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:

• 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.

• 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.

• 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
  

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:

1. Complete these fields:

   • Name: A unique name within the Question's domain, up to 20 characters.

   • Domain: The Question's domain. See Maintaining Domains.

   • Status: There are three valid statuses:

     • Provisional (P). The default status for new Questions. All attributes of provisional Questions can be modified, but they cannot be assigned to Question Groups or used in any way. Provisional Questions can be deleted.

     • Active (A). Active Questions are available for use: they can be assigned to Question Groups and DCMs, and used in test and production studies.

     • Retired (R). Retired Questions cannot be assigned to Question Groups, but Questions already in use in Active Question Groups can continue to be used.

       Note:

       You can change a Question's status from Active to Retired at any time.

       You cannot change a Question's status from Active to Provisional if the environment is replicated; that is, if there are more than one source locations set to Active in the installation reference codelist SOURCE LOCATION CODE; or if the Question is used by any other object:

       • included in an active Question Group

       • has Lab Ranges defined

       • has Preferred Lab Units in a Preferred Conversion Group

       • has Lab Test Units defined

       • is used as a DCM Qualifying Question

       • is used as a DCM Question

   • Medical Evaluation Type: A classification for how to evaluate medical responses.

   • Intent: A unique description of the meaning or intended use of the Question. The text you enter here is included in the list of values for the Questions field in the Question Groups window; it helps identify the Question when you are selecting Questions to include in a Question Group.

   • Question Type: From the list of values, select a type. Depending on the type you select, the system enables or disables other Question attribute fields for the Question you are defining. The type determines what data type is allowed for the Question, as noted. For example, if you select a Question type of Char, Unit, or Thes Validated, all of which must have a data type of CHAR, the fields for date/time, decimal places and lower bound and upper bound are disabled. Choices include:

     • Unit (Data type must be CHAR.) Informational datatype useful for identifying Questions used to capture unit information related to another Question, such as a lab Question.

     • Lab Test (Data type must be CHAR or NUMBER.) Defines the Question as collecting lab data and requires collection of the lab name for each received DCM. A Question of type LAB TEST can have a lab range defined in the Lab Subsystem; see Defining Textbook Ranges. If a DCM Question is based on a lab test Question and the DCM Question is used in a Procedure, lab range information for that Question is automatically available for use in the procedure.

       If you are using normalized lab data, you must define a Question to display the lab test name with a Question type of Lab Test; see Using Normalized Lab Data for details.

     • Date Time (Data type must be DATE or TIME.) Use for a date or time Question.

     • Non-Lab (Data type must be CHAR or NUMBER.) Non-lab Questions with a data type of NUMBER can have Lower Bound and Upper Bound values defined at the DCM Question attribute level as well as in the global library.

     • Complex. (Data type must be CHAR, NUMBER, DATE or TIME.) Complex Question values are derived by a macro from other Question responses and appear only in data extract views. They do not have to be defined as a DCM Question. Selecting Complex activates the Details button. See Defining Details for Complex and Question Set Questions.

     • Char (Data type must be CHAR.) Use for character-data type Questions.

     • Thes(aurus) Validation (Data type must be CHAR.) For use with the Oracle Thesaurus Management System (TMS) only. Thesaurus Validation Questions are not collected at a patient visit, but receive data derived from TMS, such as the dictionary term to which the verbatim term is classified. If a DCM Question is based on a Thes Validated Question and the DCM Question is used in a Procedure, the derived TMS information for that Question is automatically available for use in the Procedure. You must select the Derived? check box for the Question and include it as a child Question in a Question Set; see Defining Details for Complex and Question Set Questions.

     • Question Set (Data type must be CHAR, NUMBER, DATE or TIME.) For use with the Oracle Thesaurus Management System (TMS) only. Use for Questions you will use to collect TMS verbatim terms—responses collected at a patient visit that will be classified to a standard dictionary term in TMS. For example, you might collect a response to the Question CONCOMMITANT_MEDICATION at a visit and check the response against the dictionary WHO-Drug.

       You must include the Question as the parent Question in a Question Set, with a child Question, or variable, for each term you want to derive from TMS back into Oracle Clinical; see Defining Details for Complex and Question Set Questions and the Oracle Thesaurus Management System User's Guide for more information.

       Selecting Question Set activates the Details button.

     • Extended_Text (Data type must be CHAR.) Extended Text Questions can store a response of 10,000 characters instead of 200 characters, which is the maximum length for all other character-based Question types. See Extended Text Questions for restrictions and additional information.

   • Data Type: Data Type is a database classification: Character, Number, Date, and Time. The system generates a univariate discrepancy for responses to this Question that are of the wrong data type. For information about discrepancies, see the chapter "Using the Discrepancy Database" in the Oracle Clinical Conducting a Study manual.

   • Date Time Type: Specifies the expected precision of the response for a Question with Data Type of DATE or TIME.

     • For Questions with a data type of DATE, select DMY to include the day, month, and year; MY to include only the month and year; or Y to include only the year.

     • For Questions with a data type of TIME, select HMS to include hours, minutes, and seconds; or HM to include only hours and minutes.

   • Date Time Fmt (Format): The Date/Time Format must specify at least as much precision as specified by the Date/Time Type field.

   • Len (Length): Set the maximum length for responses to the Question. You can make the length longer when you add it to a study DCM, but never shorter. The system generates a univariate discrepancy for responses to this Question that are too long. For information about discrepancies, see the Oracle Clinical Conducting a Study manual.

     Note:

     All Extended Text Questions have a predefined length of 10,000 characters. However, the system cannot display the full text of the response in most places in the user interface. The length you define determines the number of characters displayed in these places in the user interface, including Oracle Clinical RDC Onsite discrepancy details.

     Note that the system reserves the first 24 characters for the attachment prefix, so if you define a length of 30, the system displays the prefix plus the first six characters of the response.

   • Dec Plc (Decimal Places): Specifies the expected maximum number of digits to the right of the decimal point for a response to a NUMBER Question. The number in this field counts toward the total number you specify in the Length field. Enter 0 to specify an integer response. This value is the Question's default Decimal Place value when you copy the Question to Question Groups or DCMs. You can change this field only for a provisional Question, or, for an active Question, only to increase it.

   • SAS Name: The Question's unique identification, within the Domain, for to access data through the SAS package; up to 8 characters in length, cannot end with a number, and can be comprised only of uppercase letters, numbers, underscores, or hashes. If the Question has multiple occurrences in a single Question Group, this field can be only up to 7 characters. You can change this field only for a provisional Question, or, for an active Question, only to increase it. See Data Extract for more information.

   • SAS Label: SAS variable label for data extraction. The Intent field is the default value for this field. You can change this field only for provisional and active Questions.

   • Extract Macro: Specify the Extract Macro associated with this Question, if any. A list of values is available.

   • Question Set Name: For Questions of type Question Set, enter the name of the Question Set to which you want to link this parent Question.

   • Safety Question?: Check if this is a safety-related Question.

   • Derived?: Select if this Question serves as the recipient of a response generated by a Derivation Procedure. All Derivation Procedures must have a target derived Question, which cannot collect a response in any other way. (See Defining Procedure Questions for more information.)

     Select also for all Questions to be used as TMS Question Set child Questions, because their responses are derived from TMS. You can also define a TMS Question Set parent Question as derived if its value is to be generated by an Oracle Clinical derivation procedure. See the Oracle Thesaurus Management System User's Guide for information on using parent Questions this way.

     Note:

     Oracle supports only the amount of derivation that can be accomplished within a single batch validation. Oracle does not support using an Oracle Clinical derivation procedure to populate the value of another derived parent Question with the value of the original derived parent Question.

   • Upper Case?: If selected, the system records the response in upper case characters.

   • Sight Verify?: Select this to display the Pass-1 response during Pass-2 data entry.

   • Default Prompt: The free form text (up to 60 characters), you enter is the prompt text associated with the response field when the Question is rendered in a data entry form. You can change this value later.

   • The DVG and Alpha DVG fields: You can limit the Question's responses to a static list of values, or Discrete Value Group (DVG). The system generates a univariate discrepancy for responses to this Question that are not included in the DVG. See Assigning DVGs to a Question.

     Even if you do not want to assign a DVG to this Question now, you can select DVG Modifiable? (and/or Alpha DVG Modifiable?) to allow the option to add a DVG to this Question at a later time, even after the Question's status is Active, within a particular Question Group.

   • Lower and Upper Bound: fields (Optional; applicable only to Questions of data type Number): Enter an appropriate upper and lower limit for the response to this Question. The system generates a univariate discrepancy for responses to this Question that are above the upper bound or below the lower bound.

   • Valid(ation) Failure Type: During data entry, if a response to the Question fails validation, the discrepancy record the system generates receives this classification.

     Choices include: Verify, Normal, Critical, Monitor Alert, Safety, Thesaurus-PT, Thesaurus_SCT.

   • Upper Case?: If you check this field the characters in the response to a DVG-associated Question are forced to uppercase. You can change this field only for Provisional and Active DCMs.

   • Pass 2 Sight Verify: If you check this field, the system completes the Second Pass Data Entry response field with the response from the first pass, allowing the response to be visually verified instead of being rekeyed. If this field is unchecked, the second pass field is left blank and requires reentry. You can change this field only for Provisional and Active DCMs.

   • Status Comment: If you change the Question's status, enter the reason.

   • Retirement Reason: If you change the Question's status to Retired, select the reason from the list of values.

2. Save.

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.

1. 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.
2. From the list of values in the Question Category Code field, select as many Question categories as appropriate.
3. Save.

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
  

Extended Text Question Usage Restrictions

The following restrictions apply:

• 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.)

• 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.

• Validation Procedures have access only to the truncated response value text stored the the RESPONSES table; see Database Storage.

• Data Extract does not support Extended Text Questions.

• 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.

• Special characters entered as part of an extended text response may not be displayed properly in the user interface.

Extended Text Question Definition Restrictions

The system enforces the following restrictions:

• You cannot assign a Discrete Value Group (DVG) to an Extended Text Question.

• You cannot define a default response for an Extended Text Question.

• You cannot define an Extended Text Question as Mandatory.

• You cannot define an Extended Text Question as a derived Question.

• You cannot define a Question Group as repeating if the group contains an Extended Text Question.

• 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.

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.

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.

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:

• (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.

• (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.

• (Alpha) DVG Domain The system enters the name of the DVG's domain.

• (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).

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
  
• Complex Questions
  

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.

1. 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.
2. Save.

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.

1. 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.
2. 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.

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:

• 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.

• 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.

• DATA_COMMENT_TEXT. Investigator comment, if any, for the response.

• 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.

• DVG_LONG_VALUE. Applicable only to Questions associated with a DVG.

• DVG_NUMBER. Applicable only to Questions associated with a DVG.

• DVG_SHORT_VALUE. Applicable only to Questions associated with a DVG.

• 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.

• FULL_VALUE_TEXT

• TERM_COL1. Applicable only to Questions associated with a thesaurus DVG.

• TERM_COL2. Applicable only to Questions associated with a thesaurus DVG.

• TERM_COL3. Applicable only to Questions associated with a thesaurus DVG.

Deleting a Provisional Question

You can remove a Question from the Global Library if it meets the following criteria:

• It is a provisional Question. You cannot remove active or retired Questions.

• 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.

• 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.