Questionnaire

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Questionnaire

The Questionnaire maintenance document is used to establish and maintain a unique pool of questions used to gather information from users. It provides a way for you to specify identifying information about the questionnaire, add questions as its content, and specify usage information such as the functional module in which it is to be used. The content can be built using tools that allow you to control sibling/child nodes for conditional branching in a hierarchical display for the user.

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Existing Value Modification: Some Questionnaires impact S2S submissions. Assess the impact on S2S submission before adding new questionnaires/editing existing questionnaires.

Figure 819 Questionnaire Maintenance Document Example

Details Subsection

The details subsection provides fields for identifying the Questionnaire.

Figure 820 Questionnaire Maintenance Document, Questionnaire Details, Content & Use Section – Details Subsection Example

Table 496 Questionnaire Maintenance Document, Questionnaire Details, Content, & Use Section – Details Subsection Field Descriptions

Field	Description
Details
Name	Enter a unique name for the Questionnaire so that it is easy to look up and know its purpose. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. After saved, click the green arrow symbol to view full text in a separate browser window.
Version	Display-only. Automatically generated and updated by the system, this indicates the version of the currently-accessed Questionnaire maintenance document. The version number will increment every time a questionnaire is modified and changes are saved.
Final	Flagging the Questionnaire maintenance document as final enables it for use by functional modules. Click within the checkbox to select the item. A check mark appears within the checkbox to indicate the item is selected. Click within the checkbox again to clear the mark and deselect the item.
Status	Display-only. This indicates the state the Questionnaire maintenance document is in, as opposed to the document route status displayed in the header area. It is automatically updated by actions made by approvers of the document.
Description	A longer version than the field of the same name in the Document Overview section, this expands on the detail in providing information that makes it clear what the intended purpose of this Questionnaire is. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. After saved, click the green arrow symbol to view full text in a separate browser window.

Content Subsection

The Content subsection provides you with the ability to add questions and logically arrange them. It also allows you to specify what type of answer and value are required from a parent question for a subsequent child question to appear.

Table 497 Questionnaire Hierarchy Tools and Terms Explained

Tree Command		Description
		Causes the folder icons to close so that a plus + symbol appears, indicating the node is closed so that its contents are hidden and the descendents are not displayed.
		Causes the folder icons to open so that a minus – symbol appears, indicating that the node is open and its contents are shown beneath it, including all descendant nodes.
	Descendants and Nodes: The term “descendents” is the equivalent of children, grandchildren, great-grandchildren, and so on; each of which is also referred to as a “node” in the hierarchy. Each time you copy a node, you take that entire hierarchical structure and either copy it to a new question that becomes the new “parent”, or copy this “family” to a different, existing parent question.

Figure 821 Questionnaire Maintenance Document, Questionnaire Details, Content, & Use Section – Content Subsection Example

Table 498 Questionnaire Maintenance Document, Questionnaire Details, Content, & Use Section – Content Subsection Field Descriptions

Field	Description
Content
	If you want to retain a paper copy of a Questionnaire, click the print button to print the currently-displayed hierarchy content to your local printer as a portable document format. Adjust the collapse/expand settings as desired prior to printing.
Hierarchy Display Options	Click the collapse/expand all buttons as desired to efficiently adjust the display of questions in the hierarchy.
Add Question(s)	Click the lookup icon to search for and return the value to populate the Content section with Questions. Click the lookup icon, select/enter criteria as desired on the Question Lookup screen, then click the search button. Check the desired Questions by checking one or more Select? column boxes from the search result table, then click the return selected button. Your questions are added to the Content section, each preceded by a bullet and folder icon.
Question ?
Node	A node is a question and its descendants – its children, its children’s siblings, it’s grandchildren, etc. (but not it’s siblings or its parents). Removes the node content (it is also removed from the hierarchy view). Cuts the currently-accessed node from its current position in the hierarchy to a virtual clipboard, allowing you to then click on a different question, open its folder, and then paste it there. This moves a node to a new area of the hierarchy. Copies the currently-accessed node, which allows you to then click on a different question in the hierarchy, open its folder, and paste it there. This causes the same node to appear in more than one portion of the hierarchy. Places previously copied or cut nodes in the currently-accessed location (open folder question) in the hierarchy. This can be done anywhere in the Content subsection hierarchy, regardless of relationship.
Add Question	Click the lookup icon to search for and return the value to populate the box automatically. Click the lookup icon, select/enter criteria as desired on the Question Lookup screen, then click the search button. Check the desired Questions by checking one or more Select? column boxes from the search result table, then click the return selected button. Your questions are added to the Content section, each preceded by a bullet and folder icon. • as sibling: same as adding a new question, the level is equal to existing question (not to the existing question’s hierarchy) • as child: adds the question at a lower level than the parent question, forming a hierarchical branch. Child questions include the Parent Response so you can include/exclude the child question based on the response to the Parent question in the questionnaire.
Requirements for Display
Parent Response	On a child question, select a type of parent response from this list prior to entering a corresponding value in the Value field. This specifies the type of expected answer to the parent question that allows this (currently-accessed question) to appear to the user. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection. Future Release: “Answer is Yes”, “Answer is No” and “Answer is NA” will be added in a future release.
Value	Enter the value of the expected answer to the parent question that allows this (currently-accessed question) to subsequently appear for the user of the questionnaire. Tip: Since the most common parent response to trigger one or more child question(s) is Yes or No, it is necessary to select ’Matches text’ in the Parent Response field and then enter either Y or N as appropriate to make this work.
	Multiple requirements are *not* permitted (there can only be one condition for the “Requirement to Display” section, and this button adds your selection/entry made in the Add row one at a time so that each will appear as a numbered line item row in the table below. Click the delete button to remove a previously-added line item row from the table. For more information about basic line item functionality, see “Common Line Item Operations” in Common E-Doc Operations.
Response
Type	Display-only. This indicates the type of response, which dictates the presence of any entry/selection/lookup tools necessary for the Responder to answer it. This information is maintained in the Question maintenance document for this question. For more information, see “Question” on page 855.
Values	Display-only. Acceptable answer values are described, including information that explains the expected or valid input. This information is maintained in the Question maintenance document for this question. For more information, see “Question” on page 855

Usage Subsection

The Usage subsection provides a means to make the Questionnaire available for usage by a document that is a part of a particular functional module.

Figure 822 Questionnaire Maintenance Document, Questionnaire Details, Content, & Use Section – Usage Subsection Example

Table 499 Questionnaire Maintenance Document, Questionnaire Details, Content, & Use Section – Usage Subsection Field Descriptions

Field	Description
Usage
Add / #	This column displays numbered line item rows in table format which appears below after lines are added using the add button in the Actions column. This row is where you make selections prior to adding a line. Displays sequential line item number for each table row in ascending, top-to-bottom order. Also serves as a line selection/addition row label.
Module	Required. Select the desired functional module from the list to indicate the module that this version of this Questionnaire will be used in. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection.
Mandatory	Indicates all questions in a questionnaire must be answered. When child questions exist, only those questions presented as a result of a parent response must be answered. Check to flag the usage of this version of this Questionnaire in this module as required. Click within the checkbox to select the item. A check mark appears within the checkbox to indicate the item is selected. Click within the checkbox again to clear the mark and deselect the item.
Label	Required. Enter a textual name that uniquely represents the use of this version of this Questionnaire for this module. The label = the name of the questionnaire as it appears on the IRB protocol title bar (what the Responder will see). Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. After saved, click the green arrow symbol to view full text in a separate browser window.
Version	Display-only. Automatically generated by the system.
Actions	Click the add button to add your selection to as a row in the table below, which will become a numbered line item. Click the delete button to remove a previously-added line item row from the table. For more information about basic line item functionality, see “Common Line Item Operations” in Common E-Doc Operations.

Common Features

The Questionnaire maintenance document includes the following features that are common to most KC maintenance documents:

Table 500 Common Maintenance Document Components and Topic Links

Common Maintenance E-Doc Component	Cross-reference To Usage Description
Document Header	For more information, see “Header Area” on page 99 in E-Doc Fundamentals.
Document Overview Section	For more information, see “Document Overview” on page 103 in Common E-Doc Tabbed Sections.
Notes and Attachments Section	For more information, see “Notes and Attachments” on page 104 in Common E-Doc Tabbed Sections.
Route Log Section	For more information, see “Route Log” on page 107 in Common E-Doc Tabbed Sections.
Action Buttons	For more information, see “Action Buttons” on page 81 in Selection, Entry and Action Tools.

Process

	For information about searching for, initiating, editing, copying, submitting, saving, closing, canceling, and/or routing a maintenance document, see “Common Maintenance E-Doc Operations” on page 129 in the Overview section.
	Related Information: For information on the other maintenance documents that work in conjunction with this one, see Question, Question Category, and Question Type.