Clinical data management

Data managers are responsible for seeing that information is consistent and complete, and of a high quality.

Data management describes the processing of the huge amount of data that is generated during a clinical trial. A wide range of computer applications and database systems support the collection and management of subject /patient data.

Responsibilities of a data manager

The responsibilities of someone working in this area typically include:

• Input into the design of protocols (which define what data are to be collected and when)
• Design and approval of case report forms (on which subjects’ data are collected)
• Database design for the study (ensuring it meets requirements for data entry and reporting of the data).

Data managers are responsible for seeing that information is consistent and complete, and of a high quality. It is a diverse role, which may also include compiling summaries and listings of safety and producing tables that will form part of the clinical study report. Data managers may also be involved in the development and testing of new processes and systems for the management of trials and will contribute to the training of CRAs and study site investigators.

The importance of this role makes the data manager a core member of the clinical project team - interacting with clinicians, statisticians, medical writers and regulatory affairs specialists and quality assurance personnel in order to achieve project goals.