Overview

The features of OC4 data entry include the following:

  • A Subject Matrix that allows you to easily see the data entry status of subjects
  • Auto-save – this means there is no need to click save as you enter data; all your data is automatically saved throughout the data entry process
  • Conditional field display – only see the fields that need to be entered IF they need to be entered
  • Automatic calculations and data checks occur in real time
  • Query “bubbles” for easy access to create or view queries for any data point

The Subject Matrix

The Subject Matrix lists visit-based events across the top and subject IDs down the side. Each icon represents the status of the subject/event combination. A legend of the icons is listed on the left side of the screen. Roll over the icons in the Subject Matrix to see more details about the subject event. Click an icon for options to view and/or edit data, depending on your access.

Click the view icon for a subject to see more details for each event that has already been scheduled, and to access forms that belong to “common” events. Common events collect data that is not necessarily related to a specific visit, but may occur between visits (e.g., adverse events, concomitant medications, or early termination). When you view the subject record, all visit-based events are listed first, followed by the common events.

In the above example, notice that common events may be defined as repeating or non-repeating. If the event was defined as repeating, the Add New button is available and you can add as many entries as needed. If the event was defined as non-repeating, you can only add the form to the event once.

If there are multiple forms within a common event, each form repeats independently. In the example above, notice that there are three adverse events, but only two concomitant medications. You can add more adverse events and/or concomitant medications as needed.

Entering Data

To enter data, in the Subject Details page, click for the form that you want to enter. As you enter data, you may see warnings of data issues, questions will display on an as needed basis, and calculations may automatically occur. You’ll also notice that there is no save button. Instead, All changes saved will flash on the screen periodically. This indicates that your changes are saved as you enter the data. This saves you the trouble of clicking save and minimizes the risk of losing any data due to any unexpected interruptions or down-time.

 

Conditional Field Display

Only fields that should be entered are displayed, and this may be based on values that you enter into another field.

For example, detailed questions about the Adverse Event are only available if the response to “Were any Adverse Events experienced?” is “Yes”:

                         

If the answer is “No,” the additional questions are not displayed: