In any clinical trial, the data generated is the most important thing. In multi centre clinical trials, the data shall be generated in much geography making it challenging to handle the data. Collecting the data from all the sites is a prolonged process in case of clinical trials using paper based CRFs. With the arrival of Electronic Data Capture (EDC), the data collection process has been accelerated.
EDC offers cost effective approach for clinical trials through web based data entry, medical monitoring, data review and data clarification processes. It also accelerates the report generation process by providing error free (clean) data by integrating with statistical software. So, there must be full integration in the design of the trial with clinical research, data management, and biostatistics to assure that the data entry process is user friendly for the clinical sites and that the exported database structure is compatible with the planned statistical analysis. Hence, the planning and implementation of EDC must be done prior to enrolment of first patient.
The front end of EDC contains data entry screens that have a set of data fields in to which the data is filled. All the data fields should be validated before the first data entry. Validation is defined as the culmination of evidence that a system does what it claims to do and will continue to do so reproducibly. In the back end of EDC, all the necessary programming for creating forms and validation (edit check specifications) process and annotation of CRF are done. Programming is also done to integrate the EDC system with data management and statistical analysis for generation of reports.
Once the forms are created, all the forms specific to a therapeutic area are nested together to create a complete case report form and can be assigned to a patient once the trial is initiated. The created forms can be stored in the library available in the EDC system. For future trials, these forms can be copied from the library. In order to initiate a study, one should invoke the copy function in the system and can add the roles, users and sites to access the EDC system. With the advent of EDC systems, the query management has accelerated dramatically. Earlier, the query management process was a time consuming process but with EDC systems, queries can be resolved in minutes rather than weeks assuming that the site is responsive to the query.
The data manager acts as a bridge between field operations and biostatistics. Statisticians want error free data from the data management. EDC system facilitates the generation of error free data out of a clinical trial. Standard Operating Procedures (SOPs) are to be followed to carry all these functions. SOPs should be established for, but not limited to, the following processes:
- System setup and installation
- Data collection and handling
- System maintenance
- Data backup, recovery, and contingency plans
- Change control
The Big Pharmaceutical & Contract Research Organisations have already begun to adopt EDC as a new data management tool for clinical trials. EDC acceptance is strong in these firms. Though the goal of data management will not change; to assure “clean” data at the end of the study; there is no doubt that data management processes will enhance by the use of EDC systems. Oracle Clinical, Medidata Rave and Inform by Phase Forward are some commonly used EDC Systems.