1 Introduction

This chapter contains the following topics:

• Section 1.1, "Overview"

• Section 1.2, "What Can I Do Using Oracle Health Sciences Mobile Clinical Research Associate?"

1.1 Overview

The Mobile CRA mobile application supports the clinical research associate (CRA) in conducting and monitoring site visits. It provides the CRA with alerts or notifications sent to the mobile device, location capture vis-a-vis the sites, the ability to view the status of a site-at-a-glance, and access the trip report.

The theme of Mobile CRA is to consolidate the CRA's view of the trial, collecting data from clinical data management systems, clinical trial management systems, drug supply systems, randomization systems and other systems, through an open API or Web services model.

The current version of the system has been designed to interact with Oracle Health Sciences Clinical Data Analytics (CDA), Siebel Clinical Trial Management System (CTMS), and third party systems for receiving KPIs and alerts with subscriptions.

1.2 What Can I Do Using Oracle Health Sciences Mobile Clinical Research Associate?

During site visits within any clinical trial, the CRA has to track any number of important attributes of the study or of a study site. Events such as patient enrollment, study drug supplies running low, or a high percentage of screen failures at the site maybe of interest to the CRA as they monitor sites.

CRAs typically do not have easy access to high performance internet connections as they travel from site to site. Having key site events delivered to their mobile device will relieve the CRA from having to log on to a study analytic tool such as Oracle Health Sciences Trail Center or CDA.

Following are the main features of Mobile CRA:

• Trip Report Checklist Completion - You can create a trip report in CTMS, download it to the mobile device, enter data for the trip report items, and upload the results to CTMS. Once uploaded, the trip report can be submitted to the CTMS approval workflow

• Alerts and Notifications - You can subscribe and receive alerts and notifications about various attributes, tracking progress of the study and sites. The alerts can be from OCDA and/or any 3rd party external sources.

• Adaptive Site-at-a-Glance (SAAG) - You can view the site performance information in terms of various Key Performance Indicators (KPIs) arranged in multiple configurable pages, view key site contacts, and entry points to other features like trip reports, alerts, subscriptions, and so on.

• CTMS Contacts Integration - Mobile CRA pulls out the contact details for each site from the CTMS. These can be used to store on the native device and then making calls as well.

• Geolocation Services - The CRA may indicate that they have arrived at the site by capturing their Geolocation.

Table 1-1 Mobile CRA Features

Feature	Android Tablet or Phablet	Android Smartphone
Alerts and Notifications	X	X
CTMS Contacts integration	X	X
Site Check-in	X	X
Reconcile Checkins		X
Site at a Glance	X
Trip Reports	X