About Load Sets

To load data into the Oracle Life Sciences Data Hub (Oracle LSH), you define and run a Load Set.

Oracle LSH allows you to load data from a wide variety of sources. The standard Oracle LSH installation (without any special customizations) allows you to load data from SAS, from any Oracle database, or from a text file. Oracle LSH also has a set of Load Set types developed especially for Oracle Clinical that allow you to load data from data extract views, from the discrepancy management subsystem, and from the global library.

Oracle LSH uses a specialized executable defined object called a Load Set to handle data loading. A Load Set definition identifies the type of source data system and includes Table Descriptors that specify the required structure of one or more Tables into which to load the data in Oracle LSH. For Oracle and SAS Load Sets the system can create Table Descriptors based on tables or data sets in the source data system. For all types, you can create Table instances based on Table Descriptors and map them automatically, using a job in the Actions drop-down list.

For Load Sets that load files—SAS and Text—you should not specify the file during Load Set definition because the system uploads the actual data file at that time. Let the person who executes the Load Set specify the file to get the most current data. For the same reason it does not make sense to set up a repeating schedule for running a SAS or Text Load Set; you would be loading the same data each time.

For Oracle-technology Load Sets you can specify default values in the Load Set definition for the tables to be loaded. The system only creates views during Load Set definition, and always loads the most current data when you run the Load Set. You can set up a repeating execution schedule to update the data as necessary.

At runtime, if the user submitting the Load Set specifies different external tables or files to load from the ones you used to create the Table Descriptors, the Load Set will run successfully if the data structure is compatible.

For information on loading blinded data, see Loading Real and Dummy Data.

Load Set Types: The different types of Load Sets are as follows. You see only those types that your company uses and that you have security access for.

• Oracle Tables and Views. Oracle LSH loads data and metadata from any Oracle database.

• SAS. Oracle LSH loads one SAS data set at a time or, using a CPORT or XPORT file, multiple data sets. The system loads metadata at the time of Load Set definition and data at Load Set runtime.

• Text. Oracle LSH loads one or more text files into one or more Table instances.

• Oracle Clinical Data Extract Views. Oracle LSH loads patient data from Oracle views defined in Oracle Clinical.

• Oracle Clinical Data Extract SAS Views. Oracle LSH loads patient data from SAS views defined in Oracle Clinical.

• Oracle Clinical Global Metadata. Oracle LSH loads your Oracle Clinical Global Library definitions and automatically converts them to Oracle LSH definitions as follows: converts Oracle Clinical Questions to Oracle LSH Variables. If a Question is associated with a DVG, Oracle LSH also converts the Question to an Oracle LSH Parameter with the DVG as its list of allowed values. Oracle LSH converts Oracle Clinical Question Groups to Oracle LSH Tables with Columns based on the Variables corresponding to each Question in the Question Group.

• Oracle Clinical Labs. Oracle LSH loads Lab definitions, Lab Ranges, and Lab Assignment Criteria, and other Lab-related metadata (see OC Labs Load Set Table Descriptors for a complete list).

• Oracle Clinical Study Data. Oracle LSH loads study-specific data including discrepancies, Data Clarification Forms (DCFs), page tracking information and patient status information.

• Oracle Clinical Stable Interface. Oracle LSH loads tables described in the Oracle Clinical 4.x Stable Interface Guide.

• Oracle Clinical Randomization. Oracle LSH loads Oracle Clinical tables related to the Randomization subsystem.

You can customize Oracle Clinical to use the Oracle Messenger facility to trigger a Load Set. For example, you could trigger a patient data Data Extract Load Set with a successful batch validation run, or trigger a Global Library load with a successful replication to remote nodes.

Security: Each Load Set type uses a different predefined Oracle LSH adapter to handle the data and metadata exchange between the external system and Oracle LSH. An adapter consists of a group of predefined objects in an Adapter Area, which is contained in an Adapter Domain.

Before you can create a Load Set for any Oracle source data system you must do the following setup: enter connection information for the remote location into Oracle LSH in the Remote Locations subtab of the Administration tab. Instructions are included in the chapter "Registering Locations and Connections" in the Oracle Life Sciences Data Hub System Administrator's Guide.

• Create one or more user groups and assign them to Adapter Areas (see "Setting Up Security for Adapters" in the Oracle Life Sciences Data Hub System Administrator's Guide). Each Definer who will need to define Load Sets must belong to a user group that is assigned to the Adapter Area that corresponds to the Load Set type that he or she needs to define.

  In addition, you must add an administrator a user group assigned to each Oracle-technology adapter so that the administrator can define remote locations for the Oracle adapters.

• An administrator must define remote locations for the Oracle adapters. If you want to use shared connections, the administrator must create them. See the chapter on "Defining Remote Locations" in the Oracle Life Sciences Data Hub System Administrator's Guide for further information.

• Individual users with access to external Oracle systems can create their own connections for use in defining and running Load Sets Preferences, accessed from a link on the Oracle LSH My Home screen. See "Getting Started" in the Oracle Life Sciences Data Hub User's Guide for further information.

Note:

When you define any Oracle technology-based Load Set you must enter a Remote Location and your own (or shared) connection information in the Attributes section of the Load Set definition in order to create the Load Set's Table Descriptors.

However, be careful not to enter your own or shared connection information as a runtime Parameter because this represents a breach of security on the source data system, enabling anyone with security access to the Load Set itself to run the Load Set regardless of whether he or she has the required privileges on the source system.

Leave the Parameter value empty so that the user must enter his or her own connection information to run the Load Set.

Execution: Load Sets, like other Oracle LSH executable objects, have Execution Setups that serve as the basis for the submission form for running the job. You can modify the default value of Parameters in the Execution Setup definition, and the user submitting the Load Set can change them at runtime. See Creating, Modifying, and Submitting Execution Setups.

Oracle LSH uses the Processing Type you define for the target Table instances to determine how to process the data and whether to maintain an internal audit trail of inserts, updates, and deletes (see Data Processing Types for further information).

Loading Blinded Data: See "Loading Real and Dummy Data".

Reports on Load Set Definitions and Instances: From the Actions drop-down list, you can generate reports that provide information on a Load Set definition or instance; see System Reports for information.