Tag Archives: real-time validation

X EDC: The Next Generation of EDC?

RaveX is an EDC system that is powerful and easy to learn. Medidata has one of the best eLearning and training courses to get anyone up and running from the first time you use the system.

The study design setup still requires high technical skills including C# sharp for most complex data cleaning and study setup tasks.

Let’s discuss the new study hierarchy:

We already understand the relationship between the studies, sites, and subjects in Rave EDC.

At the navigation bar in RaveX EDC, we choose the study from the list of studies assigned to your role. At the second level, we can see the study dashboard. The dashboard contains information about the sites and subject enrollment.  From the sites, you can drill down to the subject level or subject related eCRFs.

Subject’s landing page:

  • Access eCRFs
  • Perform role-specific functions (e.g. SDV, DM data review, PI signature, enter data)

Understanding Status Icons in EDC:

On a form, when you click on an icon, the action is taken on that data point. Based on your roles and permissions, you could apply this action individually or to “Apply All”.

Common status icons:

When you select a subject, you arrive at the subject landing page. Some old features are the scheduled visit dates (a feel and look of the matrix in Rave Architect), the subject status and the status of their eCRFs and some additional information.

At the scheduled level (for Oracle InForm users, this is the Time and Event Scheduled with the traffic lights), you can open a folder and access a particular form residing on that folder.  You can then proceed with normal data entry.

There are several ways to access the same eCRF for another subject. Navigate to it by selecting a subject from the subject list.

Performing data cleaning and data review:

At the study level, select the RaveX study then select the study name you would like to perform a task.

On the screen, select ‘View Task Management’ link and then select the open queries link. At this level, you can select the particular subject and form a query that is opened on. For example, I noticed an open query on the informed consent form. To view it, select the query link on the screening informed consent row.

What modules are still available in this new design?

  • Rave Architect
  • Rave User Administration
  • Rave Site Administration
  • Rave Reporter
  • Rave Configuration
  • Rave PDF Generator
  • Rave Lab Administration
  • and more…

Overall, the EDC solution has been easy to use for database development, data entry, and data validation. The online, real-time validation feature is a plus as it does no longer requires the form to be saved for the checks to fire.

Have we lost any features to this new fancy design? Find out next.

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