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use of databases for integration across functional areas

Process Workflow Changes
Changing from a paper-based data collection system to an electronic-based data collection method requires changes in the approach to data collection, processing and management. Processes in an EDC environment must be re-engineered to optimize all the benefits of the technology. For example, roles and responsibilities of the three key functional groups within a clinical study: the Investigator sites, Clinical Monitors and Clinical Data Managers need to be re-defined to realize the benefits of the technology.
The “flow” of the data must be evaluated and roles and responsibilities of each task adjusted.

Data Collection
In this context, data collection is defined as the design of the eCRFs and the underlying clinical database files during the start-up portion of the study. The EDC application design is critical as it needs to be completed in advance of the first patient being screened into a study; it must conform and follow the study protocol.
The design of an EDC application and eCRF should include all functional groups involved in a clinical study. This involvement will require procedural changes that are different from paper-based studies in how the study is planned and initiated. Not only does the team need to identify what data are required for the study via reviews of the protocol but all edit checks must be defined and programmed into the application during the study design, not after the study has begun.
Recording Data
EDC systems must be designed to facilitate entry, easy to understand and easy to navigate, as site staff do not have the time to learn or use an intricate system. An advantage of most EDC systems is the functionality to alert the site staff when entries are entered erroneously and easily allows them to revise the entry without generating a time-consuming query.
The process of documenting protocol compliance also becomes easier with EDC, as well-designed eCRFs prevent the entry of data that would be a protocol violation.

As data is reviewed and monitored in real time, errors in data entry by the site can be identified and retraining can be performed to prevent further and often more costly errors. Also, errors in eCRF design can also be detected and changed earlier in the process to prevent erroneous data from being recorded.
The monitor can verify source documentation and use their time to evaluate the site’s study conducted and provide remedial actions for any performance issues. Site performance evaluation can also be completed remotely using the metrics provided by the EDC system.

Cleaning Data
One major advantage is the change in the tracking of generation and resolution of queries. The EDC system keeps track of the all queries that are generated through the system, so time and resources are no longer necessary for query tracking.
Since all queries are generated, tracked and resolved in one system, the data cleaning process becomes an integrated process between Clinical Monitors and Data Managers which improves communication between these groups and speeds the process.
Continue reading next week about the Summary Overview of Process Changes and Benefits- Focus on Clinical Ops and CDM Interactions.

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