Oracle® Health Sciences Network

User's Guide

Release 2.0.0.0

E35514-02

September 2015

Oracle Health Sciences Network User’s Guide, Release 2.0.0.0

E35514-02

Copyright © 2013, 2015, Oracle and/or its affiliates. All rights reserved.

This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited.

The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing.

If this is software or related documentation that is delivered to the U.S. Government or anyone licensing it on behalf of the U.S. Government, the following notice is applicable:

U.S. GOVERNMENT END USERS: Oracle programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, delivered to U.S. Government end users are "commercial computer software" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, use, duplication, disclosure, modification, and adaptation of the programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, shall be subject to license terms and license restrictions applicable to the programs. No other rights are granted to the U.S. Government.

This software or hardware is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications that may create a risk of personal injury. If you use this software or hardware in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software or hardware in dangerous applications.

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registered trademark of The Open Group.

This software or hardware and documentation may provide access to or information about content, products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content, products, and services unless otherwise set forth in an applicable agreement between you and Oracle. Oracle Corporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of third-party content, products, or services, except as set forth in an applicable agreement between you and Oracle.

Contents

List of Figures

List of Tables

Preface

- Audience

- Documentation Accessibility

- Finding Information and Patches on My Oracle Support

- Finding Documentation on Oracle Technology Network

- Related Documents

- Conventions

1 Introduction

- 1.1 Overview

- 1.2 What's New

- 1.3 What Can I Do Using Oracle Health Sciences Network?

2 Accessing the Oracle Health Sciences Network

- 2.1 Logging into Oracle Health Sciences Network

- 2.2 Oracle Health Sciences Network Sponsor Home Page

- 2.2.1 Home Page

- 2.3 Oracle Health Sciences Network Provider Home Page

- 2.4 Logging out of Oracle Health Sciences Network

3 Working with Protocols (Sponsor)

- 3.1 Protocol Characteristics

- 3.2 Protocol Status

- 3.3 Creating a New Protocol

- 3.4 Editing an Existing Protocol

- 3.5 Managing Protocol Team Members

- 3.5.1 Adding Team Members

- 3.5.2 Removing Team Members

- 3.6 Defining Eligibility Criteria

- 3.6.1 Editing Existing Eligibility Criteria

- 3.6.2 Local Codes in Criteria Editor

- 3.6.3 Omics in Criteria Editor

- 3.7 Executing Eligibility Criteria

- 3.7.1 Validating from the Criteria Editor

- 3.7.2 Executing Criteria from the Analysis Panel

- 3.7.3 Cancelling the Query Request

- 3.8 Designating Protocol as Recruitment Ready

- 3.9 Creating Recruitment Request

- 3.10 Initiating Recruitment

- 3.11 Viewing Recruitment Results

- 3.12 Stopping Recruitment

- 3.13 Closing a Protocol

- 3.14 Deleting a Protocol

4 Working with Protocols (Provider)

- 4.1 Accepting a Recruitment Request for Qualification

- 4.1.1 Recruitment Status Panel

- 4.2 Viewing Patient Information

- 4.3 Marking a Patient as Qualified

- 4.4 Accepting a Protocol for Enrollment

- 4.5 Enrolling Candidates

- 4.6 Releasing Candidates

Glossary

Index

List of Figures

- 2-1 Oracle Health Sciences Network Login Page

- 2-2 Sponsor Home Page

- 2-3 Sponsor Home Page

- 2-4 Home Page Header

- 2-5 Administrator Home Page

- 2-6 Home Page

- 2-7 Provider Home Page

- 2-8 Logout

- 3-1 Create Protocol

- 3-2 Protocol Details

- 3-3 New Protocol

- 3-4 Edit Protocol Attributes

- 3-5 Edit Protocol Details

- 3-6 Protocol Details

- 3-7 Select Team

- 3-8 Protocol Details

- 3-9 Edit Team Members

- 3-10 Create Criteria

- 3-11 Select Criteria

- 3-12 Criteria Set Added

- 3-13 Criteria Set Added

- 3-14 Criteria Action Bar

- 3-15 Edited Criteria Set

- 3-16 Select Dimension with Local Code

- 3-17 Select Operator

- 3-18 Select Local Code Value

- 3-19 Select Multiple Values

- 3-20 Submit Criteria

- 3-21 Select Dimension

- 3-22 Select Operator

- 3-23 Select Value

- 3-24 Submit Criteria

- 3-25 Start Validation

- 3-26 Validation Results

- 3-27 Criteria Analysis

- 3-28 Analysis Results

- 3-29 Protocol Details

- 3-30 Analysis Results

- 3-31 Criteria Analysis

- 3-32 Analysis Requests Cancelled

- 3-33 Sharing Protocol

- 3-34 Ready to Share

- 3-35 Ready to Share

- 3-36 Shared for Qualification

- 3-37 Protocol Details

- 3-38 Initiate Enrollment

- 3-39 Enrollment Initiated

- 3-40 Recruitment Results by Partner

- 3-41 Refresh Patient Count

- 3-42 Refreshed Results

- 3-43 Recruiting Done

- 3-44 Recruitment Done

- 3-45 Close Protocol

- 3-46 Status Closed

- 3-47 Open Protocol

- 3-48 Delete Protocol

- 4-1 Provider Home Page

- 4-2 Protocol Details

- 4-3 Accept for Qualification

- 4-4 Accepted for Qualification

- 4-5 Recruitment Status Panel

- 4-6 Patient Information

- 4-7 Patient Details

- 4-8 Patient Information

- 4-9 Patient Details

- 4-10 Mark as Qualified

- 4-11 Excluded or Favorites

- 4-12 Accept for Enrollment

- 4-13 Patients

- 4-14 Enroll Patient

- 4-15 Enrolled Status

- 4-16 Patient Details

- 4-17 Reset Status

- 4-18 Changed Status

- 4-19 Dropped Patient

List of Tables

- 1-1 PVPR Functions

- 3-1 Protocol Characteristics

- 3-2 Status Values for a Protocol and a Patient

Preface

This guide provides information about how to use Oracle Health Sciences Network (HSN) application.

This preface contains the following topics:

- Audience

- Documentation Accessibility

- Finding Information and Patches on My Oracle Support

- Finding Documentation on Oracle Technology Network

- Related Documents

- Conventions

Audience

This guide is intended for:

- Healthcare providers

- Academic medical centers

- Pharmaceutical companies

- Biotech companies

Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Access to Oracle Support

Oracle customers that have purchased support have access to electronic support through My Oracle Support. For information, visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

Finding Information and Patches on My Oracle Support

Your source for the latest information about Oracle Health Sciences Network is Oracle Support's self-service Web site, My Oracle Support (formerly MetaLink).

Before you install and use an Oracle software release, always visit the My Oracle Support Web site for the latest information, including alerts, release notes, documentation, and patches.

Creating a My Oracle Support Account

You must register at My Oracle Support to obtain a user name and password account before you can enter the Web site.

To register for My Oracle Support:

1. Open a Web browser to http://support.oracle.com.

2. Click the Register here link to create a My Oracle Support account. The registration page opens.

3. Follow the instructions on the registration page.

Signing In to My Oracle Support

To sign in to My Oracle Support:

1. Open a Web browser to http://support.oracle.com.

2. Click Sign In.

3. Enter your user name and password.

4. Click Go to open the My Oracle Support home page.

Searching for Knowledge Articles by ID Number or Text String

The fastest way to search for product documentation, release notes, and white papers is by the article ID number.

To search by the article ID number:

1. Sign in to My Oracle Support at http://support.oracle.com.

2. Locate the Search box in the upper right corner of the My Oracle Support page.

3. Click the sources icon to the left of the search box, and then select Article ID from the list.

4. Enter the article ID number in the text box.

5. Click the magnifying glass icon to the right of the search box (or press the Enter key) to execute your search.
The Knowledge page displays the results of your search. If the article is found, click the link to view the abstract, text, attachments, and related products.

In addition to searching by article ID, you can use the following My Oracle Support tools to browse and search the knowledge base:

- Product Focus — On the Knowledge page, you can drill into a product area through the Browse Knowledge menu on the left side of the page. In the Browse any Product, By Name field, type in part of the product name, and then select the product from the list. Alternatively, you can click the arrow icon to view the complete list of Oracle products and then select your product. This option lets you focus your browsing and searching on a specific product or set of products.

- Refine Search — Once you have results from a search, use the Refine Search options on the right side of the Knowledge page to narrow your search and make the results more relevant.

- Advanced Search — You can specify one or more search criteria, such as source, exact phrase, and related product, to find knowledge articles and documentation.

Finding Patches on My Oracle Support

Be sure to check My Oracle Support for the latest patches, if any, for your product. You can search for patches by patch ID or number, or by product or family.

To locate and download a patch:

1. Sign in to My Oracle Support at http://support.oracle.com.

2. Click the Patches & Updates tab.
The Patches & Updates page opens and displays the Patch Search region. You have the following options:

- In the Patch ID or Number is field, enter the primary bug number of the patch you want. This option is useful if you already know the patch number.

- To find a patch by product name, release, and platform, click the Product or Family link to enter one or more search criteria.

3. Click Search to execute your query. The Patch Search Results page opens.

4. Click the patch ID number. The system displays details about the patch. In addition, you can view the Read Me file before downloading the patch.

5. Click Download. Follow the instructions on the screen to download, save, and install the patch files.

Finding Documentation on Oracle Technology Network

The Oracle Technology Network Web site contains links to all Oracle user and reference documentation. To find user documentation for Oracle products:

1. Go to the Oracle Technology Network at
http://www.oracle.com/technetwork/index.html and log in.

2. Mouse over the Support tab, then click the Documentation hyperlink.
Alternatively, go to Oracle Documentation page at

http://www.oracle.com/technology/documentation/index.html

3. Navigate to the product you need and click the link.
For example, scroll down to the Applications section and click Oracle Health Sciences Applications.

4. Click the link for the documentation you need.

Related Documents

The Oracle Health Sciences Network documentation contains:

- Oracle® Health Sciences Network Release Notes

- Oracle® Health Sciences Network Installation Guide

- Oracle® Health Sciences Network User's Guide

- Oracle® Health Sciences Network Administrator's Guide

- Oracle® Health Sciences Network Security Guide

Conventions

The following text conventions are used in this document:

Convention

Meaning

boldface

Boldface type indicates graphical user interface elements associated with an action, or terms defined in text or the glossary.

italic

Italic type indicates book titles, emphasis, or placeholder variables for which you supply particular values.

monospace

Monospace type indicates commands within a paragraph, URLs, code in examples, text that appears on the screen, or text that you enter.

1 Introduction

This chapter contains the following topics:

- Overview

- What's New

- What Can I Do Using Oracle Health Sciences Network?

1.1 Overview

Oracle Health Sciences Network (HSN) is a new SaaS services offering for both healthcare provider and pharmaceutical customer organizations. It brings together multiple customer organizations under a single cloud based, Oracle hosted, business network, thus allowing them to exchange information and (or) business services using HSN applications such as Protocol Validator and Patient Recruiter (PVPR).

Each organization participating in HSN can either offer or consume both information (such as finding cohorts to recruit into study) or business process services (such as identifying, reserving and recruiting patients into a clinical trial) to other network participants.

Any organization offering any service in HSN is typically referred to as a provider organization in HSN. Similarly, an organization may not necessarily provide these services in the network, but rather simply may avail services provided by other organizations. So any organization consuming one or more services from another organization in HSN is referred to as a sponsor (or consumer) organizations in HSN. In certain cases, a single organization may act as both a consumer and provider of HSN services simultaneously.

Oracle Health Sciences Network comprises of the following 3 services:

- Data Management Cloud Service (DM): Lets customers, for example, hospitals and Academic Medical Centers (AMC), load clinical data into HSN. They have administrative and user management privileges to grant access to third party institutions within the network for protocol validation and patient recruitment activities using their data.

- Protocol Validator Cloud Service (PV): Lets customers, for example, pharma, medical device, AMCs, perform modeling, feasibility, and validation of their clinical study protocols leveraging data from third party DM customers in the network.

- Patient Recruiter Cloud Service (PR): Lets existing PV customers, for example, Pharma, AMCs, share their validated protocols with the respective third party DM customer to initiate real time, patient recruitment activities.

1.2 What's New

In release 2.0.1, each protocol is created for a single provider only and run against that provider for validation, analysis and recruiting. You can now create one protocol per partner, selecting the partner while creating the protocol. There is no need for a network count query, which requires the ability to run the same criteria query against multiple providers. You do not have to select a provider for validation, analysis or recruitment actions. Also, there is no step to initiate validation—each protocol begins in Validation.

To support criteria finding genes and mutations, an omics lite feature is included as a top level criteria in inclusion and exclusion. A sponsor using a protocol for a partner that supports and offers omics service, can select one or more genes or mutations to add to the top level of inclusion or exclusion criteria. A sponsor can view gene and mutation criteria in the criteria editor, and analysis (if offered by provider). Providers can also configure relationships to offer omics services to selected sponsors as a service. However, providers cannot set maximum protocols or data restriction.

1.3 What Can I Do Using Oracle Health Sciences Network?

PVPR application services lets users define, save and share protocols to identify cohorts of patients that match a protocol's criteria. It provides workflow features, to help users review the feasibility of protocol definitions as well as validate discreetly identify qualified patients appropriate for study recruitment. An organization using HSN may request and receive information from one or more other organizations participating in the network.

- The HSN platform establishes a scalable framework that supports multiple participant organizations and service relationships providing significant value by eliminating the current constraint of distinct dedicated data environments.

- Introduces more flexible opportunities for collaboration and revenue because the platform will support the definition of discreet usage agreements. For example, along with unlimited data access, a participant organization can contract to participate based on a number of protocols, or querying a specific therapeutic area, meaning a diagnostic grouping like Oncology related data.

- A protocol is not restricted to a specific owner, but can have multiple users from the same partner working on it as a team (that is, to support peer review or internal approval processes before sharing the definition for recruitment.

- Ability for the protocol team to query patients across one or more DM Partners, and also share the approved protocol with one or more Data Management (DM) Partners for recruitment.

- Ability for DM Partner users to review the protocol's list of candidates (matched patients) and subsequently refine who qualifies and is appropriate to enroll in the study.

Following are the activities that can be performed using HSN PVPR:

Table 1-1 PVPR Functions

Service

Business Process

Sponsor

DM Partner

Protocol Validator (PV)

- Create and define a protocol and its eligibility criteria.

- Query the network to view matching cohort counts (gauge feasibility of the protocol).

- Refine protocol Criteria to make it feasible.

- Send the protocol to one or more partners as a request for recruitment.

- Create and Define a Protocol

- Edit a Protocol

- Delete a Protocol

- Gauge feasibility of the Protocol (execute queries and view counts)

Registered to make validation requests

Registered to provide validation responses

Patient Recruiter (PR)

- View Recruitment Requests (protocol details and matched patient information in order to validate and enroll patients in a study.

- Update patient status (for example, qualified, enrolled, excluded), based on review of patient data and protocol definition.

- Monitor progress towards target recruitment counts.

- Initiate and stop recruitment activities.

- Monitor Recruitment Requests

- Accept Recruitment Requests

- Identify and Qualify Patients

- Identify Patients for Enrollment into Trial

- Monitor Protocol Recruitment Status and Progress over Time

- Stop or Cancel Recruitment

Registered to make recruiting requests (share protocols for recruitment)

Registered to receive and act on recruitment requests

2 Accessing the Oracle Health Sciences Network

This chapter contains the following topics:

- Logging into Oracle Health Sciences Network

- Oracle Health Sciences Network Sponsor Home Page

- Logging out of Oracle Health Sciences Network

2.1 Logging into Oracle Health Sciences Network

Perform the following steps to log into the Oracle Health Sciences Network:

1. Open your browser and enter the URL provided by your company.

Figure 2-1 Oracle Health Sciences Network Login Page

2. Enter your user ID and password.

3. Click Log in. After your login credentials are authenticated, the default home page is displayed.

Figure 2-2 Sponsor Home Page

2.2 Oracle Health Sciences Network Sponsor Home Page

Figure 2-3 shows the default company home page of a sponsor.

Figure 2-3 Sponsor Home Page

It contains the following elements:

- Header - Includes features to sign out.

Figure 2-4 Home Page Header

- Navigation Bar includes the following features:

- Home - navigates to company home page and displays a list of protocols. This is the default home page when you log into HSN.

- Admin - navigates to administrator home page. For more details, see the Oracle® Health Sciences Network Administrator's Guide.

Figure 2-5 Administrator Home Page

2.2.1 Home Page

Following is the default company home page:

Figure 2-6 Home Page

It comprises of the following panels:

Note:
Based on your user permissions, the system provides an organization-specific view, displaying the available information and functions that are appropriate only for your organization.

- My Protocols- displays all protocols owned by sponsor where the user is member of team. Provides key information about a particular protocol, including name, status, date it was created and recruitment status. Clicking a protocol number displays its details.

2.3 Oracle Health Sciences Network Provider Home Page

Figure 2-7 shows the home page of a provider.

Figure 2-7 Provider Home Page

It comprises of the following:

- Shared Protocols - List of protocols shared by sponsor companies for recruiting. Displays protocol number and owner (that is, the sponsor), status, and the date it was shared on.

2.4 Logging out of Oracle Health Sciences Network

Perform the following steps to log out of Oracle Health Sciences Network:

1. Click Sign out on the top right hand corner of the screen.

Figure 2-8 Logout

2. You will be logged out of HSN and the login page is displayed.

3 Working with Protocols (Sponsor)

This chapter contains the following topics:

- Protocol Characteristics

- Protocol Status

- Creating a New Protocol

- Editing an Existing Protocol

- Managing Protocol Team Members

- Defining Eligibility Criteria

- Executing Eligibility Criteria

- Designating Protocol as Recruitment Ready

- Creating Recruitment Request

- Initiating Recruitment

- Viewing Recruitment Results

- Stopping Recruitment

- Closing a Protocol

- Deleting a Protocol

3.1 Protocol Characteristics

Following are the characteristics of a protocol:

Table 3-1 Protocol Characteristics

Attribute

Description

Title

The protocol title. This is unique within a company.

Purpose

Brief summary on the goals, objective or purpose of the study.

Description

Detailed information on the study (goals, methodology, key details).

Contact Information

Information for the person(s) to contact regarding the study.

Population Summary

Summary note about the protocol population to be recruited.

Recruitment Notes

Inclusion or exclusion narrative that cannot be structured with the criteria builder.

Protocol Number

Sponsor's unique study ID.

Phase

Most clinical trials are designated as phase I, II, III, or IV, based on the type of questions that study is seeking to answer.

NCT # (CT.gov Id)

The national identifier for the study (from the national clinical trials registry).

Target Population

Eligibility instructions that may not be structured in the criteria (to assist Partners with recruitment nuances).

Target Recruitment Start Date

Target date for starting the recruitment process for the actual study.

Target Recruitment End Date

Target date for completing the recruitment for the actual study.

Accept Healthy Volunteers?

Indicates whether or not healthy volunteers can be accepted into the study.

3.2 Protocol Status

Each Protocol has a status, which contributes to determining the functions available. As you progress through the business processes, the protocol status changes. The following table identifies the range of status values for a protocol and a patient, across the protocol life cycle:

Table 3-2 Status Values for a Protocol and a Patient

Business Process

Protocol Status

Create New Protocol

New

Execute Protocol Criteria

Feasibility

Feasibility Complete

Recruitment Ready

Delete Protocol

Deleted

Shared for Recruitment

Validating

Initiate Recruitment

Recruiting

Stop Recruitment

Done

3.3 Creating a New Protocol

Perform the following steps to create a new protocol:

1. In the My Protocols panel of the company home page, click Create Protocol. The Create Protocol screen is displayed.

Figure 3-1 Create Protocol

2. The Create Protocol screen includes the following fields and tabs:

- Partner

- Protocol Number

- Phase

- (nct)Number

- Target Population

- Target Recruitment Start Date

- Target Recruitment End Date

- Title

- Purpose

- Description

- Contact Information

- Population Summary

- Recruitment Notes

- Accept Healthy volunteers?

Note:
Fields marked with * are mandatory.

Figure 3-2 Protocol Details

3. Click Create.

4. The protocol details are displayed and the home page is updated with the new protocol. This protocol will have a default status Validation.

Note:
By default, the user who created the protocol is added to team as LEAD.

Figure 3-3 New Protocol

3.4 Editing an Existing Protocol

Perform the following steps to edit a protocol:

1. In the My Protocols panel of the company home page, click the protocol you want to edit. The protocol details are displayed.

2. In the Protocol Details panel, click Actions > Edit Protocol.

Figure 3-4 Edit Protocol Attributes

3. The protocol details are displayed.

Figure 3-5 Edit Protocol Details

4. You can add data to attributes previously null, delete or revise data from attributes previously populated. After editing the relevant details, click Update.

5. The new protocol with edited details will be displayed.

Note:
Multiple users cannot edit the same protocol at the same time.

3.5 Managing Protocol Team Members

Depending on your role, you can designate additional users from the same organization as team members, providing access to the same protocol. Protocol Team members can:

- view the protocol and eligibility criteria definitions

- edit the protocol

- execute the eligibility criteria to view counts of patients

- edit the protocol's eligibility criteria

3.5.1 Adding Team Members

Perform the following steps to manage protocol team members:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

Figure 3-6 Protocol Details

2. In the Team panel, click Manage. The following screen is displayed, with users currently assigned to that protocol. Initially, only the user who created the protocol will be displayed.

Note:
By default, the user who created the protocol is the lead. You can change this in the following screen.

Figure 3-7 Select Team

3. You can add (assign) one or more other users to the protocol team and also select their roles. You can search for users based on the user login name.

4. Click Save to confirm your changes. The system updates protocol and displays each team member's name and role as part of the protocol's summary.

3.5.2 Removing Team Members

Perform the following steps to remove team members:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

Figure 3-8 Protocol Details

2. In the Team panel, click Manage. The following screen is displayed, with users currently assigned to that protocol.

Figure 3-9 Edit Team Members

3. Select the Delete check box for users you want to remove.

4. Click Save to confirm your changes. The system updates protocol and displays each team member's name and role as part of the protocol's summary.

3.6 Defining Eligibility Criteria

You can define inclusion or exclusion statements as a logical definition of the patients to be searched (matched) for the protocol.

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

Figure 3-10 Create Criteria

3. In the New Criterion panel, enter your criteria. You can do this either by typing into the text box or selecting criteria from the pop up list.

Figure 3-11 Select Criteria

Note:
All dimensions populated are provider-specific. The list displays only those values supported by the specific provider.

4. Click Submit or press Ctrl+Enter on your keyboard. The criteria is updated in the Criteria Set panel as shown below.

Figure 3-12 Criteria Set Added

3.6.1 Editing Existing Eligibility Criteria

Perform the following steps to edit the existing set of eligibility criteria:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

Figure 3-13 Criteria Set Added

3. You can now:

- add to the existing eligibility criteria

- select a previously defined criterion and either edit or delete it

- edit (change) how the selected criteria are grouped (revise the AND,OR groupings)

Use the criteria action bar (Figure 3-14) to work on selected criterion. Buttons include (pause, resume) to ignore or permit during query, delete, edit and arrows to move selected criterion to a new position.

Figure 3-14 Criteria Action Bar

4. The criteria is updated in the Criteria Set panel as shown below.

Figure 3-15 Edited Criteria Set

3.6.2 Local Codes in Criteria Editor

You can edit criteria in the partner's local codes. You can access and select owned protocol with the role of validator or higher.

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

3. In the New Criterion panel, select a dimension such as Diagnosis to select codes.

Figure 3-16 Select Dimension with Local Code

4. Select operator such as one of. A list of codes is displayed that are local to the selected partner.

Figure 3-17 Select Operator

5. Select local code value.

Figure 3-18 Select Local Code Value

You can select multiple codes by clicking Choose Many.... The Select Many window is displayed from where you can select multiple options. Once done, click Save to save your options and return to the criteria editor.

Figure 3-19 Select Multiple Values

6. Click Submit or press Ctrl+Enter on the keyboard to add criteria.

Figure 3-20 Submit Criteria

3.6.3 Omics in Criteria Editor

For a protocol with access rights of validation or higher, the partner selected for protocol offers omics service to the sponsor.

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

3. Select Gene or Mutation.

Figure 3-21 Select Dimension

Note:
You can view these two options only if the provider offers omics.

4. The operators include is, is not or one of. Select from a common list of gene or mutation.

Figure 3-22 Select Operator

5. Select the value.

Figure 3-23 Select Value

6. Click Submit or press Ctrl+Enter on the keyboard to add criteria.

Figure 3-24 Submit Criteria

Since these criteria are visible only if the provider offers them, you cannot add gene or mutation below the top level of inclusion or exclusion, or move them into a group.

3.7 Executing Eligibility Criteria

You can submit the protocol eligibility criteria to search for matching patients from each of the selected DM Partners. Each request is executed against each DM Partner's data, distinctly and the result is displayed as a count of patients. No detailed patient information is available or accessible. The purpose of this process is to gauge the feasibility of the protocol. The protocol status accordingly changes to Feasibility. In this process, you can:

- view count for each AND and OR grouping

- view a count for each independent criterion

- refresh the current counts to view an updated summary

You can execute criteria either from the criteria editor panel or from the Analysis panel.

3.7.1 Validating from the Criteria Editor

On creating and submitting valid criteria, the start validation button is enabled. Perform the following steps to execute eligibility criteria:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Criteria on the top right.

3. In the Validation Results for Partner panel, click Start Validation.

Figure 3-25 Start Validation

4. The results are displayed for the partner. If criteria is removed, the Start Validation button is not available. After first validation, if valid criteria is entered, the Refresh Now button is displayed.

Figure 3-26 Validation Results

3.7.2 Executing Criteria from the Analysis Panel

Perform the following steps to execute eligibility criteria:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

2. Click Analysis on the top right. The Criteria Analysis screen is displayed.

Figure 3-27 Criteria Analysis

3. Click Start Analysis. The results of the analysis are displayed in the Analysis Results for Partner pane.

Figure 3-28 Analysis Results

To run the analysis again and avail up-to-date information, click Refresh Now in the Analysis pane.

3.7.3 Cancelling the Query Request

You can select one or more query requests and cancel them before they complete. Perform the following steps to cancel an analysis:

1. In the My Protocols panel of the company home page, click the protocol you wish to edit. The protocol details are displayed.

Figure 3-29 Protocol Details

2. Click Analysis on the top right. The Criteria Analysis screen is displayed.

Figure 3-30 Analysis Results

3. Click Actions > Cancel Analysis.

Figure 3-31 Criteria Analysis

4. A confirmation screen is displayed. Click Yes.

5. All analysis for that protocol will be cancelled.

Figure 3-32 Analysis Requests Cancelled

3.8 Designating Protocol as Recruitment Ready

Once the protocol team is satisfied with the protocol's definition and has performed sufficient feasibility activity, one of the team member's is expected to promote the protocol to a new status, indicating that the feasibility activity is complete. The team's organization may have an internal review (outside the team) to approve the protocol before it is submitted to an outside organization as a recruitment request.

Note:
The act of completing the feasibility is distinct from submitting the protocol as a recruitment request to a partner.

Perform the following steps to share a recruitment request:

1. Select the protocol you want to share.

2. In the Protocol Details panel, click Actions > Start Sharing.

Figure 3-33 Sharing Protocol

3. A confirmation screen is displayed. Click Yes.

4. The protocol status changes to Ready to Share and the Recruitment Status panel will have the option to start recruiting or qualifying.

Figure 3-34 Ready to Share

3.9 Creating Recruitment Request

The protocol team leader has permission to send a protocol to one or more DM Partners as a recruitment request. Once the request is created, the protocol becomes accessible (visible) to the selected partners. It is possible that the partners selected for recruitment are different from the partners selected during feasibility.

Perform the following steps to create a recruitment request:

1. Select the protocol you want to share.

2. In the Partner Status panel, click Actions > Start Qualifying.

Figure 3-35 Ready to Share

3. The partner status changes to Shared for Qualification.

Figure 3-36 Shared for Qualification

3.10 Initiating Recruitment

Once the sponsor is satisfied with the count of qualified patients, the protocol team leader can initiate recruitment. Once the sponsor updates the protocol status for one or more DM Partner(s), the partner can view the updated status of their recruitment request and move to the next step in the recruitment process.

Perform the following steps to initiate recruitment:

1. Select the protocol for which you want to initiate recruitment.

Figure 3-37 Protocol Details

2. In the Partner Status panel, click Actions > Start Enrolling.

Figure 3-38 Initiate Enrollment

3. The protocol status changes to Enrollment and partner status changes to Enrollment. Enrollment will be initiated with the DM partners.

Figure 3-39 Enrollment Initiated

3.11 Viewing Recruitment Results

The Protocol Team (Sponsor organization) can view updates to counts, from across all Partners in the Recruitment results by Partner panel. Perform the following steps to view recruitment results:

1. Select the protocol for which you want to view recruitment results.

2. The recruitment results are visible in the Recruitment results by Partner panel.

Figure 3-40 Recruitment Results by Partner

3. In the Partner Status panel, click Actions > Refresh Patient Count.

Figure 3-41 Refresh Patient Count

4. You can view the results in the Recruitment results by Partner panel.

Figure 3-42 Refreshed Results

3.12 Stopping Recruitment

Once recruitment has identified a sufficient number of Qualified or Enrolled patients, the sponsor may determine that no further recruitment activity is necessary. At this point, you can stop recruitment, for a particular DM Partner. The status is updated, and the recurring execution of the protocol's eligibility criteria is stopped.

Perform the following steps to stop recruitment:

1. Select the protocol for which you want to stop recruitment.

Note:
The protocol should have the status Enrollment.

2. In the partner status panel, click Actions > Done Recruiting.

Figure 3-43 Recruiting Done

3. The partner status changes to Recruitment Done and the protocol status changes to Stopped Sharing.

Figure 3-44 Recruitment Done

3.13 Closing a Protocol

Perform the following steps to close a protocol:

1. Select the protocol you want to close.

Note:
The protocol should have a status of either New, Feasibility, Ready to share or Stopped sharing.

2. In the Protocol details panel, click Actions > Close Protocol.

Figure 3-45 Close Protocol

3. A confirmation screen is displayed. Click Yes.

4. The protocol will be closed and its status is changed to closed.

Figure 3-46 Status Closed

To reopen a closed protocol, in the protocol details panel, click Open Protocol.

Figure 3-47 Open Protocol

3.14 Deleting a Protocol

Prior to being shared for recruitment, the sponsor may make an internal decision to discontinue the protocol. In this situation, a protocol team lead will delete the protocol, which changes the state from Active to Inactive.

Perform the following steps to delete a protocol:

1. Select the protocol you want to delete. You can only delete protocols that have not been shared.

2. In the Protocol Details panel, click Actions > Delete Protocol.

Figure 3-48 Delete Protocol

3. Click Yes to confirm your choice.

4. The protocol status will be updated to deleted and is no longer displayed in your list of available protocols.

4 Working with Protocols (Provider)

This chapter discusses how to use the Patient Recruiter for partners. It contains the following topics:

- Accepting a Recruitment Request for Qualification

- Viewing Patient Information

- Marking a Patient as Qualified

- Accepting a Protocol for Enrollment

- Enrolling Candidates

- Releasing Candidates

4.1 Accepting a Recruitment Request for Qualification

Perform the following steps to accept a recruitment request for qualification:

1. On your home page, from the Shared Protocols panel, click the protocol you want to accept.

Figure 4-1 Provider Home Page

2. Protocol details are displayed.

Figure 4-2 Protocol Details

3. Click Actions > Accept for Qualification.

Figure 4-3 Accept for Qualification

4. A confirmation screen is displayed. Click Yes.

5. The status changes to Qualification and the Recruitment Status panel is displayed.

Figure 4-4 Accepted for Qualification

4.1.1 Recruitment Status Panel

This panel displays a list of patient status and counts for each status. Initially while the patient list is being generated, the status patient results are being populated is displayed. Once populated, it displays counts for each status type of patient: All, New, Qualified, Dropped, Excluded and Enrolled.

Figure 4-5 Recruitment Status Panel

4.2 Viewing Patient Information

Once the protocol has been accepted for qualification, you can view information about each patient matched as a candidate. Recruitment leaders and recruiters can conduct more in-depth reviews of each patient, to determine whether the patient is appropriate for the protocol.

Perform the following steps to view a list of patients generated that match the criteria of the shared protocol:

1. From the Shared Protocols panel, click the protocol that you want to view patient information for.

2. Click Patients on the top right.

Figure 4-6 Patient Information

3. Click a patient to view their details.

Figure 4-7 Patient Details

Patients Matching Criteria panel to left displays filterable, sortable and searchable list of patients. Information panel to right displays details of selected patient with tabs for each type of detail including: enrollment details, demographics, diagnosis, medications, procedures, diagnostic tests, patient history and patient encounters.

You can also download a .xls list of patients by clicking Download CSV.

The Ind column displays if patient is favored (star), new (silhouette), tagged (bookmark), reserved in other (), scheduled for appointment soon (calendar), or alert if need attention (exclamation).

4.3 Marking a Patient as Qualified

Each protocol may have criteria or patient requirements that may not be specified within the eligibility criteria. The protocol's validation notes displays additional context for the recruiting process. At this point, the recruiting team can examine the patients in closer detail (chart or image lookup) to determine if they meet the requirements for the protocol.

Perform the following steps to mark a patient as qualified:

1. From the Shared Protocols panel, click the protocol that you want to view patient information for.

2. Click Patients on the top right.

Figure 4-8 Patient Information

3. Click a patient to view details.

Figure 4-9 Patient Details

4. Click Actions > Mark as Qualified in the right panel.

Note:
Although a patient is qualified, that patient remains available to be matched as a candidate in other protocols.

Figure 4-10 Mark as Qualified

Alternately, you can also mark the patient as not qualified or add as a favorite. When you Add to Favorite, the star icon will appear in the Ind column. When you Mark as not Qualified, the system will remove that patient as a candidate for that protocol, and also remove that patient from the protocol's count and patient list, as well as future execution of the protocol's eligibility criteria.

When you Reset Patient Status, the status reverts to New. When you Tag Patient, the patient is tagged for future reference.

Figure 4-11 Excluded or Favorites

4.4 Accepting a Protocol for Enrollment

Perform the following steps to accept a protocol for enrollment:

1. From the Shared Protocols panel, click the protocol that you want to recruit candidates for.

2. In the Shared Protocol Details panel, click Actions > Accept for Enrollment.

Figure 4-12 Accept for Enrollment

3. A confirmation screen is displayed. Click Yes.

Note:
The protocol status changes to Accepted for Enrollment.

4.5 Enrolling Candidates

Perform the following steps to enroll candidates for a protocol from the sponsor:

1. From the Shared Protocols panel, click the protocol that you want to recruit candidates for.

2. Click Patients on the top right to view a list of patients for this protocol.

Figure 4-13 Patients

3. Select the patient you want to enroll. Then click Actions > Enroll Patient.

Figure 4-14 Enroll Patient

4. The patient status changes to enrolled and the enrolled count on top is incremented.

Figure 4-15 Enrolled Status

4.6 Releasing Candidates

The recruiter has the ability to de-select a previously enrolled or qualified patient. Perform the following steps to release a patient:

1. From the Shared Protocols panel, click the protocol that you want to release candidates for.

2. Click Patients on the top right.

Figure 4-16 Patient Details

3. Select the patient you want to release. Then click Actions > Reset Patient Status.

Figure 4-17 Reset Status

4. The patient status changes to New.

Figure 4-18 Changed Status

You can also drop the patient from the entire process by selecting Drop Patient. In this case, the patient status changes to dropped.

Figure 4-19 Dropped Patient

Glossary

Data Management (DM) Partner

A provider organization that contributes their patient data to the HSN network. These organizations enter into relationships to provide counts of matching patients (responding to Protocol criteria) and for patient recruiting activities (that is, the Patient Recruiter service).

Eligibility Criteria

A collection of inclusion and exclusion logic statements, which defines the patient population (or cohort) that is eligible to participate in a Protocol. Each Protocol is expected to be associated to a defined set of Eligibility Criteria

Healthcare Providers

Typically they are DM customers who load their de-identified clinical data into the Health Sciences Network. Customers of this service own their data that they load into Oracle managed systems. Oracle service is only used to load and manage the data and provide them capabilities to give other participants in the network access to their data to perform protocol validation and patient recruitment. Some providers in the network can also be PV and PR customers if they have investigator lead clinical studies to execute.

Participant

Any institution that joins HSN, either as a DM, PV, or PR customer.

Partner

An organization that has registered for an HSN service with another HSN organization. For example, when a Sponsor and a DM Participant register as a collaboration with the Protocol Validator service, then each of these two organizations are partners.

Pharma, Medical Device, Biotech

They are PV and PR customers within the network. These customers enter into a separate contract with one or more DM customers inside the network to obtain access to their data to perform protocol validation and patient recruitment. Oracle provides network access only after these customers purchase the PV and PR services independently from Oracle. Oracle does not offer any assurance that DM customers will grant PV and PR customers access to their data.

Protocol

The industry definition of a research study which is formalized in a document. Within HSN, a protocol is the entity that holds many key characteristics like "Title", "ID Number", "Purpose", "Target EnrolllmentEnrollment" and "Target Start Date", along with supporting descriptions or narrative that provide context for the protocol's requirements and objectives.

Provider

A healthcare organization (that is, hospital, hospital network, academic medical center) that cares for patients and manages patient health information.

Sponsor

An institution that funds or needs to execute a clinical study (that is, Pharmaceutical Company, Medical Device Company, AMC, CRO). These organizations enter into relationships to create and define Protocols to query for matching patients, and to engage with DM Participants, for support with patient recruiting.

Index
A  C  D  E  I  L  M  O  P  R  S  V

A

accepting protocol for enrollment, 4.4

accepting request for qualification, 4.1

adding team members, 3.5.1

C

cancelling the query request, 3.7.3

Close a protocol, 3.13

creating a new protocol, 3.3

creating recruitment request, 3.9

D

defining eligibility criteria, 3.6

Delete protocol, 3.14

deleting team members, 3.5.2

designating protocol as recruitment ready, 3.8

E

editing an existing protocol, 3.4

editing existing eligibility criteria, 3.6.1

enroll candidates, 4.5

executing criteria from analysis panel, 3.7.2

executing eligibility criteria, 3.7

I

initiating recruitment, 3.10

L

local codes, 3.6.2

logging in, 2.1

logging out, 2.4

M

managing team members, 3.5

mark patient as qualified, 4.3

O

omics, 3.6.3

omics lite, 1.2

P

patches, Preface

protocol characteristics, 3.1

protocol status, 3.2

provider home page, 2.3

R

recruitment status panel, 4.1.1

release candidates, 4.6

S

sponsor home page, 2.2

stop recruitment, 3.12

V

validating from criteria editor, 3.7.1

viewing patient information, 4.2

viewing recruitment results, 3.11

Oracle Legal Notices

Copyright Notice

Copyright © 1994-2015, Oracle and/or its affiliates. All rights reserved.

Trademark Notice

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

Intel and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are trademarks or registered trademarks of SPARC International, Inc. AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. UNIX is a registered trademark of The Open Group.

License Restrictions Warranty/Consequential Damages Disclaimer

This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Except as expressly permitted in your license agreement or allowed by law, you may not use, copy, reproduce, translate, broadcast, modify, license, transmit, distribute, exhibit, perform, publish, or display any part, in any form, or by any means. Reverse engineering, disassembly, or decompilation of this software, unless required by law for interoperability, is prohibited.

Warranty Disclaimer

The information contained herein is subject to change without notice and is not warranted to be error-free. If you find any errors, please report them to us in writing.

Restricted Rights Notice

If this is software or related documentation that is delivered to the U.S. Government or anyone licensing it on behalf of the U.S. Government, the following notice is applicable:

U.S. GOVERNMENT END USERS: Oracle programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, delivered to U.S. Government end users are "commercial computer software" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As such, use, duplication, disclosure, modification, and adaptation of the programs, including any operating system, integrated software, any programs installed on the hardware, and/or documentation, shall be subject to license terms and license restrictions applicable to the programs. No other rights are granted to the U.S. Government.

Hazardous Applications Notice

This software or hardware is developed for general use in a variety of information management applications. It is not developed or intended for use in any inherently dangerous applications, including applications that may create a risk of personal injury. If you use this software or hardware in dangerous applications, then you shall be responsible to take all appropriate fail-safe, backup, redundancy, and other measures to ensure its safe use. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software or hardware in dangerous applications.

Third-Party Content, Products, and Services Disclaimer

This software or hardware and documentation may provide access to or information on content, products, and services from third parties. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content, products, and services. Oracle Corporation and its affiliates will not be responsible for any loss, costs, or damages incurred due to your access to or use of third-party content, products, or services.

Alpha and Beta Draft Documentation Notice

If this document is in preproduction status:

This documentation is in preproduction status and is intended for demonstration and preliminary use only. It may not be specific to the hardware on which you are using the software. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to this documentation and will not be responsible for any loss, costs, or damages incurred due to the use of this documentation.