Chapter 2. Data Entry

After logging in and selecting a study, you will be taken to the Subjects Page. The Subjects Page and other pages in DFweb share a similar layout.

Figure 2.1. Application Layout

The following features appear in the application layout:

Figure 2.3. Subjects Page

The Subjects page contains a list of the sites you have permission for. The site number and label are shown for each site, along with an indicator of the number of subjects at the site and a progress bar displaying the percentage of subjects with complete data so far. At the top of the list of sites, the total number of subjects and a progress bar displaying the percentage of subjects at all sites with complete data so far. Hover over any progress bar to see more details.

By default, subjects statistics are only displayed when a site is selected. Enable Auto-Load Subject Statistics on the Settings Page to show the Total row and statistics for all sites.

Click one of the sites to open the list of available subjects at that site. If you have access to only one site, the list of subjects will open automatically.

Figure 2.4. Subjects Page with Site Selected

Click a subject to open the subject binder. The icon to the left of the subject ID shows the current status of the subject binder. The status may change over the duration of the study as more visits become required and further data review takes place.

The Subjects Page also provides the following functionality when a site is open:

Figure 2.5. Tasks Page

The tasks page is accessed by selecting Tasks from the left-hand sidebar. It contains a list of the tasks you can run. Click on a task title to view any details and click Start to start the task.

For more details on how to use tasks in DFweb, see Tasks.

Figure 2.6. Queries Page

The queries page is accessed by selecting Queries from the left-hand sidebar. From this page you can browse all the queries in the study. Double-click a query to open the CRF and place the focus on the field with that query.

For more details on how to use the queries view in DFweb, see Queries View.

Figure 2.7. Reports Page

The reports page is accessed by selecting Reports from the left-hand sidebar. This page provides a list of all the DFdiscover reports you have access to. Click any report to open it in a dialog, where you can view the report and customize it with filters and other options.

For more details on how to view reports in DFweb, see Reports.

The Subject Binder contains all the information of the visits and plates related to a subject. The initial page you are taken to is the first visit and CRF for the subject.

2.1.6.1. Subject Binder Sidebar

Figure 2.8. Subject Binder Sidebar

The sidebar displays the current subject, visit, and CRF, as well as providing navigation between CRFs and visits. The current subject is displayed at the top of the sidebar. The rest of the sidebar displays all the visits for this subject that you have permission to view. The current visit is expanded to show all the CRFs in that visit that you have permission to view. CRFs are indented slightly from the visits to help visually differentiate them. CRF and visit labels follow the format [Number]: [Label].

Each visit and CRF has an icon that displays its current status. The meanings of the icons are:

• - This CRF or visit is final, and it is a required CRF or visit.

• - This CRF or visit is incomplete, and it is a required CRF or visit.

• - This CRF or visit is pending, and it is a required CRF or visit.

• - This CRF or visit is missed, and it is a required CRF or visit.

• - This CRF or visit has not been saved, and it is a required CRF or visit.

• - This CRF or visit is final, and it is an optional CRF or visit.

• - This CRF or visit is incomplete, and it is an optional CRF or visit.

• - This CRF or visit is pending, and it is an optional CRF or visit.

• - This CRF or visit is missed, and it is an optional CRF or visit.

• - This CRF or visit has not been saved, and it is an optional CRF or visit.

• - This CRF or visit is final, and it is an unexpected CRF or visit.

• - This CRF or visit is incomplete, and it is an unexpected CRF or visit.

• - This CRF or visit is pending, and it is an unexpected CRF or visit.

• - This CRF or visit is missed, and it is an unexpected CRF or visit.

Click a CRF in the current visit to make it the current and displayed CRF. Click another visit to make that visit current and to display the first CRF in that visit.

2.1.6.2. Form

The main part of the page contains the data entry form. This form allows you to view, add and modify data, queries, reasons, and missing values, and view and add documents to the form.

Data entry forms on DFweb may be presented as either eCRFs or CRFs with backgrounds, depending on the study setup for the plate. Both types of forms contain a header section and a data entry section.

Figure 2.9. Data Entry Form

At the top of the form is a header area for CRF-wide actions. The header remains visible as you scroll through the CRF contents.

Figure 2.10. Data Entry Form Header

The header contains:

• Breadcrumb. The breadcrumb is a navigation aid displaying information about the current study, site, subject, visit, and page. Click the site or study number to return to the Subjects page.

• CRF Label. The CRF label is composed of the CRF number and label. These follow the format [Number]: [Label].

• CRF Help. If CRF help has been provided for this CRF in the study setup, appears in the header area. Click to open the CRF Help Dialog.

• Locked CRF Icon. If the CRF is in use by another user, appears to the left of Save. This indicates that no editing can be done on this CRF.

• Missed Page. If the CRF has been set as missed to indicate it will not be completed for this subject, "Missed" appears to the left of Save. This indicates that no editing can be done on this CRF. To see the reason the page is missed, view the Page History from the CRF menu.

• Read Only. If the CRF is view only based on your study permissions, "Read Only" appears to the left of Save. This indicates that no editing can be done on this CRF.

• CRF Menu Button. Click or to open the CRF Menu, which contains CRF level options such as managing documents and resetting the data entry form.

• Save Button. Click Save to save the changes you have made to the current CRF and submit them to the server. Save is disabled if no changes have been made to the form. Hover your mouse over Save to display a tooltip with the last saved time, the CRF status, and the workflow save level details.

2.1.6.2.1. eCRF

On an eCRF, the remainder of the form is filled by screens, which appear as vertically stacked tabs. Click the corresponding tab to close any screen. The tab with the input focus cannot be closed.

Figure 2.11. eCRF Data Entry Form

Figure 2.12. eCRF Data Entry Form 2

Each screen is composed of rows of fields. Each field can contain:

• Field Input. Each field has an input area. The type of input determines exactly what appears in this area. For more information on input types, see Data Types.

• Date Picker. Date fields have a date picker (). Click to reveal a calendar. Picking a date in the calendar is equal to typing it in the Field Input.

• Field Help. If the study setup has defined help for the field, is visible. Click to display a help tooltip, which can be dismissed by clicking any other area of the page.

• Modified Data Indicator. If a value in the field is unable to be displayed in the input area, it is modified when you open the CRF. shows which fields have been modified. Click the indicator to display more information about the change.

• Required Indicator. If the field is required or essential, appears on the line. Fields with this indicator display a warning message if left blank.

• Reset Button. Choice (Radio Button) and VAS input areas have Reset. This can be used to set the field back to the blank value.

• Field Label. The field label shows the field prompt, if it is available. Otherwise the field description is used for the label. In addition to the field label, instructions may appear above or below the label, above or below the field input area, or to the right of the field input area.

• Metadata Indicators. Q, R, and M are displayed on each line. They allow the user to add, modify and view queries, reasons and missing values for that field. For more information on queries, reasons, and missing values, see Metadata.

• Focus Indicator. A colored bar indicates that the field is in focus, and the color indicates the status of the field. To learn more, see Focus Indicators.

• Units. If units are defined for the field, they are shown in or near the input area. Where they are displayed depends on the type of input.

• Warning Message. Warning messages appear when issues like illegal field values, missing values, or incorrectly formatted information are present in the field. Correct the issue to remove the message.

2.1.6.2.2. Paper CRF

On a paper CRF, each plate is displayed as fields laid out on a background image, and a metadata icon panel floats to the right of the window. The metadata icon panel represents metadata for the currently focused field.

Figure 2.13. Paper CRF Data Entry Form

A paper CRF can contain:

• Field Input. Each field has an input area. The type of input determines exactly what appears in this area. For more information on input types, see Data Types. Field inputs on paper CRFs can have colored borders. For more information on the borders, see Locating Metadata.

• Date Picker. Date fields have a date picker () that becomes visible when the field is focused. Click to reveal a calendar. Picking a date in the calendar is equal to typing it in the Field Input.

• Field Help. For the field that is currently focused, if the study setup has defined help for the field, is visible in the metadata icon panel. Click to display a help tooltip, which can be dismissed by clicking any other area of the page.

• Metadata Indicators. Q, R, and M are displayed in the metadata icon panel. They allow the user to add, modify and view queries, reasons and missing values for the field that is currently focused. For more information on queries, reasons, and missing values, see Metadata.

• Modified Data Indicator. If a value in the field is unable to be displayed in the input area, it is modified when you open the CRF. For the field that is currently focused, in the metadata icon panel shows that the field has been modified. Click the indicator to display more information about the change.

• Focus Indicator. When a field is in focus, the outline color indicates the status of the field. To learn more, see Focus Indicators.

2.1.6.2.3. Locking

When you enter a subject binder and the CRF becomes visible, DFweb attempts to establish a lock on the CRF. If it succeeds, you gain the lock on the CRF and other DFdiscover apps won't be able to edit the CRF until it is unlocked. If someone else already has the lock, your attempt fails and you are shown the locked CRF in read-only mode.

A locked CRF is indicated by a beside the save button. When a CRF is locked, all data fields are in read-only mode, meaning no data can be entered, and no queries, reasons, or missing values can be added to the field. Existing queries, reasons, and missing values can still be viewed by clicking the appropriate button, however all input fields and actions other than cancel are disabled. The Manage Documents dialog is accessible for document review, however no new documents can be uploaded to a locked CRF. Finally, Save and Reset Page are disabled on a locked CRF.

Exiting a CRF, whether by navigating to another CRF, exiting the subject, or logging out, unlocks the CRF.

Figure 2.14. User Profile Page

The User Profile page is accessed from the Application Menu. When your DFdiscover user account was created, a user profile was defined for you. That profile includes your full name, username, and email address, and may include your mailing address and other contact details.

You may update the information in the Contact section at any time by making the changes and clicking Update. Your full name, username, and email address cannot be updated here. Please contact your study coordinating center or DFdiscover administrator if your Profile requires updates.

When you first logged in and set a password, that password was given an expiry date. The number of days before your password expires is shown on this page, along with the option to change your password at any time. Click Change Password to set and confirm a new password.

Figure 2.15. Settings Page

The Settings page is accessed from the Application Menu. The Settings page includes two tabs, one for General settings and one for About details.

Under the General tab, the settings listed below may be customized for the current study, by enabling ( ) or disabling ( ), or selecting a different option. You may not be able to change some settings if they have been locked by the study coordinating center. If you change your settings, these settings will also be used in future login sessions in the same browser, unless the study coordinating center has configured default settings for you.

Under the About tab, the DFweb version and build details are provided along with a link to the build history and privacy policy.

It can occur during data entry that the response to a question is not available. The question may not be relevant, the response is unknown or not applicable, or the response may only be available in the future. With the exception of data fields that are identified as essential, the response for any data field can be recorded as missing. While performing data entry it is important to mark the response for such a data field as missing, rather than leaving it blank. If left blank, a query will be raised during review - was the data field simply skipped or ignored, or was it considered and there is a reason why there is no response? To prevent this uncertainty, missing data must be appropriately identified. Conversely, if data was previously marked as missing and has since become available, the missing designation must be removed and the available data entered. For both situations, the steps are described in Mark a Data Value as Missing.

Edit checks are defined during study setup. They are fragments of logic that enforce study expectations for the data collected. They run interactively during data entry and data review. Edit checks may be run when you enter a CRF or a field, or when you leave a CRF or a field. Edit checks perform various actions, such as displaying messages, adding a query, masking a field, calculating data, or changing data to view only.

The following is an example edit check. Your own study will likely have similar edit check that also masks other fields based on the answer of current field. In the edit check example shown below, the edit check has detected the answer of "Were all inclusion criteria met?" is Yes after field exit. The edit check thus masks the following two fields as there is no need to continue to answer them.

When you have completed data entry on a CRF, you must save your changes before leaving the CRF. To do so, click Save, located near the right side of the header area.

If you leave the CRF before saving, the following dialog is presented:

Select Stay on page to remain on the CRF and save your changes. Select Leave Page to discard the data on the CRF. Your changes are not saved and cannot be retrieved.

If the CRF you have saved requires an electronic signature, after clicking Save, a dialog will appear indicating that the page is eligible for signing.

Provide your username and password and click Sign to execute your electronic signature and save the CRF. The eSignature fields on the CRF (signature, date, time, reason) will be autofilled on the CRF once signed. The eSignature fields cannot be manually entered or changed during data entry.

You have a limited number of tries to enter the correct username and password. If you provide an incorrect password more than the number of tries indicated, the CRF changes will not be saved and you will be automatically logged out of DFweb.

If you do not want to sign the record, click Do not Sign to save the CRF without providing your signature. Click Cancel to return to the CRF without saving your changes.

Once you have signed one CRF, you will only need to provide your password when you sign additional CRFs during that login session.

If data on a signed CRF changes after it was signed, it will need to be signed again.

You can view the history of changes made to a CRF (audit trail) using the Page History option. On any saved CRF, click to open the CRF menu and select Page History to view the history of changes for the current CRF page.

The Page History dialog displays a table with a list changes to the data and metadata for each field on the CRF page. The details include the username of the person making the changes and the date and time of the change. All changes to a field are grouped together under the field description header. If a field is currently selected on the CRF, that field will be outlined in blue in the Page History dialog.

Click to sort the changes from newest to oldest or oldest to newest within each field. Click OK to close the dialog and return to the data entry screen.

Page History is only available when DFweb is connected to DFdiscover server and API version 5.5 or later.

Select Reset Page from the CRF menu to undo all unsaved changes and reset the CRF to the last saved database values. This can be useful if you are interrupted during data entry and lose track of where changes have been made. After confirmation, unsaved changes to data, queries and reasons are discarded.

To allow more room for the main content, the application sidebar is hidden on small displays. When it is hidden, a new button with the hamburger () icon is added at the top left of the page. Clicking this button opens the sidebar, where you can navigate to another application page or switch studies. Click again or anywhere outside the sidebar to hide it again.

On small displays, the login information is hidden from the main view. Click to view your login information in a tooltip.

To allow more room for data entry and review, the subject binder sidebar is hidden on small displays. When it is hidden, a new button with the hamburger () icon is added beside the page title or CRF label. Clicking this button opens the subject binder sidebar. Click anywhere outside the sidebar to hide it again.

On small displays, the organization of the fields on eCRFs also changes. The input area, date picker, units, reset button, and warning message are moved below the rest of the elements of the field, allowing enough room for all elements to be visible and usable. For CRFs with backgrounds, field layouts remain the same on small screens.

The application menu provides functionality that is applicable for the entire study or user session. The following functions are available:

The CRF Menu is only visible on the Subject Binder page. It provides actions for the entire CRF. A file icon on the menu indicates that this CRF has documents attached. A loading spinner on the menu button indicates that the CRF documents are still loading. The following actions are available:

Alert dialogs provide warnings of different events or states in DFweb. Information in alert dialogs is important, and you should read them carefully before closing them. Example alert dialogs include:

DFweb displays confirmation dialogs to warn you of the (potentially unintended) consequences of an action you are about to perform and to give you a chance to cancel the action. Some confirmation dialogs are:

If you have access to more than one study in DFweb, when you log in for the first time or with a new browser or device, the Select Study dialog will appear. Click a study from the list to continue in DFweb.

All the studies you have access to are listed in the Select Study dialog. If a study cannot be opened right now, Not Available will appear on the right. Click to see the reason the study is not available. Use the Search bar to search for a study name, or sort the studies by name or number.

After you have selected a study, if you want to switch to a different study, click on the study name in the header panel (on small displays, click to open the sidebar and click on the study name there). Click any study to open it, which will take you to the Subjects page. To close the dialog without selecting a new study, click X in the top right.

Select Study Help from the Application Menu to open a dialog showing the study help. The content is displayed in the main body of the help dialog. Click to close the dialog.

The CRF help dialog is displayed when the user clicks beside the CRF label. Similar to the study help dialog, the CRF help dialog displays help content in the main section of the dialog, in this case, specific to the current CRF. The dialog is closed by clicking .

On occasion, a change in the study setup can cause a value to be saved to the study database that cannot be displayed in the field. In these cases, DFweb modifies the values as best as possible to make them fit in the field. You are notified of these modifications with this dialog when you open the CRF.

The dialog shows you a list of all fields modified in this way. For each field, the dialog shows you the field label, a message explaining why the value was modified, the value in the database, and what the value is after the modification.

Leaving the CRF without saving causes the modifications to be discarded and the database values to be preserved.

The Attach Documents dialog provides a way to view and add documents to the CRF, and to download attached documents to your device. Documents are displayed in a list, and at the bottom of the list is an area for attaching a new document.

Each document in the list is displayed as a row with the document name, the size of the document, an expand document button (), and a download button (). Click to display the document in the dialog. Some document types cannot be displayed by the browser, so a message is shown in place of the document. Click to download the document to your device. This is especially useful for documents that can't be viewed in the browser as it allows you to open the document with a program designed to open files of that type.

To attach a new document to the CRF, click Choose Files. This opens a file chooser dialog. Select the file you wish to upload, and confirm the selection to close the dialog. Click Upload to attach the document.

	Note
	The label of Choose Files may differ in the browser you are using.

If the CRF has not been saved, attaching a document saves an empty version of the CRF with the status Pending and the document attached. Saving with the CRF save button is still required to save any changes you have made to field values.

At the top right of the Attach Documents dialog is the Download All button (). This button downloads a zip file containing all the documents attached to the CRF. Click Cancel to close the dialog.

The Change Password dialog is displayed when you select Change Password on the User Profile Page, when you login for the first time after being given a temporary password by the study administrator, or when your password expires. The text of the dialog indicates minimum password requirements.

To change your password, enter a new password that matches the requirements in New Password. Then enter the same password again in Confirm Password. If the password does not meet the requirements, an error message is displayed in red below Confirm Password. When you have entered both new and confirm passwords and no error messages show, click Change to submit the new password to the server. If the password change is not successful you are notified by an error message. Click Cancel to close the dialog without changing your password.

The Add Subject dialog is displayed when you click from the subjects list page. It permits you to create a new subject within the range of allowable IDs for the site.

To create a new subject, enter the desired subject ID in Enter Subject ID. Enter the same ID in Confirm Subject ID. When you have entered an ID in both input areas and no errors are displayed, click OK to create the subject. The subject binder page for the new subject is displayed. Click Cancel to close the dialog without creating a new subject.

The Query Dialogs allow you to create (), edit (), reply to () and delete () queries for a field. Separate dialogs are used for each function. For a study in which multiple queries are permitted, there is an additional Multiple Queries dialog to view and initiate actions once a query has been created for the field. Click Q to open the query dialogs for the field. For more details on query dialogs and their use, see Queries.

The Reason Dialogs allow you to create, edit, and delete reasons for a field. Separate dialogs are used for each function. Click R to open the reason dialog. For more details on the reason dialog and its use, see Add a Data Reason.

The Missing Value dialog allows you to set (or unset) a missing value for the field. Click M to open the Missing Value dialog. For more details on missing values and their use, see Mark a Data Value as Missing.

Certain edit checks may offer the opportunity to select a value from a lookup table. The behavior of lookup tables in DFweb is identical to the behavior in DFexplore. For further information, refer to DFexplore User Guide, Using Lookup Tables.

When viewing a record as part of a task, click View Tasks to open the task list dialog. This dialog can be used to view the current task's details, and switch to a new task. See Tasks for more information on tasks.

When viewing the query list, or the query binder, click to open the query filter dialog. Update the filters to change which queries are shown. To learn more about the queries view and query filter dialog, see Queries View.

On occasion DFweb may experience a problem resulting in an error dialog. This can be caused by a problem in network connectivity, the server, or DFweb itself. The dialog content gives details as to the cause of the error. Further detail regarding some errors can be found below. Depending on the error, you may be taken to a different page, or logged out, on closing the dialog.

For additional troubleshooting tips, see Troubleshooting.