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Oracle® Health Sciences Mobile Clinical Research Associate Server User's Guide
Release 1.3

E38751-04
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Glossary

Alert

Alert is the actual definition of the decision rule and the notification.

Badge Icon

The icon representing the Oracle Health Sciences Mobile CRA application on the mobile device can be modified to include a badge icon.

Badge Number

The badge can display a numeric character to indicate the number of unviewed notifications on the Mobile server.

Clinical Data

Data pertaining to the medical characteristics or status of a patient or subject.

Clinical Research Organization

A company or organization that conducts all or part of a clinical trial under contract to a Clinical Trial sponsor.

Clinical Research Team Leader

Typically is an experienced CRA that manages a team of CRAs. The Clinical Research Team Leader is primarily responsible for conducting a trial, managing the Trial CRA team, checking over budgeting and compliance.

Clinical Study

See Clinical Trial.

Clinical Trial

Before a pharmaceutical or biotech company can initiate testing on humans, it must conduct extensive pre-clinical or laboratory research. This research typically involves years of experiments on animal and human cells. The compounds are also extensively tested on animals. If this stage of testing is successful, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug on humans. This is called an Investigational New Drug application (IND). A clinical trial is a carefully designed investigation of the effects of drug, medical treatment, or device on a group of patients (also called Subjects).

CRA

Clinical Research Associate. An employee of the Sponsor, responsible for getting a site prepared to conduct a trial and getting cleaned data back from the site to the Sponsor.

Google Notification Service

The Google Notification Service will send brief messages to a mobile device. For the purposes of this application, the notification service will inform the user that a notification has been received.

Sponsor

The organization funding the clinical trial. This is typically the Pharmaceutical company whose product is being tested with the clinical trial.