Entering Data in OnCore eCRFs

Forms by Status

From the Home Page, navigate to Subjects Menu > Subjects Console > Forms By Status: This divides the forms based on where they are in their life cycle within OnCore. Each of the following statuses will appear on the horizontal toolbar in the Subject Console for users to choose which set of forms they would like to view.

1. Queried Forms - Forms the auditor has entered a query on through the DM Console. Will appear as "Grayed Out" if there are no Queried Forms.
2. To Do Forms - Forms from visits that have been marked as "Occurred" but the forms have not been opened. Once a subject visit is logged on the subject's calendar that has forms associated with it, those associated forms will become available here. As soon as a form from this list has been opened, it will move to the Active Forms tab.
3. Active Forms - Forms that have been opened and data entry has been started and "Saved" but not yet "Completed". These are the forms that are in progress.
4. Completed Forms - Forms that data has been entered in and the coordinator has hit the "Complete" button. Forms that are Completed become available for the Auditor to enter Queries on.
5. Planned Forms - Forms for visits that have not been marked as "Occurred" yet
6. Forms Summary - This section will provide an overall breakdown of the quantity of forms available and what their status is. If you are in the Subject Console, this will give you a subject specific breakdown. If you are in the CRA console, this will be a summary for all subjects on the protocol. 

Enter Data

In order to enter and submit data on an eCRF within OnCore, you will need to make the forms available for data entry. This is accomplished by marking a subject visit as "Occurred" within the subject's calendar. If that visit has forms associated with it, those forms will become available for data entry. 

1. Available Field Types
   1. Date Variable
   2. Free Text Variable
   3. Selectable Drop down Variable
   4. Multiple Checkbox Variable
   5. Radio Button Variable
2. Log Forms
   1. For forms that act as a list of multiple similar events (such as the Toxicity Form), you will need to click "Apply" once you fill in the information for each adverse event in order for the information to be added to the list at the bottom of the eCRF.
      
   2. If you have a Toxicity Form that you will be tracking Adverse Events on throughout the subject's time on the study, make sure you only "Save" the form and wait to "Complete" it until the subject is Off Study.
3. Adding Notes
   1. If you need to add a note to a specific data field, click on the blue button with a square on it next to the field and a pop up will appear that is labeled "Notes". 
      
   2. Enter the information you need to enter and click "Save".
   3. Notes can also be added to the form as a whole by clicking the blue button at the top of the page next to the "Save" button. 
      
   4. Notes made on the forms will be available to the Auditor who is reviewing the forms
4. Saving Forms
   1. There is a green "Save" button at the top and the bottom of each form page. It does not matter which button you use.
   2. Once you've hit "Save" a green banner will appear at the top of the eCRF with the message "Success! Form Saved." to let you know that the information you entered has been saved to the form.
      
5. Completing Forms
   1. When you are done entering data on a form and it is ready to be reviewed by the Data Monitor or the Auditor, you will need to Complete the form.
   2. Open the form and ensure all data is entered correctly.
   3. Click the blue hyperlink "Complete" at the top right of the page.
   4. The form will now be moved to the Completed Status forms.

Respond to Queries

Queries are added by those with the Auditor role in OnCore through use of the DM console. When a query is entered onto a form, this changes the form's Status. The form will move from "Completed" to "Queried". 

1. Open the form that has been Queried
2. There will be an area with an orange triangle on the queried form that corresponds to the field the Data Monitor or Auditor has queried
   
3. Click on the orange question mark to show the query.
4. Close the Query pop-up and make any necessary updates
5. Click the "Edit" box 
   
   
   1. Update the data as necessary
   2. Click "Apply"
6. Re-open the query by clicking on the orange question mark.
7. Click "Respond"
   
8. Enter response into text box.
9. Click "Save"
   1. A timestamp will appear in the query history with the query response and the User who responded.
10. Click "Close"
11. "Save" the form
    1. A pop-up window will appear asking for a reason for the change.
    2. Enter the reason for the change and click "Continue".
12. Click the "Respond" button at the top of the page to send form back to the auditor
    
    
    1. The form's status will now say "Amended" and can be found in the Completed Forms tab.
       

Export Data Logged on eCRFs

1. From the home page, navigate to the eCRFs/Calendars Menu > Biostat Console > Data Export
2. Mark the Check boxes on the right hand side of the page under the Export? column for all of the data forms you wish to have exported
   1. You have the option of filtering by Form Status at the top of the page
3. The Export Format defaults to Excel at the bottom of the page, but you can change this to SAS if desired
4. Click "Export"