About Questionnaires

A questionnaire is a series of questions, with or without sub-questions. Questionnaires are associated with templates used to create objects such as change orders, regulatory requests, or a adverse event reports. A route, member list, person, or impact questionnaire can be automatically added to an object created from the template based on specific responses to the questions in the questionnaire.

This page discusses:

See Also
Designing Questionnaires
Creating a Change Questionnaire
Creating a Conditional Questionnaire
Creating an Impact Questionnaire Template

Types of Questionnaires

There are three types of questionnaires available, each with its own specific capabilities:

  • Questionnaires (which have different names depending on the context in which they are used: Change Questionnaire, Decision Tree Template, or Reviewer Questionnaire) that automatically add sub-questions or related objects based on question responses.
  • Conditional Questionnaires that automatically add related objects to change orders or change requests based on attribute values.
  • Impact Questionnaires that collect information for the change order or change request to which they are added.

Questionnaires

Questionnaires allow Change Administrators (for Change Questionnaires), Regulatory Affairs Managers (for Decision Tree Templates), or Regulatory Request Administrators (for Reviewer Questionnaires) to define a question and response structure in a template, then assign sub-questions and related objects to specific question responses.

Users respond to the questions in the context of objects created from the template, such as change orders, decision trees, or regulatory requests. User responses determine whether sub-questions are asked and whether the related objects are automatically added to objects created from the change template.

For change questionnaires, the related objects assigned to specific question responses are automatically added to the object created from the change template when the user responds to all of the questions then submits the questionnaire. The related objects can be approval routes, member lists of approvers, an individual person who will be an approver, or an Impact Questionnaire to collect information.

Conditional Questionnaires

Conditional Questionnaires allow Change Administrators to automatically add a related object to an object created from a template based on the value of an attribute. Conditional Questionnaires do not require input from a user and do not have to be manually completed.

For example, if a specific person must approve change orders where the change severity is a high, the Change Administrator can use the Conditional Questionnaire in the change template to ensure that this happens. The Change Administrator adds the existing Severity attribute to the Conditional Questionnaire in the change template, then assigns one or more values of that attribute, such as High, to a specific related object, such as a specific person. That specific person is automatically added to the change order as an approver when it promoted from the Prepare state if the change order's severity is High. This happens for change requests when they are promoted from the Evaluate state. This is an automatic process that occurs without any additional input from the change order's creator, the Change Coordinator, or the Change Administrator.

Impact Questionnaires

Impact Questionnaires allow Change Administrators to define questions that gather additional information about the proposed change.

Each question in an impact questionnaire has a specific input type. Depending on the input type, questions can have a defined list of input values from which users select responses. Questions can also have text areas or text boxes that allow the user to provide a free-form response. Each question has one of the following input types for responses:

  • Check box that allows users to select one or more values from a set of defined values as a response to the question.
  • Combo box that allows users to either select one value from a list of defined values or to type a different value as a response to the question.
  • List box that allows users to select one value from a list of defined values as a response to the question.
  • Radio buttons that allows users to select one value from a set of defined values as a response to the question.
  • Text area that allows users to type a long text entry as a response to the question.
  • Text box that allows users to type a short text entry as a response to the question.

Impact questionnaires can also have extended attributes for which Change Coordinators can provide values when the impact questionnaire is added to an object.

Questionnaire Process Overview

Using a change template as an example, the following overview describes how to create and respond to a change questionnaire:

  1. In the change questionnaire for the change template, the Change Administrator creates the questions and sub-questions, then assigns related objects (routes, member lists, people, and impact questionnaires) to specific question responses.
  2. If applicable, in the conditional questionnaire in the change template, the Change Administrator adds attributes then assigns related objects (such as a route) to a specific attribute value.
  3. The Change Administrator activates the change template.
  4. The Document Center Administrator creates a change order from the change template to revise a document.
  5. If a specific attribute value in the change order, such as its severity, matches the value specified by the Change Administrator in the change template's conditional questionnaire, the related objects assigned to that value are automatically added to the change order.
  6. The Change Coordinator opens the new change order, then selects the Change Questionnaire category to view the questionnaire.
  7. The Change Coordinator enables editing in the page, then responds to each question in the questionnaire. Specific responses may open sub-questions.
  8. After all questions have responses, the Change Coordinator saves the responses, then submits the questionnaire.
  9. If a specific question response was assigned to a route, member list, or person, those are automatically added to the change order when the questionnaire is submitted.
  10. If a specific question response was assigned to an impact questionnaire, it is automatically added to the Impact Questionnaire page tab. The Change Coordinator responds to the questions, then completes the impact questionnaire.