Creating and Maintaining Questions
Oracle Clinical Questions correspond to the Questions on a CRF for a patient visit. You must define an Oracle Clinical Question for each Question on a CRF.
Question definitions are reusable.
In the Oracle Clinical Global Library, you can create Question Groups that contain multiple logically related Questions to be collected in the same section of a CRF. You then create DCMs (Data Collection Modules) that contain multiple logically related Question Groups to be collected together. You can create DCIs (Data Collection Instruments) that contain multiple logically related DCMs. In general, a DCI corresponds to a CRF.
The same Question can be included in many Question Groups. The same Question Group can be included in many DCMs, and so on. You can create standard DCMs and DCIs in the Global Library for reuse in multiple studies, and modify them as necessary for particular studies.
There are three windows in the Global Library in which you see the same Question definitions. Which of the three windows you can see depends on your user privileges:
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Query Questions (from the Glib menu, select Questions, then Qry Questions). You can query and view all Global Library Questions but cannot make any changes.
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Provisional Questions (from the Glib menu, select Questions, then Prov Questions). You can view all Global Library Questions and create and modify Questions with a status of Provisional, but you cannot change a Question's status to Active. You can delete only provisional Questions, and only when they are not included in a Question Group or DCM.
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Questions (from the Glib menu, select Questions, then Questions). You can do all Question-related Global Library tasks, including all the activities possible in the Provisional Questions window, plus changing a Question's status to Active or Retired, and changing some attributes of Active Questions.
Global Librarian
To see the Questions window you must have the database role Global Librarian. The Global Librarian is responsible for organizing and cleaning the set of Questions in the Global Library: defining Question categories and medical evaluation qualifiers to apply to each Question, determining which provisional Questions to promote to Active status for use in production, and which Active Questions to retire.
The Global Librarian is also responsible for defining values in two installation references codelists (under the Admin menu) that affect Questions: Question Category Type Code and Medical Eval Type Code. The system uses values defined in these codelists to populate the lists of values for the Question Categories and Medical Evaluation Type attributes for Questions.
For more information, see:
- Creating a New Question
- Assigning Question Categories
- Extended Text Questions
- Assigning DVGs to a Question
- Defining Details for Complex and Question Set Questions
- Defining Extended Attributes
- Deleting a Provisional Question
Parent topic: Questions and Question Groups
Creating a New Question
The Maintain Questions window has two viewing modes: Multi displays multiple Questions and their attributes, using one row per Question; and Single displays one Question at a time so that you can see all its attributes without scrolling. The Multi window has several buttons the Single window lacks; see Assigning Question Categories, Defining Details for Complex and Question Set Questions, and Defining Extended Attributes.
To create a Question:
Parent topic: Creating and Maintaining Questions
Assigning Question Categories
A Question cannot have Active status unless you associate it with at least one Question category. A Question category is a broad search classification, such as Demography or General Physical, that you can use to find existing Questions. You define these values in the QUESTION CATEGORY TYPE CODE installation reference codelist; see the Reference Codelists chapter of the Oracle Clinical Administrator's Guide for editing instructions.
Question Categories: A Question cannot have Active status unless you associate it with at least one Question category.
- With the Question selected, click Question Categories. If the Medical Evaluation Type of the Question is also a valid Question category, it is automatically assigned to the Question.
- From the list of values in the Question Category Code field, select as many Question categories as appropriate.
- Save.
Parent topic: Creating and Maintaining Questions
Extended Text Questions
Extended Text Questions support lengthy freeform text responses; for example, a description of a serious adverse event or a patient case history.
In RDC Onsite, an Extended Text Question field is denoted by a yellow note icon. When a user clicks the icon, double-clicks within the field or right-clicks and selects Show Extended Text from the right-click menu, a pop-up window appears in which the user can enter or paste up to 10,000 characters.
For more information, see:
- Extended Text Question Usage Restrictions
- Extended Text Question Definition Restrictions
- Attachment Prefix
- Database Storage
Parent topic: Creating and Maintaining Questions
Extended Text Question Usage Restrictions
The following restrictions apply:
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Responses to Extended Text Questions can be entered and updated only in RDC Onsite. You cannot use Oracle Clincial, Mass Changes or Batch Data Load to enter or update values for Extended Text Questions. (However, Batch Data Delete can delete Extended Text Question responses.)
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The system cannot display the full response text in many parts of the user interface. Instead, it displays the value in the RESPONSES table VALUE_TEXT column: the beginning of the response plus information about the version of the attachment that includes the full text; see Database Storage. This truncated response is displayed in Oracle Clinical, Discrepancy Details in RDC Onsite, Audit History in RDC Onsite, and some sections in Patient Data Reports. In the case of the RDC Onsite Audit History pane and Patient Data Reports, the full text is available in a separate window or page.
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Validation Procedures have access only to the truncated response value text stored the the RESPONSES table; see Database Storage.
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Data Extract does not support Extended Text Questions.
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Do not use an Extended Text Question as an indicator Question, as a trigger Question in a flexible study, or as a source Question in conditional branching.
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Special characters entered as part of an extended text response may not be displayed properly in the user interface.
Parent topic: Extended Text Questions
Extended Text Question Definition Restrictions
The system enforces the following restrictions:
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You cannot assign a Discrete Value Group (DVG) to an Extended Text Question.
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You cannot define a default response for an Extended Text Question.
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You cannot define an Extended Text Question as Mandatory.
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You cannot define an Extended Text Question as a derived Question.
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You cannot define a Question Group as repeating if the group contains an Extended Text Question.
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Oracle Clinical automatically sets the Enterable check box to unchecked for an Extended Text Question. You cannot change it. However, although the Question is identified an non-enterable, you can use RDC Onsite to enter and update data for an extended text field. You cannot use Oracle Clinical, Mass Changes, or Batch Data Load to enter or update data in an extended text field.
Parent topic: Extended Text Questions
Attachment Prefix
In the places where the system may not be able to display the full response to an Extended Text Question—Oracle Clinical, Discrepancy Details in RDC Onsite, Audit History in RDC Onsite, and some sections in Patient Data Reports—the system displays a prefix:
ATTACHMENT V<
X.Y
>:
X is the version number; the number of consecutively different changes saved by a user in RDC Onsite. The first time a user enters and saves a response for a patient, the version number is 1. If a user updates the response and saves again, the version number is 2 unless the actual value has not changed; the system compares the existing value against the value being saved and increments the version number only if there is a difference. The version number can have up to four digits.
Y is the subversion number; the system increments it each time the focus leaves the extended text field but before the user saves the record. It is used for internal auditing.
The system reserves 24 characters, the maximum possible, for the attachment prefix string whether all 24 characters are used or not.
Parent topic: Extended Text Questions
Database Storage
Oracle Clinical stores responses to Extended Text Questions in two database tables; a truncated version in the RESPONSES table and the full text in the RESPONSE_LOBS table. The truncated version is displayed in several places in the user interface where the system cannot display the full text.
RESPONSES
The RESPONSES table VALUE_TEXT column stores the 24-character Attachment Prefix plus the response entered, up to the defined Question length, truncating any remaining response text. The number of response text characters stored depends on the Question length:
Number of characters in truncated response text = Question length - 24
For example, if you define an Extended Test Question to have a length of 30 and a patient response to the Question begins "A 72-year-old male patient," the system stores (and displays in the user interface) the attachment prefix and the first six characters of the response, for example:
ATTACHMENT V<2.3>: A 72-y
RESPONSE_LOBS
The RESPONSE_LOBS table stores the full text, a maximum of 10,000 total characters, in the VALUE_TEXT_CLOB column. The version number is stored in the VERSION_SN column.
Parent topic: Extended Text Questions
Assigning DVGs to a Question
You can limit the valid responses to a Question to a DVG. For information about DVGs, see Creating and Using DVGs.
Questions used as Qualifying Questions to distinguish multiple occurrences of a DCM in a DCI must have a DVG. See Configuring Qualifying Questions.
The first set of fields, labeled DVG, refer to both internal and thesaurus DVGs. The second set of fields refer to alpha DVGs. Otherwise, the functionality of the two sets of fields is the same:
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(Alpha) DVG Modifiable? This box controls whether or not any changes can be made to the DVG settings for this Question within the context of a particular Question Group or DCM. If the box is deselected here, it is also deselected whenever the Question is included in a Question Group or DCM, and no changes can be made within those contexts.
If the box is selected here, it will be selected by default for the Question within a Question Group, in the Global Library and in a DCM. Within those contexts, it is then possible to change the DVG or deselect the box. See Adding DVGs to Active Questions, Question Groups, and DCMs.
The Global Librarian can always change this setting here, even after the Question is set to Active. When the box is selected, it is possible to change the DVG assignment.
Note:
The Global Librarian can assign a different subset of the same DVG at any time, even if this box is not deselected.
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(Alpha) DVG Name To assign an internal or thesaurus DVG or an alpha DVG to a Question, choose a DVG from the list of values in the DVG Name field.
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(Alpha) DVG Domain The system enters the name of the DVG's domain.
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(Alpha) DVG Subset # Specify the subset of the DVG that you want to assign to this Question. The default is Subset 1. See Creating a DVG Subset.
Note:
The base subset, which contains the complete list of values defined for the DVG, is Subset 0 (zero).
Parent topic: Creating and Maintaining Questions
Defining Details for Complex and Question Set Questions
The Details button in the Maintain Questions window is enabled only for Question Set Questions (used only in TMS) and Complex Questions (used only in Data Extract). In both cases you associate Questions with variables already defined for the current Question.
For more information, see:
Question Set Questions
In this window, associate the variables defined in the current (parent) Question's Question Set with the derived Questions that will receive the variables' values from TMS. You must first define the Question Set, the parent Question (of Question type Question Set), and each derived Question (of Question type Thes Validated).
The system populates a row for each variable defined for the Question Set.
- In the Question Name column for each variable, from the list of values select the name of the derived Question to receive the variable value from TMS. The list of values includes only Questions whose Question type is Thes Validated.
- Save.
Parent topic: Defining Details for Complex and Question Set Questions
Complex Questions
In this window, associate the Extract macro variables with the Questions whose values the macro combines to derive the value of the current (Complex) Question. You must first define the Extract macro, the Complex Question, and the Questions to be used as variables in the macro.
The system populates a row for each variable defined for the current (Complex) Question's Extract macro.
- In the Question Name column for each variable, from the list of values select the name of the Question whose value will be used as the variable value.
- Save.
Complex Questions are not DCM Questions; they are created for the purpose of data extract. They are not part of default definition, so they have to be defined in the Global Library. Once a Complex Question is defined, it references other Questions as well as the Extract macro that combines them into a single value.
When you write an Extract macro with more than one variable, you accommodate that Extract macro by creating a Complex Question, which can be broken down into simple Questions, each of which can then be associated with one of the variables.
Parent topic: Defining Details for Complex and Question Set Questions
Defining Extended Attributes
Oracle Clinical provides additional attributes that can be associated with Questions to increase the information available in data extract views. The attributes are columns in the RESPONSES table. By including them in a Question definition, you make it possible to extract the column value for a Question response.
By default, the system creates one attribute: VALIDATION_STATUS, which contains information on whether any discrepancies are logged against the response, and if so, their current status.
The other attributes available are:
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AUDIT_COMMENT_TEXT. If the record was updated after it was made accessible in the Update mode of data entry, the comment, if any, added by the operator. Value is populated on the version prior to the new version, or, in the case of deletions, on the final version.
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DATA_CHANGE_REASON_TYPE_CODE. Code indicating reason a new version of the response was created. Value is populated on the version prior to the new version, or, in the case of deletions, on the final version.
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DATA_COMMENT_TEXT. Investigator comment, if any, for the response.
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DISCREPANCY_INDICATOR. Box indicating whether a univariate discrepancy, a manual discrepancy, or both exist for the response. Possible values are U, M, and B, respectively.
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DVG_LONG_VALUE. Applicable only to Questions associated with a DVG.
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DVG_NUMBER. Applicable only to Questions associated with a DVG.
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DVG_SHORT_VALUE. Applicable only to Questions associated with a DVG.
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EXCEPTION_VALUE_TEXT. The full value of the response is stored in this column if a discrepancy has been created of the type that indicates that the value is inconsistent with the database use of the DCM Question. In particular:
Data type discrepancies store the value here with the value text null.
Length discrepancies store the full value here with the value text containing null for numbers and containing the text truncated to the DCM Question length for characters.
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FULL_VALUE_TEXT
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TERM_COL1. Applicable only to Questions associated with a thesaurus DVG.
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TERM_COL2. Applicable only to Questions associated with a thesaurus DVG.
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TERM_COL3. Applicable only to Questions associated with a thesaurus DVG.
Parent topic: Creating and Maintaining Questions
Deleting a Provisional Question
You can remove a Question from the Global Library if it meets the following criteria:
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It is a provisional Question. You cannot remove active or retired Questions.
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The Question is not part of a Question Group. If it is, you must first remove the Question from the list of Questions in the Question Group. See Managing Question Groups.
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The Question is not part of a DCM.
From the Glib menu, choose Questions, then select (Prov) Questions. Click the Delete Record button, then save your work. If you have not yet saved the Question, there is nothing to delete and you can clear the record by clicking the Clear Record button.
Parent topic: Creating and Maintaining Questions