Summary

This article describes the process of completing forms and the types of alerts that may occur while filling out the forms.


Table of Contents

As you answer questions and complete forms, the system will dynamically check the data. If any entered data fails the edit checks configured for the study or if required questions are left unanswered, the system will automatically display inline alerts. Additionally, dependent questions may appear based on the answers to previous questions.

 

Data Entry Best Practices

After opening an eCRF, complete Data Entry following the Best Practices Guidelines below:

  1. Complete Data Entry on forms in the order that the forms are presented in the Form Navigation in the Patient’s casebook.
  2. Enter data on the form starting with the first question and proceeding downward to the last question on the form.
  3. Use your Tab key on your keyboard or use your mouse to set your cursor in each response field when moving down the form and entering data.
  4. Follow all formatting directives and/or examples presented when entering data responses such as dates, numeric values, characters requiring capitalization.

Following these guidelines should ensure that you receive a minimum of errors and other complications.

 

Alerts

Red Alerts

Red alerts occur on a form when the entered data is:

  • Inconsistent or illogical based on configured edit checks
  • Out of protocol range
  • Missing but expected


Note: These alerts will not prevent a form from being saved. Red Alerts remain open until they are closed by those with appropriate permissions. When a Reason for Override is provided, they are converted to Grey Alerts.


Depending on the reason for the Alert, it can be resolved in one of the following ways:

  • Complete any blank, required questions
  • Correct data entry errors
  • Manually enter a Reason for Override – This option is used when the red alert cannot be completely resolved based on source document information. The reason for override should be a brief yet meaningful explanation why the data entered is correct regardless of the presence of the alert

 

Black Alerts

Black alerts occur on a form when the data entered is:

  • Improperly formatted
  • Does not meet the expected criteria of a critical question
  • Being changed from the previously stored answer and therefore requires a Reason for Change


Note: These alerts will prevent a form from being saved until they are addressed.


Depending on the reason for the black alert, it can be resolved in one of the following ways:

  • Correct the formatting of the data
  • Select one of the predefined Reasons for Change accessed by clicking the ‘View Choices’ icon
  • Manually enter a Reason for Change

 

Grey Alerts

Grey alerts occur on a form when the Missing Data feature is enabled. With this feature, the person performing data entry can indicate why the field has been left blank. The options made available are Not Done, Not Known and Not Applicable. These alerts will remain grey until they have been closed/approved at which point they will change to blue.

Blue Alerts

Blue Alerts occur on a form when a Red or Grey Alert has been closed or approved. Blue Alerts remain on the form until they are either reopened by those with permission to open them or when a new answer is entered for the question which renders the alert unnecessary.

Dependent Questions

Based on the study configuration, questions that only need to be answered under certain circumstances will remain hidden until needed as shown in the following example. Dependent questions that have an answer, an alert or need a RFC will be visible regardless of the answers to the questions they depend on.


All dependent questions can be made visible at any time through the form level action, View Hidden Questions.

 

Local Lab Ranges

When local lab ranges are included in the study, some forms will contain an indication of the acceptable ranges for questions on the form. These ranges may appear when the form is initially loaded or may appear once all questions used to calculate the appropriate ranges have been answered. The actual content of the local lab section depends on the configuration of the study. Typically it will contain the valid value range.




Note: The data used for the local lab feature may not be clean due to alerts present on the forms. For example, during preprocessing if a black alert is present on a date field, the invalid value is used in the local lab calculation. This may lead to undesired intermediate values until all alerts are resolved.

 

Entering Dates

Using the Date Picker

On questions that take date values as answers, a Jquery calendar will be provided as a date picker. From this menu you will be able to choose dates in a range spanning, by default, 10 years before and ten years after the current year. This can be done by using the dropdown menus to navigate to a specific month, and clicking on the desired date in the calendar.

Note: The date range available is based on the study configuration using the yearRange property in the App Properties worksheet of the DA.


Note: When the Date Picker is open and the Enter key is selected the date highlighted will be populated in the Date field.


 

Formatting Unambiguous Dates

If the study is configured to use the automatic date format feature, when you enter unambiguous dates in a format other than the format accepted for the question, the system will reformat the date accordingly. For additional information on supported date formats, see the App Properties page.

 

 

Save or Cancel Form Data

The ‘Check Data’ or ‘Submit’ button should be clicked any time that data is entered or changed on a form with the intent of saving the data. If you fail to click the ‘Save Form’ button at the bottom of an eCRF and attempt to navigate away from the partially completed form, the following message may appear (based on study design)on your screen:


Cancel Data Entry

After clicking the ‘Cancel’ button on a form, you will be prompted to confirm the cancellation and lose the data entered on the form as shown in the following example. If you wish to cancel the data entry, click the ‘Yes’ button. To remain on the page, close the confirmation window by clicking the ‘x.’

 

Save Blank Forms

In some cases, a form may need to be saved without data.

  1. Navigate to the form that needs to be saved without any data.
  2. Click the ‘Check Data’ button.
    Alerts will appear on all required questions.
  3. Answer any alerts that must be answered prior to saving.
  4. Click the ‘Save Form’ button.

 

Cannot Save Data Notification

When required questions are left blank on a form, the ‘Save Form’ button will be replaced by a ‘Cannot save. Why?’ button.


After clicking the ‘Cannot save. Why?’ button, the system will inform you as to why the form cannot be saved and alerts will appear on questions preventing you from saving the form.


You can then save the form with the open alerts or resolve the alerts prior to saving the form.


Edit Reason for Override

Each question on a Form (eCRF) has an audit icon displayed in the body of the alert followed by a Reason for Override: explanation field.

The icon launches a Reason for Override dialog for the alert question. Find the correct permissions in the Data Architect file on the Roles tab. With either permission the system displays the audit icon whether or not you have an existing audit entry. However, only with editViolation can you update existing entries once in the dialog.

 

The Reason for Override dialog contains two text fields for entries with an Audits table recording the history of that alert for the specific subject record. The updates are listed chronologically, with the most recent entry at the top of the tablular listing. In addition to any entered Reason for Override, the audit history will reflect any updates to Missing Data values logged to the field, if enabled for the study. Note that the only required field in the dialog is Reason for Change. If you make a change to the Reason for Override text field (remove entry, etc.), you are required to outline why you made the override text field change in the Reason for Change text field.

 

Selecting the Edit button closes the dialog and updates the table with your new entries. Optionally, you can select the Close button to close the dialog without making any changes or updates.


Note: The Reason for Override audit icon disappears from the form when data is changed. The icon will reappear when the Save or Cancel button is selected.

 

Network Connection Problems

When a network connection is lost during the processing of background requests, such as the preprocessing of forms or the retrieval of contact details, the system will display a confirmation box that informs you about the issue. By clicking the “Ok” button, you can attempt to reconnect. Clicking the “Cancel” button will end the session for the browser. In this case there is no way to reconnect and save the unsaved data; if required, you can copy the unsaved data out of the form prior to closing or refreshing the browser window.




Need more help?

Please visit the Fountayn Contact Information page.