Question

The Question maintenance document is used to manage questions and permitted responses that are used in Questionnaire pages of other e-docs such as the Protocol document.  Each question is uniquely identified in the system for possible use in multiple questionnaires in multiple e-docs.  It provides you with the ability to maintain the question content that is displayed to the user, with automatic version history tracking.  Further, it allows you to make a question active or inactive, and it allows you to assign the question to a category.  Additional information about the question, such as Explanation, Policy, and Regulation text is also maintained from this document.  Finally, the type of response can be specified along with detailed values for each; and based on your selections, appropriate tools are provided for the respondent.

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Existing Value Modification:  Some Y/N questions impact S2S submissions.  Assess the impact on S2S submission before adding new questions/editing existing questions.

Question Manager Section

The Question Manager section of the Question maintenance document is a unique section that allows you to specify and maintain the details associated with the reference table record in fields.

Figure 1076 Question Maintenance Document - Question Manager Section Layout

 

Table 547 Question Maintenance Document - Question Manager Section Field Descriptions

Field

Description

Question

Question

Required.  Enter the question text itself as you want it to appear to the respondent.  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 updated on save.  When creating new, 1 is the default value after initiation.  For subsequent versions, enter a description of your change in the Description field in the Document Overview section.

tip.png  The version number will increment every time a question is modified and changes are saved.

Question Id

Display-only.  Automatically generated by the system after the first save action.  A numeric code that uniquely represents the question, this does not change when modifications are made, even though new versions are created.

Status

Required.  Select either Active or Inactive from the list.  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.  Inactive preserves the version of the document so that it can activated in the future, while Active makes it available for use in a Questionnaire immediately upon save.

Category

Required.  Typically, categories are established so that questions can be assigned to (or made available for use in) a questionnaire that is a part of a document for a particular functional module (for example, IRB or Proposal).  Click the lookupsearchicon icon to search for and return the value to populate the box automatically, or if known, type the value in the box.

Explanation

A text box field that allows for further explanation of the question to clarify its purpose and expected response.  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.

Policy

A text box field that allows you to enter one or more applicable policies that make the question necessary.  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.

Regulation

A text box field that allows you to reference one or more applicable regulations that pertain to the question.  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.

Response

Type

This specifies the kind of response that is expected to the question.  Select one of the following options:  Yes/No, Yes/No/NA, Number, Date, Text, or Lookup.  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.  Based on your selection, the Values column displays additional options that are different for each type.

Values

The selection in the preceding Type field causes different content to be displayed in this column.  For each response type, follow the on-screen instructions to select and/or enter additional values that refine the response and provide corresponding tools for the respondent.

Common Features

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

Table 548 Common Maintenance Document Components and Topic Links

Common Maintenance E-Doc Component

Cross-reference To Usage Description

Document Header

link.png  For more information, see “Header Area” in E-Doc Fundamentals.

Document Overview Section

link.png  For more information, see “Document Overview” on page 93 in Common E-Doc Tabbed Sections.

Notes and Attachments Section

link.png  For more information, see “Notes and Attachments” on page 94 in Common E-Doc Tabbed Sections.

Route Log Section

link.png  For more information, see “Route Log” on page 97 in Common E-Doc Tabbed Sections.

Action Buttons

link.png  For more information, see  “Action Buttons” on page 71 in Selection, Entry and Action Tools.

Process

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For information about searching for, initiating, editing, copying, submitting, saving, closing, canceling, and/or routing a maintenance document, see “Common Maintenance E-Doc Operations” in the Overview section.

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Related Information:  For information on the other maintenance documents that work in conjunction with this one, refer to the Questionnaire, Question Category, and Question Type topics.