Setting Up Data Collection in Oracle Clinical
To use TMS with Oracle Clinical, you must define two types of questions and associate them with DCM question groups:
- A parent question to collect data (called source terms in TMS) at an Oracle Clinical patient visit
- A derived question to receive each piece of information you want to retrieve from TMS
In addition, you must define one or more question sets. A question set is a reusable structure that:
- Specifies the TMS dictionary against which to classify the parent question response (TMS verbatim term)
- Includes variables that specify the information you want to retrieve from TMS
During definition of the parent question you:
- Link the parent question to a question set
- Link a derived question to each question set variable
The diagram shows the definitional links between Oracle Clinical and TMS. In the Oracle Clinical Global Library, you define parent and derived questions and questions sets, which specify questions' relation to dictionary data, and link parent and derived questions. In Oracle Clinical studies, you include parent and derived questions in the study definition and link the study to TMS domain/dictionary combinations. In TMS, you define valid dictionary/TMS domain combinations.
![Diagram showing the links between Oracle Clinical and TMS Diagram showing the links between Oracle Clinical and TMS](img/ocinteg.gif)
For more information, see:
- Defining and Using Question Sets
- Defining Questions
- Using a Derived Question as a Parent Question
- Associating Child Questions with Question Set Variables
- Associating Questions with Question Groups and DCMs
Parent topic: Integrating TMS with Oracle Clinical
Defining and Using Question Sets
A question set defines the TMS information to be sent to Oracle Clinical in relation to a question response collected in Oracle Clinical. A question set definition has two parts:
-
Defining a Question Set. General information about the question set: its name, description, and TMS dictionary against which question responses are to be classified.
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Defining Question Set Variables. Variables that specify the dictionary level and data to be derived (such as term, ID, or code; see Defining Question Set Variables for a complete list of derivable data).
Alternatively, question set variables can derive Informative Notes from TMS to Oracle Clinical derived questions.
When you define a parent question (a question whose response is to be to a TMS dictionary term) you assign a question set to the parent question. Then, in the Details section of the parent question definition, you assign a derived question to each question set variable. Thus, the question set is the link between the parent question that collects Oracle Clinical data at a patient visit and the derived questions that contain information from TMS related to the response/verbatim term's classification in TMS.
You can assign the same question set to many different parent questions to collect the same TMS information for each parent question.
Note:
Define the question set completely before assigning it to a parent question. You cannot make changes to the question set after it is assigned to a parent question.
For more information, see:
Parent topic: Setting Up Data Collection in Oracle Clinical
Defining Question Set Variables
Question set variables link child questions to the parent question and specify the information to be sent to and retrieved from TMS.
When you define a parent question to collect a drug name or medical condition to be classified in TMS, you associate it with a question set. The system populates the parent question's Details window with the question set variables. You must associate each variable with a child question that either sends additional information to TMS or holds information derived from TMS.
You define question set variables in the lower part of the Question Sets window. Each row defines one variable.
Parent topic: Defining and Using Question Sets
Defining Questions
Two types of questions are used by TMS: parent questions are used to collect responses at patient visits; and child questions, derived questions that receive the information specified by question set variables from TMS. Use the standard Oracle Clinical question definition process for both parent and child questions, with the TMS-specific settings below.
Parent questions can also be derived questions in special cases; see Using a Derived Question as a Parent Question.
You cannot convert an active, non-TMS question set question for processing in TMS. You must define a new question with a question type of Question Set and the name of its question set as part of the definition. You may want to model your TMS parent questions on your standard Glib questions, changing their names using a convention such as suffix _TMS
.
Note:
A particular derived or parent question can be used only once within a question group: a particular question cannot be used in more than one question set, and can be used only once in a single question set.
This section includes:
Parent topic: Setting Up Data Collection in Oracle Clinical
Defining a Parent Question
The parent question collects the verbatim term (clinical data, question response) during an Oracle Clinical visit.
To define a parent question and link it to a question set:
Parent topic: Defining Questions
Defining a Child Question
Create a child derived question for each variable of the question set. Consider using a naming convention to make it easy to remember which question you should associate with which variable; for example, dictionary level_type of information
.
To define a child derived question:
Parent topic: Defining Questions
Using a Derived Question as a Parent Question
Batch Validation can run its TMS process twice, once before and once after deriving question responses with Oracle Clinical derivation procedures (see Batch Validation Execution Order), and allows parent questions to be defined as derived, making it possible to do either of the following during a single Batch Validation job:
-
Derive a value to an Oracle Clinical question in TMS, run an Oracle Clinical derivation procedure to take that value and use it to populate the value of a (derived) parent question, and send the derived parent question value to TMS to derive additional Oracle Clinical question set question values.
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Run an Oracle Clinical derivation procedure to populate the value of a (derived) parent question as necessary, and send the derived parent question value to TMS to derive additional Oracle Clinical question set question values.
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.
Also, Batch Validation runs the TMS portion twice only if a derived parent question exists and requires processing.
For more information, see:
Parent topic: Setting Up Data Collection in Oracle Clinical
Examples
Deriving a parent question may be useful in the following situations:
Deriving Data from Two Dictionaries for One Verbatim Term
To classify a single verbatim term to two different dictionaries, and derive information from both dictionaries into Oracle Clinical, you can do so by defining two question sets, as follows:
-
The first question set references the first dictionary and includes a (non-derived) parent question to collect a response during data entry and derived child questions to receive TMS values from the first dictionary as specified by the question set variables (a standard Oracle Clinical TMS question set).
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The second question set references the second dictionary and includes a parent question defined as a derived question and derived child questions to receive TMS values from the second dictionary as specified by the question set variables.
To populate the value of the derived parent question, you must write a derivation procedure in Oracle Clinical that propagates the value collected for the first parent question to the second (derived) parent question.
During Batch Validation, the system first derives values from TMS (from the first dictionary) for the first set of derived questions, then processes the derivation procedure that populates the second parent question value, and finally derives values from TMS (from the second dictionary) for the second set of derived questions.
Classifying a Term Substituted for the Original Question Response
If many of the originally collected question responses are inconsistent with current terminology—for example, in a historic study or a study conducted by a company your company has acquired—you can leave the original data and thesaurus derivations, if any, intact but add current information by doing the following:
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Define a new question for each original question whose responses may be outdated.
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Examine each response to the original question and manually enter an appropriate value in current terminology for each corresponding new question.
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Define a new derived parent question also corresponding to each original question whose responses may be outdated. Associate the parent question with a question set and child derived questions to define and receive the related information you want to derive from TMS.
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Write a derivation procedure that compares the values of the original question and the new non-derived question, and populates the new derived parent question with the value of the new non-derived question if it has a value; otherwise with the original response.
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Run Batch Validation. TMS processes the value of the new derived parent question and returns the data specified in its question set.
Classifying Previously Unclassified Terms
Add derived parent terms to legacy studies to derive TMS information for question responses that previously had no derived thesaurus information.
- Define a new derived parent question for each original question for which you want to derive thesaurus values. Associate the parent question with a question set and child questions to define and receive the related information you want to derive from TMS.
- Write a derivation procedure to populate the value of the new derived parent question with the original question's value.
- Run Batch Validation. Oracle Clinical runs the derivation procedure to populate the value of the new derived parent question, and TMS returns the data specified in the question set.
Parent topic: Using a Derived Question as a Parent Question
Associating Child Questions with Question Set Variables
After you have created a question set, a parent question to collect data, and all the child questions you need for the parent question, you must assign one child question to each variable of the question set associated with the parent question. If it is unclear what information should be associated with each variable, look up the question set definition from the Glib menu, by selecting Question Sets, and then Question Sets.
- In Oracle Clinical, from the Glib menu select Questions, then choose Questions.
- Execute a query for the parent question.
- Highlight the parent question name. This activates the Details button.
- Press the Details button. The Details window displays the prompts for the variables of the question set linked to this parent question (see Defining and Using Question Sets).
- In the row for each variable, use the LOV to enter the name of the question you created to collect it.
- Save.
Parent topic: Setting Up Data Collection in Oracle Clinical
Associating Questions with Question Groups and DCMs
Before you can use parent or derived questions in a study you must associate them with a question group, DCM, DCI, and study as usual in Oracle Clinical (see the Oracle Clinical Creating a Study manual).
You do not have to use all the derived questions associated with a parent question in the Global Library. If you choose not to derive all the information defined in the question set, in the DCM question group you can simply not include the derived question mapped to the variable you do not need.
However, the parent question and all its derived questions you do need must be in the same question group.
All questions are visible in the data entry form, but only the parent question is enterable. When values are derived for the derived questions during Batch Validation, they are displayed in the data entry form. You can reference their values as you can any other question response values, in Oracle Clinical data extract and validation procedures.
You can associate the same question set with multiple parent questions in the same DCM.
For more information, see:
- Planning Question Groups and DCMs for RDC Special Listings
- Adding Derived Questions to an Ongoing Study
Parent topic: Setting Up Data Collection in Oracle Clinical
Planning Question Groups and DCMs for RDC Special Listings
If you are using Oracle Remote Data Capture (RDC) Release 4.5.3.10 or above, you can use Special Listings to display concomitant medications and adverse events by patient. (If you are using TMS to code any other type of data, you can display Special Listings for it too.)
If RDC detects that any question in a DCM is a mapped to a TMS dictionary (is a
parent question) it displays an additional item in the drop-down list of actions a user
can take in the Home and Casebooks pages. By default, this item's text is:
Review
TMS_dictionary_name/DCM_name
. You can substitute other text
(such as Adverse Events or ConMeds) for the dictionary name by defining a special type
of Informative Note. This text appears on the Special Listings page as well; see RDC Action Informative Notes.
When a user selects a patient and selects a dictionary/DCM combination, the Special Listings page displays the patient's responses to all questions that are mapped to that dictionary in that DCM, in every visit and CRF where the DCM has been collected. In addition, the Auxiliary Information field displays the question name and the patient's response for every other question in the question group that is defined as Displayed and not as Derived.
In the figure below, the response to the parent question is displayed in the Verbatim Term column. In the Auxiliary Information column, the system displays all other nonderived, displayed questions in the same question group as the parent question; in this case, Start Date, End Date, and SAE (Yes/No).
To optimize Special Listings behavior, plan Question Groups and DCMs as follows:
- Question Groups. Include any questions related to the parent question that you would like to have displayed with it in RDC Special Listings, and do not include any questions you do not want displayed.
- DCMs. To enable viewing all adverse event or all concomitant medication data for a patient at the same time, use the same DCM to collect adverse event or conmed data in any DCI/CRF where you need to collect it.
Figure 4-1 Figure 4-2 RDC Special Listings Page
![Description of "Figure 4-2 RDC Special Listings Page" Description of "Figure 4-2 RDC Special Listings Page"](img/rdc_spec_list.gif)
Parent topic: Associating Questions with Question Groups and DCMs
Adding Derived Questions to an Ongoing Study
If you initially do not include all the derived questions associated with a parent question and then decide midway through a study that you do want to derive that information, do the following:
- Add the derived question to the DCM in the DCM's Question Group Questions window.
- In Oracle Clinical, from the Plan menu, select TMS Domains. The Maintain Domain Elements window opens.
- Select the project to which the DCM's study belongs, and click Studies. The Studies window opens.
- Select the study to which the DCM belongs.
- Click Domain Elements. The Domain Elements window opens.
- Select the dictionary referenced by the parent question's question set.
- Click Force Rederivation. During the next Batch Validation run, all the parent questions associated with the study will be reprocessed and the associated derived questions repopulated or, in the case of the new question, populated for the first time.
Parent topic: Associating Questions with Question Groups and DCMs