Integrating Oracle Clinical with Other Products and Options

You can integrate Oracle Clinical with some other products and options and develop applications that read data from Oracle Clinical. Each product listed below must be purchased separately:

• Oracle Clinical Remote Data Capture Onsite
  
• Oracle Thesaurus Management System
  
• Oracle Life Sciences Data Hub
  
• SAS
  
• Custom Applications for Oracle Clinical
  

Oracle Clinical Remote Data Capture Onsite

Oracle Clinical Remote Data Capture Onsite (RDC Onsite) is an electronic data capture (EDC) Web application that works with studies that are defined and designed using Oracle Clinical. You can use RDC Onsite to collect, perform immediate validation on, review, verify, approve, and report clinical data collected during a patient visit in a clinical study. Patient data is stored in the Oracle Clinical database. You can use Oracle Clinical features including batch validation, discrepancy management, mass changes, and data extract with data collected using RDC Onsite.

Installing Oracle Clinical also installs Oracle Remote Data Capture (RDC) Onsite. For information about using RDC, see the Oracle Clinical Remote Data Capture Onsite User's Guide. For license information, see Prepare to Install Oracle Clinical

Oracle Thesaurus Management System

Oracle Thesaurus Management System (TMS) allows you to code specified patient data to standard terminologies such as MedDRA and WHO-Drug so that the data can be accurately analyzed. When fully integrated with Oracle Clinical, TMS processes new and updated patient data during each Oracle Clinical batch validation and either automatically codes incoming data—those that match standard terms exactly or match previously manually coded terms exactly—or creates an omission that must be manually coded in TMS. TMS can return to Oracle Clinical related terms from one or more levels of the standard terminology—for example the preferred term and system organ class in MedDRA, or the preferred name and Anatomical-Therapeutic-Chemical Level 1 term in WHO-Drug—for each coded term, associated with the correct RDCI (collected CRF).

You can install TMS and Oracle Clinical on the same application tier or on different application tiers. You must install both products on the same database if you want integrate the two systems. Oracle recommends installing Oracle Clinical before TMS.

For more information, see the Oracle Thesaurus Management System Installation Guide and the Oracle Thesaurus Management System User's Guide.

Oracle Life Sciences Data Hub

Oracle Life Sciences Data Hub (Oracle LSH) is a powerful data warehouse and transformation tool with built-in version control, data auditing, lifecycle management, and validation tools. Oracle LSH includes adapters specifically designed to load most metadata and patient data from Oracle Clinical into Oracle LSH. In Oracle LSH you can then, for example, create your own reports on study patient data, merge data from multiple trials and create reports on cross-study data, and view data using state-of-the-art visualization tools.

You can load Oracle Clinical metadata and Oracle LSH converts it to appropriate LSH objects, for example:

• Oracle LSH loads all Oracle Clinical Questions and converts them to Oracle LSH Variables.
• If a Question is associated with a Discrete Value Group (DVG) in Oracle Clinical, Oracle LSH converts the Question to a Parameter and converts its DVG values to a list of allowable values for the Parameter.
• Oracle LSH loads all Oracle Clinical Question Groups and converts them to Oracle LSH Table definitions with Columns based on the Variables corresponding to each Question in the Question Group.

Other Oracle Clinical adapters include:

• Oracle Clinical SAS and Oracle Data Extract Views—load patient data from views you create in Oracle Clinical
• Oracle Clinical Stable Interface—loads the metadata of all Oracle Clinical tables that are part of Oracle Clinical's stable interface.
• Oracle Clinical Design and Definition—loads DCMs, DCIs, Procedures, Copy Groups, and Data Extract queries and templates.
• Oracle Clinical Labs—load lab reference ranges and associated information from Oracle Clinical Labs-related tables.
• Oracle Clinical Randomization—loads real or dummy treatment pattern information for Oracle Clinical studies.
• Oracle Clinical Study Data—loads study-specific non-patient data into LSH, including discrepancies, data clarification forms, patient status information, and page tracking information.

In addition, other non-Oracle Clinical-specific adapters allow you to load data from any Oracle table or view, text file, SAS data set, or SAS CPORT or XPORT file.

SAS

Oracle Clinical supports integration with the statistical software application SAS 9.4 for data extract.

Custom Applications for Oracle Clinical

You can build custom applications for Oracle Clinical:

• See the Oracle Clinical Stable Interface Technical Reference Manual for proprietary information about data access, internal tables, and APIs. The Oracle Clinical Stable Interface provides access to data and a smooth transition between Oracle Clinical versions. Contact Oracle Health Sciences Support to obtain a free electronic copy of the manual. You must be a licensed customer.
• See the Oracle Clinical Application Programming Interface Guide for information about using Oracle Clinical's Data Capture API.