5.1 Enter Data Directly into Forms

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 - no need to click save/submit as you enter data; all your form data is automatically saved as you go
  • 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

Once you have entered data for Participants, use the Participant Matrix to view and navigate Participant records.

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.

The General Information section displays information about the Participant, the Study, the Site, and the Participant Status.

  • If the study has been set up for manual entry of Participant IDs, the Edit link displays above the Participant information, and the Participant ID can be edited.
  • If the study has been set up for system-generated Participant IDs, the Edit link is not available.
    • If the Participant ID is somehow incorrect and must be edited, contact your Data Manager to change the Participant ID. S/he can temporarily change the settings to manual entry and make the appropriate change. For more information, see Edit Participant ID Settings.

The Participant Details page includes Visit-based events and related forms followed by any common events and related forms. The page initially opens with the visit-based events displayed and all common events collapsed. To expand the common events sections, click the Expand All link to expand all common events, or click an individual common event section to expand only that section.

As part of the study design, events may be archived. This means that they are no longer available for data entry. Common events that contained data prior to being archived are still displayed on the details page. Common events that did not contain data prior to being archived are not displayed.

 

The following example shows the full view of the Participant Details page.

 

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

Access to specific forms may be restricted in your Study. If you receive a message stating that you do not have access, this means that access has been customized in your study and you do not have sufficient privileges to perform the task. 

To enter data, in the Participant Details page, click for the form that you want to enter. If you have access to that form, the form displays and is ready for data entry or editing.

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 as you make any changes to the data. 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, session timeouts, loss of internet connectivity, etc. 

 

 

Some fields may be defined to allow you to upload a file, audio recording, video, or image, or to capture annotations, drawings, or signatures (though these are not 21 CFR Part 11 compliant signatures). If any files have been uploaded into a form, or any annotations, drawings, or signatures added, a download button displays in the field and allows you to download what was collected. The download button is available in edit, review-only, and read-only modes.

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.

When you close this form, all edit checks applied to that form are run. If your changes do not meet the data requirements defined for the items, the following message displays: