e-DC - electronic Data Capture and Management

    The e-DC functionality is a straightforward, logical and user-friendly tool with role-based, user restricted access which allows site personnel (e.g. study nurses, investigators, pharmacist) to capture and access data for patients from their site.

Data capture is facilitated by easy navigation between the e-CRF pages in addition to the automatic display of clear, colour-coded messages. During the data capture process, the completeness and plausibility of the data is enhanced by online queries. Detailed instructions for data acquisition procedures and e-CRF completion are available on each e-CRF page. Site-specific patient overviews provide easy access to any part of the e-CRF via user-friendly status icons.

During the data management process, e-Data Clarification Forms (e-DCFs) are created and posted to site personnel with automatic notifications being sent for e-DCFs requiring urgent resolution. Site users have direct access and can follow simple procedures to resolve posted e-Data Clarification Forms (e-DCFs).

The utilisation of e-SOCDAT™ is straightforward so minimal training is required. However, users do have continuous access to detailed and attractive training support.

Key features and benefits of e-DC are: Secure and user restricted access Straightforward and user friendly with tailored data entry items Minimal training required Clear display of colour-coded messages and prompts during data entry Online instructions for each e-CRF item and page Customised online queries Central overview of visit completion status for all patients at a site Direct access to each patient’s e-CRFs and e-DCFs Easy navigation between e-CRF pages with continuous display of page status Simple processing of e-DCFs Automatic site notification for e-DCFs requiring urgent resolution Possibility to capture additional comments for each data item Dynamic approach for electronic signature process Automatic notification to sites and data management team of tasks to be performed Clean data locked on an ongoing basis

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