typically used to collect, verify, code, and prepare the data for further statistical analysis. This tool or set of tools is used by the organizations conducting the studies and clinical research sites participating in the studies to collect and verify the patient data during the conduct of the study. In addition, external organizations such as labs or third-party contract research organizations may also utilize the system to enter or verify patient data. Ultimately, the verified collective patient data is extracted and made available to statisticians in a pre-defined format for statistical analysis on the effectiveness of the clinical study.
At a Glance Details
The following three CDMS tools currently support connection to the caBIG® Clinical Trials Suite using the caBIG© Clinical Connector:
Other CDMS products have been certified as caBIG-compatible at the Bronze level. For a complete list of these other tools, please see Bronze Compatible Products. NCI will continue to work with the NCI clinical research community to develop pathways to caBIG® interoperability for other CDMS products in use.
Clinical trials staff (CRAs, study coordinators, site coordinators), data managers, statisticians
Update on the NCI’s procurement of CDMS software
Documents and Related Information
NCI CDMS Usage Guidelines. These guidelines may be used to facilitate consistent practices in electronic data capture by users of CDMS that support connection to the caBIG® Clinical Trials Suite.