Oracle Health Sciences InForm Multi-Trial Cloud Service

Oracle Health Sciences InForm Multi Trial Dedicated Hosting Service

Service Descriptions and Metrics
June 4, 2015

Table of Contents
Metric Definitions .................................................................................................................................................. 2
Customer ........................................................................................................................................................................................ 2
Service Description for Oracle Health Sciences InForm Multi-Trial Cloud Services ................................................. 3
Oracle Health Sciences InForm Multi-Trial Dedicated Hosting, including Oracle Health Sciences InForm Multi
Trial Setup ............................................................................................................................................................................... 3

Page 1 of 6
Metric Definitions

Customer: is defined as the customer entity specified on your order. The programs may not be used or
accessed for the business operations of any third party, including but not limited to your customers,
partners, or your affiliates. There is no limitation on the number of computers on which such programs
may be copied, installed and used.

Page 2 of 6
Service Description for Oracle Health Sciences InForm Multi-Trial Cloud Services

Oracle Health Sciences InForm Multi Trial Dedicated Hosting, including Oracle
Health Sciences InForm Multi Trial Setup

Oracle Health Sciences InForm Multi Trial Setup

Your Oracle Health Sciences InForm Multi Trial Dedicated Hosting Services Environment will be deployed
in a hosting facility and will be maintained and managed by Oracle. The deployment of the Services
Environment will consist of three instances: Production, User Acceptance Testing (UAT), and Training.
The Production instance is the instance which will be used to capture the clinical data (“Data”). The UAT
instance will be used to perform User Acceptance Testing pre-go-live and will be used to test changes
and fixes after go-live. The Training instance may be used by You to conduct training in addition to the
online training provided. You may also contact Oracle for additional training options for which there may
be additional cost. This information can be provided based on request to Oracle. More information is
available here.

Oracle Health Sciences InForm Multi Trial Dedicated Hosting - Users and Access by Users

Your use of the Services is limited to personnel related to Your Trial as authorized by You. Normally this
consists of two main groupings of personnel: Sponsor and Site. The Sponsor group typically consists of
personnel from Your company and may also include other sub-contracted personnel such as Contract
Research Organization personnel, Monitors, and Data Managers. The Site personnel typically consist of
the Site Coordinators (Clinical Research Coordinators) and Trial/Study Investigators (Principal
Investigators and Sub-Investigators).

Oracle Health Sciences InForm Multi Trial Dedicated Hosting - Deliverables and Customer
Dependencies

The deliverables for a given project are dependent upon the components included in that project. Not all
projects will produce all of the deliverables and entitlements listed below. Some common deliverables
and entitlements that apply to most projects include:

 Validation Package – If you build Your own Trials, this documentation may be used by You to perform
Installation Qualification (IQ), Operational Qualification (OQ) and/or Performance Qualification (PQ)
for the InForm product. It is Your responsibility to request the package from Oracle if desired.
 InForm Application Release for UAT – This is the initial release by Oracle of the configured InForm
application in a UAT instance of Your environment that You may use to conduct UAT activities.
 InForm Application Release for Go-Live – This is the release by Oracle of the configured InForm
application in a Production instance or Your environment that Your approved Users may access.
 Database Extracts – These database extracts may be used by You to analyze and report on Your
data captured by the configured InForm application. It is Your responsibility to request an export
online and to download the export. Authorized Users may obtain a database extract in one of two
ways:
o Proactively log into InForm and generate an extract as needed
o Request Oracle to schedule the extract generation – You may request up to once per day
for each Trial in this manner
 Up to two generations of PDFs for each Trial – PDFs may be generated by Oracle at the end of the
Trial after confirmation of Your final Trial lock or during the course of the Trial (1 set per site
containing that site’s Data and Your 2 copies containing all Trial Data). These are intended to

Page 3 of 6
 document the Data as it existed in the Production instance of the configured InForm application.
Generation of additional set(s) of output with different output requirements, such as a subset of data
for auditing purposes, is not covered by this Services Description and would need to be contracted for
separately.
 Online training for InForm for the named Trials for InForm users. The list of available online courses
for InForm is provided in the Oracle Health Sciences Online Training for Oracle Health Sciences
InForm Cloud Service Data Sheet
 User Management Tool and Site Assessment
 Online training for User Management Tool (UMT) for the named study(ies) for UMT users. The list of
available online course(s) for UMT are provided in the Oracle Health Sciences Online Training for
Oracle Health Sciences InForm Cloud Service Data Sheet
 Archival Documentation – This is a package of documentation that was maintained by Oracle during
the course of each Trial. After the InForm Trial is decommissioned, this package is sent to You.
 Maintenance of the Production Instance –. Oracle will maintain the Production instance in accordance
with support services detailed in the Oracle Cloud for Industry Hosting and Delivery Policies
document, including product upgrades to new releases and in-place upgrades and migrations in
accordance with Oracle’s Software End-of-Life Support Lifecycle Policy for Oracle Health Sciences
InForm Cloud Services. Upgrades are applied per InForm server and all Trials on the same server
are upgraded at the same time. Migrations typically include a Trial move to a new hardware server.
Upgrades and migrations are scheduled with You and are performed during the maintenance window.
Oracle will coordinate change management requests required for upgrades and migrations.
 Maintenance of the UAT Instance – Upon request, Oracle will update the UAT instance with a fresh
extract of the Production instance each time a change or fix to the Production InForm application
requires testing. This involves removing the UAT instance (including UAT Data) and replacing it with
a fresh extract of the Production instance containing all the Data as it exists in Production. Oracle will
maintain the UAT instance in accordance with support services detailed in the Oracle Cloud for
Industry Hosting and Delivery Policies document, including product upgrades to new releases and in-
place upgrades and migrations in accordance with Oracle’s Software End-of-Life Support Lifecycle
Policy for Oracle Health Sciences InForm Cloud Services. Upgrades are applied per InForm server
and all Trials on the same server are upgraded at the same time. Migrations typically include a Trial
move to a new hardware server. Upgrades and migrations are scheduled with You and are
performed during business hours for UAT Trials. Oracle will coordinate change management
requests required for upgrades and migrations.
 Maintenance of the Training Instance – Oracle will set up a Training instance using Trial
implementation files similar to those used for the Production instance. Upon request, the training
environment is updated to reflect subsequent changes or fixes within the Production instance unless
agreed otherwise. Copying Data from the Production instance to the Training instance is not allowed.
Oracle will maintain the Training instance in accordance with support services detailed in the Oracle
Cloud for Industry Hosting and Delivery Policies document, including product upgrades to new
releases and in-place upgrades and migrations in accordance with Oracle’s Software End-of-Life
Support Lifecycle Policy for Oracle Health Sciences InForm Cloud Services. Upgrades are applied
per InForm server and all Trials on the same server are upgraded at the same time. Migrations
typically include a trial move to a new hardware server. Upgrades and migrations are scheduled with
You and are performed during business hours for Training trials. Oracle will coordinate change
management requests required for upgrades and migrations .
 Production Instance Backups - Oracle will make the following backups for the production
environments for Your Data hosted by Oracle: (Backup media is not intended for use as archive of a
Trial for any purposes other than as a means of Data protection at a secure off-site location and to
provide the ability for recovery activities to occur in the event of a disaster)
 Daily backups of hosted application system and database files.
 On four-hour intervals, backups are made of the Oracle Database Archive files where
applicable.
 Daily replication of backups to an offsite facility.
 Clinical Development Analytics (CDA) - The Oracle Health Sciences InForm Cloud Service includes
the deployment of the Oracle Health Sciences Clinical Development Analytics (CDA) integration

Page 4 of 6
 package into the InForm Trial database to support integration to compatible versions of CDA for
customers that have licensed and deployed CDA external to the Oracle Cloud for Industry hosted
environment.

Your responsibilities related to the above services are dependent upon the components included in the
project. Examples include but are not limited to:

 Testing the InForm application (e.g., conducting UAT) in accordance with Your own standard
operating procedures and/or work instructions as well as creating and testing Your own test cases.
 Ensuring packages and scripts are adequately tested as per Your own standard operating procedures
and/or work instructions before sending it to Oracle Cloud Services for implementation on
UAT/Production instances. For packages or scripts submitted by You for implementation, it is Your
responsibility to examine the implementation logs for potential error messages and take appropriate
action. Note that a ‘successful’ ticket completion means the script completed with or without errors.
 Adding site and user information directly into an Oracle-provided tool (UMT) or providing a completed
Oracle template listing the site and user information to be loaded into the UMT (for the initial creation
of sites and users).
 Ensuring that all users are trained prior to accessing the system. This includes maintaining all training
records.
 All Data management activities for the Trial, including but not limited to dictionary coding, query
resolution, Serious Adverse Event (SAE) reconciliation, and Trial lock.
 Managing and overseeing third party vendors (e.g., lab vendors, external partners, Your
subcontractors, etc.). If Oracle will not supply End User Help Desk support then You must ensure
Your End User Help Desk vendor is aware they need to administer Oracle users where appropriate.
 Submitting Your PDF archival requirements promptly allowing for Your Request to Decommission to
be submitted by the end of Your Services Period. It is recommended that the request for archival
PDFs is submitted ninety (90) days prior to the end of the Services Period to allow time for PDF
generation and Your review. Failure to request archival PDFs with at least ninety (90) days
remaining in the Services Period may require You to execute an extension to Your order
and/or result in Oracle decommissioning Your Study at the end of the Services Period.
 Distributing archival PDFs and Trial Archival Package (TAP), as appropriate.
 Submitting the Request to Decommission prior to the end of the Services Period.
o If You require additional time beyond Your Services Period, You will be required to execute
an extension to Your contract.
o If You fail to meet Your obligation to submit the Request for Decommission prior to the end of
the Services Period and You have not contracted for an extension to the Services Period,
Your Trial will be decommissioned upon the end of the Services Period.
o If You submit the Request to Decommission no later than thirty (30) days prior to the end of
the Services Period, then, following Your written request, Oracle will provide You with a
refund of any recurring fees actually paid to Oracle for the period following Oracle’s receipt of
Your Request to Decommission.
o If You build Your own Trials, You are responsible for submitting a ticket for each Trial to
request decommission.
 Reviewing and accepting the Trial Archive Package (TAP) within sixty (60) days of delivery.
 For integration of Your InForm Trials to Clinical Development Analytics, You are responsible for
submitting a request for the deployment of the CDA integration package to each InForm Trial. For
CDA deployed on Your premise, You will also need to provide necessary network connectivity to
support this integration (e.g. VPN, MPLS, other such network connectivity) which may need to be
contracted separately.

Page 5 of 6
Usage Limits: Oracle Health Sciences InForm Multi Trial Dedicated Hosting is subject to usage limits
based on:

 Number of Customers per your ordering document

 The following usage limits apply per licensed metric:
Licensed Metric Database Storage File Storage (GB) Bandwidth # of Instances
(Records) included with
License
Per Customer Per Customer specified N/A N/A 3 (UAT, Training
requirements and Production)

Service Level Targets: The Oracle Health Sciences InForm Multi Trial Dedicated Hosting has the
following service level targets:

Cloud Service Recovery Time Objective Recovery Point Objective Target System
(RTO) (RPO) Availability
Oracel Health 90 days 48 hours 99%
Sciences InForm
Multi Trial Dedicated
Hosting

Cognos Reporting installations will be completed within 5 business days from the date the request was submitted.

InForm Multi Trial Dedicated Hosting includes access to the following modules*:

 InForm Application
 InForm Portal
 User Management Interface
 InForm Adaptor
 InForm Publisher

*Multi Trial Software Usage rights must be purchased separately

Third Party License Requirements:

Oracle Health Sciences InForm Multi Trial Dedicated Hosting includes the use of Cognos reporting model
embedded into the InForm application. The use of IBM Cognos Report Studio is not included in this
service and needs to be licensed by You separately.

Oracle Cloud Policies

The Services are subject to the Oracle Cloud for Industry Hosting and Delivery Policies document, which
is part of the Service Specifications of Your order and may be viewed at www.oracle.com/contracts.

Page 6 of 6