Maintaining Global Library Copy Groups

Copy groups simplify copying multiple data definitions between studies or between studies and the Global Library. They allow you to perform one copy operation for a group of related definitions instead of one copy operation for each definition, without violating any data model rules in the process. You can perform copy group operations between studies, or to or from the Global Library.

This section describes Global Library copy group activities. For study-level activities, see Copy Groups

In the Global Library, you classify copy groups by domains and standards affiliations. For example, a Standard Safety copy group might consist of a standard Adverse Event DCM, a standard Blood Chemistry DCM, and several other similar DCMs, together with all the standard DCIs, Procedures, and view definitions associated with those DCMs. Copy groups have a status of Provisional, Active, or Retired.

For more information, see:

• Copy Group Restrictions
  
• Creating a Global Library Copy Group
  
• Performing Copy Group Operations as Batch Jobs
  
• Performing Ad Hoc Copies
  

Copy Group Restrictions

These Oracle Clinical rules control which definitions you can add to a copy group:

• Definitions allowed in a copy group are DCMs, DCIs, Procedures and view definitions.
• All definitions to be grouped must be related to the included DCMs. Conversely, DCMs referenced by another object in the group cannot be removed.
• For DCMs, you specify whether to copy just the base subset or all subsets.
• Definitions can come from multiple domains, but the object name and object type must be unique within the group. Specifically, a single object may be included only once in a given copy group, and you cannot include definitions from different domains with the same name.
• Provisional and active definitions can be added to a provisional copy group, but all definitions must be active before a copy group can be made active.
• Definitions are included in copy groups by reference. Changes to the underlying definitions are reflected in the results of subsequent copy operations.

For more information, see:

• Validation Rules
  
• DCMs
  
• DCIs
  
• Procedures
  
• View Definitions
  
• Copy Rules
  
• DCM Copy Rules
  
• DCI Copy Rules
  
• Procedures Copy Rules
  
• View Definitions Copy Rules
  

Validation Rules

Oracle Clinical does not modify any object names or attributes to prevent failure of a copy group action. Error messages are recorded in a log file. The system follows these rules to validate individual definitions:

DCMs

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

If a DCM with the same name exists in the target domain, Oracle Clinical allows the copy to proceed only if that DCM is functionally equivalent to the DCM being copied. To be functionally equivalent, the two DCMs must meet these criteria:

• same Qualifying Question, if any

• same named DCM Question Groups with the same repeat value

• same name, short name, and subset names

• same Question/occurrence numbers in DCM Questions for each group with the same settings for Collected_in_study_flag, Derived_flag, and DVG_ID

DCIs

The DCI name and short name must not be present in the target domain.

Procedures

The Procedures name must not be present in the target domain.

View Definitions

Name must not be present in the target domain. If the source domain is a study, then there must not be a view template of the same name in the target domain.

Copy Rules

These rules are in effect during a copy activity:

• All active definitions are copied; definitions that have been retired are not copied.

• Definitions are copied in this order: DCMs, DCIs, procedures, view definitions.

The rules for copying specific definitions are:

DCM Copy Rules

All of the DCMs must be in Active status. Depending on the setting of the Base Subset Only? field, the system either just copies Subset 1 Layout 1 of a DCM, or all subsets and layouts. The system copies all child definitions.

DCI Copy Rules

The system copies all DCI modules. The system treats clinical planned events as they currently exist.

Procedures Copy Rules

The system copies active versions. The system ensures that the copied procedure references the equivalent DCM in the target.

View Definitions Copy Rules

The system copies all view definitions and all of their components, with these limitations:

• If the view definition references a library view template, the system only copies the view definition; the template remains a reference to the library template.

• If the source of the view definition is a study, the system also copies the view template.

• The mapping of the view definition to the DCM in the copy group ensures that the copied view definition references the equivalent DCM and DCM Questions in the target.

Creating a Global Library Copy Group

You create a copy group by assigning the group a name, a domain, and a description; selecting one or more DCMs; and, finally, picking the related definitions and adding them to the group.

You can use these groups immediately to copy definitions to the library or study, and then dispose them. To create a permanent library or study object, make the copy group active before exiting the form.

The following steps describe creating a copy group in the Global Library. You can also create a study-level copy group from the Definition menu.

1. From the Glib menu, select Copy Groups, then choose Copy Groups. The Maintain Library Copy Groups window opens.
2. Enter values for these mandatory fields: Copy Group Name, Domain, and Description.
3. Save the copy group name.
4. Click the Copy Group Details button.
5. Click the DCMs button. Since all other copy group elements must relate to DCMs, this is the only active button at this stage. A list of candidate DCMs opens.
6. Select one or more DCMs.
7. Save the DCM choices.
8. Click each of the other buttons to include any other types of definitions you want to include in the copy group. As you complete adding each type of object, click OK to return to the Details form.
9. Perform one of these operations:

   • To make a reusable copy group, click Save. You can then immediately perform a copy operation, or you can back out of the window.

   • Click Exit to store the copy group or choose Copy to Study from the Special menu to immediately use it.

Performing Copy Group Operations as Batch Jobs

Copy groups are utilized by submitting a batch job. When you submit the batch job, the expectation is that you are copying a copy group from another study or the Global Library to your current location.

You have these options:

• Copying from the Global Library to a Study
  
• Copying from Study to Study
  
• Copying from Your Current Study to the Global Library
  

Copying from the Global Library to a Study

To perform a copy group operation from the Global Library to your current study, navigate to Definition, then Group Copy from Library to Study. Then choose a domain and a Global Library copy group.

Copying from Study to Study

To copy a copy group from another study into your current study, navigate to Definition, then Group Copy from Study to Study. Then choose the other study and the target copy group.

Copying from Your Current Study to the Global Library

To perform a copy group operation from a study to the Global Library, navigate to Glib, Copy Groups, and then Group Copy from Study to Library. Then choose the target copy group, its study, and its domain.

Performing Ad Hoc Copies

Oracle Clinical lets you create a copy group to perform an ad hoc copy of multiple database definitions. This allows you to easily copy multiple definitions without the overhead of maintaining the new copy group in the database. If you don't intend to activate the copy group: a provisional copy group is sufficient.