Throughout clinical trials, the data manager (DM) is heavily involved in constructing databases, managing reports, programming quality checks and managing the collection of data in the clinical trial. The DM is responsible for managing and training users the concepts of computerised clinical data base systems as well as fulfilling other duties such as design basic reports for investigators, entering data into protocol-specific forms and ensure there is high level of quality and integrity of data. The roles that the DM play is fast changing with the prevalence of electronic data capture (EDC) as the preferred platform for data collection.
Although DM may come across numerous developments and innovations throughout their line of work, the introduction of electronic data capture (EDC) systems– which replaced traditional paper based data collection methodology to streamline data collection – is most likely the biggest change to the data management field in clinical trial implementation. The incorporation of EDC into clinical trials largely reduces the amount of time DM spend on extracting and analysing data whilst improving accuracy and quality – from collecting data through forms to producing real time data via EDC.
Within a clinical trial, the DM often acts as an architect, being able to take on the role of a project manager, programmer, medical coder and drug inventory administrator in addition to fulfilling their own role. Furthermore, the role of a programmer and DM has been merged – with a large amount of programming tools available, the DM has greater control over the design of the study. Time will be saved as communication between historically two separate roles is now redundant. The capabilities of the DM continue to advance and in turn provides a new dimension to the role.
The challenges to paper studies were numerous, as case report forms (CRF) and data clarification forms (DCF) can be lost in transit and it was difficult to track them. With data being entered directly into the EDC, there has been no use for second pass data entry or the need to manage large amounts of paper received from the sponsor.
Through the EDC system, the DM will be notified of issues such as incorrect or missing data arising in sites that need attention, and in turn notify the project team which consists of the project manager, statisticians, data management and clinical operations. If issues are consistent throughout the study, alternative methods of notification are through newsletters or emails with clinical research associates (CRAs).
As DM continue to manage EDC systems, they are expected to be increasingly involved in resolving issues at an early stage of the study. The role of the DM has become more pivotal. In addition, there may be a greater need for collaboration with statisticians and CRAs to identify the data used. Follow ups are required on primary and secondary endpoints for data cleaning, as well as targeting any missing data or incorrect forms. Cleaner data will be accessed at an earlier stage of the study, nonetheless there must be consistency across sites as real time data is constantly updated and entered into the system. The DM no longer makes data changes in the system based on site query responses, as that responsibility now falls on site staff to enter the data changes. Moreover, the DM assists site staff by performing data reviews using listings and reports to fully ensure data is complete, consistent and logical.
With DM continuously exposed to innovative technology and constant software updates, the demand for highly experienced resources and professionals will increase to support the ever changing technology system. Although data management is most commonly a global centralized function, demand for such resources in countries such as China has also increased due to the large amount of clinical trials taking off there and the need to overcome language barriers… Furthermore, the rising familiarity and experience across service providers and sponsors, is essential in a clinical trial environment that is fast becoming electronic.