SOCAR's e-Clinical solution

e-DC - electronic Data Capture

    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, pharmacists) 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-DataM 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-DataM Clarification Forms (e-DCFs).

Within this functionality, the site personnel can report both serious and non-serious adverse event data and the pharmacovigilance group coordinate and perform all pharmacovigilance related activities.

For any new or updated serious adverse event, an automatic email notification can be sent to authorised safety personnel thereby guaranteeing the reporting of SAEs / SUSARs within required timelines.

This functionality also enables the generation and resolution of SAE related e-DCFs with email notifications being sent to the responsible site personnel when prompt resolution is required. The generation of customisable reports in industry standard formats (e.g. CIOMS, E2B, patient narratives) combines patient data from e-CRFs with information completed in the adverse event section. Workflow between clinical sites and safety management teams is streamlined, resulting in significant time and resource savings.

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 the 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
Timely creation of patient reports (e.g. CIOMS, E2B format) and SAE narratives
Reconciliation of SAEs unnecessary within the system as SAEs are only reported once in the application
Increased efficiency for the management of SAEs
CDISC and ODM import/export compliant


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