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Oracle® Clinical Remote Data Capture Classic Data Entry User's Guide
Release 4.6.2

Part Number E18824-01
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16 RDC Classic Windows

This section describes the windows that are present when you are entering the data in the RDC Classic application. It consists of the following topics:

Data Entry Window

This section describes the Data Entry window components and provides an overview of its functionality. It also includes topics that describe the windows that are related to functionality associated with the Data Entry window.

This section covers the following topics:

Discussion

The Data Entry window is the primary tool that you use to record, review, and modify response data. For each CRF in the study, the application displays an electronic representation of the CRF header, which contains information that identifies and describes the CRF; CRF section header(s), which, if present, contain information that identifies and describes each CRF section; and the questions and response fields, which are used to collect the response values.

Access

In general, you access the Data Entry window by clicking on a CRF cell.

Several other factors can affect whether the system opens the Data Entry window:

  • If you click a CRF cell that represents a CRF that is not part of the workset, the system displays a message window and does not open the Data Entry window.

  • If the CRF is not part of the current book, the system displays a window that allows you to change the book. If you choose to not change the book, the system does not open the Data Entry window.

Components

Table 16-1 describes the three main components of the Data Entry window.

Table 16-1 Major Components of the Data Entry Window

Label Description

Title Bar

Provides relevant information about the current CRF displayed in the Data Entry window.

CRF Header

Provides a location to collect information about the CRF, such as the date, time, and comment.

CRF Section

The location where CRF questions are listed and you record the response data for each applicable question. It is also where you review and update data.


Title Bar

The Data Entry window Title bar serves three purposes:

  1. It displays pertinent information about the current CRF and the data point in focus.

  2. It provides access to the Sizing Window (refer to "Re-size the Data Entry Window").

  3. It provides a means to close the Data Entry window (refer to "Close the Data Entry Window").

The information that can be displayed in the title bar of the Data Entry window includes:

  • Patient number

  • Page number

  • CRF name

  • Event number

  • CRF page number

  • Response field information

CRF Header

The Data Entry window header is present at the top of every CRF. It is used to capture information about the CRF. It includes three standard items:

  1. Visit date text box

  2. Blank check box (the "blank flag")

  3. Comment text box

Figure 16-1 Typical CRF Header (with the Title Bar)

Description of Figure 16-1 follows
Description of "Figure 16-1 Typical CRF Header (with the Title Bar)"

Comment Text Box

The CRF Header allows you to attach a text comment to a CRF by using the Comment text box. Place the cursor in the text box and type the comment you wish to include.

Note that comments that are entered here are associated with the entire CRF, not with a particular datapoint.

CRF Section

The bulk of the Data Entry window is comprised of the CRF Section area, which is where you work with patient data. In RDC Classic, a section is a grouping of like questions in a CRF.

Multi-section CRF Data Entry Windows

When the Data Entry window displays a multi-section CRF, several features that may not be displayed in single-section CRFs are present.

Figure 16-2 Example of a Multi-section CRF Data Entry Window

Description of Figure 16-2 follows
Description of "Figure 16-2 Example of a Multi-section CRF Data Entry Window"

When performing data entry for a multi-section CRF, process each section in the sequence in which it is presented. This means, for each CRF section, you should:

  1. Complete any required values in the section header.

  2. Complete the questions in the question area.

  3. Proceed to the next CRF section.

If you must work with only one CRF section and it is not the first section in the CRF, mark each section prior to it as blank, by selecting the blank flag in the section header, and navigate to the next section until you reach the section on which you want to work.

Sizing Window

You can use the Sizing window lets you move and/or re-size the Data Entry Window. The system applies the changes that you make to the Sizing window, that is, the way that you re-size and re-locate it, directly to the Data Entry window. These changes persist for the current session. This section describes the purpose and functionality of the Sizing window.

Access

You access the Sizing window by clicking the Data Entry window title bar. It allows you to modify size and position of the Data Entry window.

Oracle recommends that you resize the Data Entry window, if necessary, so that the Spreadsheet view tabs, the current patient list, and the task tabs remain visible.

Figure 16-3 Sizing Window

Description of Figure 16-3 follows
Description of "Figure 16-3 Sizing Window"

Components

The Sizing window is a window that the system allows you to re-size and/or re-position. It consists of instructional text and two components to close the window when it is the correct size and in the appropriate position. These components are:

  1. Done button

  2. "X" button

Usage

This section describes how to use Data Entry window components to complete the following tasks:

Complete the CRF Header

The CRF header is located at the top of the Data Entry window. When you open a CRF, RDC Classic places focus in the first required field in the CRF header. You must complete all required fields in the CRF header before RDC Classic assigns the entry status "Created" to the CRF.

The CRF header collects and stores information about the CRF, such as the patient name, visit number, visit date, etc. RDC Classic automatically collects a portion of this information based on the CRF cell you click to open the CRF. However, you may be required to provide certain other information that RDC Classic cannot automatically discern, for example, the date that the visit took place.

The CRF header area of the Data Entry window contains fields that collect required information about the CRF. It may also contain fields that collect optional information, for example, a Comment field.

All required fields in the CRF header must be complete before you can begin to enter response field data in the CRF question area.

Use the instructions in the following sections to complete the CRF header fields in a CRF.

Visit date field

The Visit Date field may or may not be present in a CRF header and, if present, can either be required or optional. When you create a CRF by clicking an empty CRF cell, if the date is required, you must enter a valid date before you can proceed to other parts of the Data Entry window. However, the functionality is identical in the required and optional cases. When focus is in the Visit Date field, there are several methods you can use to record a date.

Method Description
Type value Use the current date input format to type the correct visit date in the field. (Refer to "Date Format" for information about this Preferences Window setting.)
Shortcut key Type:
  • "T" for today's date

  • "Y" for yesterday's date

  • "L" for the last entered value

LOV Open the List of Values window, which displays:
  • all previously entered visit dates

  • Today (the current date)

  • Yesterday (the previous day's date)

  • Last Entered (the most recently entered date in the current session)


When focus is in the Visit Date text box, a List of Values (LOV) button is displayed, If you click the button (or type F9) the Visit Date window opens. The graphic in Figure 16-4, "Visit Date Window" depicts a typical example of this window, which allows you to select from a variety of dates, such as the current date (Today), the previous day's date (Yesterday), the date you last entered, and a the dates that you have entered for the current visit for the current patient.

Figure 16-4 Visit Date Window

Description of Figure 16-4 follows
Description of "Figure 16-4 Visit Date Window"

After the correct date is displayed in the field, use either the Tab or Enter key to navigate to the next field, which is:

  • the next required CRF header field, if present, or

  • the first response field in the Question area of the first CRF section.

Alternatively, you can use the mouse to navigate to another CRF header field. This is necessary if you want to complete an optional CRF header field because RDC Classic does not automatically navigate to such fields.

Comment field

A comment field is included in the document header of a CRF to provide a means for you to associate a text message to the entire CRF.

To insert the comment, put focus in the Comment text field and type the message you want to include. The maximum length available for the comment is 200 characters.

You can also use the RDC Classic Field Editor to type the comment. This is particularly useful if the text of the comment exceeds the viewable portion of the field.

Select Edit, then Field Editor from the option list (or the Alt+e, e quick key combination) to open the Field Editor Window.

Process the Blank Flag in a CRF or CRF Section Header

The Blank check box is used to mark the current CRF as "blank." When you select the check box, you are presented with a confirmation window that prompts you to confirm that you want to mark the CRF as blank and then save it (refer to Figure 16-5, "Blank CRF Confirmation Window").

  • If you click the OK button, the CRF is saved and the next CRF in sequence is opened in the Data Entry window (depending on Automatic Progression settings).

  • If you click the Cancel button, the confirmation window closes and the Blank check box is cleared.

Figure 16-5 Blank CRF Confirmation Window

Description of Figure 16-5 follows
Description of "Figure 16-5 Blank CRF Confirmation Window"

Note:

If you mark as blank a CRF that has already been created and for which data has already been entered, the data is deleted from the CRF. However, the delete action is captured in the Audit Trail for each individual datapoint.

Re-size the Data Entry Window

Changes to the size and position of the Data Entry window allow you set up your work environment for maximum efficiency. When you change the Data Entry window, your choices are persistent throughout your work session.

There are two methods that allow you to change the size and/or position of the Data Entry window. Both are invoked by clicking on the Data Entry window title bar:

  • Step-wise, or discrete re-sizing and/or re-positioning, using the right-click menu

  • Free-form changes in size and/or position, using the Sizing window

Before you can move and/or resize the Data Entry window, you must open the Sizing Window. You use this window to change the size of the Data Entry window. You also use it to move the Data Entry window to a new position. Any changes, in size and/or position, that you make to the Sizing window are made to the Data Entry window after you close the Sizing window.

  • To access the Sizing window; single-click on the Data Entry window title bar

  • To close the Sizing window after moving and/or resizing; click the Done button.

To change the size or position of the Data Entry window:

  1. Single-click on the Data Entry window title bar. The Sizing window is displayed. It is the same size and in the same position as the Data Entry window.

  2. Depending on which action you wish to perform, do these steps:

    1. To move the window:

      • Click-drag the Sizing window title bar.

      • Move the window to its desired position.

      • Release the mouse button.

    2. To resize the window:

      • Move the mouse pointer over the border you wish to change.

      • When the pointer changes to a double-headed arrow, click-drag the border to resize the window to the desired position.

      • Release the mouse button.

  3. Repeat Steps 2a and 2b until the window is the size and in the position you choose.

  4. Click the Done button.

You can also change the size of the window through menu commands. Using this method allows you to change the size and position of the Data Entry window in one direction at a time. There are two choices for each change:

  • a relatively small change, or

  • the maximum or minimum change that the system allows.

You access this method by right-clicking on the Data Entry window title bar, which displays a menu of options. Table 16-2 describes the function of each command in the Sizing window.

Table 16-2 Functionality of Menu Commands in the Sizing Window

Menu Command Description of Window Change

Left

Move the window one unit to the left

Right

Move the window one unit to the right

Up

Move one unit up

Down

Move one unit down

Max Left

Move as far left as permitted

Max Right

Move as far right as permitted

Max Up

Move as far up as permitted

Max Down

Move as far down as permitted

Increase Height

Increase the vertical size one unit

Increase Width

Increase the horizontal size one unit

Decrease Height

Decrease the vertical size one unit

Decrease Width

Decrease the horizontal size one unit

Max Height

Increases the vertical size as much as permitted

Max Width

Increases the horizontal size as much as permitted

Max Size

Increase the horizontal and vertical size as much as permitted

Min Height

Decreases the vertical size as much as permitted

Min Width

Decreases the horizontal size as much as permitted

Close

Closes the Data Entry window


Close the Data Entry Window

Use the "X" button that is in the far right-hand side of the Title bar to close the Data Entry window.

  • If there are no changes pending, the Data Entry window closed immediately.

  • If there are pending changes, you are prompted to do one of three choices (refer to Figure 16-6, "Confirm Close with Pending Changes" for a graphic of the confirmation window):

    1. Yes - save the pending changes and close

    2. No - close the Data Entry window without saving the pending changes

    3. Cancel - go back to the Data Entry window without closing or saving pending changes.

Figure 16-6 Confirm Close with Pending Changes

Description of Figure 16-6 follows
Description of "Figure 16-6 Confirm Close with Pending Changes"

Windows Associated with Data Entry Tasks

This section provides descriptions of the windows that RDC Classic presents when you are completing data entry tasks.

Investigator Comment Window

The Investigator Comment window allows you to associate an investigator comment with the response field that is in focus in the Data Entry Window. You also use the window to review or update an existing investigator comment.

Access

Because each investigator comment must be associated with a particular datapoint, you must have the Data Entry Window open and focus must be in a data field in order to insert a comment.

Figure 16-7 Investigator Comment Window

Description of Figure 16-7 follows
Description of "Figure 16-7 Investigator Comment Window"

There are two ways to open an Investigator Comment window so you can initiate an comment:

Components

The Investigator Comment window is a simple feature, comprised of three main components:

  1. a text area

  2. an OK button

  3. a Cancel button

Use the text area to compose the comment. The comment may be up to 2000 characters (including spaces) in length.

When you complete the comment and want to save it, click the OK button. If at any point before you click the OK button you decide not to add a comment to this datapoint, click the Cancel button.

Usage

You can use standard Microsoft Windows keyboard functionality as you compose or edit the investigator comment. This includes copy, cut, and paste shortcut key combinations.

Task Reference

The following tasks use the Investigator Comment window:

Audit Information Window

This section describes the different types of Audit Information window, describes the situations under which the system displays each, and provides usage information.

The following four windows are covered in this section. Each is a different version that is displayed in specific circumstances. Three of the windows consist of identical sets of components, while the fourth is slightly different due to variations in processing CRF header and CRF section header updates.

  1. Audit Information for Data Change

  2. Audit Information for Investigator Comment Change

  3. Audit Information for CRF Deletion

  4. Audit Information for CRF Change.

Discussion

The Audit Information window allows you to select a change reason and include comment text when you update a CRF that is at the entry complete data entry status.

RDC Classic audits every change that a CRF undergoes and includes a system-generated reason for each change. However, when the CRF reaches entry complete status, such that changes to response data are considered data updates, RDC Classic prompts you for a user-specified change reason each time you update a datapoint. You choose the change reason from among a set of choices that your system administrator defines. In addition, you are provided the opportunity to augment the change reason with an optional text message.

When it is displayed, a change reason is pre-selected, based on your user role and the study design. You can, however choose another reason from an LOV.

Access

The Audit Information window is displayed automatically when you initiate a change in a CRF that must be audited with a user-supplied change reason.

An Audit Information window It is displayed in the following circumstances: whenever you update a datapoint in a CRF that has an entry status of "Entry Complete."

Table 16-3 Display Conditions for Audit Information Windows

Window Conditions for Display

Data Change

When you change the contents of a response field and attempt to navigate away from the field.

Investigator Comment

When you click the OK button in the Investigator Comment window.

CRF Deletion

When you click the OK button in the Delete CRF window.

CRF Change

Change CRF or CRF section header information, including the Blank flag. The window is displayed for the first change and the system automatically uses the change reason selected for all subsequent CRF changes until the CRF is saved.


Figure 16-8 Audit Information for CRF Change Window

Description of Figure 16-8 follows
Description of "Figure 16-8 Audit Information for CRF Change Window"

Response Data Change

The system displays the Audit Information for Data Change window when you change the value of a response field in a CRF that is at the entry complete status.

If there is a pending change to the investigator comment associated with the current response field when you update the response, this window displays the change reason you specified for the investigator comment update. You can then use this window to alter the change reason, the optional comment, or both. Any changes you make to the Audit Information window are then applied both to the response field and the investigator comment.

If you want to use a different change reason for the investigator comment, save pending changes after you update the comment and before you modify the response field.

Investigator Comment

The system displays the Audit Information for Investigator Comment window when you initiate a new or update an existing investigator comment in a response field that is part of an entry complete. However, if there is an update pending to the associated response field, that is, if you changed the response value and have not saved the change, the system does not display this window when you update the investigator comment. Rather, it uses the change reason that you specified for the update to the response.

If you want to use a different change reason for the investigator comment, save pending changes prior to updating the investigator comment.

Refer to "Update an Existing Investigator Comment" for a complete description of this task.

CRF Change

The system displays the Audit Information for CRF Change window when you change the value of any field in a CRF header or CRF section header for an entry complete CRF.

Only one change reason can be associated with changes to the header information for a given save action. When you change one header field and select a change reason, the system uses that change reason and comment (if supplied) for subsequent changes to header fields until the CRF is saved.

If you want to change more than one header field and provide different change reasons for each field, save pending changes after each update.

CRF Deletion

The system displays the Audit Information for CRF Deletion window when you delete an entry complete CRF.

Components

The Audit Information windows are comprised of the components that are listed and described in Table 16-4.

Table 16-4 Audit Information History Window Components

Label Type Description

Change Reason

Text Field w/LOV

A short description of the change reason; you can use the LOV to choose another reason from the Audit Change Reason Type Codes Window.

Description

Info Text

A read-only, long description of the currently selected Change Reason.

Comment

Text box

A text box that allows you to type an explanatory comment that is associated with the change. The comment is displayed in the Comments field of the Audit History Window.

Save

Button

Initiates an explicit save, which commits the data update, the Change Reason, and the Comment (if present) to the study database.

This button is present in all windows except the Audit Information for CRF Change window.

OK

Button

Sets the CRF header and/or CRF Section header update(s) and the change reason as pending changes which are saved the next time the CRF is saved.

This button is only present in the Audit Information for CRF Change window.

Cancel

Button

Closes the window and puts the data field in focus, which allows you to revert back to the original value of the response.

Note that this button is unavailable in the CRF Delete and Investigator Comment Change versions of the window.

Note

Explanatory text

Specifies how RDC Classic processes pending changes in the CRF header and CRF section header.

This component is only present in the Audit Information for CRF Change window.


Change Reason

The Change Reason component displays the default selection from the sponsor-defined Change Reason Type Code List. The list includes a default change reason that is associated with your user role, which the system selects by default. When you select a change reason other than the default, that choice becomes the new default change reason.

There are two sets of change reasons. Each set is defined by the sponsor, however, one set is specific to CRF changes, that is, changes to CRF and CRF section header information. The system accesses the second set for all other actions that use an Audit Information window.

Usage

When the system displays the Audit Information window, a default value is displayed in the Change Reason text field. You have the option to use the default or to select an alternative from the sponsor-defined list of change reasons. To view the list, click the LOV button adjacent to the Change Reason component, which causes the Audit Change Reason Type Codes Window to open.

To include a comment with the change reason, place the insertion point in the Comment text box and type the comment. You can also paste the contents of the Windows Clipboard in the text box. Use the Ctrl-c key combination to copy text to the Clipboard and then use the Ctrl-p key combination to paste the text into the text box at the insertion point location.

Audit Change Reason Type Codes Window

This window provides a list of change reasons for the current task you are performing on an entry complete CRF.

Access

You access the Audit Change Reason Type Code window by accessing the Change Reason LOV in an Audit Information window.

Figure 16-9 Audit Change Reason Type Code Window

Description of Figure 16-9 follows
Description of "Figure 16-9 Audit Change Reason Type Code Window"

Components

The Audit Change Reason Type Codes window consists of a text box, labeled "Find," that allows you to search the list of change reasons, which are displayed in a tabular field below the text box. There are three buttons that allow you to initiate a search, select a change reason, and cancel the action by closing the window.

Audit History Window

The Audit History window (refer to Figure 16-10) allows you to view the intervening changes that have occurred to a response value between its "Current value," and its "Original value," as it is displayed in the Audit Trail. It provides a row for each change to the datapoint that describes:

  • when the change was made

  • what the new value is

  • who made the change

  • why the change was made.

The window displays a row of data for changes that correlate to columns in the Audit Trail task tab:

  • one row for the Original value

  • one row for the Current value

  • one row for each intervening change.

The number of rows for intervening changes equals the number displayed in the Intervening Changes column in the task tab.

Figure 16-10 Audit History Window

Description of Figure 16-10 follows
Description of "Figure 16-10 Audit History Window"

Access

You access the Audit History window by clicking the Show button on the Audit Trail for a given response field.

Components

The information in the Audit History window is organized into columns and rows. Each field is described by its column header. The fields in the window are read-only, that is, you cannot edit any of the information that is displayed. Table 16-5, "Listing and Descriptions of Components in the Audit History Window", lists and describes the components in the window.

Table 16-5 Listing and Descriptions of Components in the Audit History Window

Label Type Description

Descriptive title

Title bar

The window title and descriptive information about datapoint.

Date

Field

The date and timestamp of the change to the datapoint.

Value

Field

The value that the datapoint was changed to.

By

Field

The user name of the person who changed the value of the datapoint.

Reason

Field

The change reason that was given at the time the datapoint value was changed.

Comment

Field

The optional comment that was included with the Audit Information Window.

OK

Button

Closes the window.


Windows Associated with CRF Approval

The Password confirmation windows allow you to approve or rescind approval for a CRF with the equivalent of an electronic signature.

This section consists of the following topics:

Approval Password Confirmation Windows

The Password Confirmation window is displayed whenever you approve a CRF. The following actions will cause it to be displayed:

  • initial approval

  • re-approval.

When you approve a CRF, you type your user name in the Password text box of the Approval and press the Enter key. This action displays a version of the Password confirmation window that is specified for approving CRFs.

Discussion

There are two Password confirmation windows that are associated with the Approval and the approval process. While the components of each are similar, each is displayed at a different point in the approval process. The first is the "Approval" Password Confirmation window, which is displayed whenever you approve a CRF (refer to Figure 16-11, ""Approval" Password Confirmation Window"). The second is the "Undo Approval" Password Confirmation window, which is displayed whenever you undo the approval of a CRF (refer to Figure 16-12, "Password Confirmation Window for Undo Approval").

Refer to "Approve a CRF" for further information about the procedure to approve a CRF.

Figure 16-11 "Approval" Password Confirmation Window

Description of Figure 16-11 follows
Description of "Figure 16-11 "Approval" Password Confirmation Window"

Components

There are five components of the Password Confirmation window. Four of the components are identical for the "Approve" and the "Undo Approval" windows. The only component that is different is the explanatory text, which describes the action that is occurring, i.e., you are either performing an approval or undo approval operation.

Table 16-6 lists and describes the components of that are present in the Password Confirmation windows.

Table 16-6 Password Confirmation Window Components

Label Type Description

Explanatory Text

Info Text

A description of the action you are taking. There is a different message for approval and undo approval. Each is configurable by your sponsor.

Username

Text box

Location where you type your user name, including the OPS$ prefix. This field is not case-sensitive.

Password

Text box

Location where you type the password that is associated with your user name. Each character is represented by an asterisk. This field is case-sensitive.

OK

Button

Performs the action you initiated on the Approval task tab and closes the window.

Cancel

Button

Dismisses the action you initiated on the Approval task tab and closes the window.


The explanatory text that is included in the window is dependent on which operation you are preforming.

When you perform initial approval of a CRF by typing your password in the text box that is in the Approval task tab and pressing the Enter key, the Password Confirmation window is displayed with your password pre-filled in the appropriate field, you are only required to type your user name (included the OPS$ prefix).

Undo Approval Password Confirmation Window

The system presents a password confirmation window when you initiate an undo approval action. It is similar to the window that is displayed during the approval action.

Figure 16-12 Password Confirmation Window for Undo Approval

Description of Figure 16-12 follows
Description of "Figure 16-12 Password Confirmation Window for Undo Approval"

Access

The Password Confirmation window is displayed whenever you undo the approval of a CRF. When you undo an approval, you click the Undo Approval button on the Approval. This action displays a version of the Password Confirmation window that is specified for undoing the approval of CRFs.

Refer to "Undo CRF Approval" for further information about the procedure to undo approval for a CRF.

Components

There are five components of the Password Confirmation window. Four of the components are identical for the "Approve" and the "Undo Approval" windows. The only component that is different is the explanatory text, which describes the action that is occurring, i.e., you are either performing an approval or undo approval operation.

Table 16-7 lists and describes the components of that are present in the Password Confirmation windows.

Table 16-7 Password Confirmation Window Components

Label Type Description

Explanatory Text

Info Text

A description of the action you are taking. There is a different message for approval and undo approval. Each is configurable by your sponsor.

Username

Text box

Location where you type your user name, including the OPS$ prefix. This field is not case-sensitive.

Password

Text box

Location where you type the password that is associated with your user name. Each character is represented by an asterisk. This field is case-sensitive.

OK

Button

Performs the action you initiated on the Approval task tab and closes the window.

Cancel

Button

Dismisses the action you initiated on the Approval task tab and closes the window.


The explanatory text that is included in the window is dependent on which operation you are preforming.

When you perform initial approval of a CRF by typing your password in the text box that is in the Approval task tab and pressing the Enter key, the Password Confirmation window is displayed with your password pre-filled in the appropriate field, you are only required to type your user name (included the OPS$ prefix).

Windows Associated with Managing Discrepancies

This section describes the windows that you work with while managing discrepancies:

Discrepancy Windows

You can use the discrepancy windows to modify existing univariate, manual, and section discrepancies. This includes updating Error Messages, Comments, Comment Reason (for manual and section discrepancies), and taking action. You must use the Individual discrepancy tab to work with multivariate discrepancies.

The windows that are displayed for the following discrepancies are all comprised of similar components. Refer to these topics for a description of each window:

The following table (Table 16-8) lists the type of discrepancy that you use each of these windows to manage.

Table 16-8 List of Windows Used for Univariate and Manual Discrepancies

Discrepancy Window name Description

CRF Page (section discrepancy)

Discrepancy for CRF Section Window

Used to enter a manual header discrepancy, which is associated with a CRF page. Subsequent editing and actions for the discrepancy must be done through the Discrepancy.

Multiple manual header discrepancies can be initiated for a CRF by selecting Insert, then Data Entry from the option list.

Manual discrepancy

Comment for Question Window

Used to enter or edit a manual discrepancy, which is associated with a response datapoint. Subsequent editing and actions for the discrepancy can be done in this window or in the Discrepancy.

One manual discrepancy can be associated with a response datapoint.

Discrepancy

Validation Failure Window

Displayed as the result of an edit check of a value entered in a response datapoint. Used to alert the user to the occurrence of the discrepancy; to describe or add to the discrepancy Message or Comment; and to take action on the discrepancy. Subsequent editing and actions for the discrepancy can be done in this window or in the Discrepancy.

One discrepancy can be associated with a response datapoint.


Discrepancy for CRF Section Window

The Discrepancy for CRF Section window allows you to add a section discrepancy that is associated with a CRF. Figure 16-13 is a graphic that depicts a typical Discrepancy for CRF page window.

Access

The Discrepancy for CRF page window is displayed when you select either:

  1. Insert, then Section Discrepancy from the option list, or

  2. Edit, then Section Discrepancy from the option list when a section discrepancy is already associated with the CRF section

  3. Click the New button on the Discrepancy task tab; when you do this, the system displays a window that allows you to choose which type of manual discrepancy, CRF section, or response field, that you want to add.

You can associate more than one section discrepancy with a CRF.

Figure 16-13 Discrepancy for CRF Page Window

Description of Figure 16-13 follows
Description of "Figure 16-13 Discrepancy for CRF Page Window"

Components of the CRF Section Discrepancy Window

The components of the Discrepancy for CRF page window are listed and described in Table 16-9.

Table 16-9 Components of the Discrepancy for CRF Page Window

Label Type Description

Operator Comment Reason

LOV

A pre-filled LOV that allows you to specify the reason that you are inserting the manual header discrepancy.

Message

Text box

An editable text box for comments that are displayed in the Text field on the Discrepancy task tab.

Message editor

Button

Provides access to a text editor you can use to compose the Message.

Comments

Text box

Location for a text comment that is displayed in the Comments field on the Discrepancy task tab.

Internal Comment editor

Button

Provides access to the Internal Comment Window.

Internal Comment History

Button

Provides access to the Internal Comment History Window

Save

Button

Saves all pending changes and closes the window.

Cancel

Button

Discards all pending changes and closes the window.

Status

Info Text

Displays the current status of the discrepancy.

Action

Drop-down list

A drop-down list that gives you access to the set of Discrepancy Actions available.

Review Status

Info Text

Displays the current review status of the discrepancy.

Resolution Code

Info Text

Displays the Resolution Reason for discrepancies that are resolved.

Resolution Comment

Text box

Displays the reason that was given when the discrepancy was resolved.

Resolution Comment Editor

Button

Provides access to the Resolution Comment editor.


Comment for Question Window

You use the Comment for Question window to review, insert or update a manual discrepancy that is associated with the individual response field

The graphic in Figure 16-14 depicts a typical Comment for Question window. In this case, a manual discrepancy is about to be inserted for a question named "Systolic BP."

Each response field can have one open manual discrepancy associated with it.

Figure 16-14 Comment for Question Window

Description of Figure 16-14 follows
Description of "Figure 16-14 Comment for Question Window"

Access

If a manual discrepancy is not associated with a response field, you can use the Comment for Question window to initiate a discrepancy by selecting Insert, then Discrepency (manual) from the option list.

If a manual discrepancy is associated with a response field, you can use the Comment for Question window to review or update the discrepancy record by selecting Edit, then Discrepency (manual) from the option list.

Components of the Comment for Question Window

The components of the Comment for Question window are listed and described in Table 16-10.

Table 16-10 Components of the Comment for Question Window

Label Type Description

Question name

Title bar

Informative text that describes the currently active question.

Comment Reason

LOV

An LOV that allows you to select a reason from a set of sponsor-defined choices.

Message

Text box

An editable text box for typing the error message that you want to display in the Text field on the Discrepancy task tab.

Message editor

Button

Provides access to a text editor you can use to compose the error message.

Comments

Text box

A location to type an explanatory comment that augments the error message.

Internal Comment editor

Button

Provides access to the Internal Comment Window.

Internal Comment History

Button

Provides access to the Internal Comment History Window

Save

Button

Saves all pending changes and closes the window.

Cancel

Button

Discards all pending changes and closes the window.

Status

Info Text

Displays the current discrepancy status of the discrepancy.

Action

Drop-down list

A drop-down list that provides access to the set of discrepancy actions.

Review Status

Info Text

Displays the current review status of the discrepancy.

Resolution Code

Info Text

Displays the Resolution Reason for discrepancies that are resolved.

Resolution Comment

Text box

Displays the resolution reason that accompanied the resolution action.

Resolution Comment Editor

Button

Provides access to the Resolution Comment editor.


Task Reference

The following tasks use this window:

Validation Failure Window

This window is displayed when you enter or update a datapoint with a value that violates the criteria established for that question in the study protocol. This causes a univariate discrepancy for that response datapoint.

The graphic in Figure 16-15 depicts a typical Validation Failure window. In this case, the letter "D" has been typed in a data response field for a question that collects values for gender. The study is designed such that the system expects either an "M" or an "F" to be entered in the response field. When a different value is entered and the user attempted to navigate out of the response field, the system generates a discrepancy and displays the window.

Figure 16-15 Validation Failure Window

Description of Figure 16-15 follows
Description of "Figure 16-15 Validation Failure Window"

Access

There are two conditions that will cause the system to display the Validation Failure window, either the system presents it automatically, or you select Edit, then Discrepancy from the option list to open it.

The system displays this window when you enter a value in a response datapoint that does not meet certain criteria. When you attempt to navigate to the next datapoint, the Validation Failure window is displayed. This allows you to:

  • review the reason why the discrepancy was raised

  • include a comment with the discrepancy

  • take action, such as routing it for review or resolving it.


Note:

When the system presents the Validation Failure window in response to a discrepant datapoint, you can use the Cancel button to close the window, put focus back in the response field, and address the problem with the response, without generating a discrepancy. This gives you the opportunity to correct a mis-read or mis-typed value with the actual value. However, if you do not change the datapoint to a non-discrepant value and attempt to change focus, the window will be displayed again.

In order to view this window manually, the Data Entry Window must be open and focus must be in a response field for which a univariate discrepancy exists. When these conditions are met, select Data Entry, then Discrepancy from the option list to open the window. If you attempt to open this window when focus is in a response field that does not contain a discrepancy, a message window is displayed which states that there is no discrepancy associated with the response.

Tip:

When focus in the Data Entry Window is in a response field for which a discrepancy exists, the title bar of the Data Entry window includes the following, as an indicator: <Univ>

When you open the Validation Failure window for an existing discrepancy, you can do all of the tasks described above, and you can view, edit, and comment on any pre-existing comments that you or another user has entered for the discrepancy.

Components

The components of the Validation Failure window are listed and described in Table 16-11.

Table 16-11 Components of the Validation Failure Window

Label Type Description

Univariate Failure Reason

Info Text

A short description of the criterion that the response data failed to satisfy.

Message

Text box

A longer description of the reason for the discrepancy. When the discrepancy is initiated, this text box is pre-filled with a system-generated description of the cause for the discrepancy, which you can edit.

Message editor

Button

Provides access to a text editor you can use to edit the message.

Comments

Text box

Location for a text comment that is displayed in the Comments field on the Discrepancy task tab.

Comment editor

Button

Provides access to the Internal Comment Window.

Comment History

Button

Provides access to the Internal Comment History Window.

OK

Button

For system-generated display of the window: Acknowledges the discrepancy and saves it to the database.

For manual display of the window (for existing discrepancy): Saves pending changes and closes the window.

Cancel

Button

Closes the window without saving any changes made in the window and returns focus to the discrepant datapoint.

Status

Info Text

Displays the current status of the discrepancy. The status is not defined until the discrepancy is saved.

Action

Drop-down list

A drop-down list that gives you access to the set of Discrepancy Actions available.

Review Status

Info Text

Displays the current review status of the discrepancy.

Resolution Code

Info Text

Displays the Resolution Reason for discrepancies that are resolved.

Resolution Comment

Text box

Displays the reason that was given when the discrepancy was resolved.

Resolution Comment Editor

Button

Provides access to the Resolution Comment editor.


Usage

The primary purpose of the Validation Failure window is to allow you to acknowledge that the current value of the response field raised a discrepancy. However, you can also use the window to take immediate action on the discrepancy.

There are two types of discrepancy actions: routing and resolution. Routing actions assign the discrepancy to the members of another user role. For example, a routing action that could be available for the Investigator role is, "Send to Site," which assigns the discrepancy to the Site user group. The system permits you to include an optional comment that it saves with the discrepancy.

In contrast, resolution actions immediately close the discrepancy. However, you must provide a resolution reason and, optionally, a resolution comment when you select this action.

Internal Comments Windows

The windows that you use to work with internal comments for a discrepancy are:

There are several methods you can use to work with internal comments for a discrepancy. You can use the windows that are described in this section or you can use the components in the Discrepancy to make the same kind of changes. The Comment windows provide an editor that allows you to work with lengthy comments more efficiently. However, whichever method you use, you access and work with only one set of data for each discrepancy. Each time you add new comment or make changes to an existing comment, the changes are saved as a new comment entry.

Using the windows that are described in this section, you can:

  • view a chronological listing of previous comments

  • add new comments

  • edit existing comments

Although you can edit existing comments, it is important to note that this is equivalent to adding a new comment. When you make changes in a comment text field, whether you erase the existing comment and compose new text, or make a simple change to the existing comment, the new comment is saved in its entirety as a separate entry in the comment history for that discrepancy.

Table 16-12 Internal Comment Windows Functionality and Access

Window Name Function Access

Internal Comment Window

Text editor for composing and editing internal comments for discrepancies.

Comment button on the Discrepancy Windows.

Internal Comment History Window

A chronological listing of the comments that have been entered for a manual or discrepancy. Includes the user name of the person who changed the comment.

Comment History button on Discrepancy Windows.

Internal Comments for Discrepancy Window

A combination of the Internal Comment Window and the Internal Comment History Window.

Double-click the Comments field in either the Individual Discrepancy Tab or the List of Discrepancies Tab for the relevant discrepancy.


Internal Comment Window

The Internal Comment window is a text editor with access to search and replace functionality that you can use to compose and edit internal comments that are associated with a discrepancy.

Figure 16-16 Internal Comment Window

Description of Figure 16-16 follows
Description of "Figure 16-16 Internal Comment Window"

Access

You access the Internal Comment window from the Discrepancy Windows, by clicking the button that is adjacent to the Comments text box. Three different windows, which are displayed for different types of discrepancies, provide access to the Internal Comment window. The windows are:

Figure 16-17 Internal Comment Window Button

Description of Figure 16-17 follows
Description of "Figure 16-17 Internal Comment Window Button"

Components

The Internal Comment window consists of the components that are listed and described in Table 16-13.

Table 16-13 Components of the Internal Comments Window

Label Type Description

Editor

Text Editor

An editable field for changing the existing or inserting a new comment for the discrepancy.

OK

Button

Saves pending changes and closes the window.

Cancel

Button

Discards pending changes and closes the window.

Search

Button

Opens the Search and Replace window.


Internal Comment History Window

The Internal Comment History window provides a record of the comments that have been entered for a manual or discrepancy. It is not an editable window, such as the Internal Comments for Discrepancy Window, rather it provides a listing of all internal comments that have been recorded for a discrepancy.

Figure 16-18 Internal Comment History Window

Description of Figure 16-18 follows
Description of "Figure 16-18 Internal Comment History Window"

Access

You access the Internal Comment History window by clicking its button on the following windows:

The button that you use to open the Internal Comment History window is the same on all of these windows. It located next to the Comments Editor button, adjacent to the Comments field. The graphic depicted in Figure 16-19 shows the button with a red square for identification.

Figure 16-19 Internal Comment History Button

Description of Figure 16-19 follows
Description of "Figure 16-19 Internal Comment History Button"

Components

The Internal Comment History window consists of four components, which are listed and described in Table 16-14.

Table 16-14 Components of the Internal Comment History Window

Label Type Description

Comment History

Info Text

A non-editable listing of each comment that has been saved for the discrepancy. The listing is in reverse chronological order and the save timestamp and user name of the author precedes each comment entry.

OK

Button

Closes the window.

Cancel

Button

Closes the window.

Search

Button

Opens the Search and Replace Window, however, because the listing cannot be edited, the Replace function is not enabled.


Internal Comments for Discrepancy Window

The Internal Comments for Discrepancy window serves two purposes. It is an editor for new and existing comments, and it tracks each comment that is saved and displays each version with a timestamp and the name of the user who saved the comment.

Figure 16-20 Internal Comments for Discrepancy Window

Description of Figure 16-20 follows
Description of "Figure 16-20 Internal Comments for Discrepancy Window"

Access

You access the Internal Comments for Discrepancy window by double-clicking the Comments field in either the Individual Discrepancy Tab or the List of Discrepancies Tab for the relevant discrepancy.

When you open the window, the current comment is displayed in the text edit field and all previous comments are displayed in the history field. You can use standard editor functionality, such as Cut, Copy, and Paste, to edit the existing comment or insert new comment text.

Note that only changed comments are saved as new entries in the history listing.

Components

The components of the Internal Comments for Discrepancy window are listed and described in

Table 16-15 Components of the Internal Comments for Discrepancy Window

Label Type Description

Editor

Text Editor

An editable field for changing the existing or inserting a new comment for the discrepancy.

Comment History

Info Text

A non-editable listing of each comment that has been saved for the discrepancy. The listing is in reverse chronological order and the save timestamp and user name of the author precedes each comment entry.

Save

Button

Saves pending changes and closes the window.

Cancel

Button

Discards pending changes and closes the window.


Resolution Reason Window

This window is displayed when you attempt to manually close a discrepancy. It is associated with Discrepancy Actions that allow you to resolve, or close, a discrepancy. The graphic in Figure 16-21 depicts the Resolution Reason window with a resolution reason of "Investigator Verification."

Note:

You can also resolve a discrepancy using the Validation Failure Window.

Figure 16-21 Resolution Reason Window

Description of Figure 16-21 follows
Description of "Figure 16-21 Resolution Reason Window"

The window allows you to choose a reason from a list of study-specific options and it provides a free-text field that provides a method to add pertinent comments, which are saved and displayed in the Resolution Comment fields for the discrepancy in the Discrepancy.

Access

You access the Resolution Reason window from one of several other components that are associated with Discrepancy Management. All of these components include a Discrepancy Action drop-down list that includes one or more actions that resolve, or close, a discrepancy. When you select such an action, the Resolution Reason window is displayed.

Examples of components that give you access to the resolution actions on the Action drop-down list include:

Components

There are four components in the Resolution Reason window, which are listed and described in Table 16-16.

Table 16-16 Components of the Resolution Reason Window

Label Type Description

Resolution

Drop-down box

A pre-filled list of possible resolution reasons. This is determined and set at the study sponsor level.

Comment

Text box

An editable field that you use to type comments about the current discrepancy resolution.

Save

Button

Resolves the discrepancy, using the resolution reason you selected and the (optional) comment text you typed. Note that you must select a resolution reason.

Cancel

Button

Closes the window without resolving the discrepancy or saving the comment text.


Discrepancy History Window

The Discrepancy History window provides a chronological listing of the changes that have been made to a discrepancy. It is similar to the Audit History Window.

Access

You access the Discrepancy History window by clicking the History button on either the List of Discrepancies Tab or an Individual Discrepancy Tab.

Figure 16-22 Discrepancy History Window

Description of Figure 16-22 follows
Description of "Figure 16-22 Discrepancy History Window"

Components of the Discrepancy History Window

The components that comprise the Discrepancy History window are listed and described in Table 16-17, "Discrepancy History Window Components".

Table 16-17 Discrepancy History Window Components

Label Type Description

Date

Info

The timestamp that the discrepancy was saved to the study database.

Text

Info

A description of the discrepancy cause or the reason for the change in status; this is either user- or system-generated, depending on the type of discrepancy.

Status

Info

The discrepancy status at the time specified in the Date field.

Comments

Info

The comment that the user included with the discrepancy.

Resolution

Info

If the discrepancy is resolved, the reason that was selected in the Resolution Reason Window.

Resolution Comment

Info

If the discrepancy is resolved, the comment that the user included in the Resolution Reason Window.

By

Info

The user name of the person who resolved the discrepancy.

OK

Button

Closes the window.