Oracle Health Sciences InForm Cloud Services Service Descriptions and Metrics June 18, 2015 Table of Contents Metric Definitions... 2 Customer... 2 Instance... 2 Patient... 2 Site... 2 Trial... 2 Service Descriptions for Cloud Services... 3 Oracle Health Sciences InForm Cloud Service, InForm Direct Cloud Service, InForm Multi- Trial Hosting including Cloud Service Set Up... 3 Oracle Health Sciences InForm Cloud Service End User Help Desk... 8 Oracle Health Sciences InForm Cloud Service Central Coding... 9 Oracle Health Sciences InForm Cloud Service Lab Normals Management Tool (LNMT)...11 Oracle Health Sciences InForm Cloud Service InForm Integration...12 Oracle Health Sciences InForm Cloud Service Report Extractor (RE)...14 Oracle Health Sciences InForm Cloud Service Medication Adherence Insights (MAI)...17 Oracle Health Sciences Trial Design Environment Cloud Service (TDCS)...20 Service Descriptions for Configuration Services... 24 InForm Cloud Service Trial Build...24 InForm Cloud Service Study Project Management...26 InForm Cloud Service Study Project Management and Advisory Services...26 Central Coding Configuration...27 Lab Normals Management Tool Configuration...27 InForm Integrations Configuration - Standard File-Based Integration*...29 InForm Integrations Configuration - Direct Data Loader (DDL) **...33 CRF Submit Additional Runs...38 Acceptance of Deliverables... 39 Page 1 of 39
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. Instance: is defined as single deployment of the Oracle program. For details of deployment specific to the Oracle program please refer to service descriptions/entitlements. Patient: is defined as a person receiving healthcare related treatment such as receiving drugs, medical devices or alternate treatment/therapies and/or enrolled/participating in a clinical study. For the purposes of licensing, the maximum number of Patients enrolled in the Study must be counted. The quantity stated for Patients excludes screen-failed patients (i.e. patients who have not received medication). The terminology Patient is use interchangeable with Subject. Site: is defined as a single location from which the Service will be accessed (e.g., an investigator site or a customer location). Trial: is defined as each research project, study or procedure created, modified, tracked and/or conducted by a sponsor using the Oracle program(s) or Service(s). Page 2 of 39
Service Descriptions for Cloud Services Oracle Health Sciences InForm Cloud Service, InForm Direct Cloud Service, InForm Multi-Trial Hosting including Cloud Service Set Up Cloud Service Set Up Your InForm 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. InForm Direct Cloud Service InForm Direct is a type of InForm that excludes Reporting. Specifically this excludes: installation of Cognos in hosted environment (including access to Cognos custom reporting tool) access to the 28 built-in standard reports access to reporting Ad hoc clinical and operational data model InForm Direct provides full access to Data Viewer for clinical data review and Reporting Data Extract (RDE) for clinical data analysis. You have the option to build Your own reports - Oracle can provide an extract of the Review/InForm Schema for You to build Your own reports and /or You may purchase consulting services from Oracle to build custom reports. InForm Cloud Service - 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 Study Investigators (Principal Investigators and Sub-Investigators). InForm Cloud Service - 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: Page 3 of 39
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 Your Trial in this manner Up to two generations of PDFs for Your 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 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 Your 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 program 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 inplace 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 Page 4 of 39
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 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. Working with Oracle to upgrade the contract to provide a dedicated environment if not contracted as such at the outset and Your usage exceeds the limits defined below. 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. Page 5 of 39
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 Trials, You are responsible for submitting a ticket 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. Users of the InForm Cloud Service and InForm Direct Cloud Service are authorized to access the following modules: InForm application InForm Portal User Management Interface InForm Publisher InForm Adaptor Usage Limits: The InForm Cloud Service and InForm Direct Cloud Service are subject to usage limits based on: Number of Patients contracted The following usage limits apply per licensed metric: Licensed Metric Patient/Trial standard hosting Patient/Trial dedicated hosting Database Storage (Records) File Storage (GB) Bandwidth # of Instances included with License 25 GB N/A N/A 1 Trial pack ( UAT, Training and Production) 2000 GB N/A N/A 1 Trial pack ( UAT, Training and Production) Service Level Targets: The InForm Cloud Service and InForm Direct Cloud Service have the following service level targets: Cloud Service Recovery Time Objective (RTO) Recovery Point Objective (RPO) InForm Cloud Service 90 days 48 hours 99% Target System Availability Page 6 of 39
Cognos Reporting installations will be completed within 5 business days from the date the request was submitted. Third Party License Requirements: InForm Cloud Service 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. Oracle Health Sciences InForm Multi-Trial Hosting per Trial The Services available for this offering are described in the sub-sections above entitled o Cloud Service Set Up o InForm Cloud Service Users and Access by Users o InForm Cloud Service - Deliverables and Customer Dependencies. (Note that User Management Tool and Site Assessment may be included in the Multi-Trial offering or purchased separately as agreed by You and Oracle.) o Service Level Targets o Third Party License Requirements o Oracle Cloud Policies Users of the Multi-Trial Hosting Application Management & Hosting are authorized to access the following modules*: InForm Application Inform Portal User Management Interface InForm Publisher InForm Adaptor *Multi Trial Software Usage rights must be purchased separately Usage Limits: The Oracle Health Sciences InForm Multi-Trial Hosting Service is subject to usage limits based on: Contracted as a Trial The following usage limits apply per licensed metric: Page 7 of 39
Licensed Metric Database Storage (Records) File Storage (GB) Bandwidth # of Instances included with License Trial 25 GB N/A N/A 1 Trial pack ( UAT, Training and Production) 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. Oracle Health Sciences InForm Cloud Service End User Help Desk Users of the InForm Cloud Service End User Help Desk are able to perform the following activities: Routine User Management o InForm user activation/inactivation requests o InForm user termination/un-termination o InForm site or user addition or change o InForm user password change Management of UMT accounts Change of InForm Trial configuration settings Creation/change of rights, roles and groups Change of Trial version Usage Limits: The InForm Cloud Service End User Help Desk is subject to usage limits based on: Number of Sites contracted Service Level Targets: The Cloud Service End User Help Desk has the following service level targets: Severity one issues will be responded to within one hour. Severity one = A catastrophic issue impacting multiple system users of an active production system. The issue may be perceived as presenting potential data integrity risks. 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 8 of 39
Oracle Health Sciences InForm Cloud Service Central Coding Users of Cloud Service Central Coding are authorized to access the following modules or functionalities: Central Coding Central Coding purchased per Trial allows Your Trial to connect to Central Coding for Your use of the Central Coding application: for the exchange of relevant data including o verbatim terms o indication and route of administration from the InForm Trial to return codes, terms, coder name, and dictionary used in Central Coding. Users and Access by Users The Services may be accessed only by personnel involved in coding activity for Your Trial. Oracle will grant User Manager and User Administrator roles to the Central Coding customer, The customer will then be able to create individual end user accounts for their personnel in the Central Coding application. Oracle will not create individual end user accounts for the customer. Deliverables For a new Central Coding deployment, Oracle will provide the following common deliverables that apply to most projects: o o o o o o Two Instances of the Central Coding application: one UAT Instance and one Production Instance Demonstration of the Central Coding application for use during requirements gathering and specifications Configuration of synonym lists and stopword lists based on customer requirements Completion of the Central Coding Configuration Specification in coordination with the customer Configuration of the Central Coding application based on the Configuration Specification including Coding Algorithm review and modification Coding definition for each unique dictionary Assignment of coding rules Assignment rules for coding work teams Configuration of InForm Adapter setting in Central Coding Application and scheduling of jobs. Addition of trial(s) to Central Coding Application and jobs to the scheduler. Configuration of a version of MedDRA and WHODD standard dictionaries in the Central Coding application. As part of decommissioning a study, Oracle will provide You with a full Central Coding database extract (i.e. a.dmp (dump) file showing data for all Trials in Your Central Coding database). If there is a need to separate out the data for a specific Trial from the full Central Coding database extract provided (e.g. in order for You to distribute to a third party) this separation and distribution is Your responsibility. Page 9 of 39
Online training for Central Coding for the named Trials for Central Coding users. The list of available online course(s) for Central Coding is provided in the Oracle Health Sciences Online Training for Oracle Health Sciences InForm Cloud Service Data Sheet Validation Package If You build Your own trials and Central Coding integration, this Validation Package documentation may be used by You to perform Installation Qualification (IQ), Operational Qualification (OQ) and/or Performance Qualification (PQ) for the Central Coding integration. It is Your responsibility to request the Validation Package from Oracle if desired. Third Party Licensing Requirements You are solely responsible for licensing any dictionaries used (e.g., MedDRA or WHODD) and must maintain a valid license to such dictionaries for the duration of the Services Period. Such dictionaries are considered materials provided by You for purposes of the infringement indemnification obligations of the applicable agreement governing use of the Cloud Services. Dictionaries need to be licensed separately. Oracle will use reasonable efforts to attempt to verify with the appropriate licensing authority (e.g., MSSO or WHO) that You have a valid license prior to loading the dictionary in the Central Coding environment and on an annual basis. However, this does not alleviate Your obligations to maintain a valid license to such dictionaries. Oracle may suspend access to the Cloud Services immediately if Your dictionary licenses have expired. In such an event, You remain responsible for payment obligations hereunder. Usage Limits: The InForm Cloud Service Central Coding is subject to usage limits based on: Contracted as a Trial The following usage limits apply per licensed metric: Licensed Metric Database Storage (Records) File Storage (GB) Bandwidth # of Instances included with License Central Coding - Trial 60GB N/A N/A one Production and one UAT implementation Service Level Targets: The InForm Cloud Service Central Coding has the following service level targets: Cloud Service InForm Cloud Central Coding Recovery Time Objective (RTO) Recovery Point Objective (RPO) 90 days 48 hours 99% Target System Availability Page 10 of 39
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. Oracle Health Sciences InForm Cloud Service Lab Normals Management Tool (LNMT) Users of the Cloud Service Lab Normals Management Tool (LNMT) are authorized to access the following modules or functionalities: Association of Lab Results in a Trial with Lab Normal Ranges Users and Access by Users The Services are intended to be used by personnel involved in the management of Your Trial as authorized by You. Deliverables The deliverables for a given project are dependent upon the components included in that project. Not all projects will produce all of the deliverables listed below. Some common deliverables that apply to most projects include: LNMT Application Release for UAT This is the initial release by Oracle of the configured LNMT Application in a UAT instance of the Production environment that You may use to conduct UAT activities. LNMT Application Release for Go-Live This is the Production release by Oracle of the configured LNMT Application that Your Users may access. 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 for Production trials. Oracle will coordinate change management requests required for upgrades and migrations. Maintenance of the UAT Instance Oracle will update the UAT instance with a fresh extract of the Production instance each time a change or fix to the Production LNMT Application needs to be tested by You. 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. Migrations typically include a Trial move to a new hardware server. Page 11 of 39
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. Remove the UAT LNMT Application configuration instance. Decommission and recycle the Trial environment. Usage Limits: The InForm Cloud Service Lab Normals Management Tool is subject to usage limits based on: Contracted as a Trial The following usage limits apply per licensed metric: Licensed Metric Database Storage (Records) File Storage (GB) Bandwidth # of Instances included with License Trial N/A N/A N/A one Production and one UAT implementation Service Level Targets: The Cloud Service Lab Normals Management Tool has the following service level targets: Cloud Service Lab Normals Management Tool (LNMT) Recovery Time Objective (RTO) Recovery Point Objective (RPO) 90 days 48 hours 99% Target System Availability 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. Oracle Health Sciences InForm Cloud Service InForm Integration Your InForm Integration will be deployed and will integrate Your main InForm Trial with any of the contracted integrations below. These contracted integrations may be configured by Oracle or by You as contracted. Standard File-Based Integration* Direct Data Loader (DDL)** * Previously named Integrated Voice Response System (IVRS) ** DDL no longer available for purchase from August 2014 Page 12 of 39
The InForm Cloud Service InForm Integration as described below may also be purchased independently of the specific integration types listed immediately above. Users and Access by Users The Services are intended to be used by personnel related to Your Trial as authorized by You. Normally this consists of three main groupings of personnel: Sponsor, Site, and Patient. 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 Study Investigators (Principal Investigators and Sub-Investigators). The Patient population is not expected to interact with the Integration. Deliverables The deliverables for an InForm Integration are dependent upon the components included in that project. Not all projects will produce all of the deliverables listed below. Some common deliverables that apply to most projects include: Release for UAT This is the initial release by Oracle of the configured Integration in a UAT instance of the Production environment that You may use to conduct UAT activities. Release for Go-Live This is the Production release by Oracle of the configured Integration that Your approved end-users may access. 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 for Production trials. Oracle will coordinate change management requests required for upgrades and migrations. Maintenance of the UAT Instance Oracle will update the UAT instance with a fresh extract of the Production instance each time a change or fix to the Production Integration needs to be tested by You. 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 inplace 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. 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. Remove the UAT Integration configuration instance. Decommission and recycle the Trial environment. Usage Limits: The InForm Cloud Service InForm Integration is subject to usage limits based on: Contracted as a Trial The following usage limits apply per licensed metric: Page 13 of 39
Licensed Metric Database Storage (Records) File Storage (GB) Bandwidth # of Instances included with License Trial N/A N/A N/A Implementation on one Production and one UAT Trial for each integration purchased Service Level Targets: The Cloud Service InForm Integration has the following service level targets: Cloud Service Recovery Time Objective (RTO) Recovery Point Objective (RPO) Cloud Service InForm Integration 90 days 48 hours 99% Target System Availability 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. Oracle Health Sciences InForm Cloud Service Report Extractor (RE) Users of the Cloud Service Report Extractor are authorized to access the following modules or functionalities: Report Extractor (RE) - is configured to install, run, save, extract and aggregate (or any combination thereof) reports on a schedule. The RE addresses the need to extract Data from one or more InForm Trials on a scheduled basis. It relies on the creation of Your defined Cognos reports to extract data from the InForm Reporting Database. The output of the RE are may be saved to the Oracle sftp server for delivery to You. Users and Access by Users The Services are intended to be used by personnel involved in the management of Your Trial as authorized by You. Configuration The RE application offering is configured based on mutually agreed requirements. The configuration of the RE includes performing one or more of the following actions on a maximum of 20 Cognos Reports (or SQL objects) per Trial and connecting to a maximum of 200 InForm Trials: Page 14 of 39
Installation of a maximum of 4 SQL objects per Trial Installation of a maximum of 15 reports per Trial Saving a maximum of 10 unique report outputs in InForm per Trial Extracting a maximum of 20 unique report output formats per Trial to the Oracle sftp server Aggregation of a maximum of 10 unique report outputs across multiple InForm Trials and outputting to the Oracle sftp server Prerequisites Coordination is required between You and Oracle to ensure the configuration of the RE conforms to Your requirements and specifications. Reports to be aggregated must be constructed in such a way (single query) to support such aggregation. Assumptions & Limitations Design of the Cognos Reports must conform to RE requirements and specifications. Development of the Cognos Reports is not included in with this Service and must be purchased separately. Files extracted from InForm Trials will be placed in Your agreed upon folder on the Oracle sftp server. If You cannot meet the RE base requirements, Oracle may provide programming services at additional cost. 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 listed below. Some common deliverables that apply to most projects include: Requirements These are written by the Oracle project team to document Your specific Data integration needs for the RE Application. Configure RE Application components as defined in the requirements specifications Perform smoke testing to validate the configuration. Document the test cases needed for this configuration, and perform formal testing of the RE Application. Conduct an independent validation of the RE Application configuration by testing components against approved specifications. Install and configure the RE Application in Your UAT environment. Changes and Fixes to the Production RE Application. RE Application Release for UAT This is the initial release by Oracle of the configured RE Application in a UAT instance of the Production environment that You may use to conduct UAT activities. RE Application Release for Go-Live This is the Production release by Oracle of the configured RE Application that Your-approved end-users may access. 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 in accordance with Oracle s Software End-of-Life Support Lifecycle Policy for Oracle Health Sciences InForm Cloud Services. Oracle will coordinate change management requests required for upgrades. Page 15 of 39
Your responsibilities for a given project are dependent upon the components included in the project. Examples include but are not limited to: Delivering clear and complete requirements in accordance with the agreed timeline planning. These may include Data mapping, Data restrictions, or notifications. If final requirements are not available, You and Oracle may mutually agree to begin the configuration of the RE Application with draft requirements. This latter approach may be subject to additional fees. Ensuring that all key stakeholders, decision-makers, and team members are present and/or involved with all key meetings and deliverables (i.e., planning and review of the RE Application specifications, UAT, etc.). Ensuring that all key stakeholders, decision-makers, and team members adhere to the agreed timelines. Ensuring specifications meet the regulatory requirements for the Trial. Acceptance of requirements specifications in a timely manner. Acceptance of the configured RE Application for release to UAT and for release to go-live. Testing the RE Application (UAT) to Your own standard operating procedures and/or work instructions and for creating and testing Your own test cases. This includes capturing UAT feedback that is clear, reproducible, and actionable in the Oracle-provided template. If changes introduced during UAT are required, the change management process will be followed (including additional fees and time). Reviewing and approving documents related to Production RE Application changes and fixes. Ensuring that all users are trained prior to accessing the system. This includes maintaining all training records. Usage Limits: The Cloud Service Report Extractor is subject to usage limits based on: Contracted as a Trial The following usage limits apply per licensed metric: Licensed Metric Database Storage (Records) File Storage (GB) Bandwidth # of Instances included with License Trial N/A N/A N/A one Production and one UAT implementation Service Level Targets: The Cloud Service has the following service level targets: Cloud Service Recovery Time Objective (RTO) Recovery Point Objective (RPO) Report Extractor 90 days 48 days 99% Target System Availability 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 16 of 39
Oracle Health Sciences InForm Cloud Service Medication Adherence Insights (MAI) The Medication Adherence Insights (MAI) option for InForm integrates Data from the Proteus Digital Health Feedback System (DHFS) with InForm Trials. For purposes of the InForm Cloud Service, including the MAI, Data from the Proteus DHFS shall be considered Your Data (also referred to as Your Content ). Users and Access by Users Your use of the InForm Cloud Service, including the MAI and Data from the Proteus DHFS, is limited to personnel related to Your Trial as authorized by You. Secure Data Transfer Procedure Data transfer procedures between the Proteus DHFS data center and the InForm Services Environment conform to the Oracle Cloud for Industry (OCI) Secure Data Transmission Standard. Changes to the OCI Secure Data Transmission Standard supersede any Data transfer mechanisms described for the InForm Cloud Services. Data is transferred from the Proteus DHFS data center to Your InForm Services Environment via a set of secure (SSL based) and authenticated web service calls. Error Handling Oracle Medication Adherence Insights Web Services If there is a connectivity issue between Your InForm Services Environment and the Proteus DHFS data center (for example due to Proteus web services or due to the InForm server), then Oracle Customer Support may work directly with Proteus for purposes of resolving the issue. InForm Import After You import or Data is otherwise transferred from Proteus DHFS into the InForm Services Environment, the standard audit log will be generated to indicate the status of the import or transfer. The audit log, along with the copy of the Data file, will be stored in persistent Data storage, and viewable on the Adherence Data Log Viewer page within the InForm Portal. Cloud Services Deliverables and 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 listed below. Some common deliverables that apply to most projects include: End User Help Desk support of MAI for Your Users of the InForm Cloud Services. MAI Release for UAT This is the initial release by Oracle of the configured MAI integration in a UAT instance of the Production environment that You may use to conduct UAT activities. MAI integration Release for Go-Live This is the Production release by Oracle of the configured MAI integration that Your Users may access. 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 Page 17 of 39
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 for Production Trials. Oracle will coordinate change management requests required for upgrades and migrations. Maintenance of the UAT Instance Oracle will update the UAT instance with a fresh extract of the Production instance each time a change or fix to the Production MAI Application needs to be tested by You. 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. 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. Remove the UAT MAI integration configuration instance. Decommission and recycle the Trial environment. Your responsibilities for a given project are dependent upon the components included in the project. Your responsibilities and obligations include, but are not limited to: You must contract directly with Proteus Digital Health ("Proteus") for the Proteus DHFS. Oracle will use reasonable efforts to coordinate with Proteus, but You are ultimately responsible for interacting with Proteus and ensuring all components of the Proteus DHFS are available for usage during the Trial. You are responsible for enrolling Patients participating in the Trial using the Proteus DHFS You must acquire, from Proteus, training and support of the Proteus DHFS for Your Site, personnel and Patients. Oracle does not provide any training and support for the Proteus DHFS. You will not place into Your InForm Services Environment any protected health information ( PHI ) as that term is defined by the Health Insurance Portability and Accountability Act ( HIPAA ) of 1996, as amended, unless prior to delivery to Oracle You have de-identified the PHI 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 ). The Proteus DHFS, including maintenance, manufacturing, distribution, and use, is the sole responsibility of You and Proteus. You and Proteus are responsible for correcting and resubmitting incomplete, inaccurate or corrupted Data and records. Assumptions The availability and performance of importing or otherwise transferring Data into InForm is dependent on Proteus, including the Proteus data center, which can be impacted by Patient interaction with the Proteus DHFS (e.g., not wearing the patch sensor). Configuration The Medication Adherence Insights (MAI) option for InForm uses standard integration capabilities and forms to integrate Data from the Proteus Digital Health Feedback System (DHFS) with InForm Trials. Page 18 of 39
Configuration - 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 listed below. Some common deliverables that apply to most projects include: Requirements Definitions Document (RDD) These are written by the Oracle project team to document Your form requirements related to the MAI integration. Specifications These are written by the Oracle project team to document the design of the MAI integration configuration. Specifications may include form data element mappings, data types, data element restrictions, and notification information. One design iteration is included for the design specifications. Project Plan This plan will be created and maintained by the Oracle Project Manager. It will detail the tasks, timelines, and milestones that Oracle and You are responsible for, as applicable. Communication Plan This document is created and maintained by the Oracle Project Manager. It describes the team members, their responsibilities, and their contact information. MAI InForm ecrf - Oracle will document and implement the standard forms in InForm to accommodate the MAI integration. Configuration - Configure MAI integration in support of the requirements and integration specifications. Testing o Perform smoke testing. o Document the test cases needed for this configuration, and perform formal testing of the MAI integration. UAT (up to 1 round) o Install and configure the MAI integration in Your UAT environment. o One (1) User Acceptance Testing (UAT) findings meeting. o Respond to questions that You raise in UAT. o If required, deploy a new configuration to the UAT environment for You to re-test. o If additional rounds of UAT are required, the Change Order process will be followed (including additional fees and time). Once UAT is concluded, install and configure the MAI integration in Your Production instance. Fixes to the Production MAI integration Related documents are created by Oracle and provided to You. Decommission - Provide associated project documents to You. This will include a copy of the Study Lifecycle Records pertaining to the MAI integration configuration. Your responsibilities for a given project are dependent upon the components included in the project. Your responsibilities include but are not limited to: Delivering clear and complete requirements in accordance with the agreed timeline planning. These may include Data mapping, data restrictions, or notifications. If final requirements are not available, you and Oracle may mutually agree to begin the configuration of the MAI integration with draft requirements. This latter approach may be subject to additional fees. Specifications for Data to be integrated by MAI integration must be identified and any update required in standard MAI forms must be finalized before construction of the InForm Trial. Providing input into the creation and maintenance of the project plan as requested by the Oracle Project Manager. Negotiating in good faith an estimated timetable for any revised or additional milestone dates that are introduced after the initial timeline agreement. Ensuring that all key stakeholders, decision-makers, and team members are present and/or involved with all key meetings and deliverables (i.e., planning and review of the MAI integration specifications, UAT, etc.). Page 19 of 39
Ensuring that all key stakeholders, decision-makers, and team members adhere to the agreed timelines. Ensuring specifications meet the regulatory requirements for the Trial. Acceptance of requirements specifications in a timely manner. Acceptance of the configured MAI integration for release to UAT and for release to go-live. Testing the MAI integration (UAT) to Your own standard operating procedures and/or work instructions and for creating and testing Your own test cases. This includes capturing UAT feedback that is clear, reproducible, and actionable in the Oracle-provided template. If changes introduced during UAT are required, the change management process will be followed (including additional fees and time). Ensuring that all users are trained prior to accessing the system. This includes maintaining all training records. Reviewing and approving documents related to Production MAI integration changes and fixes. Usage Limits: MAI is subject to usage limits based on: Number of Patients contracted The following usage limits apply per licensed metric: Licensed Metric Database Storage (Records) File Storage (GB) Bandwidth # of Instances included with License Patient N/A N/A N/A one Production and one UAT implementation Service Level Targets: The Cloud Service has the following service level targets: Cloud Service Recovery Time Objective (RTO) Recovery Point Objective (RPO) MAI 90 days 48 hours 99% Target System Availability 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 Oracle Health Sciences Design Environment Cloud Service (DECS) - Trial Oracle Health Sciences Design Environment Cloud Service - Trial Your Oracle Health Sciences Design Environment Cloud Service (DECS) environment will be deployed in a hosting facility and will be managed by Oracle. The deployment of the DECS environment will consist of Central Designer and InForm. The purpose of this DECS environment is to build and test your InForm Trial prior to the deployment of a production environment. This DECS environment is not intended to Page 20 of 39