An element of a Workflow; either an executable object such as a Program, a structural object such as a Fork, or a Notification.
An interface between Oracle LSH and another system. Oracle LSH includes adapters that allow you to load data into Oracle LSH from other systems, to transform data by creating Programs in integrated development enviroments, and to create visualizations of Oracle LSH data for display in other systems.
The set of all the defined objects required to perform a particular business function such as loading and analyzing data for a study or producing a particular set of reports.
A container that is used to develop and manage the Oracle LSH objects required for a single business application (such as a study, project, or set of reports); contains one or more Work Areas where the set of object instances (such as Table and Program instances) necessary for the business application are installed.
A record of each change made to each record in a Table instance defined with a processing type that includes auditing, with the timestamp of the change and the user ID of the person who made the change. You can recreate the state of data in an audited table as it was at any point in time.
A single execution of a job on data defined as blinded in Oracle LSH, so that the sensitive blinded data is displayed in the job output, but is not permanently unblinded. Blind breaks may be required for patient medical emergencies or for reporting purposes during the course of a clinical trial.
Data that must be hidden in Oracle LSH because its display would reveal patient treatment patterns in a double-blind clinical trial. If you specify that a table supports blinding, Oracle LSH creates a partition, allowing you to load the blinded data in the "real data" partition of the table and, optionally, to load dummy data in the "dummy data" partition. Oracle LSH requires standard object security privileges to run a Program on dummy data but requires additional security privileges to run the same Program on real (blinded) data.
Oracle LSH definitional object used by a visualization tool such as Oracle Business Intelligence Enterprise Edition to create ad hoc, onscreen visualizations of Oracle LSH data.
A check constraint applies to a particular Table column and specifies allowed data values for that column.
(1) The act of associating an Oracle LSH object definition or object instance with one or more values in one or more classification hierarchies, for the purpose of categorizing the object so that it can be found during searching and browsing. (2) The actual classification hierarchy value or set of values associated with an Oracle LSH object definition or object instance. (3) The Oracle LSH subsystem of single- and multi-level hierarchies and their values used in searching and browsing.
Hierarchical or flat structure consisting of one or more levels, with one or more values in each level. If a hierarchy contains multiple levels, they must be logically related and the values in each level must be logically related to values in adjacent levels (each value must be related to one and only one value in the next higher hierarchy level, but can be related to many values in the next lower level). Used in searching and browsing.
A special copy operation for Work Areas that results in an identical Work Area, including all its contained object instances and mappings. All object instances in the clone have the same version number and validation status as their counterparts in the original Work Area, and the two Work Areas share a user-specified label.
A constraint on an Oracle LSH Table or Column similar to an Oracle column or table constraint. See also check constraint, primary key constraint, and unique key constraint.
An Oracle LSH user who retrieves (consumes) information from the Oracle LSH database by running and viewing reports and creating onscreen data visualizations.
An object that contains, or owns, another object; also called a parent object or organizational object.
(1) A large quantity of data extracted from one or more user-defined Oracle LSH Table instances in one of several formats. (2) The definitional object that generates the Data Mart output.
An Oracle LSH Table instance or source data system table, view, or data set from which an Oracle LSH Program reads data.
See Program.
The Oracle date data type is defined as the number of days since the beginning of the Julian Calendar in a floating point numeric. Oracle LSH stores all date values in this format but displays dates and accepts entry of dates in one of several European, US or Standard formats (such as DD-MON-YYYY) based on user preference.
An Oracle LSH user who develops applications by defining objects in Oracle LSH, typically a programmer.
See object definition.
Objects defined by the user in Oracle LSH, including Oracle LSH Tables, executables, and their components; includes both object definitions and object instances. See also object definition and object instance.
An installed Work Area whose usage intent is set to Development and whose database schemas are used for the purpose of developing Oracle LSH object definitions and instances. Oracle LSH supports maintaining separate Work Areas and schemas as development, quality control, and production environments so that data from a development or quality control environment is never mixed with production data.
A container that is used to group Application Areas and/or other Domains and/or to store and control a library of object definitions.
A set of object definitions contained directly in a Domain; intended as a collection of valid, production-quality object definitions suitable for reuse.
Alternative data with blinded information obfuscated that you can load, processed instead of the real (sensitive, blinded) data for the purpose of testing Programs and producing reports prior to unblinding the real data.
See Report Set Entry.
(1) The running of a particular Oracle LSH job; for example, running a Program to generate an output. (2) The Oracle LSH runtime subsystem that manages the execution of jobs.
A defined object that is a component of each Oracle LSH executable object instance (Programs, Report Sets, Data Marts, Load Sets, Workflows) whose purpose is to control the execution of the executable object. It includes input Parameters whose values are either bound or settable at submission. The Execution Setup serves as the basis for the submission form of an executable object.
An Execution Setup that has been explicitly made available for use as a template to other instances of the same executable object definition version. Definers can use Execution Templates as the basis for an Execution Setup in another instance of the same executable object definition.
Processing mode for executables writing to Reload Tables in which the current state of all rows in a data source are reinserted by a Program or other executable object, and rows that are not reloaded are soft-deleted. Oracle LSH automatically detects which rows are new inserts, which are updates, which are unchanged and, implicitly, treats any rows that are not reloaded as deleted.
Processing mode for executables writing to Reload Tables in which only those rows that have been added or modified since the last time the same Program or other executable object was run are processed. Unchanged rows can also be reloaded and are ignored by the processing. Incremental reload processing does not delete records and therefore can be used to selectively load different subsets of data without impacting other data in the target table.
A non-unique index provides a way to optimize access to data in a table via columns included in the index. See also unique indexes unique key constraint and primary key constraint.
See object instance.
The process of converting selected Oracle LSH object instances in a single Work Area into installable components such as PL/SQL packages and DDL scripts and instantiating those components in an Oracle LSH schema.
Integrated Development Environment (IDE)
In Oracle LSH, an external source code development software application that can be launched directly from the Oracle LSH user interface for the purpose of writing or editing Program source code, integrated with Oracle LSH by a system that includes: a syntax-directed editor, graphical tools for program entry, integrated support for compiling and running the program, and a mechanism for relating compilation errors back to the source.
See Domain library and Application Area library.
an Oracle LSH executable whose purpose is to move data and metadata into Oracle LSH from an external source data system that is connected to Oracle LSH by an adapter customized for the source data system. The adapter handles constraints on the structure of the target Table Descriptors, provides the Parameters, and supplies the source code for the installed Load Set.
(1) (noun) A mapping defines the relationship between a Table Descriptor in a Program or other executable object and a Table instance in a Work Area that the executable object reads from or writes to. Each column of the Table Descriptor and the Table instance must be mapped to a column of a compatible data type and length in the other, or to a constant. (2) (verb) Creating a mapping.
A job launched by the submission of an Execution Setup. When a user submits a Load Set, Program, Data Mart, Report Set, or Workflow, the resulting job is a master job. Some master jobs have subjobs: Report Set executions include Program executions as subjobs. Workflow executions may include Program, Load Set, Data Mart, and/or Report Set executions as subjobs.
A block of text that annotates a generated report or report set. May precede the body of the report (pre-narrative) or follow it (post-narrative).
Message routed within Oracle LSH or (optionally) by email; contains a subject name, text, and one or more hyperlinks to Oracle LSH outputs or other objects; can be used for collecting informal approvals or comments or for broadcasting text.
The definitional metadata details of an Oracle LSH object, stored in an Application Area or Domain library and created (normally) through an instance of the definition that is contained in a Work Area. The metadata varies depending on the definition's object type, but includes a name, subtype, validation status and classification(s). For example, Table definitions also contain Columns and Constraints; Program definitions contain Source Code, Parameters, Planned Outputs, and Table Descriptors.
An instance of Oracle LSH object definition; contains a pointer to an object definition, which contains most of the definitional details, and a few attributes including a name, subtype, validation status, classification(s), and (for executable instances only) mappings. Object instances are located in a Work Area and installed in the database.
Subcategory of a predefined object type that serves to differentiate classification and security requirements among objects of the same object type; for example, Financial Report Set and Clinical Report Set. Object subtypes have the same operations allowed as their object type. One subtype for each object type is shipped with Oracle LSH; an Administrator may define additional object subtypes.
A predefined category of Oracle LSH definitional objects shipped with Oracle LSH; for example, Report Sets or Tables. Object instances constitute a separate object type; that is, a Report Set instance is a different object type from a Report Set definition and can have different classification and security requirements defined at the subtype level.
An action that can be performed by a user on an object; for example, view or modify. Operations are predefined for object types. The Oracle LSH Administrator defines roles and associates them with operations on object subtypes as part of the Oracle LSH security system.
A set of Oracle database schemas (one primary schema and one or more auxiliary schemas) that owns all permanent objects that are populated by the installation of a single Oracle LSH Work Area, including tables, views, packages, or schema stores. An Oracle LSH schema also contains all data loaded into its tables.
Category of Oracle LSH object types used solely as containers of other objects; includes Domains and Application Areas.
In Oracle LSH, a file generated by the execution of a Program, Workflow, Report Set, or Data Mart; either the primary output reporting on or containing data, or a secondary output such as a log file or an error file. Also called an actual output to distinguish it from a Planned Output definition.
Overlay Template Definition (OTD)
A layout template for PDF outputs of Oracle LSH Report Sets; can include boilerplate text, graphical elements such as logos and lines, and placeholders for Parameter values for data (such as Study) and publishing specifications (such as font style and size).
A defined object that acts as a simple scalar variable and is based on an Oracle LSH Variable definition. In a Program or other Oracle LSH executable object, an input Parameter supplies a runtime value to the executable object and an output Parameter holds a value generated during execution. In addition to a pointer to an Oracle LSH Variable, a Parameter contains a list of allowable values, rules for validating the supplied value, a mandatory/not mandatory setting, and classification(s). Parameter values can be propagated within the context of a Report Set or a Workflow.
A definitional object created automatically by Oracle LSH to contain the Parameters contained in a single primary definitional object.
An object definition contained in an Oracle LSH executable object definition that serves as a placeholder for an actual output to be generated during execution and specifies the classification(s) of the actual output. Primary Planned Outputs report on or contain data; secondary Planned Outputs include log files and error files.
A column or set of columns whose value(s) identify a row in a Table as unique; often a unique ID. The system enforces the following constraints on the data contained in primary key columns: values cannot be null, and the value or combination of values in primary key column(s) must be unique for each row.
In Oracle LSH, a privilege is an operation on an object subtype assigned to a user through a role in a user group. A user has the privilege necessary to perform an operation on an object when he or she is assigned to a user group that has access to the object, and within that user group is assigned to a role that allows the operation on the object's subtype.
An installed Work Area whose usage intent is set to Production and whose database schemas contain only valid Oracle LSH objects interacting with real clinical or other data in an audited and regulatory-compliant manner.
an Oracle LSH defined executable object that functions as a computer program to transform data and/or generate one or more reports. Contains Source Code and one or more Table Descriptor(s); may also contain one or more Planned Outputs and Parameters.
quality control (QC) environment
An installed Work Area whose usage intent is set to Quality Control and whose database schemas are used for the purpose of testing Oracle LSH object definitions, adapters, and loads of data and metadata before using them in a production environment. Oracle LSH supports maintaining separate Work Areas and schemas as development, quality control, and production environments so that data from a development or quality control environment is never mixed with production data.
(1) The primary output generated by a Program; contains a set of clinical or other data for in-house review or submission to regulatory agencies. Reports may be displayed as listings, figures, tables, or text and may be generated in one of several file formats. (2) A predefined output generated by the system on demand; for example, a coversheet for a report.
(1) A collection of reports generated by a single execution process and integrated with a table of contents. May be generated in PDF format using custom templates with graphics and including bookmarks and hyperlinks. (2) The primary Oracle LSH definitional object that produces the Report Set output.
One of the items in the table of contents of a Report Set; may contain other Report Set Entries, narratives, and/or one or more reports generated by a single Program; a Report Set chapter or subchapter.
(1) User-defined component of the Oracle LSH security system corresponding to a professional title or function; assigned to operations on object subtypes, to user groups, and to individual users within those groups. To perform a particular operation on an Oracle LSH object, a user must have a role assigned to that operation for the object's subtype in a user group with access to the object. (2) Predefined application roles shipped with Oracle LSH that control access to portions of the Oracle LSH user interface.
The Oracle LSH subsystem that manages the execution of installed executable object instances as well as the tracking of, and access to, the progress and results of the executions.
Facility for finding existing defined objects and outputs in Oracle LSH, using criteria including object type, name, and classifications (including keywords). Oracle LSH includes simple and advanced search options.
(uppercase) A secondary definitional object owned by an Oracle LSH Program containing a file of user-written computer instructions (source code) whose purpose is to perform a task.
(lowercase) The computer instructions used by a Program to perform a task. Source code may be written in an Integrated Development Environment (IDE) in the context of an Oracle LSH Program or written outside Oracle LSH and then uploaded and stored in Oracle LSH; in Oracle LSH, source code is stored in the definitional object called Source Code.
An application external to, but integrated with, Oracle LSH that collects data loaded into or accessed by Oracle LSH through an adapter.
A Table Descriptor used to link a Program to a Table instance containing data used as input to the Program.
Data processing type used for Programs that write to Tables defined as Staging. If the Table is defined as Not Audited, each time the Program that writes to it is executed, the system hard-deletes the data resulting from the previous execution. If the Table is defined as Audited, the system saves a copy of the complete set of data resulting from the previous execution, but operates only on current data.
See Workflow Structure and Table structure.
A subjob is a job that is executed as part of a master job. For example, Report Set executions are master jobs that include Program executions as subjobs, and Workflow executions are master jobs that can include Load Set, Program, Report Set, and/or Data Mart executions as subjobs.
See object subtype.
an Oracle LSH metadata representation of a table-like object (Oracle view or SAS dataset); includes a description of the object as a whole, its columns, and constraints that apply to one or more of its columns. Appears as an Oracle view to all installed Programs except those based on SAS technology, where it appears as a SAS dataset or SAS view.
See constraint.
An instance of an Oracle LSH Table defined within an Oracle LSH executable object—Load Set, Program, Workflow, Report Set, or Data Mart—or in a Business Area, for the purpose of linking the executable object or Business Area to an installed Table and its data by mapping.
The number of Columns a Table definition contains and the data type and length of each one.
A Table Descriptor used to link a Program to a Table instance to which the Program writes data.
transform, transforming Program
See Program.
Data processing type used to write to Table instances defined as transactional. Programs writing to transactional Tables must use explicit Insert, Update, and Delete commands in their source code.
An element of a Workflow that defines one workflow activity as sequential to another and specifies the condition, if any, for the execution of the second.
A column or combination of columns that identifies a row in a Table as unique; similar to a primary key except that null values are allowed in columns that are part of the unique key. You can explicitly disallow null values at the column level.
An attribute of Work Areas indicating the Work Area's purpose; either Development, Quality Control, or Production. Oracle LSH enforces rules based on the interaction of a Work Area's usage intent attribute and the validation status of the Work Area and the object instances contained in it.
Unit defined by an Oracle LSH Administrator for use in security that includes one or more users and one or more roles, and is assigned to one or more Oracle LSH objects. To perform an operation on an Oracle LSH object or output, a user must belong to a user group assigned to that object and be assigned a role within that user group that permits the operation on the object's subtype.
(1)Process through which object definitions and instances reach the stage where they can be declared stable and valid according to an Oracle LSH customer's policies. (2) Process required by regulatory agencies to certify that a computer system used in clinical trials is stable and functions properly.
An object attribute that indicates the life cycle stage of the object: Development, Quality Control, Production, or Retired. Oracle LSH enforces rules based on the interaction of a Work Area's usage intent attribute and the validation status of the Work Area and the object instances contained in it.
an Oracle LSH defined object equivalent to a SAS variable or Oracle table column that serves as a source definition for Oracle LSH Parameters and Table Columns. Oracle LSH creates Variables from Oracle table columns and SAS dataset variables the first time a particular Oracle table or SAS dataset is loaded into Oracle LSH. The user can define Variables during Parameter or Table Column definition.
An ad hoc graphical and/or text presentation of data created in an interactive onscreen environment.
A container in an Application Area where Definers create the object instances required to support the business purpose of the Application Area. Work Areas have two special operations: installation, during which some or all of the object instances contained in the Work Area are instantiated or upgraded in an Oracle LSH schema and the Oracle LSH schema is created if necessary; and cloning, which creates a duplicate Work Area that shares a label with the original Work Area.
An executable Oracle LSH defined object that includes other Oracle LSH executable defined objects such as Load Sets, Programs, Data Marts, and Report Sets, as well as Notifications; executed as a whole in a defined sequence that can include conditional branching.
Predefined object that controls the execution of the Workflow; a Workflow Structure can detect the completion status of the previous activity and fire the next one or more activities as specified for their type: Start, End, And, Or, Fork.