Clinical data management system

A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for clinical data management can be self-contained or part of the functionality of a CTMS. A CTMS with clinical data management functionality can help with the validation of clinical data as well as helps the site employ for other important activities like building patient registries and assist in patient recruitment efforts.

The CDMS can be broadly divided into paper-based and electronic data capturing systems.

Case report forms are manually filled at site and mailed to the company for which trial is being performed. The data on forms is transferred to the CDMS tool through data entry.The most popular method being double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by the system. In case the entry of a value conflicts, system alerts and a verification can be done manually. Another method is Single Data Entry.

The data in CDMS are then transferred for the data validation. Also, in these systems during validation the data clarification from sites are done through paper forms, which are printed with the problem description and sent to the investigator site and the site responds by answering on forms and mailing them back.

In such CDMS the investigators directly uploads the data on CDMS and the data can then be viewed by the data validation staff. Once the data are uploaded by site, data validation team can send the electronic alerts to sites if there are any problems. Such systems eliminate paper usage in clinical trial validation of data.

Once data have been screened for typographical errors, the data can be validated to check for logical errors. An example is a check of the subject's date of birth to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there are errors in the data or if clarifications from the investigator are required.

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