The Global Library is an organization-wide central repository for containing standardized data definitions. If you are using replication, you must choose one location to own the Global Library. All other locations replicate it. You can partition the Global Library into domains so to accommodate different definitions of the same data objects. This chapter describes the Oracle Clinical's utilities for managing Global Library definitions.
This chapter contains the following topics:
Global Librarian is an Oracle Clinical database role that you must have to save and activate Questions, Question Groups, DVGs, key templates, and extract macros. The creation of these definitions is described in other chapters. Designers then model these Global Library objects into study-level definitions. They create DCMs, DCIs, procedures, view definitions, view templates, and copy groups. The Global Librarian can then copy any of them into the Global Library and make them available for all studies.
You can create and maintain Data Collection Modules in the Global Library, but it's more practical to refine them at the study level and then copy them to the Global Library. The maintenance tasks are the same for either module. See "Defining DCMs" for all DCM maintenance topics.
Copying Study-Level DCMs to the Global Library
To promote a DCM from the study level to the Global Library, you must copy it. The target DCM must be active at the study level before you can copy it. To copy a DCM, follow these instructions:
Navigate to Glib, DCIs DCMs Procedures, then DCMs.
Select Special, and then Copy DCMs. The system starts the Locate DCMs utility. A dialog box opens where you choose between Library and Study.
Choose the study. The Study Query dialog box opens.
Locate the study that contains the target DCM.
Execute a query and select the target DCM.
Click OK. A dialog box opens where you can choose to copy all of the DCM's associated subsets or just the base subset. (See "Configuring DCM Subsets".)
Choose which subsets to copy. The system creates the copy in the Global Library.
Click Save.
You can create and maintain Data Collection Instruments (DCIs) in the Global Library, but it's more practical to refine them at the study level and then promote them. The maintenance tasks are the same for either module. See "Defining DCIs" for complete all DCM maintenance topics.
Copying DCIs into the Global Library
To promote a DCI from the study level to the Global Library, you copy it. The DCI must be active at the study level before you can copy it. To copy a DCI, follow these instructions:
Navigate to Glib, DCIs DCMs Procedures, then DCIs.
Select Special, then choose Copy Study DCI. The system starts the Locate DCIs utility.
Choose the study containing the target DCI.
Locate the target DCI.
Click OK. A dialog box opens where you choose to copy all the DCI Modules.
Choose Yes or No to copying all of the DCIs DCI Modules. The system creates the copy in the Global Library.
Rename the DCI and save your work.
You cannot generate or test procedures in the Global Library. Therefore, define Procedures at the study level. See Chapter 16, "Validation and Derivation Procedures" for more information.
Copying Procedures to the Global Library
To promote a procedure from the study level to the Global Library, you must copy it. The procedure must be active at the study level before you can copy it. To copy a procedure, follow these instructions:
Navigate to Glib, DCIs DCMs Procedures, then Validation (Derivation) Procs.
Select Special, and then Copy Proc - Study. The system starts the Locate Validation utility.
Choose the study containing the target procedure, if necessary.
Locate the target procedure and click OK. The system creates a copy of the procedure.
Save.
You create view definitions in the Data Extract Module. See Chapter 14, "Data Extract" for more information.
Copying View Definitions to the Global Library
To promote a view definition from the study level to the Global Library, you must copy it:
Navigate to Glib, Data Extract View Builder, and then View Definitions. The Maintain Library View Definitions window opens.
Select Special, and then Copy Vies - Study. The system starts the Locate View Definition utility.
Change to the study containing the target view definition, if necessary, by clicking the Change Study button.
Locate the target definition and click OK. The system creates a copy of the view.
Rename the view definition and save your work.
Global Library domains provide a way to create any number of unique name spaces within Oracle Clinical. When you define Global Library domains, object names are required to be unique only within the domain, rather than across the entire Global Library. Definitions can be moved from one domain to another as long as the new domain does not contain an object with the same name.
The flexibility that domains allow you is particularly useful in cases where you want separate namespaces to handle both legacy data and data from new studies.
This section includes the following topics:
The Global Library can store definitions that you copied into or modified in studies. Each library object belongs to a domain, and together, the library object name and domain form a unique key. Two library definitions with the same name cannot exist in one domain, but different domains can contain library definitions with the same name.
Each user and each study has a list of domains from which definitions are accessible to either the user or the study. The user domain list determines what data is accessible to someone working in the Global Library. The study domain list limits the domains in which studies may access Global Library definitions during such operations as copying a DCM into a study. Definitions in a domain that is not on a user or study domain list are not accessible to that user or study, depending upon the task.
Default domain lists are created by the system administrator or Global Librarian for all users and all studies; with the appropriate privileges these lists can be modified for individual studies or users.
Definitions that reference other definitions, such as DCMs, can be seen as parent objects, being made up of child objects, such as DCM Question Groups.
Parent objects in the Global Library are:
Discrete value groups
Questions
Question Groups
DCMs
DCIs
Derivation Procedures
Validation Procedures
Where clauses
Queries
Parent definitions may reference child definitions belonging to different domains. If the domain of any child object is changed, the parent object continues to reference the same child object in its new domain.
When parent definitions are composed of child definitions belonging to different domains, the user domain list needs to be modified to allow access to these domains. (See "Overriding Default Domain Lists".) Restrictions on using definitions from different domains are:
You can modify the domain of a library object, provided an object with the same name does not exist in the new domain. When a parent object's domain is modified, the child definitions retain their domains.
When a child object in the Library moves to another domain, all instances of its use continue to reference it.
When a library object is copied into a study, the domain of the object at the parent level becomes the name of the study, since object names must be unique within a domain/study combination. The effective domain is therefore the study. The child definitions of the copied object continue to reference their domains as defined in the Global Library, although these domains may be changed if the domain of the child object is changed at the Library level.
Note:
You can modify an object's domain only in the parent form. For example, you can change the domain of a Question in the Maintain Questions form, but not in its instantiation as a child object in the Question Group Questions window of the Maintain Question Groups form.The system administrator or Global Librarian creates domains by adding values to the reference codelist OCL_DOMAINS. This codelist is an installation codelist, and only a user with appropriate privileges can modify it. To add or modify a domain in the OCL_DOMAINS codelist, from the Admin menu, select Reference Codelist, and then Installation Codelists. Query and modify the codelist OCL_DOMAINS. The domains are available immediately after you save your work.
Note:
No Oracle Clinical validation prevents the name of a Library domain from coinciding with that of a study; company rules need to be in place to enforce this restriction.The sequence of domains on the user- and study-level domain lists is significant. The first domain listed has priority over other domains. For example, while creating a Question in the Maintain Questions form, when you navigate from the Question field to the Domain field, the first domain in the user domain list automatically defaults into the field. This defaulted value can be modified, but will be defaulted into the Domain field when any new or copied object is created. If you are creating a number of Library definitions, it is helpful to have the domain in which they should be created appear first on your user domain list.
Similarly, when you are copying definitions by name, such as adding Questions to a Question Group by typing their names, Oracle Clinical copies the first object it finds with a matching name in the order of your domain list.
You can set a Retired Global Library object's status back to Active. In addition, Library domains allow for the reuse of the names of retired definitions. For example, a retired Question in one domain can be copied into another domain as an active object. Or, a retired Question can be moved to another domain, for example, OBSOLETE, thus freeing up the Question name in the original domain.
This section describes how to define domain lists for all users or all studies, then how to override a default for a particular user or study.
The Maintain Default Domain Lists window allows the study administrator or Global Librarian to select the default domain or domains, either for all users or in all studies. If user- or study-level domains are set for particular users or studies, they take precedence over these default lists.
Depending on your role permissions, you can change the default domain listing for a particular user or a particular study.
To define default domain lists for all users or all studies, from the Admin menu, select Glib Admin, and choose Default Domains. Toggle between User and Study in the Domain List Sub Type field to set the user or study default domain lists.
You can add domains to, remove domains from, or resequence the domains on the domain list by using these buttons:
All Domains populates the domain list with all domains in the OCL_DOMAINS reference codelist.
Up moves a selected domain in the list up in prioritization.
Down moves a selected domain down in prioritization.
Any domain can be removed from the list by deleting its record from the Define Default Domain Searchlist window.
The default domain lists take effect immediately for all users and studies without defined domain lists, once you save and exit the form.
If you have the proper privileges, you can override the default domain lists for a particular user or study by defining user- or study-level domain lists. The domain list determines the accessibility of data in various domains and also prioritizes activities involving domains.
You may need to override the default domain list because you want to query data from domains not on a default list, or to order domains differently from the default.
To set a user-level domain list, from the Admin menu, select Glib Admin, and choose User Domain. Alternatively you can invoke the Special menu and choose Define Domain Searchlist from the Global Library forms for maintaining definitions. Whenever you invoke the domain searchlist from the Special menu, the system prompts you to save unsaved work.
If you have the necessary privileges (access to the Oracle Clinical menu path Admin, GLIB Admin, Define User Domain Searchlist, if the Oracle-defined menu-role associations have not been modified), you can modify your domain list with these buttons:
Note:
If you do not have the necessary privileges, you can only resequence the domains in the list when you access the Define Domain Searchlist form from the Special menu in other forms such as Maintain Questions.Default returns the list to the default listing set by the system administrator or Global Librarian.
All Domains populates the domain list with all domains.
Up moves a selected domain in the list up in prioritization.
Down moves a selected domain down in prioritization.
Delete Record removes any domain from the list.
To set the study domain list for a particular study, from the Design menu, select Studies, then choose Clinical Studies. Navigate to or query the study whose domain list you want to modify, and choose Define Domain Searchlist from the Special menu. Modify your domain list, using these buttons:
Working in the Global Library, you can view and access only definitions belonging to domains defined in your user domain list, which may be based on a default user domain list or on a customized user-level domain list. As well as limiting the domains where you can access data, the domain list sets up certain prioritization.
Note:
A Question name and/or SAS name must be unique for any one Question Group. Also, two Questions with the same name, but in different domains, cannot appear in the same Question Group.Any queries you make in the Global Library are restricted to the domains on your user domain list; they bring up all objects that belong to domains in that list. When you query parent objects, only objects belonging to domains on your user domain list are returned. However, when you select a particular object, you can view all child objects of the parent, regardless of the domain of the child object. For example, if you have access only to objects in domain STANDARD and query on DCMs, all DCMs with domain STANDARD are returned. If you click the DCM Question Groups button, you see all the DCM Question Groups associated with that DCM, even if those Question Groups belong to domains not on your user domain list.
When you create a Global Library object, the domain of the created object must be on your user domain list. The first domain listed on the user domain list automatically defaults into the Domain field, so if you are working primarily in one domain, it is helpful to have that domain appear first on your user domain list.
You can change the defaulted domain to another domain, provided the combination of object name and domain does not already exist. A list of values (LOV) is available to select a domain.
The domain of any library object can be changed, regardless of the status of the object, provided the new combination of object name and domain is unique.
When an object is copied, either from a different domain in the Global Library or from a study, the newly copied object is created in the first domain on the user domain list. After copying the new object, you can rename it to another domain, provided the object name/domain combination is unique.
Certain copy functions allow you to copy an object from within the Global Library or from a study. If you are copying from the Global Library, you are limited to objects belonging to domains on your user domain list. If you choose to copy from a study, you are under no such restriction.
The domain of all parent-level objects in a study is the study name, since all object names must be unique within the study. The default or study-level domain list limits access to library objects from study data definition forms. Only library objects belonging to the domains on this list are accessible to the study during copy functions.
Note:
A Question name or SAS name must be unique for any one Question Group. Also, two Questions of the same name cannot appear in the same Question Group if they are in different domains.When you create an object in a study, the domain is the study name, and it cannot be modified.
When you copy an object from the Global Library to a study, you are limited to accessing the domains on the domain study list. Restrictions on copying from another study are determined through security and not by domain accessibility.
Objects copied from the Global Library have the study name as the domain at the parent level, and child objects retain their Global Library domain names. If the domain of a child object is changed in the Global Library, this change is reflected in any studies in which the object appears.
Here are some examples of the ways that you can use domains and manual procedures.
Create a new domain, CONVERSION, in addition to the domain STANDARD. Create library definitions for converted studies that cannot be modified to comply with new standards. Enforce the standard operating procedure that converted studies can only use objects containing objects from the CONVERSION domain, while new studies may reference only STANDARD definitions. You must manually enforce that unique parent objects are created in the CONVERSION domain if any component objects are from the CONVERSION domain.
In addition to the STANDARD domain, create a domain for each new project. Define in each new domain any objects specific to the project. If objects defined at the project level later become candidates for general use, they can be moved to the STANDARD domain. For any study, the project name domain would be the first on the study domain list, with STANDARD second.
Manually enforce the following constraints:
A given project can copy objects only from its own project domain and from the STANDARD domain.
Candidate objects—first defined at the project level so that they might later become standards—initially have unique names.
No STANDARD objects are created with the names of candidate objects while the decision to elevate them from "candidate" to "standard" is pending.
In addition to the STANDARD domain, create domains OBSOLETE, OBSOLETE1, OBSOLETE2, etc. When it is determined that a standard object must be retired from use, and that also a new object of the same name must take its place, change the domain of the retired object to OBSOLETE. If, by some rare circumstance, the successor object must itself be retired and moved out of the way, rename its domain to OBSOLETE1.
You cannot move the successor object to OBSOLETE, since OBSOLETE already contains the original object with that name. Manually enforce the constraint that you cannot copy objects from an OBSOLETE domain to a new study or to be part of a new library object.
In addition to the STANDARD domain, create the domain INSTALL_TEST to hold objects for testing purposes in a new database installation. Manually enforce the constraint that two domains should not reference each other, and that only STANDARD objects be used for production work.
A goal of Global Library management is to maximize conformity among data collecting components common to all clinical studies, or to groups of similar clinical studies, so that you can make direct comparisons. Standards affiliations standardize data collection in new clinical studies by helping classify, locate, and track the use of the Global Library objects.
For example, if a standard Question Group is affiliated with the affiliations type SYSTEM, you can suggest that all studies in the Oracle Clinical system reference that Question Group. Such a reference, constituting a system-wide standard, might be a requirement of uniform collection of data about safety, which would require that all studies use a standard safety Question Group called SAFETY_QUES. The Global Librarian sets these requirements.
Standards are defined by affiliations types, which are maintained through the form Maintain Standards Affiliations (from the Glib menu, select Standards Affiliations).
Affiliations is the means by which Oracle Clinical reaches these ends.
This section includes these topics:
This section describes the workflow for affiliations in the Global Library and the procedure for locating library Question Groups, DCIs, DCMs, and both Derivation and Validation Procedure definitions with affiliations.
These are the tasks that you can accomplish by using standards affiliations:
You can locate library objects such as Active Questions, Question Groups and DCMs, Global Library DCIs, DCMs, and Validation and Derivation Procedures. For this task, first choose the affiliations types pertinent to the study. Then use these to locate the library objects for the new clinical study. Related reports help you identify library objects left out of the new clinical study and to monitor other uses of affiliations.
Affiliating library objects with affiliation types, so that the objects can be located later. This activity is performed by the Global Librarian.
You can use the following method to locate library DCMs, DCIs, and Validation and Derivation Procedures from the corresponding study definition forms.
To locate Question Groups with affiliations, select Locate QG by SA from the Special menu to open the Query Library Objects by SAS dialog box.
Move the insertion point to the Standards Affil. Type field. Enter the affiliation type you want, or select a value from the list of values. If you select one of the listed values, the Standards Affiliation Name field is filled automatically.
Select the Required? field if you want only Question Groups that are REQUIRED; or, to locate all affiliated Question Groups, leave that field blank.
Select the OK button or Save to initiate the query. The Question Groups form reappears, displaying only those Question Groups that have been associated with the affiliations you entered.
You can map library Question Groups, DCMs, DCIs, and procedures to affiliation types.
For example, if you want to associate a Question Group with the indication of angina and a particular compound, enter the same set value for the two records. If the affiliation is for the indication of angina or a particular compound, use different set numbers to indicate that they are independent affiliations. Select the Required? field if this is a required affiliation, or leave it blank if the affiliation is simply recommended.
To map library objects to affiliation types, follow these instructions:
Navigate to one of these Global Library maintenance windows, or their Provisional equivalents:
From the Glib menu, select Question Groups, then choose Question Groups.
From the Glib menu, select DCIs DCMs Procedures, then choose DCIs.
From the Glib menu, select DCIs DCMs Procedures, then choose DCMs.
From the Glib menu, select DCIs DCMs Procedures, then choose Validation Procedures.
From the Glib menu, select DCIs DCMs Procedures, then choose Derivation Procedures.
Locate or create the object you want to map to an affiliation.
Select the Standards Affiliations button. The Standards Affiliations Set dialog box opens.
Create a new affiliation by entering values in the Standards Affiliations Type and Standards Affiliations Name fields. Use the Set field to group two SA records in the same affiliation.
Click Save to save the affiliation, then click Back to return to the Question Groups window.
Maintaining affiliations consists of determining whether affiliations are active and whether Question Groups affiliated with specific standards are required or recommended. New standards affiliations areas are created in the Maintain Standards Affiliations form; from the Glib menu, select Standards Affiliations. The Maintain Standards Affiliations form appears, with the cursor in the Standards Affiliations Type field.
Enter a type or select a value from the list of values. (You cannot create a new standards affiliations type from this form; the types are part of a reference codelist and populated at the installation level.)
The cursor goes to the Affiliation Name field, and existing values are displayed. Enter a new affiliations name by moving the cursor to the first blank field and typing in the name.
Click Save to save the new entries. The entries are immediately available for association.
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 Chapter 13, "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.
This section includes these topics:
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.
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:
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
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.
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:
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.
The system copies all DCI modules. The system treats clinical planned events as they currently exist.
The system copies active versions. The system ensures that the copied procedure references the equivalent DCM in the target.
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.
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.
From the Glib menu, select Copy Groups, then choose Copy Groups. The Maintain Library Copy Groups window opens.
Enter values for these mandatory fields: Copy Group Name, Domain, and Description.
Save the copy group name.
Click the Copy Group Details button.
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.
Select one or more DCMs.
Save the DCM choices.
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.
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.
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:
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.
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.