You can enter and manage clinical trial data electronically in Medidata Rave® EDC. It is comparable to a collection of Electronic Case Report Forms (eCRF). All data related to studies, sites, and subjects collected during a clinical trial are entered and modified in EDC. Specific privileges and functionality that a user has and can access, such as, answering queries and viewing audit trails, is dependent on the user role. Likewise, display of specific pages, for example, a single study, a single site, multiple studies, or multiple sites, is dependent on how EDC is configured.
The Surveillance Data Record (SDR) feature that is woven into EDC enables users to conduct surveillance studies. SDR includes advanced patient management and search capabilities that integrate with the existing Rave Core solution. Once a user selects a patient and navigates to the CRF, all interactions with data are consistent regardless of the study type, whether, open-ended or end-point driven research.
You can do the following in EDC:
Access live and auxiliary studies
Access site listing and perform site search
Access subject listing and perform subject search
View subject summary and perform subject tasks
Add and administer subjects
Maintain subject pages
Add events
Add, enter, and maintain form data
Utilize markings
Review and verify data
Freeze or hard lock data
Batch sign for surveillance records
Create template forms
Enter missing codes
Cancel changes
Perform translation tasks
Inactivate forms
Apply electronic signatures
Maintain lab data and ranges
Upload files or images to forms
Complete elearning training requirements
View Standard reports
Note: A customized Welcome Message displays on the EDC home page, as well as on the Study and Site pages within the EDC module. This message is configured to display for specific studies, specific Roles, or a combination of the two in Rave Welcome Message. Messages are prioritized and configured to display according to date range, or only for Production or Auxiliary studies, or when enrollment falls above or below Study and Site targets.
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