Remember the early days of Electronic Data Capture? Those first systems, which were revolutionary for their time featured basic data entry screens, simple edit checks and a handful of reports.
Technology has come a long way since then, and the EDC landscape has matured dramatically along with it. Current EDC must-haves include easy user and site management, secure automated password retrieval, robust reporting, query and SAE management, as well as Source Data Verification, and Risk based monitoring. Many sites need to be active at the same time; labs need to enter or upload data directly into the system; medical coding should be performed inside of the tool; images need to be uploaded and stored; email and text alerts sent to investigators and sponsors, and patient reported outcomes and diaries need to be available.
Counter intuitively, while EDC system functionality is becoming ever more sophisticated, the interface to build the systems is becoming easier to use and understand.
Software is shifting from a programmer -only environment to solutions where a graphical, more intuitive interface is being offered.
This creates an opportunity for enhancements in how the data management process is resourced and managed. With the EDC build becoming more accessible, we can derive a number of benefits from providing Data Managers with the tools and training to handle those technical aspects which were traditionally the domain of the database programmer.
The CDM can control timelines better by not depending on outside resources.
Often, there are assertive timelines involved with EDC database builds. Of course, one of the differences with an EDC based study versus paper is that the database must be complete and edit checks ideally programmed before FPI. Having a CDM who is also able to handle the build process can reduce complexity in timeline management.
The CDM knows the issues with CRFs/reports/queries and can design the system accordingly
The CDM will be working with the system throughout the course of the project. They are aware of the potential issues with the CRF and query management and are able to anticipate these. They are consequently able to ensure that the database is built to mitigate any potential issues during study conduct.
Communication with the sponsor is streamlined
It is important that communication between CRO and sponsor is effective and streamlined during the database build process. Where the CDM is managing the build as well as the study conduct phase, communication with the sponsor is simplified.
Project Coverage is improved with a diversely skilled team
Work flow is rarely linear within data management. Having team members who are able to cover a variety of tasks ensures there is resource contingency in case of unexpected events.
Enrichment and career development for the CDM
The opportunity to develop additional technical skills can add variety and satisfaction to the Data Manager’s role. Importantly, the technical route may not always be suitable for every data manager and alternative tracks can therefore be proposed.
At Cytel, our Data Managers are accredited to build the EDC systems primarily chosen by our clients. Using this approach contributes to our success in delivering data management projects on time and to budget.
To learn more about our Data Management services click below.
With thanks to Patti Arsenault, Director Clinical Data Management at Cytel