Overview

The features of OC4 data entry include the following:

  • A Participant Matrix that allows you to easily see the data entry status of participants.
  • 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 Participant Matrix

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

Click the view icon for a participant 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 participant detail 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.

 

Entering Data

To enter data, in the Participant 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.

 

Concurrency Locking

Two users cannot access the same form for data entry/editing at the same time. If another user is currently editing the form or working with queries on the form you selected, a warning displays, indicating that the form is in use by another user:

You can still view the data on that form, but will not be able to edit data or add/modify queries associated with that form. When the user listed in the displayed message closes that form, logs out, or times out of OpenClinica, the record is released and available for data entry/editing. In most cases, if you see this message, wait a few minutes and try accessing the form again.

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:

Marking a Form Complete

If you indicate that the form is complete, you are prompted to confirm that it is, indeed, complete. Once a form is marked complete, any changes made to data on that form require that a Reason for Change is provided.

A message displays below the edited value, guiding you to provide a reason for change at the bottom of the page.

You can provide an individual reason for each change or, if all changes were made for the same reason, provide one reason for change on the first line of the change form and check the Apply to all check box. Even after applying one reason to all changes, you can edit individual reasons if needed.

Printing a Form

A Print icon is displayed at the top of each form. To print a form, click the icon and complete the Print Settings form:

If you choose the Show History option (show), all queries and editing history for all items on the form are printed as well. Note that the Paper Size and Paper Orientation settings should also be set in your browser’s print menu for them to take effect properly.