In trying to project the future, it is important to understand the past. How did the data manager role come to be? In the early days of paper trials, a flood of paper was coming through to the sponsor from study sites. This data had to be entered into the Clinical Data Management System (CDMS). Inconsistent or illegible data had to be sent back to the study site for clarification. Data was entered a second time (double date entry or second pass data entry) to minimize the possibility of any transcription errors. Someone had to manage all these activities and keep track of where each CRF was at any given time. Thus was born the data manager, someone to literally, “manage the data.”
In addition, the CDMS systems of old were cumbersome and needed to be recreated and recompiled for each study. The complexity of the task required that there be dedicated study builders, whose sole job was to build each study and then maintain changes. There were also report writers, whose job function it was to get periodic snapshots of data as the study progressed. This was not even to conduct the final study analysis, but merely to manage the conduct of the study, generate listings of outstanding and overdue site queries, etc.
That future role of the data manager is a combination of the above three roles: traditional data manager, study builder, and report writer. Now the data is being entered directly into EDC, so there is no need for second pass data entry or to manage the stacks of paper coming from the site. However, someone still needs to make sure that outstanding queries in the EDC are being answered by the study sites in a timely manner. Someone needs to track the missing forms and follow up with sites to enter them or to create protocol deviations. That someone is the data manager. In addition, with the advent of advanced tools like Clinical Studio, the data manager ought to be the one building the study and implementing any mid-study changes instead of a designated study builder. As well, the data manager ought to be able to create basic listings and reports to keep updated on the progress of the study and follow up where necessary without the need for a report writer. There is increased efficiency in having the data manager build the study and reports. Since there is no programming involved, it is more a matter of utilizing the various study configuration tools than programming.
The form builder in Clinical Studio allows the data manager to configure CRFs and edit checks, rather than program them. The user need only have an understanding of the study protocol, the data that must to be collected and the types of edit checks that should be included. No programming knowledge is required. Register online and start building your own study to find out how empowering it is to be able to build your own study.