Overview

Oracle Clinical interfaces with your company's applications in the areas of study planning, investigator management, and drug supply. The interface provides tables and modules that support basic requirements in these areas. You can use these Oracle Clinical tables and modules at your site, or you can replace them with tables and modules from your system. Oracle Clinical provides the means for validating responses using your company's own thesaurus system.

The Oracle Clinical tables and modules that are part of the Interface Configuration interface with external applications. The table names begin with OCL_. You can use these Oracle Clinical tables and modules at your own sites; alternatively, you can choose the following methods for your interface:

• Synonyms to customer tables
• Views on customer tables
• Batch/parallel maintenance of the OCL_ tables from customer applications

Mapping can be limited to the tables and columns required by the core Oracle Clinical functionality and does not have to reproduce exactly the Oracle Clinical version of these tables, described in Table Details.

Note:

If you customized the interface then do not maintain these tables with Oracle Clinical functions.

Pay particular attention to performance when you test your modifications. This observation has special importance when views have contributed to the mapping, because they can seriously affect performance. Also, the underlying structure and indexing of the customer application may not be tuned to meet Oracle Clinical access requirements.

The following sections describe the layout and content of each Oracle Clinical table and the required components that a customized interface supports.

• Study Planning
  
• Drug Supply
  
• Investigator Management
  
• Thesaurus
  

Study Planning

Study planning is the process of controlling and managing all studies within a company and across all company locations. The standard procedure is to define studies only at the company location where they are to be conducted or analyzed. Study planning also contains information about studies that are to be run by outside organizations, such as CROs, as well as details of possible future studies.

Oracle Clinical requires that study planning provide:

• A two-tier hierarchy of studies to which users can be assigned as an alternative to maintaining security by individual user assignments to studies
• A list of studies that are approved for definition in Oracle Clinical

Table 3-1 Study Planning Tables

Table	Description
OCL_STUDIES	Master list of all studies
OCL_STUDY_REGIONS	List of regions where each study is to be conducted
OCL_ORGANIZATION_UNITS	List of company departments that can support studies
OCL_PROGRAMS	Upper tier where studies can be grouped and security managed
OCL_PROJECTS	Lower tier where studies can be grouped and security managed
OCL_PROGRAM_PRODUCT_MASTERS	List of the compounds for which each program is responsible

Drug Supply

A drug supply system interacts with Oracle Clinical in two ways:

• At the front end of the clinical process, the drug supply system provides a list of drugs formulated for a clinical study.
• At the back end of the process, the drug supply system takes the randomization generated in the design subsystem of Oracle Clinical and produces from it the packaged and labeled supplies for the study.

Table 3-2 Drug Supply Tables

Table	Description
OCL_DOSAGE_FORMS	Look-up list of dosage forms
OCL_PRODUCT_MASTERS	List of active substances (raw chemicals) and formulated products (medications) that a clinical study can use

Investigator Management

An investigator management system is responsible for maintaining a list of the investigators who can work on studies and the records of their assignments to studies.

Table 3-3 Investigator Management Tables

Table	Description
OCL_INVESTIGATORS	List of potential and actual investigators who can work on studies
OCL_SITES	List of locations where a clinical study can be conducted
OCL_STUDY_SITES	List of the assignments of sites to a particular clinical study
OCL_STUDY_SITE_ROLES	List of which investigators have been or are responsible for each study site

Thesaurus

The thesaurus, or dictionary, is used to validate responses to questions marked as requiring thesaurus validation. There are two types of dictionaries: Drug Names and Adverse Events.