Defining DCMs

Generating Layouts from DCMs

You can generate a character-based layout from a DCM that becomes the form used for data entry in Oracle Clinical. Alternatively, you can associate the DCM with a Data Collection Instrument (DCI) and generate a graphic layout that becomes the HTML form used for data entry in RDC Onsite and the PDF form used to generate the Patient Data Report.

The order in which you add Question Groups determines the default layout of the data entry form. Although you can edit the default layout, you can reduce layout work if you are aware of how the DCM's definition affects the layout, especially since regenerating the layout overrides your edits. In the layout:

DCM Questions become fields
DCM Question Groups become blocks

For more information, see:

Parent topic: Defining DCMs

Using Variations of the Same DCM

Oracle Clinical does not permit you to create multiple identical study DCMs in one clinical study because identical DCMs would be indistinguishable during data analysis. However, it is likely that your study design calls for you to collect certain kinds of data repeatedly throughout the study. You handle this requirement with base DCMs.

You can define a base DCM that includes all related Question Groups and then create DCM subsets that collect only a portion of the base DCM Questions.

You can also differentiate occurrences of the same DCM by defining Qualifying Questions; for example, Questions about eyes might begin with a Qualifying Question asking if it is the right or left eye.

Parent topic: Generating Layouts from DCMs

Using Provisional and Active DCMs

You can modify DCMs with a status of Provisional without constraints. You can use provisional DCMs in test mode to enter test data and identify required modifications to the DCM definition. When you are ready to use the DCM to collect production data, set its status to Active. If you have defined the DCM in the Global Library, copy it to your study.

Parent topic: Generating Layouts from DCMs

Creating a New DCM

To create a new DCM:

From the Definition menu, select DCMs, and choose DCMs for the Data Collection Modules window of the Maintain Study DCMs form.

If you have not already selected a study during this Oracle Clinical session, the system prompts you to choose a study.
Insert a new record and enter a name for the new DCM. The name can be up to 16 characters, but limiting it to eight can make it easier to identify after it is added to a DCI.
The Name field is the subset name. This value becomes the default subset name when you add it to a DCI. The default subset starting number is one. It increments each time you make a new subset.
Give the DCM a short name of up to four characters.

Tip:

Avoid using "CON" as a DCM short name. In a Data Extract SAS view, the SAS view creation file con.sas fails because "CON" is a reserved device name.
Choose a Type from the list of values. The values are set in the DCM DCI QG TYPE CODE installation reference codelist.
Add a description. It can be specific to the subset.

Tip:

Avoid including the colon (:) character in the description field. They considerably reduce performance when you edit the graphic layout. A layout that would take a few seconds to open can take several minutes if there is a colon in the description.
Click Save.
Add Question Groups; see Adding Question Groups to a DCM.

Parent topic: Defining DCMs

Copying a DCM

The most common procedure for creating a DCM is to copy an existing DCM and modifying it to suit the needs of the study.

To copy a DCM:

From the Definition menu, select DCMs, then choose DCMs.
From the Special menu, select Copy DCM. A dialog box appears.
Select one of the two buttons in the dialog box: Library or Study. If you select Study the system prompts you to select the study from which you want to copy a DCM.

The Data Collection Modules window opens in Query mode. You can query DCMs by entering the DCM name, qualifying value, or another attribute value and executing the query. You can perform multiple queries.

Note:

The Study Domain Search List controls what you see when you search the Library from the study level.
Select the DCM you want to copy and click OK.

The system creates a copy of the selected DCM. If a DCM of this name already exists in the target study, the system copies the DCM with the name COPYOF DCM. The system prompts you to change the name before saving because you cannot save a study DCM with a name beginning with COPYOF. Furthermore, you may not copy another DCM until you have removed the COPYOF name and the short name beginning C- from the one you just copied.

Parent topic: Defining DCMs

Adding Question Groups to a DCM

After saving a DCM to your study, populate it with DCM Question Groups. From the Maintain Study DCMs window, select your DCM and click the DCM Question Groups button. You cannot create a new Question Group from any of the forms in the Definition subsystem. You can create new Questions and Question Groups only in the Global Library.

You can only add a Question Group that has a status of Active. When you add a Question Group to a DCM, it becomes local to that DCM. Some of its library attributes are copied into the local copy, some are not, and some new ones are available.

From the Definition menu, select DCMs, then DCMs. The Data Collection Modules window opens.
Click the DCM Question Groups button. The DCM Question Groups window opens.
Either select a Question Group from the list of values in the DCM Question Group Name field or, from the Special menu, select Add Ques Group. You can then query for Question Groups by various attributes.
Select the DCM Question Group to copy.
Save. The system returns you to the DCM Question Groups window and displays a message that the copy either succeeded or failed.

You can modify Question Groups for use in this DCM; see Configuring Question Groups in a DCM

Parent topic: Defining DCMs

Configuring Question Groups in a DCM

In the context of a DCM, Question Groups are called DCM Question Groups. Some of their Global Library attributes cannot be changed and others can. They also have additional attributes that apply only in the context of the current DCM. DCM Question Group attributes include:

DCM Question Group Name You can give this local copy a different name.
Library Question Group Name The system copies this name from the library version. You cannot change it.
Question Group Domain The system copies this name from the library version. You cannot change it.
Short Name An abbreviated name used for naming data extract views.
Collect in Subset If this field is checked, responses to the Questions in the DCM Question Group of this DCM subset are collected. You can change the Collect in Subset? field only for Provisional and Active DCMs. You can exclude a Question group from this DCM subset without removing it from its record by deselecting this box.

Tip:

Avoid unchecking this field once data has been collected for the DCM. If you must uncheck the field, you must immediately regenerate the form.

Otherwise, in HTML data entry (RDC Onsite), the form opens and the field is still displayed. However, the field is no longer updateable. Discrepancies, Investigator comments and audit history for the field are still displayed. Discrepancies and Investigator comments appear to be updateable, but they are not.

Once the form is regenerated, the field does not appear, nor do associated discrepancies, Investigator comments and audit history. However, note that the data remains in the database and cannot be deleted.
Display Seq#: Sets the default cursor tab sequence among all of the Question Groups you add to the DCM. As a data entry operator enters data and tabs, this number determines the default tab sequence in which the operator's insertion point moves through the form. You can change this value later when you lay out the DCM, but this default sequence remains with the DCM if you use it in another study.
Repeating Group? Select this box if this Question Group needs to be collected multiple times in this DCM; for example, if you are loading normalized lab data using this Question Group; see Using Repeating Question Groups and Using Normalized Lab Data.
Max Reps Expected Graphic layouts, which are used in RDC Onsite, always display the number of repeats specified here. Character-based layouts, which are used in Oracle Clinical, allow dynamically adding scrollable displays of repeating Question Groups up to this value. The default value is one. You can change the Max Reps Expected field only for Provisional and Active DCMs. For non-repeating Question Groups, this field is display-only.
Reps to Display (Applies to character-based layouts only.) This setting determines the size of the scroll area in terms of the number of repeats displayed at one time; if set to 2, the user can see two repeats in the layout without scrolling. For non-repeating Question Groups, this field is display-only.
Enforce Max Reps? (Applies to character-based layouts only.) This box prevents more than the set value of Max Reps Expected from being collected, except for users with privileged update. For a repeating Question Group, you can change this field only for Provisional and Active DCMs. For a non-repeating Question Group, this field is display-only, with a value of unchecked.
Has Border? Selecting this causes the default layout generator to add a rectangular border around the Question Group. You can change this field for both Provisional and Active DCMs.
Prompt Position This value determines the location of the response field's label, or prompt text, in the layout. Select Left or Above.
Protect Repeating Defaults? Select this box to protect the displayed default values serving as prompts from being changed in the Layout Editor or during data entry; see Using Default Repeat Values. You can change this field only for Provisional and Active DCMs. For a non-repeating Question Group, this field is display-only, with a value of unchecked.
Save Repeat Defaults? Select this box to create a set of rows with repeating defaults, even if the repeats are blank after data collection.

If checked, this DCM definition overrides the automatic deletion of any empty rows so that these rows are saved. This override allows the use of empty repeating default Question Groups as targets of derivation.

You cannot check this if there are no repeating defaults defined for any of the Questions in the Question Group.
Help Text Add extra information, up to 200 characters, about the Question Group. The text you enter here is available for display during data entry. You can change this field only for Provisional and Active DCMs.
Normalized? Check this flag if you are planning to batch load normalized lab data and want the input formats of the Batch Data Loader to accommodate normalized lab data modeled as lab test name/lab test result value pairs in the data files by automatically generating, for both inserts and updates, two response records for each incoming data record; see Using Normalized Lab Data.

Note:

The Normalized? flag is available only for repeating Question Groups.

You may need to Save before checking Normalized? to enable the lists of values for the First and Second Repeat fields.

Enter values for the following fields only if you checked the Normalized? flag. You must first define the Questions in the Question Group.

First Repeat Descriptor Question From the list of values, which displays all Questions in the Question Group that are collected in the DCM Subset, select the first Question in the normalized pair (the lab test name Question).
Occ Sn (Question occurrence sequence number) The system enters this value when you select the first repeat descriptor Question. You cannot change it.
First Repeat Descriptor Label The system enters the Default Prompt defined for the Question you selected as the First Repeat Descriptor Question. You can change it. This value is stored in dcm_question_groups.repeat_descr1_label and is available to use as a variable (\DESCRIPTOR1\) in Standard Text in a discrepancy comment wherever discrepancies are displayed.
Second Repeat Descriptor Question From the list of values, which displays all Questions in the Question Group that are collected in the DCM Subset, select the second Question in the normalized pair (the lab test result Question).
Occ Sn (Question occurrence sequence number) The system enters this value when you select the second repeat descriptor Question. You cannot change it.
Second Repeat Descriptor Label The system enters the Default Prompt defined for the Question you selected as the Second Repeat Descriptor Question. You can change it.

Parent topic: Defining DCMs

Adding or Modifying DCM Question

After creating a new study DCM or having copied a DCM from another study, you can add more Questions to the Question Groups or modify the existing Questions. To add or modify a DCM Question:

From the Definition menu, select DCMs, then choose DCMs. The system displays the DCM Questions window.

Note:

You can only copy or add new Questions into a Question Group if the Question Group is flagged as expandable. (Expandability is an attribute set at the Global Library level.) Oracle Clinical prevents you from copying Questions into a non-expandable Question Group.
Click the DCM Question Groups button. The DCM Question Groups window opens.
Choose a DCM Question Group name and click the DCM Questions button.
Select Add Question from the Special menu. The system displays the Locate Active Questions form.
Enter, or select from the list of values, the name of the Question you want to copy.
Click the Commit button. The system returns you to the DCM Questions window and displays a message that the copy succeeded or failed.

Alternatively, you can add Questions to a Question Group:

From the Definition menu, select DCMs, then choose DCMs.
Enter or select from the list of values, into the first blank record, the name of the object to copy.
Save.

You cannot create a new Question in the Definition subsystem. You can create new Questions and Question Groups only in the Global Library.

Parent topic: Defining DCMs

Configuring DCM Subsets

Using DCM subsets, you can have multiple occurrences of a DCM in a single DCI, but collect some DCM Questions in one subset and other DCM Questions in another subset.

All subsets contain the same Questions and Question Groups, and when you add a Question to one subset, the system automatically adds it to all the other subsets. The difference is that the Question's Collected? box can be selected in one or more subsets but not in others. A Question appears in data entry and in a layout only if it is marked as collected.

You can also associate different DVGs, or lists of allowable values, with the same Question in different DCM subsets.

Each subset can have one or more layouts.

To Create a New DCM Subset

Parent topic: Defining DCMs

To Create a New DCM Subset

To create a new subset of a DCM, from the Data Collection Modules window, do the following:

Put your cursor on an existing DCM that you want to create a subset for. If the DCM has more than one layout, select the one you want to use for the new subset.
In the Special menu, choose Create DCM Subset. The system creates a new subset with the subset name (labeled "Name") given a default value of "Copy original_name."
Give the new subset a better name and, in the Description field, explain its purpose.
Click the Question Groups button. If there is a whole Question Group that you do not want to collect in the subset, deselect its Collect in Subset? box.

If there are individual Questions you do not want to collect in the DCM, but you do want to collect other Questions in the same Question Group, select the Question Group in the Question Groups window and click the Questions button. Then deselect the Collect in Subset? box of the Questions you do not want to collect.
(Optional) In the Questions window you can select a DVG, or list of allowable values, for a Question that is different in this subset than in other subsets of the same DCM.
Save your changes.

Parent topic: Configuring DCM Subsets

Configuring Qualifying Questions

If you need to collect responses to the same set of Questions more than once in the same DCI, you can group the Questions into a DCM and define a Qualifying Question for the DCM, the response to which identifies the set of responses. You then create the number of DCMs you need for the DCI.

For example, you may want to record a patient's blood pressure and other vitals in both the standing and the sitting position. You create a DCM called Vitals with a Qualifying Question named Vitals Position, for example, associated with a DVG that includes two values: Standing and Sitting.

You can define a Question especially for this purpose, or use an existing Question. If you create a new Question for the purpose, you may want to give it the same name as the DCM and, in the Description, note that it is used as the Qualifying Question for the DCM. Qualifying Questions must be associated with a DVG, or static list of allowable values.

Do one of the following to create two of the same DCMs within the DCI:

In the DCM window, copy the DCM (see Copying a DCM) and give it a different name and a different qualifying value in the DCMs Qualifying Question tab; for example, create DCM VITALS_SIT and DCM VITALS_STAND and give VITALS_SIT the default value Sitting and VITALS_STAND the default value Standing.
In the DCI window, click the DCI Modules button. Here you can enter the same DCM multiple times, each with a different qualifying value. For example, enter the DCM called VITALS twice, once with the qualifying value Sitting and once with the qualifying value Standing.

The Qualifying Question prompt (defined as part of the Question) appears in the DCM header during data entry. If you define a qualifying value (in this case, either Standing or Sitting) for each occurrence of the DCM, that value appears in the DCM header after the prompt. If you do not define a default value, the field is blank in the DCM Header and the data entry operator must enter the appropriate qualifying value.

To Associate a Qualifying Question with a DCM

Parent topic: Defining DCMs

To Associate a Qualifying Question with a DCM

You associate a Qualifying Question with a DCM in the Qualifying Questions tab of the Maintain DCMs window:

Put your cursor in the Qualifying Question Name field for the DCM for which you want to define a Qualifying Question.
From the list of values, which displays only DVG Questions, choose the Question you want to use.
Put your cursor in the Qualifying DVG Name field. The field enters the DVG that is defined for the Question. You can choose a different DVG from the list of values if you want to.
(Optional) Enter one of the DVG values in the Qualifying Value field. This value appears as the default value for the Qualifying Question in the DCM Header.

Parent topic: Configuring Qualifying Questions

Using Repeating Question Groups

Sometimes you need to collect the same group of Questions multiple times at the same visit. Depending on your requirements, you can handle this different ways in Oracle Clinical:

DCM Qualifying Questions: If there is a key difference in each collection—for example, you need to collect one set of Questions about the right eye and the same set of Questions again for the left eye; see Configuring Qualifying Questions.
Repeating Question Groups: If you need to collect the same set of Questions repeatedly within the same DCM, use a repeating Question Group.
For example, if you need to collect vitals at predefined time Intervals after a dose, make the Vitals Question Group a repeating Question Group within in the DCM.

For more information, see:

Using Default Repeat Values

Parent topic: Defining DCMs

Using Default Repeat Values

To simplify Question definition and to make Question prompts available in data extract views, you can define a repeating Question Group where the first question is used to display a label or prompt for the remaining questions in the row (or repeat). You specify the number of repeats expected for the Question Group in a particular DCM, and then specify the label to be displayed for each repeat (Occurrence Sequence Number, or Occ SN) of the first Question as a "default repeating value" and protect the value of that Question from update.

Note:

Because you are using the same Question definition for each repeat of the response value Question, all responses must be collected as the same data type. If you want to use the repeating Question Group for both text and numeric Questions, you can collect all Questions as text and then use a derivation procedure to derive each numeric response value entered as text (based on the occurrence SN) into a Question with a data type of NUMBER.

Prompts defined as default responses are available in data extract views, unlike boilerplate text (text the layout generator derives from the Default Prompt values of Questions in a DCM) or text objects added in the DCM Layout Editor.

Example 1
As a variation on the interval example above, specify the expected intervals with default values for a question 'Interval'.

Example 2
Use default repeating values in batch loading normalized lab data; see Using Normalized Lab Data.

Example 3
If you want to collect a finding about various organs, such as the brain, the liver, and the heart, you can define an ORGAN Question to have default values of BRAIN, LIVER, and HEART for Repeats 1, 2, and 3 of the Question. Then define the next Question as FINDING. In this case, the values for the Question ORGAN would not be user-collected, but would simply serve as prompts for the Question FINDING. The  data entry form would look like this:

Organ	Finding
BRAIN	field for user-entered response
LIVER	field for user-entered response
HEART	field for user-entered response

resulting from the following Repeating Default Value definition:

Occurrence SN	Organ Question Value
1	BRAIN
2	LIVER
3	HEART

To create default repeat values:

From the Definition menu, select DCMs, then choose DCMs.
Click the DCM Question Groups button and select a repeating Question Group.
Select the Question to which to assign default repeat values.
Click the Default Repeat Values button.
Enter the number of the repeat and the value to display for that occurrence of the Question.

Tip:

If you are using default repeating values as question prompts, select Protect Repeating Defaults and Save Repeating Defaults for the Question Group and in the Status Comment field of the DCM enter this string: ADDREPDEF.

This ensures that, if a user enters data in a CRF that then has a status of Saved Complete or Pass 1 Complete, and additional repeats are later added (Max Repeats is increased) to the form and additional repeating default values are specified for the new repeats—and a new form version generated and the document migrated to it—when the user opens the document again, the new repeating default values (prompts) are displayed in RDC Onsite. The user must open and save the document to save the repeating default values.

Parent topic: Using Repeating Question Groups

Defining Conditional Branching

Branching occurs when a data entry interface directs a user to a different set of questions on a CRF, depending on the response entered for a question. There are several types of branching, including Indicator branching, conditional branching, and flexible study design; see Designing Response-Dependent Branching for a comparison of these types.

In conditional branching, you specify a source Question and a response value or range of values that, when entered as patient data, triggers the activation of a target Question in the same DCM. You can specify multiple responses or ranges of responses for the same source Question, and different target Questions for each response or range of responses.

For example, define a Question "Are you pregnant?" with a DVG containing three values: Yes, No, and I Don't Know. For the response Yes, define a target of the first Question in a Question Group about the pregnancy. For I Don't Know, define a Question "Is lab test scheduled?" as the target, with the Question "Date scheduled" nested. For No, either define a target of "Verification that lab test confirms" or do not define a target at all, in which case the cursor goes to the next sequential Question during data entry.

You can define conditional branching on numeric, time, and date Questions. You can specify ranges using greater than (>) or less than (<) operations in combination with each other or with the equal to (=) operation. For example, use a numeric range for a Question Year of Birth to bypass age-specific Questions that are inappropriate for a particular patient.

To define a conditional branch:

From the Definition menu, select DCMs, then choose DCMs. The system displays the Maintain DCMs window. You can also define conditional branching directly in the Global Library: From the Glib menu, select DCMs, then choose DCMs.
Query for or create the DCM.
Click the DCM Question Groups button. The DCM Question Group window opens.
Select the DCM Question Group containing the Question that initiates the branching.

Note:

If you are using graphic layouts (for RDC Onsite), do not define conditional branching within a repeating Question Group.

If you are using character-based layouts (for Oracle Clinical) you can define conditional branching within a repeating Question Group. If the target Question is before the source Question in the Question Group, entering the trigger response value during data entry moves the cursor to the target Question in the next repeat of the Question Group.
Click the DCM Questions button.
Select the initiating, or source DCM Question. You may want to use a Question with a DVG; see Creating and Using DVGs, especially if the source Question is a character Question.
Click the Conditional Branch button. The system displays the Conditional Branches for (Question Group, Question) form.
For each response that should result in a branch, specify the target Question for that branch:
1. In the Value column, enter the response value that will serve as the trigger for the conditional branch you are defining.
  - If the Question has a DVG, select a value from the list.
  - If the Question is of data type CHAR but does not have a DVG, only NULL or NOT NULL are allowed.
    
    Note:
    
    If the source Question is of data type CHAR, and you want a particular response (such as Y, WHITE, or SEVERE) to trigger a branch, create a Discrete Value Group (DVG) containing all possible responses to the source Question; see Creating and Using DVGs. You may also want to use a DVG for some numerical Questions.
    
    If you want to trigger the branch if any response is entered, do not assign a DVG to the Question and enter NOT NULL here.
    
    If you want to trigger the branch if a response is not entered, enter NULL here. In this case, tabbing into the field and out again triggers the branching.
  - If the Question is of data type NUMBER any numerical value is allowed.
  - If the Question is of data type DATE the value must be in a date format.
2. In the target Question Group Name column, select the Question Group that you want to branch to if the specified response value is entered. This can be the same Question Group that contains the source Question.
3. In the target Question Name column, select the Question in the Question Group that you want to collect next, based on the response to the source Question.
4. In the Occ Sn (Occurrence Sequence) column, enter 0 (zero) if the Question is included in the Question Group only once. If the Question occurs more than once in the Question Group, enter the number for the occurrence of the Question that you want to use, starting with 1.
5. Select a Branch Oper (ation) value:
  - Select EQ (Equals, =) if the branch should be triggered if the patient response value entered is the same as the specified response value.
  - Select GT (Greater Than, >) the branch should be triggered if the patient response value entered is greater than the specified response value.
  - Select LT (Less Than, <) the branch should be triggered if the patient response value entered is less than the specified response value.
  You can create combined conditions greater than or equal to (>=) or less than or equal to (<=) by defining multiple branches with the same source and target Questions, one with the operation GT or LT and the other with EQ.
Repeat the last task for each source Question value that you want to serve as a trigger for a conditional branch.
Save.

The system automatically sets the Has Conditional Branch? value for the DCM Question upon saving.

If you are using graphic layouts, the conditional branch definition is incomplete until you define conditional blocks in the DCM graphic layout editor; see Creating and Maintaining Conditional Blocks, and the following:

Parent topic: Defining DCMs

Conditional Branching and Character-Based Layouts

For character-based layouts, which Oracle Clinical uses, conditional branching has no visual impact and is immediately in effect in the data entry form if there is a layout in use. The conditional Questions are always visible and displayed the same way as other Questions. The branching logic makes the cursor jump to the target Question when the user enters the response trigger value, but the user can navigate back and enter or update intervening fields.

Parent topic: Defining Conditional Branching

Conditional Branching and Graphic Layouts

To complete the definition for graphic layouts, which RDC Onsite uses for data entry, you have to do more work in the layout editor. The default layout identifies all source and associated target Questions you have defined. For each source Question, you create target blocks for each target Question. Then, you can move other Questions—except the target Question—in and out of the block(s). These Questions do not necessarily have to be part of the same Question Group as the target Question. In addition, you can reposition Questions such that the target Question is not necessarily the Question that the cursor automatically goes to first when the trigger response is entered; see Creating and Maintaining Conditional Blocks.

Note:

You control whether diabled blocks are displayed as hidden or greyed in the DCI Forms Local Study Settings window at the database or study level, in the Represent Disabled Block setting; see Configuring Study-Level DCI Form Settings.

If you have existing conditional or indicator branching definitions used in Oracle Clinical data entry, you can make use of them in your graphic layouts by adding the graphic conditional blocks to your layouts.

Tracking Conditional Block Status at the DCM Level

The display-only field CB Graphic Blocks Defined? in the DCM Conditional Branches window and the DCM Questions window indicates whether the target conditional blocks for the current source Question have been defined in the graphic layout:

The checkbox is checked once target conditional blocks are defined in the Layout Editor.
The checkbox becomes unchecked and the target conditional blocks are deleted when:
- The DCM layout is regenerated.
- The conditional blocks for the current source Question are explicitly deleted by the user in the Layout Editor.
- Certain types of updates are made to the conditional branch definition. See "How Updating Conditional Branching Definitions Affects DCM/DCI Graphic Layout Flags" for more information.

How Updating Conditional Branching Definitions Affects DCM/DCI Graphic Layout Flags

After the set of target conditional blocks for a source Question are defined in the Layout Editor, updates made to the base conditional branch definitions can affect the DCM and DCI graphic layout settings. The following table provides details:

Table 9-1 Impact of Updating Conditional Branching Definitions

Update	Indicator/ CB Graphic Block(s) Defined?	Avail- able?	Needs Edit / Verifi- cation?	Post- Edit Up- dates?	Immediate Effect in RDC Onsite Data Entry	User Action Needed in Layout Editor
a. Update Value or operator for an existing branch. Block already exists. b. Add a new branch or update target for an existing branch where target is already used in an existing branch for this source Question. Block already exists. c. Delete a branch. Block/target Question is referenced by another branch for this source Question and should not be deleted in the LE.	No effect until you open the layout editor. Then the blocks are deleted with a confirmation message. When you return to DCM Questions, the check box is unchecked.	No effect	No effect	No effect	New branching behavior is observed Any of these changes may result in conditional branch violations.	None
d. Add a new branch. (Target is NOT already referenced in a defined block. New block is needed.) e. Update Target in an existing branch. (Target is NOT already referenced in a defined block. New block is needed.) f. Delete a branch. (Block is not referenced by another branch, so should be deleted.)	No immediate effect; becomes unchecked when you open the Layout Editor and blocks are deleted.	Unchecked	Checked	Checked	Branch has no target block. Branch goes to first enabled Question in the form following the Question with the conditional branch.	When you open the DCM Layout Editor, all conditional blocks are automatically deleted. The user must recreate the remaining conditional blocks.
g. Turn a Question into a branching source Question (by defining conditional branches).	No effect (initialized to unchecked)	No effect	No effect	No effect	No effect. No blocks, no hiding, no branching.	Create conditional blocks.
h. Check as mandatory a Question which appears in a conditional block.	No effect	Unchecked No effect	Checked No effect	Checked No effect	A mandatory discrepancy will be raised. If the block is disabled, the user is unable to resolve the discrepancy.	If mandatory Question is in a conditional block and does NOT have a default value, it must be moved.
i. Uncheck Collect in subset for a source Question or a Question in a target block. (Note this action is disallowed for a Question that is definitionally identified as a target on the Conditional Branches form.)	No effect	Unchecked	Checked	Checked	Label and response fields are still displayed. Response can no longer be entered. However, a pre-existing response can be updated.	Edit the layout and save. Create new form version.*
j. Uncheck Displayed. (Can only do this for a non-enterable Question.)	No effect	Unchecked	Checked	Checked	Question continues to be displayed (still not enterable), Branching is as before.	Same as for item j, above.

*Upon edit, the Question is automatically removed from the layout. If this is a source Question with conditional blocks, the Layout editor should also automatically delete conditional blocks for this Question. If this is a target Question, the system removes the Question from the layout.

Parent topic: Defining Conditional Branching

Using Normalized Lab Data

To use normalized lab data, you must define a pair of Questions in a repeating Question Group to collect the lab test name and lab test result, respectively, for multiple lab tests. Make the number of occurrences of the Question Group equal to or greater than the number of lab tests required.

When you batch load lab data in a normalized format, the system automatically creates two records from each normalized lab data record. The lab test name is then stored as a Question response and you can use it in data extract and in validation Procedures to identify the test name for each test result.

For example, from records with a normalized input file format as follows:

,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,HCT,0,1,43 
,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,HGB,0,2,17

where the lab test names are HCT and HGB and the respective lab test values for the patient are 43 and 17: a DCM question, LTEST, has been defined to collect the lab test Question name and another DCM question, LVALUE, has been defined to collect the lab test result, the Batch Data Load process converts the preceding two input records to the following four records:

,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,LTEST,0,1,HCT 
,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,LVALUE,0,1,43 
,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,LTEST,0,2,HGB 
,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,LVALUE,0,2,17

The system stores "HCT" as the response value for REPEAT_SN 1 of Question LTEST and "HGB" for REPEAT_SN 2 of LTEST.

To use normalized lab data, define the following Questions and include them in a repeating Question Group in a DCM:

Lab Test Name You must define a Question to collect the name of the lab test. It must have a data type of CHAR, and it must not be derived.
Lab Test Result You must define a Question to collect the lab test result. It must have a Question type of CHAR and a data type of CHAR, even if the lab data is expected in numerical format. This accommodates responses to numeric Questions with text such as "TRACE" and the use of special characters such as less than (<) and greater than (>), and allows you to use the same Question for all lab tests.

The lab test result Question must not be derived, but you may want to define an additional Question that is derived and numeric to hold the value of numeric tests, and a derivation Procedure to populate its value; see Validation and Derivation Procedures.

Note:

Since these same two Questions are used for all lab tests that are loaded in a normalized format, it is difficult to understand discrepancies based on lab test Questions. However, you can use the repeat sequence number as a variable (\REPEAT_SN\) in a Standard Text definition to identify which lab test result is discrepant wherever discrepancies are displayed. For information on Standard Text, see the Oracle Clinical Administrator's Guide.

Parent topic: Defining DCMs

Defining Date Formats

You can specify the order in which the system displays a Question's date components (day, month, and year). Set the date format at the DCM level.

During Log-In, by selecting Preferences from the Special menu, the data entry operator can set the value of a user preference, data entry display format, to determine the format of the DCI and DCM dates' values:

European format is DD-MM-YYYY
Swedish format is YYYY-MM-DD
U.S. format is MM-DD-YYYY
Standard format is DD-MON-YYYY
Dynamic format is based on the log-in header

If you set the date format at the DCM level to US, EUROPEAN, SWEDISH, or STANDARD, the display format for Date-type Questions in data entry is as described above, regardless of the values of the data entry display format user preference set in the Log-In form. However, if you set the date format for the DCM to DYNAMIC, the display format for Date-type Questions in data entry defaults to the value of the data entry display format used in the log-in process.

Because the DYNAMIC date format allows more flexibility for the data entry operator, it is especially useful in distributed studies with different country locations where forms might be identical except for their date format. In these situations, the date displays in the appropriate country date format at a location other than its origin.

To set the country date format:

From the Definition menu, select DCMs, then choose DCMs. The system displays the Maintain DCMs form.
Query or create the DCM.
Select the Date Format field.
Use the List function to select the appropriate value.
Save.

Parent topic: Defining DCMs

Scheduling DCMs

You can schedule DCMs by associating them with Clinical Planned Events (CPEs), which are ordinarily clinical visits by patients. You can define a DCM once and collect it at multiple visits.

If you are using RDC, do not schedule DCMs directly to CPEs. Instead, define a DCI Book that defines associates all study visits with DCMs. You can also use DCI Books for Oracle Clinical data entry; see Defining DCI Books

In this section:

Parent topic: Defining DCMs

Associating DCMs to CPEs

The study's protocol determines the number of CPEs and the Intervals between them. You associate each DCM to a specific clinical visit. Mapping a DCM to a CPE lets Oracle Clinical track patient data over time. Mapping a DCM to several CPEs lets Oracle Clinical track specific study Questions under different circumstances, usually after the passage of time or under various experimental situations.

You create a study's Intervals and CPEs in the Design subsystem. Each DCM corresponds to medical data at an instant in a patient's history, and that instant is defined by associating the DCM with the clinical visit during which the data is collected. The results of this mapping task are presented in a matrix format, with CPEs along the top row as an event sequence, and DCMs or DCM subsets on the left as a data collection sequence. Each intersection of row and column defines a possible association between DCM and CPE.

Values for these points are as follows:

E – You expect a site to collect the DCM's data at this CPE.
O – Collection of the DCM is optional at this CPE.
(Blank) – DCM is not scheduled to be collected for this CPE.

When you have completely defined the associations, commit the schedule.

Parent topic: Scheduling DCMs

Schedule DCMs Form

You schedule DCMs from the Schedule DCMs form. From the Definition menu, select DCMs, then choose Schedule DCMs. The form appears with a pop-up window for you to select a clinical study. The system arranges the DCMs in the collection sequence. From the Special menu of the Schedule DCMs form, you can copy DCMs, copy CPEs, resequence the DCMs, or change the study.

Navigating to any point on the grid and clicking the DCMs button displays a window with detailed information on the current DCM. Similarly, pressing the Clinical Planned Events button displays detailed information on the current CPE.

Parent topic: Scheduling DCMs

Copying the CPE Schedule

You may find you want to use the DCM schedule of one CPE for another CPE—that is, you want to copy the DCM values from one CPE column to another. To copy CPE values:

From the Definition menu, select DCMs, then choose Schedule DCMs. Select the DCM schedule with the CPE you want to copy.
From the Special menu, select Copy CPE. A pop-up window appears, Copy Schedule for CPE.
Enter a CPE in the pop-up window to copy the schedule from, or use the List function to view and select valid CPEs.
Click:
1. OK to copy the schedule from one CPE.
2. Cancel to return to the Schedule DCMs form without copying.

Parent topic: Scheduling DCMs

Copying the DCM Schedule

You may find that you want to use the CPE schedule of one DCM for another DCM—that is, you want to copy the CPE values from one DCM row to another. To do this, follow this procedure in the Schedule DCMs form:

Navigate to Copy DCM or CPE Definition, DCMs, Schedule DCMs, Special Menu, Copy DCM.
Select Copy DCM from the Special menu. A pop-up window appears, Copy Schedule for DCM.
Enter a DCM in the pop-up window to copy the CPE schedule from, or use the List function to browse the valid DCMs.
Click OK to copy the DCM schedule, or cancel and return to the Schedule DCMs form without copying.

Parent topic: Scheduling DCMs

Resequencing DCMs

The DCM sequence is the order in which DCMs are displayed in reports (except the DCM Detail Tracking Matrix Report, which is ordered by ascending DCM ID) and on the DCM schedule. When you first enter the Schedule DCMs form, you may receive a message that you must resequence the DCMs. This is because the DCMs in the study are not currently sequenced consecutively—probably because a DCM was added or deleted from the study. The system requires that you alter this sequencing, making the DCM consecutively numbered from 1 to n before proceeding.

To resequence the DCMs:

Select Resequence DCM from the Special menu. Oracle Clinical displays the DCM Sequencing form.
Change the sequence number (Seq #).
Select Commit. The system moves the DCM to a new position in the sequence.

Parent topic: Scheduling DCMs