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:
Edit, Read-Only, and Review-Only Mode
Edit Mode: Allows data entry and adding or editing queries; Default for Data Managers, Investigators, Data Entry Users, and Data Specialists (Monitors cannot access Forms in this mode.)
Review-Only Mode: Allows adding or editing queries but user cannot enter data. Monitors automatically access Forms in this mode.
Read-Only Mode: View only (Does not allow data entry or adding/editing queries); User accesses Form in this mode automatically if the Event/Form is locked or another user is entering data.
Participant Contact Data in Forms
You or the Participant can enter contact data in Forms if keywords are included on the Form Template. This is a good way to keep track of contact information, especially because Participants can enter and manage their information.
Only CRC-based and Investigator-based roles or users with permission tags for the Forms can view the contact information (unless the Forms have other permission tags applied to them). If included in a Form, contact information appears in the Participant Contact Table on the Participant Details screen.
(See the instructions on the Form Template for information on how to add Participant Contact Data to Forms.)
Note: Participant contact data is encrypted. Contact data that is entered into a Form with the reserved keywords is not saved with the other Form data.
A Participants phone number must be in the format of:
+# ##
This format:
- Starts with +
- Has up to 3 digits after + for the country code
- Has a space after the country code
- Has up to 14 digits after space for the area code and local code
- Has up to 17 characters total
- Does not have other characters
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:
You have two options:
- Review the data and/or add a manual query:
- Click Cancel and review the value to make sure you entered it correctly. If the value is correct, manually create the query that includes an appropriate message for that value.
- Allow the system to automatically create a query for the item in question
- Click Proceed. The system will auto-generate the query based on the default message text defined in the form.
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.
For a form that has a style of theme-grid, the print options are as follows:
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.
Removing or Deleting a Form from an Event
The Participant Details page includes action icons to remove or delete an Event CRF. These actions function as follows:
- Remove an Event CRF removes access to that specific form data in that event. The data can still be viewed, but it cannot be edited or extracted.
Anything that has been removed can be restored. Click the restore icon for any removed Event Form to restore access to that form data. - Delete an Event Form clears all the data from the form, auto-closes all the queries associated with the form, sets the status of the form to Data Entry Started, and records all details of this action in the Participant’s audit log.
Deleted data cannot be restored – it would have to be re-entered. This action might be used in cases, for example, where a participant’s data was entered into another participant’s form.
Note: If you do not have permission to access a form, you also do not have permission to remove or delete a form. A message displays indicating that you do not have permission to perform the action.
Viewing Data
Once you have entered data for Participants, use the Participant Matrix to view and navigate Participant records.
You can also click Tasks in the header bar of Runtime and select CRFs to go to the Manage CRFs screen. On that screen, you can click the View button next to the Form you want to view.
