Global Library 4.5 Usage Guide

7/28/2019 Global Library 4.5 Usage Guide

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CLINTRAIN Global Library Usage Guide

Overview

1. The Global Library is the central repository of objects that allows a company tomaintain standards among different user groups or sites.

2. The Global Library is typically maintained by one or more Global Librarians whomake sure that standards are adhered to.

3. In Oracle Clinical, a number of different objects can be created, or copied to andstored in the Global Library. These include Questions, DVGs, and QuestionGroups, which can only be created in the Global Library.

DCMs, DCIs, View Definitions, View Templates, Validation Procedures, andDerivation Procedures can be created at the Global Library or Study level, and can

be copied between the two.

This template covers the objects that can only be created in the Global Library.There are separate templates on DCMs/DCIs (Study Definition), Views (Data

Extract), and Procedures.Each company must determine its own standards for deciding:

• Who can create standard objects (Questions, Question Groups, DVGs) andwho can activate them.

• Which of the other objects will be created in the Global Library or copiedto the Global Library.

• Which of these other objects are users obligated to copy from the GlobalLibrary to their study.

4. Questions, Question Groups, and Discrete Value Groups are typically created bythe Global Librarian, or by a Data Manager and then approved and activated bythe Global Librarian. This process depends on your company standards.

5. Over time a company will build an extensive library of objects. These objects arethen used in creating new studies. Additions are made to the Global Library asneeded for new studies iteratively through the work of Data Management andGlobal Library personnel.

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Domains1. Domains are sub-divisions of the Global Library. All objects in the Global Library

must be placed in a domain. Oracle Clinical comes pre-populated with a domaincalled STANDARD.

2. New domains can be created by the Administrator in the Installation CodelistOCL_DOMAINS.

3. Domains allow like objects to be stored together for standardization and security.Domains can be optionally created to represent Projects, Divisions, or Clients(CRO use for example).

4. Domains also allow two objects of the same type to have the same name by placing each one in a different domain. This allows an object, which has beencreated and activated with the wrong characteristics (which are unchangeable likeSAS Name) to be re-created with the correct characteristics in another domain.

5. Domains also provide a level of security (users must be granted access to domainsand studies must be granted access to domains). This allows domains to be used to

partition objects in different projects without concern that the unauthorized userswill change/create objects in the wrong domain.

6. Users are assigned domain access by the Administrator in the Oracle Accountsform or in the Glib Admin menu. Studies are assigned access to domains in theGlib Admin form or in the Special menu of the Easy Study Design form.

7. Users may only change their domain hierarchy (which domain defaults when theycreate a new object). They can change the hierarchy using the Special, DefineDomain Searchlist menu in any Global Library form.

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Glib Menu Structure

1. Each of the menus in the Global Library has a maximum of three different paths(e.g. Questions, Prov Questions, and Qry Questions).

2. These menus are used to provide different levels of security to Global LibraryFunctions.

3. The standard menu (e.g. Questions) allows users to perform any function allowedin the module (i.e. create, activate, change active objects - where allowed).Typically only the Global Librarian would have access to such menus.

4. The Prov menu (e.g. Prov Questions) allows users to create and change provisional objects, but does not allow activation or changes to be made to activeobjects. Typically a user with a Data Management role in the Company would begiven access to such menus to provisionally create objects that would be reviewed

by the Global Librarian.

5. The Qry menus (e.g. Qry Questions) is for users who need Display only access tothe Global Library, but are not allowed to create or update objects.

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Questions1. Questions are the structures used to collect data on a CRF (e.g. Height, Pulse, AE

Name, etc.)

2. Questions are created in the Questions module (menu Glib, Questions, Questionsor Prov Questions).

3. Create questions by giving them a unique name (within a domain) and definingthe other key attributes. Questions have a number of attributes that can be set inthe Global Library or at the study level (when attached to a DCM).

All settings can be updated at the Study Level with the exception of Question Name, Domain, Question Type, Data Type, and SAS Name (can be optionallychanged in the Extract Views).

4. Key attributes to define when creating a question (See the Field Summaries for more information on all fields) include:

• Domain• Question Type

• Question Data Type

• SAS Name

5. Questions must be assigned to at least one question category and activated beforethey can be used in Production studies.

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Question Groups1. Question Groups are logical collections of questions that are commonly re-used

(e.g. DEMOG, AE, or PHYSICAL_EXAM).

2. Question Groups are created in the Question Groups module (menu Glib,Question Groups, Question Groups or Prov Question Groups).

3. Create Question Groups be entering a unique name (within a domain) and saving.

4. Add questions to Question Groups by clicking on the Question Group Questions button and typing the questions in manually, selecting from the LOV, or using themenu Special, Copy Questions. When questions are added to the Question Groupall of their attributes are copied with them. All of these attributes (except name,SAS Name, Domain, Question Type, and Data Type) can be optionally amendedat the Question Group Question level.

5. Question Groups can have provisional questions added to them (while they are

still provisional). Activate the Questions and Question Groups before using themin Production.

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Discrete Value Groups1. Discrete Value Groups (DVGs) are codelists that are used to limit the acceptable

responses to a question during Data Entry (e.g. SEVERITY with values MILD,MODERATE, and SEVERE).

2. DVGs are created in the Discrete Value Groups module (menu Glib, Discrete ValueGroups, Discrete Value Groups or Prov Discrete Value Groups).

3. Three types of DVGs can be created: Internal, Thesaurus, and Alpha.

3.1. Internal DVGs have the list of values defined within Oracle Clinical.

3.2. Thesaurus DVGs point to an external list of values (in a view or table). ThesaurusDVGs are not required for use of the TMO or TMS and are usually usedseparately.

3.3. Alpha DVGs provide a way to assign a list of values to a numeric or date time

question. When the Alpha value is entered, (e.g. ‘NA’ for a numeric field) a DataType discrepancy is not created.

3.3.1. Responses that are discrete values from the Alpha DVG are always storedin the EXCEPTION_VALUE_TEXT field of the response table.

4. Create DVGs by entering a unique name within a domain. See the Field Summariesfor other attributes.

5. After the DVG is created, assign the appropriate discrete values. The discrete valuesconsist of a sequence number, short value (the actual response), and a long value(description).

6. The “Create Mand(atory). Discrep(ancy)?” tick box is only available for AlphaDVGs. If checked, and the question using the Alpha DVG is also marked asMandatory, it will create a Mandatory Discrepancy.

6.1. If unchecked, and the question using the alpha DVG is marked as Mandatory, noMandatory discrepancy will be created if a value is entered. If no value is entered,a mandatory discrepancy will be created as usual.

7. When a DVG is first created it is called the Base and automatically assigned a Subset Number of 0. This DVG cannot be used in production.

8. Subsets of the DVG can be created which can be used in Production. Subsets containone or more of the discrete values from the primary (base) DVG. For example, the

base DVG for Hair Color may include RED, BROWN, BLACK, and BLONDE - asubset may include BROWN and BLACK only.

9. Create DVG subsets by using the Special, Create DVG Sub menu. Discrete values can be removed from a Subset (while provisional) or deactivated in the Subset at anytime. Discrete values can be added to a Subset (as long as they are in the Base DVG).

10. DVG Subsets (Internal) (not the Base) can be assigned to character questions in the

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Global Library or at the Study Level. Alpha DVGs can be assigned to any question.

11. A question can have different DVG Subsets assigned at the Question, Question GroupQuestion, and DCM Question level.

12. During Data Entry, DVG values can be selected from the list of values for questions

that have a DVG assigned. Optionally, Data Entry personnel can enter the sequencenumber for the short value and the system converts it into the short value (based onthe Enter by Sequence setting at the DVG level for Internal DVGs only).

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Standards Affiliations1. Standards Affiliations (SA) are optional categorizations of objects that can be

used to help find objects and be used to make sure that objects of a certain SAtype have been included in a study.

2. SAs are created in the Global Library in the SA module (menu Glib, StandardsAffiliations). Create an SA by selecting a Type (from an LOV) and entering aunique Name.

3. Once the SA is created, objects (QGs, DCMs, DCIs, and Procedures) can beassigned to an SA.

4. At the study level objects within an SA can be searched for and reports can be runto identify which objects within the SA have not been used in the study.

5. SAs do not provide any level of security and are not part of the unique identifier for an object like domains.

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Documents

Global Library 4.5 Usage Guide