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Release Content Document (RCD)
Release 7.0
E23217-01
May 2011
CONTENTS:
This Release Content Document (RCD) describes product features that are proposed for the specified release of the Oracle Argus Insight. This document describes new or changed functionality only. Existing functionality from prior point releases is not described. It is intended solely to help you assess the business benefits of upgrading to Release 7.0.
This document in any form, software or printed matter, contains proprietary information that is the exclusive property of Oracle. Your access to and use of this confidential material is subject to the terms and conditions of your Oracle Software License and Service Agreement, which has been executed and with which you agree to comply. This document and information contained herein may not be disclosed, copied, reproduced or distributed to anyone outside Oracle without prior written consent of Oracle. This document is not part of your license agreement nor can it be incorporated into any contractual agreement with Oracle or its subsidiaries or affiliates.
This document is for informational purposes only and is intended solely to assist you in planning for the implementation and upgrade of the product features described. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described in this document remains at the sole discretion of Oracle.
The Release Content Document (RCD), produced as part of Oracle's Applications Product Lifecycle (APL), communicates information about new or changed functionality in the specified release of Oracle Argus Insight. Existing functionality from prior point releases is not described. However, content introduced by Family Packs, Mini-Packs or Standalone patches since the prior point release has been included in this document and denoted accordingly.
Oracle Argus Insight 7.0
Contract Research Organizations (CROs) may offer a range of global safety and pharmacovigilance services which span from limited case management activities to full clinical trial and post-marketing services and anything in between.
Multi-tenancy support increases a CRO's ability to increase its profit margin. Multi-tenancy users are able to reduce from many databases to a single database. This enables them to reduce the amount of hardware needed for an implementation, reduce the number of patches and dictionary upgrades periodically performed, and subsequently reduce the resource requirements to support the implementation. They can leverage standard configurations such as code lists, workflow steps, and centralized user and enterprise setup.
Following are the features that are new with the release of Oracle Argus Insight 7.0.
The option of segregating data by enterprise profiles allows the user to maintain the data set in one database but protected between different enterprises based on the security permissions defined for each user.
The identifier for the partitioned data set is displayed when a user is viewing or processing queries, case series and reports.
Users are able to create or access queries, case series and reports for one enterprise at a time. However some users may have been configured with permission to access multiple enterprises. Such users are able to switch from one enterprise to another without the need to log off from the application.
When processing data for an enterprise, a CRO user requires that the enterprise's data and configuration be partitioned from other enterprises. Partitioning of data and the additional interfaces that support accessing separate enterprises are only available in the multi-tenancy deployment and not impact single-tenant implementations.
An "enterprise" is the highest level for which data is isolated. An enterprise can include one or more studies/programs, one or more products, one configuration, and one set of user permissions such as access to unblinded data. Each enterprise may have one or more dictionaries (i.e. dictionary by study).
To correctly set up a new enterprise, several sequential steps must be completed. The system administrator is able to quickly establish a new enterprise in the database, based upon selecting from standard libraries or by copying from an existing setup. Enterprise-specific adjustments can be to be made during the initial setup, or alternatively at some later time when enterprise-specific configurations are clearly identified.
Enable the administrator to copy an existing enterprise configuration. Some enterprise-specific data is not included in a copy, including products, actual study information and license information.
The wizard is launched from Argus Safety rather than Argus Insight, so that enterprise configuration is centralized in one place within the Argus suite.
The setup of an enterprise may need to be change. New studies or post-marketing services may be added or completed in an existing enterprise; therefore the configuration may need to be modified.
When an administrator modifies an enterprise setup, that enterprise's existing options must be clearly presented to the administrator. The ability to modify enterprise configurations is controlled by user permissions.
A large CRO houses data for hundreds of clinical trials at a given time and can be the constant target of computer attacks. Since part of the safety application is exposed outside of the CRO, the application must be able to defend itself from hacking. Types of potential attacks include but are not limited to cross-site scripting, SQL injection, cross-site request forgery, and parameter tampering.
| Term | Definition |
|---|---|
| CRO | Contract Research Organization |
| Enterprise | A tenant; the highest level at which data is partitioned in a multi-tenant environment |
| Study | Studies (or protocols) to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people |
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Oracle Argus Insight, Release Content Document (RCD), Release 7.0
E23217-01
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