Creating and Maintaining Question Groups

Question Groups organize Questions in a study and collect related data by grouping related Questions. For instance, Question Group DEMOG may collect demographic data about patients and contain the Questions: BIRTHDATE, RACE, and SEX.

You can group multiple Question Groups in a single Data Collection Module (DCM) and multiple DCMs in a single Data Collection Instrument (DCI), which generally corresponds to a CRF. You can define a Question Group either in the Global Library or in a particular study DCM, but to promote consistency and reusability, define Question Groups in the Library and then copy them to study DCMs, where you can modify them for the needs of the study. Library Question Groups should be as general and complete as possible so that designers can easily modify them to work in any clinical study.

For example, a Library Question Group ALLERGIES might contain many Questions, each collecting data medically useful in various studies. If a study designer copied and modified ALLERGIES into a cardiovascular study study DCM, the designer might confine it to four Questions that gather a patient's history of allergic reactions to medication (HX_ALLERGIC_SENS, MED_NAME_II, ALLERGIC_REACTION, and FIRST_INCIDENT_YEAR). The designer would designate the other Questions in ALLERGY as "Not Collected."

For more information, see:

• Creating a New Question Group
  
• Assigning Questions to a Question Group
  
• Defining Indicator Branching
  
• Creating a Question Group by Copying
  
• Deleting Provisional Question Groups
  
• Managing Question Groups
  

Creating a New Question Group

Some choices of attributes you make in the library version of Question Groups impact what you are able to do when you include a Question Group in a study DCM and DCM subset. This section addresses some of these attributes:

If you disable COLLECTED at the library level, you cannot enable it in the study DCM Question Group.

If you enable both REQUIRED and COLLECTED at the library level, you must enable both in the study DCM and enable COLLECTED at the subset level.

If you enable REQUIRED but disable COLLECTED at the library level, you do the same at the study level, and you must enable COLLECTED in the DCM subset.

If you disable both REQUIRED and COLLECTED at the library level, then you cannot enable COLLECTED at the study level, but COLLECTED is enabled at the subset level.

If you disable REQUIRED and enable COLLECTED at the library level, but do not enable COLLECTED at the study level, then COLLECTED is also not enabled at the subset level.

If DERIVED is enabled, then ENTERABLE and MANDATORY must be disabled.

If MANDATORY is enabled, then ENTERABLE must be enabled. If ENTERABLE is enabled, then DISPLAYED must be enabled.

The maximum number of Questions in a Question Group is equal to 255, minus the number of fields in the key template. If the system does not present the Prov Question Groups menu item to you, see Assigning Questions to a Question Group.

To create a new Question Group:

1. From the Glib menu, choose Question Groups, then select Prov Question Groups or Question Groups.
2. Enter values as follows:

   • Name – Must be unique within the given domain. Query only to view listings of existing Question Groups for guidance in naming.

   • Domain – The system supplies the first domain in your domain list. Use the List function to choose another, if necessary.

   • Status – There are three valid statuses:

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

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

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

       Note:

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

       You can change a Question Group's status from Active to Provisional only if the Question Group is not used as a DCM Question Group. In addition, you cannot change a Question Groups's status from Active to Provisional in a replicated environment; that is, if there are more than one source locations set to active in the installation reference codelist SOURCE LOCATION CODE.

   • QG Type – The kind of data gathered by the Question Group. A list of values is available.

   • Expand? – If checked, you can add more Questions to a saved Question Group.

   • Description – A description of the Question Group to help other people know if they should use it.

   • Status Comment – (Optional) If you change the Question Group's status, provide a reason.

   • Retirement Reason Type – Required when you change the Question Group's Status to R. Select a value from the list. These values are set in the RETIREMENT REASON TYPE CODE installation reference codelist.

3. Save your work, or click the Exit button to discard it.
4. Click the Question Group Questions button to populate the Question Group. See Assigning Questions to a Question Group for details. The other fields in this window are for Question Group maintenance:

   • Use the status comment to explain changing a Question Group's status.

   • Select a retirement reason if you choose to prevent a Question Group from being used in new studies.

5. Click the Standards Affiliations button to assign the standards affiliations to the Question Group. For information on standards affiliations, see the Oracle Clinical Getting Started manual.

Assigning Questions to a Question Group

Once you create a new provisional Question Group, assign Questions to it. A Question must meet the following conditions to be assigned to a Question Group:

• The Question must exist in the Global Library. If it does not, create the new Question first. See Creating a New Question.

• The Question Group must be provisional. (To add Questions to Active Question Groups, see Managing Question Groups.)

To assign Questions to a Question Group:

1. From the Glib menu, select Question Groups, then choose Prov Question Groups.
2. Query and select the Question Group where you want to assign Questions.
3. Click the Question Group Questions button to display the Question Group Questions window.
4. Enter the name of the Question in the Question Name field. The system fills in the Question's current values when you select another field.
5. Fill in all mandatory fields. Depending on your computer's display configuration, you may have to perform several scroll actions to see all fields.

   Note:

   You can assign the same Question to the Question Group multiple times if needed. If there is only one occurrence of a Question in the Question Group, the system give it an Occurrence Sequence Number (Occ SN) of zero (0). If there are multiple occurrences, the system gives the first one an Occ SN of 1, the second an Occ SN of 2, and so on.

Defining Indicator Branching

Indicator branching allows you to control whether or not Questions in a Question Group are collectible for a particular patient depending on that patient's response to the first Question in the Question Group.

You mark the first Question in the Question Group as the indicator Question and specify the response value that, if entered for a patient, makes the rest of the Questions in the Question Group collectible.

If a patient response to the indicator Question matches the specified indicator value, the remaining Questions in the Question Group are collectible. Otherwise, the remaining Questions in the Question Group remain disabled, and the branch is to the first Question outside of the Question Group.

• In RDC Onsite the Questions are enabled and the data entry form branches to the next Question.

• In Oracle Clinical, there is no change in the appearance of the Questions but the remaining Questions in the Question Group become enterable.

If a patient response to the indicator Question does not match the specified indicator value:

• In RDC Onsite the remaining Questions in the Question Group remain disabled and the data entry form branches to the first Question outside the Question Group.

• In Oracle Clinical, there is no change in the appearance of the Questions but the remaining Questions in the Question Group remain unenterable.

For example, define the first Question, SEX, to collect the patient's gender. If a patient's response to SEX is FEMALE, then in RDC Onsite the remainder of the Questions in the Question Group, which cover pregnancy, become collectible for the patient. If the patient is male, these Questions are not collectible for the patient. The next Questions available in data entry are in the next Question Group in the DCM, if any, or the next DCM, if any.

You define indicator Questions and values in the Question Group Questions window in the Global Library.

Restrictions:

• indicator Questions must be the first Question (according to sequence number) in the Question Group. If you do not define it first, on Save the system repositions the Question as first.

• Only one value can make the rest of the Questions in the group collectible

• An indicator Question cannot also be a conditional branch source Question, and should not be an Extended Text Question.

Creating a Question Group by Copying

To create a new Question Group similar to an existing Question Group, you can copy an existing one. You can then add or change attributes to make the new Question Group fulfill all its purposes. Note that as soon as you make a copy, it exists as a distinct record; changes to the copy do not affect the original Question Group.

1. Navigate to Glib, then Question Groups, and Prov Question Groups.
2. Select Copy Ques Group from the Special menu to view the Locate Question Groups window.
3. Query to identify an existing Question Group with the attributes you want.
4. Select the Question Group.
5. Click the OK button to copy the Question Group.

   The system closes the Copy window, redisplaying the Question Groups window. Its first field contains the name of a new record the system generates by prefixing COPYOF to the name of the original Question Group.

6. Change the name of the copied Question Group. If you do not change the name, the system retains the COPYOF prefix.
7. Save.

Deleting Provisional Question Groups

You cannot delete an Active or Retired Question Group. To delete a Provisional Question Group:

1. From the Glib menu, select Question Groups, then choose Prov Question Groups.
2. Query and select the Question Group you want to delete.
3. Click the Delete Record button.
4. Save.

Managing Question Groups

Question Group management concerns setting the status of Question Groups, rejecting provisional Question Groups, defining sets of Question Group types, and other administrative tasks.

You can find the Question Group you want to work with by selecting Locate QG by SA (Standards Affiliation) from the Special menu. (See the Oracle Clinical Getting Started for information on standards affiliations.) For example, the standards affiliation type CARDIOVASCULAR may locate the Question Groups ECG_TRACE, ECG_ABNORM, EXER_STAGE, TREADMILL, and STOP_REASON.

For more information, see:

• Setting Question Group Status
  
• Creating Lists of Values of Question Group Types
  

Setting Question Group Status

Only the Global Librarian, who has access to the full-privilege Question Groups, can set the status of a Question Group to Active or Retired. A Question Group must have one or more Questions before you can make it Active. When you retire a Question Group, the system prompts you to fill in the Retirement Reason field.

Creating Lists of Values of Question Group Types

To create lists of values (LOVs) of Question Group types, you (or someone who has the correct privileges) must modify the installation reference codelist DCM DCI QG TYPE CODE. Note that Question Groups have the same type codes as DCMs and DCIs.

Examples of Question Group types are: DEMOGRAPHY, MEDICAL HISTORY, PHYSICAL EXAM, ADVERSE EVENTS, MEDICATION, and COMPLETION. See the Reference Codelist chapter of the Oracle Clinical Administrator's Guide for instructions on maintaining reference codelists.