1 Getting Started
This section contains information on the following topics:
What Can I Do with the Oracle Life Sciences Data Hub?
The Oracle Life Sciences Data Hub (Oracle LSH) allows your company to gather data from many other systems such as clinical data management systems, clinical trial management systems, adverse event reporting systems, even financial or other nonclinical systems, together in one data repository where you can analyze data from all these sources together as necessary.
For example, your company can create programs to compare data from different trials in the same therapeutic area, compare adverse events reported for different drugs, or compare data from a current trial with data from a closed trial.
Oracle LSH allows your company to develop large sets of reports executed together and produced as a single- or multi-volume PDF output with a table of contents, page numbering, and hyperlinks. You can develop custom templates for use in these Report Sets.
Oracle LSH helps you remain in compliance with regulatory requirements by supporting the validation of all programs and other defined objects that handle data in Oracle LSH, and auditing changes to data over time. You can create and label snapshots of data at a particular point in time and later run the version of a program that was current at that time on that data to recreate your original results.
Each time you generate a report on data, you can generate a coversheet that traces the history of the reported data in Oracle LSH: when and from where the data was loaded into Oracle LSH, what programs and other objects manipulated the data in Oracle LSH, and whether those objects have been validated.
Your security privileges determine what reports you can see and what you can do in Oracle LSH. Depending on your privileges, you may be able to do the following:
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View reports that have already been generated on Oracle LSH data. See Viewing Reports and Other Outputs and Searching for more information.
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Create onscreen visualizations of Oracle LSH data. See Creating Data Visualizations for more information.
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Generate reports on the latest data, or on a data snapshot. See Generating Reports and Running Other Jobs for more information.
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Load data into Oracle LSH. See Generating Reports and Running Other Jobs for more information.
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Create Data Marts for export out of Oracle LSH. See Generating Reports and Running Other Jobs for more information.
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Run and view reports on sensitive, blinded data during the course of a trial. See Generating Reports and Running Other Jobs for more information.
For information on creating the programs and other defined objects required to load data and to produce reports, data visualizations, and data marts, see the Oracle Life Sciences Data Hub Application Developer's Guide.
For information on developing a custom Oracle LSH implementation design for your company, see the Oracle Life Sciences Data Hub Implementation Guide.
For information on administrative tasks, see the Oracle Life Sciences Data Hub System Administrator's Guide.
For instruction on installing Oracle LSH, see the Oracle Life Sciences Data Hub Installation Guide.
Parent topic: Getting Started
Logging In
To log in to Oracle LSH, you must have a browser on your computer and a URL, username and password provided by your company:
Parent topic: Getting Started
Setting Preferences
You can specify your preferences for some aspects of Oracle LSH's display and behavior.
There are general preferences that are the same for many Oracle applications, including display preferences and access requests.
There are other preferences developed especially for Oracle LSH, including user preferences and user connections.
Note:
You must click Preferences from an Oracle LSH screen such as My Home to see the Oracle LSH-specific preferences. If you still cannot see some of these preferences, your company's policy may be to set them for you.
To set your preferences:
- Click the Preferences link in the upper right corner of the My Home screen.
- Click the link in the panel on the left side of the screen to display the preferences you want to set.
- Enter your preferences.
- Click Apply.
You can find details on each type of preference in the following sections:
Display Preferences
Display preferences affect the way information is displayed for you in Oracle LSH. See the following topics for details:
Parent topic: Setting Preferences
Accessibility
You can choose one Accessibility preference. See this topic for details:
Parent topic: Display Preferences
Accessibility Features
Choose one of these settings:
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Standard Accessibility. Renders Oracle LSH screens accessible to users using assistive technologies.
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Screen Reader Optimized. Optimizes screens for screen readers. This option may degrade the output for sighted readers.
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None. If you choose this option, some Oracle LSH screens may include features that are not accessible to some users.
Parent topic: Accessibility
Regional
There are several regional preferences:
Parent topic: Display Preferences
Date Format
From the drop-down list, select the way you want Oracle LSH to display dates.
Parent topic: Regional
Number Format
From the drop-down list, select the way you want Oracle LSH to display numbers.
Parent topic: Regional
Client Character Encoding
This setting is used when uploading and downloading files to and from your computer through your browser. If you use non-English characters in source code, object names, or data, Oracle recommends that you change this setting to Unicode (UTF8) to ensure that these characters are displayed correctly in Oracle LSH.
Parent topic: Regional
Change Password
Use this section to change the password you use to log on to Oracle LSH. See the following topics for details:
Parent topic: Display Preferences
Known As
Enter your name as you would like it to appear in the welcome banner onscreen.
Parent topic: Change Password
Start Page
These settings determine the screen that opens when you log in to Oracle LSH.
Parent topic: Display Preferences
Responsibility
Select Oracle LSH Responsibility to access the Oracle LSH user interface. See this topic for details:
Parent topic: Display Preferences
Page
Select the tab you want to see when Oracle LSH opens; for example, My Home.
Parent topic: Responsibility
Notifications
You may receive emails notifying you of an event in Oracle LSH (such as the release of an updated report) or requesting an approval from you. These messages also appear in the Notifications section of your Home page. See this topic for details:
Parent topic: Display Preferences
Access Requests
If you are unable to access part of the Oracle LSH user interface or perform a function that you feel you need to do, you can request increased privileges.
To request additional access:
- Click the Preferences button.
- Click Access Requests in the Preferences tab. The system displays your current roles.
- Click the Help button and follow instructions there.
Parent topic: Setting Preferences
User Preferences
The following user preferences are specific to Oracle LSH. You can change the following settings:
- Preferred Domain
- Preferred Validation Status for Simple Search and Browse
- Database Password Management
- Database Account Name
- Old Password
- New Password
- Confirm Password
- SAS Connection Type
- SAS IDE Client
Parent topic: Setting Preferences
Preferred Domain
When you log in to Oracle LSH, Oracle LSH will automatically open the Domain whose name you enter here. You can click the Search icon to see a list of Domains and select one. If you type all or the beginning of the Domain name and then click the Search icon, you see only the Domains that match what you entered.
You can change Domains in the Application Development screen as necessary.
Parent topic: User Preferences
Preferred Validation Status for Simple Search and Browse
Check the box if you prefer to see only objects and outputs whose validation status is Production when you conduct a Simple Search or browse the Reports or Applications tab. (You can request to see objects or outputs of any validation status when you use Advanced Search regardless of this setting.)
This setting is recommended for people who only need to view production data and reports in Oracle LSH. It is not recommended for people who are developing Oracle LSH applications.
Parent topic: User Preferences
Database Password Management
Use this preference to change the password for your database user account.
Parent topic: User Preferences
Database Account Name
The system displays your database user account name, if you have a database account.
Parent topic: User Preferences
SAS Connection Type
This preference applies only to application developers who will work in SAS to create or upload programs to run on Oracle LSH data.
Oracle LSH handles data access from SAS as an integrated development environment (IDE) differently, depending on the connection mode you specify here:
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Connected Mode. When you launch SAS from an Oracle LSH Program instance, Oracle LSH downloads views based on the Table Descriptors defined in the Program. You can see the current data in Oracle LSH while you work in SAS. If your program writes data to data sets, when you execute the program in the SAS IDE you pull data from Oracle LSH over the network and write to local data sets.
Your PC must have SAS Access to Oracle as well as the SAS client installed and must be connected to the Oracle LSH database through a network.
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Disconnected Mode. When you launch SAS from an Oracle LSH Program instance, Oracle LSH downloads data sets with the same structure as the Program's Table Descriptors to your PC. In addition, Oracle LSH downloads the actual data contained in the Table instances to which the Table Descriptors are mapped. You can write your program working on the downloaded data.
Your PC must have the SAS client installed and must be connected to the Oracle LSH database through a network. SAS Access to Oracle is not required.
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SAS Connected Mode with Work Area Data. This mode is the same as Connected mode except that it connects to the Work Area schema in the database. From SAS, you can browse views of current data in all Table instances in the Work Area, not just the Table instances linked to Table Descriptors of the Program.
You must use the SAS Access to Oracle tool to connect to Oracle LSH.
Parent topic: User Preferences
SAS IDE Client
This preference applies only to application developers who will work in SAS to create or upload programs to run on Oracle LSH data. This setting determines the SAS client that is used when you launch a SAS integrated development environment (IDE) session. Your company may have removed this preference or added options.
Parent topic: User Preferences
User Connections
To create or run Load Sets to load data into Oracle LSH from an external Oracle system, you must have an account on the external system that allows you to access the data you are loading. Enter information about your external Oracle system accounts so that when you create or run a Load Set, Oracle LSH can log on to the external system using your account to perform the data load. No other Oracle LSH user can use your connections.
To add a user connection for yourself, do the following:
Parent topic: Setting Preferences
Navigating the Life Sciences Data Hub User Interface
The tabs you see in the Oracle LSH user interface depend on your security access.
If you are an administrator or a programmer you may see additional tabs. Information about the Classifications, Security, and Administration tabs is included in the Oracle Life Sciences Data Hub System Administrator's Guide and for the Applications tab in Oracle Life Sciences Data Hub Application Developer's Guide.
For more information, see the following topics:
Parent topic: Getting Started
My Home
The My Home screen has two the following two sections:
Notifications
If you click on the My Home tab you see a section on Notifications. These are messages sent to you within Oracle LSH. They may require action on your part or simply provide information. For further information on Notifications, see Using Notifications.
Parent topic: My Home
Job Executions
If you scroll down the page you see a section on Job Executions. Every time you run a job—for example, run a report on fresh data, or load data from an external system—the system displays information on the progress of the job on this screen. For further information, see Tracking Job Execution.
Parent topic: My Home
Reports
If you click on the Reports tab, you see two subtabs:
Outputs
The Outputs subtab has two purposes: to display existing reports, Report Sets, and Data Marts; and to display the submission screen for reports, Report Sets, and Data Marts as well as Workflows and Load Sets so that you can run the same job on fresh data as necessary. For further information, see Viewing Reports and Other Outputs and Generating Reports and Running Other Jobs.
Parent topic: Reports
Visualizations
In the Visualizations subtab you can see Business Areas that you can use to create visualizations—graphical or tabular displays of Oracle LSH data—in Oracle Business Intelligence Enterprise Edition or Oracle Discoverer Plus. Business Areas consist of a set of views of Oracle LSH tables and their data, with joins and hierarchies defined to allow you to best compare and analyze the data. For further information, see Creating Data Visualizations.
Parent topic: Reports
Using Online Help
You can get context-sensitive online help for any screen in Oracle LSH (except pop-up windows) by clicking the Help link in the upper right corner of every screen.
The information you see in online help is taken from one of the following Oracle LSH user manuals, depending on the topic:
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Oracle Life Sciences Data Hub User's Guide (this book)
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Oracle Life Sciences Data Hub Application Developer's Guide
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Oracle Life Sciences Data Hub System Administrator's Guide
In addition, you can see these books and the Oracle Life Sciences Data Hub Implementation Guide under Health Sciences in the navigation tree on the left side of the help screen.
Parent topic: Getting Started
Standard Buttons and Icons
Many Oracle LSH screens display the icons and buttons as described in the following sections:
Parent topic: Getting Started
Buttons
The following button functions are the same throughout Oracle LSH application development:
Parent topic: Standard Buttons and Icons
Apply
Oracle LSH applies changes you have made on the current screen to the database and opens a new screen. Always paired with Cancel.
Parent topic: Buttons
Cancel
Oracle LSH discards any work you have done in the current screen and returns you to the previous screen. Always paired with Apply.
Parent topic: Buttons
Check In
Oracle LSH saves the new version of the object definition in the database and allows other Definers to check out the object, according to normal security limitations. Only the person who checked the object out can check it in (except for Report Set definitions, which have shared editing; see "Concurrent Editing" in the Oracle Life Sciences Data Hub Application Developer's Guide).
Parent topic: Buttons
Check Out
To modify an existing object definition, you must check it out first. See "Understanding Object Versions and Checkin/Checkout" in the Oracle Life Sciences Data Hub Application Developer's Guide for further information.
Parent topic: Buttons
Continue
Used for processes that require a series of screens. Oracle LSH saves your work temporarily and displays the next screen in the process. If you cancel before the Save or Apply operation at the end of the process, which saves your work in the database, the system discards the temporarily saved work.
Parent topic: Buttons
Copy
Creates a copy of each selected object definition or instance that you can paste into a new location. The original object remains unchanged. To copy, you must first select the item(s) you want to copy and click the Copy button. Then go to the location into which you want to paste the copy, and click Paste. The system prevents you from doing anything else until you either cancel or paste. You can copy multiple objects from the same container at the same time. When you click Paste, the system pastes all the objects into the new location. See "Copying Objects" in the Oracle Life Sciences Data Hub Application Developer's Guide.
Parent topic: Buttons
Move
Moves each selected objects to a different location without breaking any links; use Paste to complete the operation. See "Moving Objects" in the Oracle Life Sciences Data Hub Application Developer's Guide.
Parent topic: Buttons
Paste
Places one or more object(s) into a single Oracle LSH location to complete the Copy or Move operation.
Parent topic: Buttons
Uncheck
Oracle LSH discards the new version of the object you checked out. Only the person who checked the object out can uncheck it. The previous version continues to function as before.
Parent topic: Buttons
Icons
Oracle LSH uses icons for actions and to represent object types. See the following topics for details:
Parent topic: Standard Buttons and Icons
Action Icons
The following icons appear on the main Application Development screen:
- Check Out
- Check In
- Clone
- Collapse
- Create Child
- Expand
- Focus
- Manage Definitions
- Mapping
- Move
- Reorder
- Select
- Version History
Parent topic: Icons
Clone
Cloning is an option only for Work Areas. See "Cloning Work Areas for Testing and Production" in the Oracle Life Sciences Data Hub Application Developer's Guide
Parent topic: Action Icons
Collapse
When Oracle LSH displays the Collapse icon, the child objects are displayed, but you can click the icon to hide them.
Parent topic: Action Icons
Create Child
Click Create Child to create a new object that is a child of the row object. The type of object you can create as a child varies depending on the parent.
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For an Application Area, Work Area is the only child you can create in this way. To create definitions of primary objects, either click Manage Definitions or create an instance and a definition in a Work Area within the Application Area. Oracle LSH automatically creates the new definition in the Application Area that contains the Work Area.
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For a Work Area, you can create any primary object type: Business Area, Data Mart, Load Set, Program, Report Set, Table, or Workflow. Oracle LSH automatically creates the new definition in the Application Area that contains the Work Area, and an instance of it in the Work Area.
Parent topic: Action Icons
Expand
Oracle LSH displays either the Expand or the Collapse icon to the left of every object that owns one or more objects. When Oracle LSH displays the Expand icon, the child objects are hidden, but you can click the icon to show them.
Parent topic: Action Icons
Focus
Use the Focus icon to move your selected container to the top of the tree and expand all its branches.
Parent topic: Action Icons
Manage Definitions
Click this icon to create or modify the definitions contained in the Domain or Application Area.
Parent topic: Action Icons
Mapping
Click this icon to open the Mapping screen and map Table instances to Table Descriptors inside Program instances or other Oracle LSH executable objects.
Parent topic: Action Icons
Move
Use the Move operation to remove an object from its current location and paste it into a new location.
Parent topic: Action Icons
Reorder
Click Reorder to rearrange the display of objects on this screen.
Parent topic: Action Icons
Select
There are two kinds of icons to select objects in Oracle LSH.
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Square. The square checkbox allows you to select multiple objects.
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Circle. The circular radio button allows you to select only one object.
Select the required objects. Then click a button in the toolbar immediately above, such as Copy to copy all selected objects or Remove to remove all selected objects.
Parent topic: Action Icons
Version History
Click this icon to see the version history of the object.
Parent topic: Action Icons
Object Icons
Each Oracle LSH object type has its own icon. See the following topics for details:
- Domain
- Application Area
- Work Area
- Business Area
- Variable
- Data Mart
- Load Set
- Notification
- Notification With Approval Request
- Program
- Report Set
- Report Set Entry
- Table
- Workflow
Parent topic: Icons
Using the Keyboard and the Mouse
There are two ways to navigate around Oracle LSH screens and invoke actions:
Parent topic: Getting Started
Using the Mouse
Point to the field or button you want to use. Left-click to select a field or invoke the action of the button.
To enter text in a field, select it and then type the text.
Parent topic: Using the Keyboard and the Mouse
Using the Keyboard
Use the Tab and arrow keys (up, down, left and right) to navigate around the screen. The active onscreen item is outlined with a dotted line. If an enterable field is active, anything you type appears in the field.
To move from one frame of the screen to another, press Ctrl+Tab.
Press Enter to invoke the action of a button when the button is active.
Press the spacebar to select a radio button or checkbox.
Parent topic: Using the Keyboard and the Mouse