About the OutcomeLogix application

The OutcomeLogix application is an application for late-phase, post-marketing, and observational studies. The OutcomeLogix application is accessed through an internet browser. Users, such as patients, study sponsors, and site investigators, enter study-specific data into electronic forms. The data is saved in an Oracle database and is available for data monitoring, reporting, and exporting from the OutcomeLogix application. The OutcomeLogix features described below provide flexibility, reliability, and scalability, and comply with regulatory requirements such as documenting changes through audit trails.

OutcomeLogix features

Feature	Description
Audit trail	Creates a secure record specifying the user name, the date and time of the action, and the reason for change for all types of data that are entered, modified, and deleted.
Call Center	Enables sponsors to follow up with patients who have missed a data entry window or who require assistance in providing patient-reported data.
Configuration of study attributes	Provides a user interface for configuring studies; for example, changing how long a user account remains locked before it is automatically unlocked.
Custom Homepage	Provides an alternative to the Dashboard as the Homepage. Creation of a custom Homepage is performed outside of the OutcomeLogix application.
Data extract	Extracts a defined set of clinical data, based on the study design, for analysis. Sponsors can analyze and integrate data from the application into other systems in their own environment. Extracted data can be delivered as Oracle DMP files, Oracle Data Pump format, comma-delimited ASCII (CSV) files, SAS datasets, SAS CPORT files, or SAS XPORT files. The Oracle Data Pump format is the database extract format using the Oracle Data Pump Export utility that was introduced in Oracle Database 10g.
Database-driven forms	Stores forms in an Oracle database, making customization, maintenance, and reuse easy.
EDC and ePRO forms	Collects data entered at sites or by patients or other parties through the OutcomeLogix application. Permits a combination of Electronic Data Capture (EDC) and Electronic Patient-Reported Outcome (ePRO) forms.
Multilingual functionality	Presents the OutcomeLogix application user interface in multiple languages. Help Desk assistance is also multilingual.
Patient transfer	Transfers a patient and the patient record and forms from an originating site to a destination site.
Reporting	Provides a set of standard operational reports and allows users to create and save ad hoc reports using operational and clinical data.
Security	Keeps Personal/Protected Health Information and study data secure.

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