Definitions Schedule
for Oracle Health Sciences SaaS Services
Version 4.0
Effective Date: 01-Jul-2013
This Schedule provides definitions that may apply to an Ordering Document for Oracle Health Sciences SaaS
Services and all other Schedules under Customer’s Ordering Document for terms that are not otherwise defined in
the Ordering Document and such other Schedules. Not all definitions apply to all orders. The definitions that apply to
any given order are only the definitions for terms used explicitly in the applicable Ordering Document or any other
Schedule.
In the event of any inconsistency between a definition contained in this Schedule and a definition contained in the
Ordering Document or another Schedule, the definition in the Ordering Document and other Schedule shall control.
The definitions in this Schedule do not in any way expand Oracle obligations under an Ordering Document.
Section 1: Definitions
Clicking on a letter below will move the cursor to the associated section of the Definitions Schedule.
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B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
A
@Oracle - the deployment model under which Oracle Health Sciences Services are delivered by Oracle at
Oracle’s Data Center on Infrastructure provided and managed by Oracle.
Ability to stop dispensing – used when a treatment arm may be dropped during a study OR where a
subject could register 0 dose to stop dispensing (and may start up again).
Access Management - the management of End User access to the Environments.
Adaptive Design Trial – a trial that contains elements that can be changed during the trial, so long as the
conditions under which changes are made and the nature of those changes are established in the study
design. Data accumulated during the course of the trial is analyzed to determine if and what elements are to
be modified.
Additional Server - a Server for Oracle Managed Applications.
Administrative User - an End User assigned by Customer to (i) identify the End Users permitted to use
certain components of the Oracle Health Sciences Environment and, (ii) to assign one or more
responsibilities to each End User.
After-Action Review - the meeting held between Oracle and Customer after Production Go-Live of a
migration or Transition to Oracle Health Sciences Services for the purpose of assessing the current status of
the project and any outstanding issues.
Agreement - the agreement that governs the Ordering Document under which Oracle provides the Oracle
Health Sciences Services, as identified in the applicable Ordering Document.
ANP – see Authorized Network Provider
Anticipated Peak Workload - Customer’s target or goal workload for the Oracle Health Sciences
Environment during testing.
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Application Decommission - See Decommission
Application – the Oracle Program
Applications Administrator - the role assigned by Customer to an End User under which such End User is
responsible for performing as Customer’s technical lead administrator.
Application availability to UAT – the completion of the deployment step of the UAT instance of a study
which indicates that the study is available for use by customer to commence with testing activities within the
environment.
Application Tier - the server that resides in a middle-tier, between the desktop clients and the database
tier. Desktop clients send their requests to a server in the Application Tier, which processes the request or
sends it to another server, such as the database server. Examples of Application Tier servers are the
following:
•
•
•
•
Web Server
Application Server
Reporting Server
Discoverer Server
Approved Third Party Software - Third Party Software separately acquired by Customer that adheres to
Oracle’s integrations standards and that is expressly approved by Oracle for Customer’s optional integration
in Customer’s Environment. Customer is responsible for managing all Approved Third Party Software.
Architecture Design Document - a document prepared by Oracle that specifies Customer’s Oracle Health
Sciences architecture at the commencement of Oracle Health Sciences Services.
Architecture Document - a document(s) prepared and maintained by Oracle that reflects the configuration
of Customer’s Environment during the performance of Oracle Health Sciences Services
Assembly - A collection of hardware and software deployed in support of a particular Oracle Health
Sciences Cloud Service.
Authorized Network Provider (ANP) - a network provider approved by Oracle that Customer has retained
for the purpose of providing connectivity for the Oracle Health Sciences Services in accordance with service
level standards set by Oracle.
B
Back Out Plan - a list of steps and the roles or individuals responsible for performing such steps that are
required to reverse Changes that had been applied to Customer’s Production Environment.
Base Products - unaltered software components, such as executable programs and compiled libraries of
Oracle Programs.
Blocked Randomization – the framework in which Oracle’s IRT application assigns a predefined (also
called fixed or static) sub-list, or "block", or dynamically allocates a block to a specified group (either by
region, country or site). Treatment arm assignments are made from the block.
Break-fix - a code change designed to restore, to its pre-Change state, the logic or functionality of a CEMLI
that had been affected by a Change to an Environment.
Bulk non serial - study supply units packaged without unique identifiers.
Bulk & dispensing individual units at sites - a set quantity of study supply is stored at the depot then
converted when it arrives at the site (for example, bottles are shipped from the depot, at the site they
dispense capsules from bottle.)
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Business Service – A particular Oracle Health Sciences Service.
C
Calculated Treatment Dose – the dose is calculated based on response(s) entered in the application, e.g.
weight or lab entry.
Capacity Management - the process of planning, analyzing, and sizing storage and transaction processing
capability to enable the Production Environment to handle data processing demand.
CEMLI - an acronym for any “configuration, extension, modification, localization, and integration” made to an
Oracle Program or Service.
CEMLI Promotion Slot - a predefined period of up to a specified number of continuous hours during which
Oracle will (i) promote CEMLIs from a Non-Production Environment to a Production Environment.
Central randomization - application selects the next subsequent treatment arm from a central list of codes
file.
Change - an Oracle or Customer-initiated deployment of a specific addition, modification or removal, of a
component, item, feature or function, to an Environment. Examples of Changes are the deployment of a
Release into the Environment and a modification to the Environment configuration.
Change Action Plan - a plan that identifies the steps, and the roles or individuals responsible for performing
such steps that are required to complete a specific Change to an Environment.
Change Management - the management and deployment of Changes to an Environment.
Change Request - a request by Customer via Oracle’s Change Management process for a Change to an
Environment.
Code Refresh - the process of copying the full application code from a Source Environment to a Target
Environment and making the required configuration Changes within the application tier of the Target
Environment.
Cohort - a group of subjects that will be enrolled/randomized separately from other groups/cohorts. There
may be stratification and multiple treatment arm assignment within a cohort.
Configuration Migration - the process of copying application metadata and artifacts from a Source
Environment to a Target Environment and making the required configuration Changes within the Target
Environment.
CPE - Customer-provided network equipment.
Critical Patch Updates - updates that are provided to Customer by Oracle’s Support Services organization
as part of Oracle’s technical support services and that are applied to the Environment as part of the
Emergency Release Management process. Critical Patch Updates are designed to address significant
security vulnerabilities and other issues that may relate to, or serve as prerequisites to, security issues, and
may also include non-security fixes that are designed to address interdependency issues related to security
patches.
Cross-over within a study arm - subjects receive one treatment type after randomization, but will be
reassigned to a different (but known in advance) treatment type in the same study arm at a set time during
the treatment period.
Cross-over switching study arms - subjects receive one treatment type after randomization, but will be
reassigned to a different (but known in advance) treatment type in a different study arm at a set time during
the treatment period.
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Customer - the entity that is identified in the Ordering Document as the recipient of the Oracle Health
Sciences Services.
Customer-Controlled Environments - the environments identified in the applicable Schedule in which
Customer or its designee is authorized by Oracle to use, apply Changes to, and maintain. Possible uses of
Customer-Controlled Environments are development or testing.
Customer Handling Instructions - Customer-specific information in Oracle’s support system that is used
by Oracle personnel performing services for Customer.
Customer-Provided Network Equipment - network devices and circuits provided and managed by
Customer that are installed in Oracle’s Data Center.
Customer’s Help Desk - the point of contact provided by Customer for its End Users with respect to
questions or issues that arise regarding the Oracle Health Sciences Services and Environments.
D
Data Center - the physical location where the Environments for which Oracle performs Oracle Health
Sciences Services reside.
Data Center Security Policy - a document prepared and maintained by Oracle that outlines access control
requirements applicable to the Data Center, including access requests, physical screening, on-site behavior
and prohibited items.
Database Lock - the point in time at which you advise Oracle that no further data will be entered into the
LIVE instance. Database Lock represents the end of FastForward services and the beginning of FastLock
services.
Database Refresh - the process of copying a database from a Source Environment to a Target
Environment and making the required configuration Changes within the database of the Target Environment.
Decommission - the process defined by Oracle under which Customer’s use of Environments is ended and
the Oracle Health Sciences Services are terminated and Customer’s data is returned to the Customer
De-identified Data – Health information that, if not de-identified prior to delivery to Oracle in
accordance with 45 C.F.R. § 164.514(b)(1) (“Statistical De-Identification”) or 45 C.F.R. § 164.514(b)(2)
(“Removal of Identifiers”), would be governed as “Protected Health Information” (PHI) under the Health
Insurance Portability and Accountability Act (“HIPAA”) of 1996, as amended. All such data must be deidentified before being provided to Oracle, unless Oracle and Customer have expressly agreed in writing to
provisions governing the transfer PHI to Oracle.
Demilitarized Zone - the "neutral zone" between the Internet and Oracle’s, or as applicable, a Customer’s,
private network.
DEMO and DEMO Environment - a Demonstration Environment.
Demonstration Environment - a type of Production Support Environment that is used for demonstration
purposes.
Depot – stores and provides study supplies to sites.
DEV and DEV Environment - a Development Environment.
Development Environment - a type of Non-Production Environment in which Customer performs
development activities in support of Oracle Health Sciences Services, such as the creation of
customizations.
Disaster - an Unplanned Outage that causes a complete loss of access to and use of the Oracle Programs
in the Production Environment at the Primary Site for a period greater than 24 hours, as declared by Oracle.
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Disaster Recovery (DR) - services provided by Oracle in accordance with the applicable Schedule to
recover Production Environment data and to re-establish the Production Environment.
Disaster Recovery Plan - a plan prepared and maintained by Oracle that identifies tasks related to
recovery and business continuity in the event of a Disaster, as described in the applicable Schedule.
DMZ – see Demilitarized Zone.
DNS - the translation of a URL text address (e.g., grantasticdesigns.com) into a numeric Internet address.
(e.g., 201.214.12.6).
Do Not Dispense (DND) for Replacement Visit for Dispensing – allow to not dispense study supply
during a replacement visit.
Do Not Dispense (DND) for Unscheduled Visit – allow to not dispense study supply during an
unscheduled visit.
Drug accountability - study supply is tracked from packaging to destruction electronically, includes
reconciliation by site and monitor and by return depot.
DR – see Disaster Recovery.
Duty Manager - the Oracle personnel identified by Oracle as Customer’s point of contact for escalating
Service Requests within Oracle.
Dynamic stratification - end user's entries are used in a calculation to determine into which strata the
subject should be placed. For example, a numeric value (e.g., weight, creatinine range, age) is entered and
the application derives the appropriate stratum (e.g., subjects age < 50, subjects age >=50).
E
Embedded Software - Third Party Software that is incorporated by Oracle into certain Oracle Programs.
Emergency Release Management - the process by which Critical Patch Updates are applied to Customer’s
Environment.
EMR – Electronic medical record, or records about patient care that are kept on a computer rather than on
paper.
End User - an individual who is authorized by Customer to use the Oracle Programs and Services within the
Environment as defined in the Ordering Document.
End-user helpdesk - provides Customer Support to end users of the clinical applications as described in
the relevant support policy.
Entitlement - the base level of services that are included as part of Oracle’s standard Health Sciences
Services, as described in the Applicable Entitlement Schedules. The Entitlement does not include any
Service Options that may be purchased by Customer.
Environment - the combination of Infrastructure and supporting software that is (i) configured for the Oracle
Programs operating on it and for specific uses as part of the Oracle Health Sciences Services, and (ii) used
by Oracle to perform Health Sciences Services. The Environment consists of the Production Environment,
any Production Support Environment(s) and any Non-Production Environment(s), as referenced in the
applicable Ordering Document and Applicable Entitlement Schedules. For Pre-Production Environment
Services, the Environment consists of a Development Environment as referenced in the applicable Ordering
Document.
Environment Plan - a document prepared and maintained by Oracle that identifies the environments used
during implementation of the Health Sciences Services and their respective purposes, such as development,
CEMLI design and test, UAT, or staging purposes.
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Expected Schedule – end users are expected to access the application to obtain study supply assignments
according to the programmed schedule.
Extract, Transform and Load (ETL) – a process of extracting data from a source system, transforming that
data into a different structure, and loading the restructured data into another database.
F
FastForward – the phase of the Services delivery process during which study conduct occurs including data
entry, query management, reporting, drug supply management and randomization. FastForward
commences when the application is made available for User Acceptance Testing (UAT) and ends on receipt
of your agreement to complete this phase.
FastLock – the phase of the Services delivery process from FastForward completion to study
decommission. During this phase, system users typically are given view-only access while activities take
place prior to closing down the application. The phase ends on receipt of your agreement to decommission
the application.
FastStart – the phase of the services delivery process when a study is designed and configured. This phase
begins with requirements provided from the customer which are used to create specifications. The
specifications are then used to configure and test the study prior to release for User Acceptance Testing
(UAT). The phase ends at application availability of UAT.
Forced Randomization - the application will move to the next treatment/randomization number for which
there is study supply available when the study supply units for the assigned treatment are not available
Forced Drug Dispensing - to force a different dose when the required dose is not available which may also
be used to dispense one supply type (e.g. vials) before another supply type (e.g. bottle).
Full Refresh - the process of copying of the database and full application code from a Source Environment
to a Target Environment and making the required configuration Changes within the database and application
tier of the Target Environment.
FDA AERS - The United States Food and Drug Administration Adverse Event Reporting System. This is a
source of adverse event case data for signal detection.
Functional Service Desk - the Service Option under which Oracle Health Sciences creates, receives,
monitors, routes, and closes Functional Service Desk Service Requests, as described in the applicable
Schedule for Functional Service Desk services.
Functional Service Desk Service Request - a request for assistance with Customer’s Environment or any
component thereof submitted to the Functional Service Desk.
G
Go-Live - Production Go-Live.
H
Health Sciences Cloud Services - Oracle Health Sciences Services.
I
Intrusion Detection System (IDS) - a device or software application that monitors network and/or system
activities for malicious activities or policy violations and produces reports
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Implementer - a Third Party Vendor retained by Customer via separate contract to provide implementation
services to Customer in support of Health Sciences Services. For the purpose of this definition, an
Implementer may be Oracle’s Consulting line of business.
Incident - any event experienced by Customer in its use of the Health Sciences Services for which a
Service Request has been submitted, that is not consistent with the standard, documented operation of the
Health Sciences Services, and which causes, or may cause, a Service Interruption.
Individual Patch - a software fix, created by Oracle, to an Oracle Program or Infrastructure and provided
between patch set releases. Individual Patches are designed to address specific software errors or
vulnerabilities but not otherwise intended to change the functionality of programs.
Information Security Incident Response Commander (ISIRC) - the Oracle employee assigned by Oracle
to lead Oracle’s response to Severity 1 and Severity 2 information security Incidents.
Information Security Incident Response Plan (ISIRP) - a document prepared by Oracle that details
activities that are to be performed in the event of an information security Incident related to the applicable
Environment and Health Sciences Services. Oracle periodically updates the ISIRP document to reflect
current information security Incident response planning.
Information Security Incident Response Team (ISIRT) - the Oracle team that is designated by Oracle to
prepare for and respond to information security Incidents.
Information Security Manager (ISM) - an Oracle employee designated by Oracle to act as a liaison
regarding security issues that affects the applicable Oracle line of business. Each Oracle line of business
unit has an Information Security Manager.
Infrastructure - the combination of Oracle’s Data Center, hardware, servers, operating system, storage,
SFTP service, and networking equipment, used for the delivery of Oracle Health Sciences Services.
Servers for Customer Managed Applications are not included in this definition.
Infrastructure Requirements - information provided by Customer in the Infrastructure Requirements
Document regarding the Infrastructure for the Oracle Health Sciences Services, such as capacity and usage
information.
Infrastructure Requirements Document - the document required by Oracle in which Customer specifies
its Infrastructure Requirements.
Internet Protocol Security (IPSec) - a security framework based on open standards and designed to
protect communications over Internet Protocol networks through the use of cryptography.
Intrusion Detection System - a system that monitors Customer’s Environment for security violations such
as attack signatures, anomalous ports, and anomalous protocols being accessed.
IPSec – see Internet Protocol Security
ISIRC – see Information Security Incident Response Commander.
ISIRP – see Information Security Incident Response Plan.
ISIRT –see Information Security Incident Response Team.
ISM – see Information Security Manager.
J [Reserved]
K [Reserved]
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L
Laptop provisioning - where a site or end user does not have access to a computer in order to participate
in a clinical study, Oracle can work with suppliers to provision, on a global basis, the required hardware.
LIVE Instance – the deployment of a study to an environment which is used by the customer to conduct
data collection or related functions on actual study data.
Limited Access Oracle Programs - certain Oracle Programs that, as part of their standard functionality,
may be accessed only on a limited basis through a web browser using standard application interfaces via
HTTP or HTTPS protocols. An example of a Limited Access Oracle Program is Oracle Exchange.
M
Maintenance Code Release - any Release designed to address the manner in which Oracle Programs
process data or operate, and neither contains new functionality nor changes the results of processing data.
Examples of Maintenance Code Releases are software patches, tool updates, tax updates, bug fixes, and
maintenance packs. The term Maintenance Code Release specifically excludes any Service Pack or
Upgrade.
Maintenance Window - the regularly scheduled period of time during which Oracle may schedule Planned
Outages to perform maintenance activities on shared Infrastructure.
Major Release - an Upgrade that is designated by Oracle as a Major Release as follows: (i) for all Oracle
Programs except PeopleSoft Enterprise Programs, by the identifying first number of the Upgrade (e.g.,
change from Oracle9i to Oracle 10g), and (ii) for PeopleSoft Enterprise Programs, by the identifying first
number of the Upgrade after the decimal place (e.g., change from version 9.1 to 9.2).
Major Upgrade - a Major Release.
Management Link - the type of Network Connectivity used for Administrations Services.
Migration Readiness Assessment - a document that contains Oracle’s assessment of Customer’s
Infrastructure and that is used for creating a Production Environment that conforms to Oracle’s Certified
Configuration.
Minor CEMLI Enhancement Request - a request by Customer, via Oracle’s Change Management process,
for Oracle Health Sciences Services to enhance a CEMLI to an Oracle Program within Customer’s
Environment, where such enhancement is designed to improve the functionality of the CEMLI and does not
require Oracle more than 40 person hours to perform. A “person hour” is one hour of work performed by one
Oracle resource.
Minor Release - an Upgrade that contains new functionality and that is upwardly compatible to an earlier
Release of the applicable Oracle Program.
Multiple Depots Supplying a Site - more than one (1) depot listed to supply a site.
N
Non-Production Environment - an instance that is specifically configured for Customer’s use (or, as
applicable, Customer’s Implementer’s use) of the Oracle Programs for non-production activities that relate to
the Oracle Health Sciences Services, such as development, training, data conversion, and CEMLI
maintenance.
O
OCCN – see Oracle Continuous Connection Network.
OHSCP – see Oracle Health Sciences Customer Portal
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OHSC – Oracle Health Sciences Cloud
Omics – informally refers to a field of study in biology ending in -omics, such as genomics, proteomics or
metabolomics. The related suffix -ome is used to address the objects of study of such fields, such as the
genome, proteome or metabolome respectively.
Optional Third Party Software - Approved Third Party Software.
Oracle Continuous Connection Network (OCCN) - a dedicated network designed to support Network
Connectivity between Oracle and Customer’s Environment, and that uses the following elements: a firewall,
VPN, intrusion detection, authentication, reporting, and DNS.
Oracle-Controlled Environments - the environments in which Oracle has sole control to make Changes.
Oracle’s Data Center - the Data Center retained and managed by Oracle, or by a third party retained by
Oracle, at which Oracle delivers Health Sciences Services.
Oracle Data Center Badge Access Form - an Oracle form that must be completed by a person seeking to
visit Oracle’s Data Center. Once completed by the visitor, the form is forwarded within Oracle for review and
approval purposes, and is retained by Oracle in accordance with Oracle policy.
Oracle Health Sciences Customer Portal (OHSCP) - the Customer-specific Internet based portal provided
by Oracle to Customer as part of the Oracle Health Sciences Services by which Customer may view
performance reports generated by Oracle and the status of Service Requests.
Oracle Product Issue - an Incident associated with the functioning of Oracle Program(s) (including program
errors) but is not caused by Oracle’s performance of Oracle Health Sciences Services.
Oracle Program - the Oracle software product for which Oracle Health Sciences performs Services as
identified in the applicable Schedule. If a Schedule does not specifically define which Oracle Programs apply
to that Schedule, references to the term Oracle Programs in that Schedule shall be deemed to mean all the
Oracle Programs identified in the Ordering Document for which Oracle is providing Services. The term
Oracle Programs shall not apply to Oracle Software that is not managed by Oracle. The term Oracle
Program includes any Embedded Software within the applicable Oracle Program.
Oracle Project Plan - the document prepared by Oracle that outlines the tasks to be performed by Oracle,
including anticipated start and end dates, for Transition Advisory Services.
Oracle Software Not Managed By Oracle refers to any Oracle Software or Service that is located in the
provided Customer Environments but is managed by a Customer or their agent.
Ordering Document - the contract signed by both Oracle and Customer that is governed by the Agreement.
Outage - a complete loss of access to and use of the Production Environment, the Production Support
Environment, the Non-Production Environment, or the Pre-Production Environment. An Outage may be a
Planned Outage or an Unplanned Outage.
Overall Program Plan - a project plan prepared by Oracle that outlines the necessary tasks, task
performance schedules, and the roles or individuals required to perform such tasks, for a transition.
P
Patient – for the purposes of the InForm study order the quantity stated for ‘Patients’ excludes screen-failed
patients. The terminology ‘Patient’ is use interchangeable with ‘Subject’
Partial Dispensing/Drug Assignment – used when a subject is dispensed multiple study supply units at
one visit. If the study supply units are taken in order (not at the same time) and the site only has 2 study
supply units but needs to dispense 4 study supply unit, the application will give the maximum number at the
site and then allow the subject to come back for an unscheduled visit to complete the rest of the
dispensation.
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Partial Refresh - the process of copying a database and/or a portion of application code from a Source
Environment to a Target Environment and making the required configuration Changes within the database
and application tier of the Target Environment.
Password Manager Utility - an Oracle-proprietary Tool used by Oracle to manage passwords and provide
controlled-access to database and application passwords to those End Users who have named Linux
operating system accounts and associated PowerBroker policies.
Performance Management - a subset of Oracle Health Sciences Services under which Oracle manages
the speed of transaction response of the Oracle Programs, and batch job execution in the Production
Environment.
Periodic Maintenance Plan (PMP) - a written plan prepared and maintained by Oracle that generally
describes the schedule for the application of Changes, new Releases, and Upgrades, to the Production
Environment.
Planned Outage - an Outage scheduled by Oracle during which Oracle performs system maintenance and
other activities for the Environment and the Oracle Health Sciences Services.
PMP – see Periodic Maintenance Plan.
Point Release - a Minor Release.
Pooling drug supply - used when multiple protocols are using the same study supplies with the same
packaging/labeling. This option allows the application to order and track study supplies from the same "pool"
and use them for the different protocols.
Post Production Go-Live - the period following the Production Go-Live of the Production Environment.
Primary Site - the Data Center at which Customer’s Environment is located and at which Oracle delivers
Oracle Health Sciences Services under the Ordering Document. If Customer purchases an applicable
Service Option, the Environment and the delivery of Oracle Health Sciences Services may be relocated to a
Secondary Site in the event of a Disaster pursuant to the terms of such Service Option.
Priority Level - the classification used in conjunction with Severity Level to identify the priority of a Service
Request with respect to the Oracle Health Sciences Services.
Problem - (i) the collection of multiple recurring Incidents that exhibit common symptoms and that originate
from a single, common cause, and for which the cause is unknown, or (ii) a single Incident that results from
a single error and that has an on-going significant impact on the Oracle Health Sciences Services (such as
an Unplanned Outage), and for which the cause is unknown.
Problem Management - a subset of Oracle Health Sciences Services under which Oracle manages
Problems within Customer’s Environment, as defined in the applicable Schedules.
Production Assessment - a document that is prepared by Oracle prior to Production Go-Live and that
contains Oracle’s assessment of the compliance of Customers' Environment with Oracle Health Sciences
standards.
Production Environment - the instance within the Environment that is specifically set up and configured to
support Customer’s use of the Oracle Programs, and used by Customer, for production operations. The
Production Environment consists of the collection of database servers, application (“mid-tier”) servers, and
other servers comprising Customer’s transactional production application.
Production Go-Live - the date on which Customer first commences use of the Production Environment for
production operations (i.e., to process live data).
Production Ready Status - a designation given by Oracle to Customer indicating that Customer may
commence use of a Production Environment for production operations.
Production Request – a request to carry out specific instructions related to a study in the environment.
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Production Support Environment - the TEST and DEMO Environments that are specifically set up and
configured in a manner that closely resembles the Production Environment, and that are used, as
applicable, to troubleshoot and facilitate Incident resolution, to test changes prior to promotion of such
changes to the Production Environment and for demonstration purposes.
Program Responsibilities - the functionality that a User may use within the Oracle Programs.
Program-Specific Application Management Services Schedule - the Application Management Services
Schedule specifically applicable to a certain set of Oracle Programs as identified in such Schedule.
Program-Specific Standards - the Standards Schedule specifically applicable to a certain set of Oracle
Programs as identified in such Schedule.
Protocol - A protocol is a Sponsor created study plan on which all clinical studies are based. The plan is
designed to address the health of the participating patients as well as to answer specific research
questions. A protocol also describes what qualification criteria is required for people to participate or be
recruited into the study; dosages; the length of the study, etc.
Provisioning Release Plan - a document or set of documents prepared by Oracle that describes the
installation and configuration of hardware and software required for the Oracle Health Sciences
Environment.
Q [Reserved]
R
RCA - Root Cause Analysis.
Recovery Point Objective (RPO) - Oracle’s objective for the potential maximum time period of data loss,
calculated from the onset of a Disaster, and as described in the applicable Schedule.
Recovery Time Objective (RTO) - Oracle’s objective for the potential maximum period of time between the
declaration of a Disaster and the point at which Customer can resume production operations in the
Production Environment, as described in the applicable Schedule.
Refresh - the process of copying a Customer’s database files, application files, and/or the application
metadata and artifacts from a Source Environment to a Target Environment and updating related
configurations within the Environment. The types of Refreshes to be performed as part of the Oracle Health
Sciences Services are identified in the Ordering Document, and may include, as applicable, Code
Refreshes, Database Refreshes, Full Refreshes, Partial Refreshes, and Configuration Migrations.
Release - a software change or set of software changes, to Oracle Programs, that is provided to Customer
by Oracle’s Support Services organization as part of Oracle’s technical support services. The term Release
includes Upgrades and Maintenance Code Releases.
Release Management - a subset of Oracle Health Sciences Services under which Oracle manages the
deployment of Releases into Customer’s Environment.
Release Plan - a document that details the planning, testing, and executing of proposed Releases. The
Release Plan includes a Back Out Plan.
Replacement randomization – used to replace a subject that withdraws early from a study with a subject
randomized to the same treatment arm.
Replacement Visit for Dispensing - used to assign replacement study supply unit(s) if the subject’s
previous assigned study supply unit(s) has (have) become lost or damaged.
Request For Change (RFC) - Change Request.
Required Software - Third Party Software for which Oracle requires Customer to separately purchase a
license and technical support in connection with Oracle Health Sciences Services for certain Oracle
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Programs, and for which Oracle expressly performs Oracle Health Sciences Services, as described in the
applicable Schedule.
Re-randomization – the application performs a subsequent randomization.
Restore - the process of copying a database and/or full application code from a disk or tape backup to the
Environment from which the copy was made.
Resupply of Depot Just in Time – instead of predicting based on trigger or resupply weeks, the
application only sends a set amount to the depot at certain time intervals.
Resupply of Site Just in Time – instead of predicting based on trigger or resupply weeks, the application
only sends a set amount to the site at certain time intervals.
Resupply of Depot using defined triggers – instead of predicting based on trigger or resupply weeks,
the application orders a resupply when the depot levels reach a predefined quantity.
Resupply of Site using defined triggers – instead of predicting based on trigger or resupply weeks, the
application orders a resupply when the site levels reach a predefined quantity
RFC – see Request For Change.
Root Cause Analysis - a process by which Oracle seeks to determine the root cause of a Problem and/or
an Incident, identify details of any work-around including reasons for the work-around as applicable, and the
history of the Problem or Incident.
Run-in/Lead-in Dispensing – used to assign study supply unit(s) prior to randomization.
S
Schedule - a schedule that is referenced by the Ordering Document and that describes Oracle Health
Sciences Services ordered by Customer under the Ordering Document.
Secondary Site - the Data Center other than the Primary Site to which the Environment and delivery of
Oracle Health Sciences Services is relocated in the event of a Disaster, as described in the applicable
Schedule.
Server - a computing platform with defined processing power, memory capacity, and operating system. The
Server may be implemented as a virtual or shared allocation from one or more physical computing
platform(s).
Service Interruption - a material reduction of the functionality and responsiveness of a component of the
Production Environment, a Production Support Environment, or a Non-Production Environment, such that
Customer’s ability to use the Oracle Health Sciences Services to process one or more of Customer’s key
business transactions is significantly impacted.
Service Pack - a Minor Release.
Service Request (SR) - a request for assistance with the Environment or any component thereof submitted
to My Oracle Support or the Oracle Health Sciences Service Desk.
Service-Specific Application Management Services Schedule - Program-Specific Application
Management Services Schedule.
Service-Specific Standards - Program-Specific Standards.
Service(s) Option - services and/or Infrastructure that Customer may purchase to (i) increase the quantity
of Oracle Health Sciences Services (including Infrastructure) provided by Oracle as part of Customer’s
Entitlement, or (ii) support or enhance the Oracle Health Sciences Services. Service Options available for
purchase by Customer are identified in the Applicable Service Options Schedule.
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Severity Level - the level of criticality assigned to a Service Request based on defined criteria.
Site – for the purposes of the InForm study order, a site is counted if it exists in InForm regardless of the
recruiting status at that site
SSH - Secure Shell (SSH) is a network protocol for data communication, remote shell services or command
execution and other network services between two networked computers connected via a strong
authentication and an encrypted channel.
SFTP – A method of transferring files over an SSH data stream.
Site Personnel - typically consist of the Site Coordinator (Clinical Research Coordinators) and Study
Investigators (Principal Investigators and Sub-Investigators).
SOP - Standard Operating Procedures
Source Environment - a Production Environment or Production Support Environment from which data for a
Refresh is obtained.
Sponsor - the sponsor of a clinical trial or an investigational product.
SR - see Service Request.
SSL - “secure sockets layer,” a commonly used protocol for managing the security of a data transmission on
the Internet. SSL uses a public-and-private key encryption system, which also includes the use of a digital
certificate.
Staging Environment – An Environment configured to simulate the Production Environment to test whether
an analytical automation is ready for production. Staging Environments cannot be used to store, load or
process actual Data.
Standard Operating Procedures - Oracle’s set of documented processes that set forth the standard
procedures, activities and tasks performed by Oracle resources while delivering Oracle Health Sciences
Services to Oracle customers.
Stratification - the process of grouping members of the subject population into subgroups during
randomization.
Study – the configured set of forms, rules and workflow structure that is rendered or deployed using an
Oracle program (InForm, IRT, OLX) for the purpose of collecting clinical data.
Study Closeout – See Decommission
Study Decommission – See Decommission
Standby Environment - an Environment located at the Secondary Site that closely resembles the capacity
and performance capabilities of the Production Environment at the Primary Site, and that may be used for
production operations in the event of a Disaster as described in the Schedule for the applicable Service
Option.
Super User - an End User that Customer has assigned to assist other End Users in the use of Oracle
Health Sciences Services. Super Users serve as the liaison between End Users, Customer’s Help Desk,
and the Oracle Health Sciences Service Desk.
Supplemental Services - Service Options.
Supported CEMLIs - CEMLIs that were reviewed and approved by Oracle as part of the Production
Assessment process and for which Oracle provides Oracle Health Sciences Services in the Production
Environment.
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System Administrator - an Oracle resource assigned by Oracle to perform tasks to maintain the
Environment as part of the Oracle Health Sciences Services.
System – Environment
T
Target Environment - the Production Support Environment or Non-Production Environment to which data
for a Refresh will be applied.
Technology Stack - any database, operating system and middleware used in an Environment.
Terabyte - Terabyte is defined as one terabyte of uncompressed data received from the customer in its
original form before loading into Oracle applications. Such data may include data files containing clinical or
omics data delivered via file transfer methods or via computer storage devices, or downloaded via the
internet, as specified by Oracle. Oracle may subsequently convert, compress, or transform the original data
before retaining the data within Oracle applications and the original data may be discarded.
TEST or TEST Environment - a type of Production Support Environment that is used by Oracle for testing
and validating Changes prior to promotion to the Production Environment as well as for recreating events
and duplicating issues occurring in the Production Environment for the purposes of troubleshooting and
facilitating Incident resolution.
Third Party Software - any software from a Third Party Software Vendor, which is not provided by Oracle
as part of the Oracle Health Sciences Services, and any software developed or provided by Customer.
Third Party Software Vendor - a provider, other than Oracle, of software.
Third Party Vendor - a provider, other than Oracle, of products or services.
Titration – there are three types of titrations. For fixed titration the protocol specifies that an assigned
medication dose might be adjusted (higher or lower or maintain) at pre-determined visits/assignment
transactions. For manual titration the application allows the user to select a higher, a lower or the same
medication dose for a subject's assignment. This selection assumes titration rules work the same throughout
study with every application assignment transaction allowing 6 titration steps (dose level adjustments). For
dynamic titration the application is programmed with rules to adjust the subject's medication (dose up or
down or maintain) automatically based on input data such as lab results or weight.
Tools - software scripts provided and used by Oracle for the delivery of Oracle Health Sciences Services
(e.g., to perform environment clones, password changes, service monitoring, and file system maintenance).
Trial - For the purposes of Oracle Health Sciences Clear Trial Cloud Services, Trial is defined as a project,
study or procedure that is created, modified or tracked using the Oracle Health Sciences Clear Trial Cloud
Services during each twelve month period following the effective start date of the contract.
TRAINING Instance – the deployment of a study to an environment which is used by the customer to
conduct user training on the use of the study and training on the related Oracle program used to deploy the
study.
Transaction Link - the type of Network Connectivity used for Computer and Administration Services.
U
UAT - User Acceptance Testing.
UAT Instance – the deployment of an Oracle Program to an Environment which is used by the Customer to
complete the User Acceptance Testing against the defined specifications that describe the configuration of
that Oracle Program.
Unplanned Outage - an Outage that was not scheduled by Oracle or Customer and is caused by an
Incident or Problem.
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Unscheduled Dispensing Visit - used to assign extra study supply unit(s) in addition to study supply unit
assigned at the last scheduled visit.
Uncompressed Data Under Management – describes data received from the customer in its original form
into Oracle hosting environments before storage within Oracle applications (Databases, file systems etc).
Such data includes data files containing clinical Omics data delivered via file transfer methods or via
computer storage devices, or downloaded via the internet. The data may subsequently be converted,
compressed, or transformed before being retained within Oracle applications and the original data may be
discarded.
Upgrade - a new Release of an Oracle Program that contains new functionality and/or under which the
results of how such program processes data differs as compared to an earlier Release of such program.
User - an End User.
User Acceptance Testing - a formal testing process conducted by the Customer that for the purpose of
verifying that the Services (including the configured Oracle Program) support the specifications agreed-to
between the parties. This process is also part of the Change Management Process conducted by Customer
of a specified Change to the Environment for the purpose of determining whether such Change meets
identified acceptance criteria.
User Management Tool (UMT) - the tool used pre Go-Live to manage the collation of user and site data,
collect configuration data (when applicable), and load data at Go-Live and used post Go-Live to manage
changes, additions, and terminations. For IRT studies, UMT is only used for InForm-IRT Integrated
solutions.
V
VAERS - the Vaccine Adverse Event Reporting System managed jointly by the US FDA and the US Centers
for Disease Control and Prevention (CDC).
VPN - Virtual Private Network.
W
WAN - Wide Area Network.
WHO UMC Vigibase - Vigibase is the name used by the World Health Organization (WHO) Uppsala
Monitoring Center (UMC) for the adverse event case data from the WHO International Drug Monitoring
Program.
Windows Software Update Service (WSUS) - a Microsoft service provided to Oracle under which
Microsoft delivers current security updates to Oracle-owned Windows-based computers.
WSUS – see Windows Software Update Service.
X [Reserved]
Y [Reserved]
Z [Reserved]
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