13 Copy Groups

Use copy groups to immediately copy multiple database objects either between the Global Library and a study, or between studies. The advantage is that you make one copy operation for several objects instead of one copy operation for each object, and that you do not violate any data model rules in the process. The Copy Groups feature also has a Provisional branch with all of the same functionality.

This section includes the following topics:

• Creating Copy Groups

• Grouping Objects

• Adding DCMs

• Adding DCIs

• Adding Procedures

• Adding View Definitions

You can create copy groups at either the study level or Global Library level. The definitional activities are the same at either level. However, most customers create and test copy groups at the study level, then promote them to the Global Library. This chapter describes study level activities. For promoting and maintaining copy groups at the study level, see "Maintaining Global Library Copy Groups". You need to choose the variety of copy group to use, depending on your plans for it.

Copy groups can be ad hoc, provisional, or permanent.

Ad Hoc Copy Groups  If you do not intend to reuse a copy group, and you have no need to leave a record of the group's constituents, perform an ad hoc copy operation. You collect the definitions in the Copy Group form and move them somewhere else from the Special menu. If you do not save your work before exiting, the copy group does not remain in the database. You can perform an ad hoc copy operation from either the study or Global Library level.

Creating ad hoc copy groups is the same as creating global or study level copy groups. The difference is that after you invoke the copy operation from the Special menu, you exit the Copy Group form without saving your work.

Provisional Copy Groups  The Provisional Copy Groups windows in the Definition and Global Library subsystems provide a testing area for developing copy groups. When you are satisfied with them, you can promote them. Since the maintenance operations for provisional copy groups are the same as their counterparts, follow the same maintenance procedures as for their equivalents.

Permanent Copy Groups If you expect to re-use a copy group at the study level, you can save it before exiting. The next time you perform a copy operation, you can choose it instead of re-creating it. You maintain study-level copy groups in the Definition subsystem. If your company enforces standardized copy group operations across studies, you can create a copy group in, or promote a copy group to the Global Library. You maintain these copy group records in the Global Library subsystem. (See "Maintaining Global Library Copy Groups".)

Creating Copy Groups

The following instructions give an overview of creating a copy group. Each instruction is described in more detail later.

1. From the Definition menu, select Copy Groups, then choose Copy Groups. The Maintain Copy Groups form opens.

2. Enter values in the fields: Copy Group Name, Domain, and Description.

3. Click the Copy Group Details button.

4. Click the DCMs button. (Since all other copy group elements must relate to DCMs, this is the only active button at this stage.)

5. In the DCM list that displays, click the DCM to include. To select multiple DCMs simultaneously, hold the Control key and click each DCM or Shift-click a region.

6. To create a permanent library or study object, make the copy group active before exiting the form.

7. Save the DCM choices. Other object type buttons become active.Click each of the other appropriate buttons to include desired objects.Repeat the previous step as many times as necessary to include the other objects.When you have added all the objects, either:

   • Click Exit to store the copy group.

   • From the Special menu, select Copy to Study to immediately use it in a Study.

   • From the Special menu, select Copy to Library to immediately use it in the Global Library.

Grouping Objects

You add objects to the copy group in the Details form. From the Definition menu, select Copy Groups, then choose Copy Groups, and click the Copy Groups Details button.

The following rules control the objects you can add:

• Objects allowed in a copy group are DCMs, DCIs, procedures and view definitions.

• For DCMs, you specify whether to copy just the base subset or all subsets.

• All objects must be related to the included DCMs. Conversely, DCMs that are referenced by another object in the group cannot be removed from the group.

• Objects can only come from the study you are working in.

• Provisional and active objects can be added to a provisional copy group, but all objects must be active before a copy group can be made active.

• Objects are included in copy groups by reference. Changes to the underlying objects are reflected in the results of subsequent copy operations.

• Retired copy groups are not available for use and cannot be modified.

Adding DCMs

You can enter the DCMs to include in a copy group by selecting Copy Groups from the Definition menu, then choosing Copy Groups, clicking the Copy Groups Details button, and the DCMs button.

This following list describes the validation rules for adding DCMs to a copy group:

• If copying all subsets is specified, all subsets in the source DCM must be active or the copy procedure will abort.

• If a DCM with the same name exists in the target domain, Oracle Clinical allows the copy to proceed only if it is functionally equivalent to the DCM being copied. Functional equivalency is defined as:

  • Same Qualifying Question, if any

  • Same named DCM Question Groups with the same repeat value

  • Same name, short name, and subset names

  • Same Question (or occurrence) numbers in DCM Questions for each group with the same settings for Collected_in_study_flag, Derived_flag, and DVG_ID.

Depending on the setting of the Base Subset Only? field, either just Subset 1, Layout 1, or all subsets and layouts of a DCM are copied. Additionally, all child objects of the DCM are copied.

Adding DCIs

You add DCIs to a copy group by selecting Copy Groups from the Definition menu, then choosing Copy Groups, clicking the Copy Groups Details button, and the DCIs button.

When you add a DCI, all DCI modules are copied. The name and short name must not be present in the target domain. Explicit references to CPEs are treated as they are currently by DCI copying.

Adding Procedures

You add procedures to a copy group by selecting Copy Groups from the Definition menu, then choosing Copy Groups, clicking the Copy Groups Details button, and the Procedures buttons.

When you add a procedure to a copy group, the system copies the active version. The procedure name must not be present in the target domain. The system takes the mapping of the procedure to the DCM in the copy group to ensure that the copied procedure references the same equivalent DCM in the target.

Adding View Definitions

You can add view definitions to a copy group by selecting Copy Groups from the Definition menu, then choosing Copy Groups, clicking the Copy Groups Details button, and the View Definitions button.

When a view definition is used, the view definition and all of its components are copied. The name must not be present in the target domain. If the view definition references a library view template, only the view definition is copied: the template remains a reference to the library template. If the source of the view definition is a study, then the view template is copied as well. The mapping of the view definition to the DCM in the copy group is used to ensure that the copied view definition references the equivalent DCM and DCM Questions in the target.