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1 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 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 Page 1 of 39

2 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

3 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

4 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

5 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

6 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

7 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 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

8 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 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 Page 8 of 39

9 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

10 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

11 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 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

12 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 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

13 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

14 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 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

15 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

16 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 Page 16 of 39

17 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

18 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 (b)(1) ( Statistical De-Identification ) or 45 C.F.R (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

19 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

20 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 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

21 perform in a manner consistent with an Oracle production hosting deployment that is designed for hosting live clinical trials or live data. You may not load any protected health information (PHI) or similarly sensitive personal information that imposes specific data security obligations for the processing of such data into the DECS environment. Oracle Health Sciences Design Environment Cloud Service - Users and Access by Users Your use of the DECS is limited to personnel related to Your Study as authorized by You. Normally this consists of personnel from Your Company and may also include other sub-contracted personnel such as Contract Research Organization personnel. It is Your responsibility to ensure that anyone who is authorized by You to access the environment has a unique and individual account provisioned in order to enable appropriate audit trails. Oracle Health Sciences Design Environment Cloud Service - Deliverables and Customer Dependencies Oracle responsibilities and deliverables under Design Environment Cloud Service include: Responsibilities Configure Your dedicated virtual network (VLAN). Configure firewall and F5 content switch rules to secure Hypertext Transfer Protocol Secure (HTTPS) access to Oracle Programs. Manage Domain Name Service (DNS) inside of DECS environment Install and configure virtual servers and physical Oracle database servers (where applicable) and the associated Storage Area Network (SAN) and tape storage devices. Install and configure the Oracle Programs and related Oracle database instance. Patch operating system and databases, where applicable. Create table spaces to be used with required applications Create operating system and database accounts required to install required applications Install and manage Anti-virus software on Windows servers Maintain database instance availability Manage database system table spaces Monitor system availability, file system usage, operating systems, CPU usage, and memory usage Backups - Oracle will make the following backups for the purposes of DECS: (Backup media is not intended for use as archive of study 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) o Daily backups of hosted application system and database files. Prior to handover to You, perform DECS environment functional verification check after initial provisioning and after upgrades. Provide You with DECS environment documentation Perform patches and major and minor upgrades of the Central Designer instance (including data migration where applicable). Conduct regular maintenance of the DECS environment, including upgrades to new releases of the Oracle Programs as described in the Ordering Document, including the Service Specifications, upon request or as determined by Oracle. Provision additional instances and upgrades of InForm servers within DECS that are required to accommodate upgrades for Oracle hosted InForm trials. This provisioning is intended for major and minor upgrades for interim periods of up to 12 months. Upon completion of upgrades to Oracle hosted InForm Trial, the server(s) required during the upgrade period will be decommissioned. Provision additional instances and upgrades of Central Designer servers within DECS that are required to accommodate upgrades for Central Designer. This provisioning is intended for major and Page 21 of 39

22 minor upgrades for interim periods of up to 3 months. Upon completion of upgrades to Central Designer, the server(s) required during the upgrade period will be decommissioned. Provide technical support for the Oracle Program as set forth in the Ordering Document. Online training for Central Designer users. The list of available online course(s) for Central Designer is provided in the Oracle Health Sciences Online Training for Oracle Health Sciences InForm Cloud Service Data Sheet. In addition to the activities above, the following activities to provision, set-up and maintain InForm within the DECS apply: Work with You to provision the VPN from DECS environment to Your premise Configure firewall and F5 content switch rules to secure remote access 1 to Your virtual servers and the Oracle database server from Your facilities. Provision Your administrator accounts in operating system Provision Your administrator accounts in database Provide You with access to URI Manager tool Any data migrations between InForm versions and upgrades within DECS are excluded. Deliverables Oracle deliverables for the DECS environment include: o Central Designer software usage that comprises of the required virtual application server setup and hosting, and prerequisite Oracle database. o InForm application software usage that comprises of the required virtual application server test environment setup and hosting and prerequisite Oracle database. You are responsible for the following activities related to DECS: Building and testing the InForm trial design (this includes and is not limited to form design, visit structure design and programming of edit checks) in accordance with Your own standard operating procedures and/or work instructions as well as creating and testing Your own test cases. Ensuring that all users are trained prior to accessing this environment for DECS activities. This includes maintaining all training records. Provisioning and maintenance of all application administrator and user accounts for Your users within the Oracle Programs o Includes provisioning of application accounts for Oracle as required for support o Includes management of password policies and complexity Requesting software upgrades You agree that the DECS environment is not certified under the Health Insurance Portability and Accountability Act (HIPAA) security standard and Oracle shall not be responsible for compliance under this standard. You shall comply with all laws to the extent that such laws are applicable to Your use and receipt of this service. Performance of the InForm application and prerequisite Oracle database will vary based on Your configuration and use. You should use the InForm application and Oracle database consistent with Oracle documentation and recommended practices. 1 Note: Secure remote access currently defined as Hypertext Transfer Protocol Secure (https) and either secure shell (ssh) or terminal service access to the applications and servers in the VLAN. Page 22 of 39

23 In addition to the activities above, You will be responsible for the following activities for InForm within the DECS: Work with Oracle to provision the IPSEC site to site VPN from Your premise to the DECS Provisioning required operating system accounts for Your users using the Oracle provided customer administrator account Provisioning required database accounts (e.g. to deploy trials or load data) using the Oracle provided customer administrator account Deploying InForm Trial servers and enable Trial servers to the Internet via URI Manager Tool Managing InForm Trial servers (start/stop/delete/configure) Managing InForm Trial server system configuration Copying trial metadata design files (e.g. Central Designer deployment package, XML files) to InForm server as needed Maintaining Trial Server data Loading InForm data extracts when desired including transferring extract files, creating trial specific table spaces (as required) and loading data Dropping InForm data in database as required Managing file system space as necessary Do not delete required data Do not restart database or operating systems Do not relax operating system, database, or application security hardening You shall also have the right to download and self-host and use the InForm application and prerequisite Oracle database solely in connection with Your order for DECS. You may not use the InForm application and prerequisite database for any other purpose including deployment of Trials into production. You may not install or configure Cognos Business Intelligence with the InForm application. Your right to use the InForm application and Oracle database shall co-terminate with Your order for DECS and at termination You shall no longer use the InForm application and Oracle database and shall uninstall the InForm application and Oracle database from Your system. You may download the InForm application and prerequisite Oracle database at the following URL: You acknowledge that Oracle is under no further delivery obligation under this Service Description or Your order. You are solely responsible to ensure proper installation and configuration of the InForm application and prerequisite Oracle database and You are responsible for all related costs for configuration and installation. Users of the Oracle Health Sciences Design Environment Cloud Service are authorized to access the following modules: Central Designer InForm and the following InForm integration product o InForm Adapter Note: Use of Cognos reporting with InForm is excluded. Usage Limits: Oracle Health Sciences Design Environment Cloud Service is subject to usage limits based on: One Trial The following usage limits apply per licensed metric: Page 23 of 39

24 Licensed Metric Database Storage (Records) File Storage (GB) Bandwidth Included with License Trial N/A N/A N/A One DECS implementation Service Level Targets: The Oracle Health Sciences Design Environment Cloud Service has the following service level targets: Cloud Service Recovery Time Objective (RTO) Recovery Point Objective (RPO) Target System Availability DECS (Central Designer 90 Days 48 hours 99% component) DECS (InForm component) N/A N/A (data is not stored 99% (infrastructure offsite) only) Oracle Cloud Policies The Oracle Cloud for Industry Hosting and Delivery Policies describe and govern the Central Designer components. The Oracle Health Sciences Design Environment Cloud Service, Service Level Guide describes and governs the InForm components. Both policies are part of the Service Specifications of Your order and may be viewed at Service Descriptions for Configuration Services InForm Cloud Service Trial Build InForm Cloud Service Trial Build services relate to project initiation and application set-up tasks to ready the InForm application for UAT. The deliverables for InForm Cloud Service Trial Build services 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: Specifications These are written by the Oracle project team to document the design of the InForm application configurations. Specifications may include EDC form content, rules and edit checks, InForm application configurations, and database requirements. 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. Page 24 of 39

25 Team List This document is created and maintained by the Oracle Project Manager. It describes the Oracle team members, their responsibilities, and their contact information. Configuration Oracle will configure or build Trial components in support of the mutually agreed Trial requirements. Oracle will conduct an independent test of Your Trial by testing Study components against the mutually agreed Trial requirements UAT (up to 1 round) 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 Your findings. 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 the Trial in Your Production instance. Fixes to the Production InForm Application Related documents are created by Oracle and approved by You. Your responsibilities for InForm Cloud Service Trial Build are dependent upon the components included in the project. Examples include but are not limited to: Testing the InForm application (UAT) in accordance with Your own standard operating procedures and/or work instructions as well as creating and testing Your own test cases. This includes capturing UAT feedback that is clear, reproducible, and actionable in the Oracleprovided template. If changes are introduced following finalization of the documented requirements, the change management process will be followed (including additional fees and time, as appropriate). Delivering clear and complete requirements in accordance with the agreed timeline planning. These may include form, edit check, Trial configuration, and database requirements. 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 (e.g. requirements discussion and UAT, etc.). Ensuring that all key stakeholders, decision-makers, and team members adhere to the agreed timelines. Ensuring requirements meet the regulatory needs for the Trial. Reviewing and approving documents related to Production InForm application changes and fixes. InForm Cloud Service Trial Build Assumptions: A Form is considered to be reused from a client library or previous InForm Trial when no changes are required. There are certain updates that can be made to a re-used form (at the discretion of the Oracle form designer): updating the year range for a date field deleting items that do not impact rules, reports or integrations, or minor updates to text that do not impact rules, reports or integrations. The quantities stated in the Study Order for Total, Unique and Re-Used ecrf pages and for Rules represent Oracle s estimate of the effort involved to build the ecrf based on the parameters that You provided to Oracle prior to execution of the Study Order. A different combination of forms, rules and re- Page 25 of 39

26 use may be necessary as the Trial build proceeds, and this may require additional effort. You agree to enter into a Change Order with Oracle for any such additional effort, which must be executed prior to Trial go-live. InForm Cloud Service Study Project Management Applies either to Trials built by Oracle or to Trials Built by You. InForm Cloud Service Study Project Management provides project management services for an InForm SaaS Trial during the Services Period. Project Management services include coordination of professional services requests and communications and Trial project planning (project plan containing key milestones to be mutually agreed with You). InForm Cloud Service Study Project Management specifically excludes contractual additions, such as Change Orders A Project Manager will be assigned as the primary contact to You for Services activity. InForm Cloud Service Study Project Management and Advisory Services Study Project Management and Advisory Services applies either to Trials built by Oracle or to Trials built by You. Oracle will provide these Services up to the number of hours contracted in the Study Order. Once the number of hours purchased has been utilized, additional hours may be purchased. Hours not used on or before the end of the Services Period expire without refund and are not available for future use by You. Hours are restricted to Services performed by Project Management (PM), Design Consultant (DC) & Technical Consultant (TC) roles. InForm Cloud Service Study Project Management and Advisory Services may include assistance with the following as mutually agreed: o Assisting You with questions regarding: Trial design, form design, workflow and rule design, deployment packages, data extract setup and data extract usage. PM services may include coordination of professional services requests and communications, project planning and project status reporting. A PM will be assigned as the primary contact to You for Services activity. Assumptions: o Services will be delivered from the location of the Oracle staff employee. o Services can be applied only to the specific Trial contracted for in the Study Order. o You must request use of these hours is via the project manager assigned to the Trial. Oracle requires lead time of at least 2 business days to respond to a request for consumption of these hours. Study Project Management and Advisory Services specifically excludes: o Customizations related to the Trial build. o Change Orders related to the Trial build. Page 26 of 39

27 Central Coding Configuration For the configuration of Central Coding with one (1) InForm integrated Trial, Oracle will provide the following services that apply to most projects: Initial set-up including defined rights and roles. Demonstration of the Central Coding application for use during requirements gathering and specifications. In coordination with You, documentation of requirements in the Central Coding Configuration Specification for the setup and integration of one (1) InForm Trial with Central Coding. Configuration of the Central Coding application in the two environments, one for user acceptance testing (UAT) and one for live, based on the Configuration Specification including: Coding Algorithm Coding definitions for up to two standard coding dictionaries Assignment rules based on the agreed specification for coding work teams Configuration of synonym lists and stopword lists Configuration of one (1) integrated InForm Trial with the InForm Adapter and associated Central Coding job scheduler and Configuration of a version of MedDRA and WHODD standard dictionaries in the Central Coding application (subject to Your separate licensing requirements for such dictionaries). Standard dictionary upgrades of MedDRA and WHODD up to two (2) times per calendar year per mutually agreed schedule. This includes any required impact analysis in preparation for an upgrade assuming total Oracle effort per upgrade does not exceed 32 hours. Central Coding version upgrades per mutually agreed schedule. Any Central Coding mappings required for the InForm Cloud Service Trial Build will be the responsibility of the party building the Trial, which may be Oracle for InForm on-demand Trials where Trial build services are ordered in the applicable Study Order or Enterprise customers who are responsible for Trial builds. Lab Normals Management Tool Configuration The Lab Normal Management Tool (LNMT) for InForm is an application that allows sponsors to compare lab Data entered into InForm with lab normal ranges. The association of subject lab results and the defined Lab Normal Ranges is specific to the studiestrials leveraging the LNMT Integration application. A common ecrf design practice must be used in designing the lab ecrf s for the data capture of the lab data. In conjunction with the ecrf design, a set of edit checks that are Trial specific are used to auto generate InForm queries. LNMT then supplies the functionality to extract the lab results data from the InForm ecrf s, compare them against the predefined normal ranges, and insert/update the results back to the original InForm ecrf. This is an automated process that is scheduled to run in batch. The batch can be scheduled to run as frequently as hourly. Formatted: Space After: 2 line Prerequisites: ecrfs must be designed using LNMT specifications Page 27 of 39

28 All Lab Tests and Units are pre-identified for each Trial for entering normal ranges through the LNMT User Interface. 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 LNMT Application. Specifications These are written by the Oracle project team to document the design of the LNMT Application 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. Configuration - Configure LNMT Application components 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 LNMT Application. UAT (up to 1 round) o Install and configure the LNMT Application 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 LNMT Application in Your Production instance. Fixes to the Production LNMT Application Related documents are created by Oracle and approved by You. Decommission - Provide associated project documents to You. This will include a copy of the Study Lifecycle Records pertaining to the LNMT Application configuration. 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 LNMT Application with draft requirements. This latter approach may be subject to additional fees. 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 LNMT Application specifications, UAT, etc.). Page 28 of 39

29 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 LNMT Application for release to UAT and for release to go-live. Testing the LNMT 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). Ensuring that all users are trained prior to accessing the system. This includes maintaining all training records. Reviewing and approving documents related to Production LNMT Application changes and fixes. InForm Integrations Configuration - Standard File-Based Integration* * Previously named Integrated Voice Response System (IVRS) The Standard File-Based Integration for InForm integrates InForm Trials with external systems via a flat file transfer. This feature requires coordination between the Study Sponsor, Vendor or other source of electronic data and Oracle. There are three possible configurations of the Standard File-Based integration; inbound integration, outbound integration and two-way integration. Inbound integration is importing Data from the external system to InForm via a flat file. Outbound integration is exporting Data from InForm and transferring it to the external system or to You via a flat file. Two-way integration includes inbound and outbound integration. The Inbound process encompasses the import data flow from the external system to the InForm Service. The process consists of the following steps: 1. Site users will enter Data through the external system; such as creating and randomizing subjects, adding or updating clinical Data for a subject via the telephone or web interface. 2. Once this information is submitted, the external system will initiate a process to extract the Ddata into an Oracle specified Data format (MedML or pipe-delimited format) and transmit those files across an sftp connection to the Oracle hosted sftp server. 3. Once the Data is received at Oracle, the Data is thereafter recorded into the InForm Trial database. 4. InForm users can now view this Data within InForm. The Outbound process of encompasses a single data flow between the external system and InForm system where InForm is the sending system. The process consists of the following steps: 1. Site users will enter Data into the InForm system. 2. Once this Data is submitted, InForm will generate a data file (in an agreed upon format) and transmit the files across a secure sftp connection to the Oracle hosted sftp server. 3. The Data is thereafter received and processed by the external system. The Two-way integration process consists of both the Inbound and Outbound processes configured on a single Trial. Page 29 of 39

30 Prerequisites Specifications for Data to be loaded must be incorporated into the Trial and form layout at the beginning of the InForm Trial project. Coordination is required between Study Sponsor, the external system vendor, and Oracle. Oracle will use reasonable efforts to coordinate with the external system vendor, but You are ultimately responsible for interacting with such vendor. Upload of Data files to a secure server from the external Vendor system is necessary. In addition, manual review and correction of rejected files by You and the external system vendor is required. Inbound data files must match the format described by Oracle. Outbound data file format must be mutually agreed upon. Assumptions & Limitations Pricing includes the integration of a maximum of 20 data fields spread across up to 5 unique InForm Forms. You must ensure that the external system vendor adheres to the approved Configuration Specification, and provides necessary files for UAT testing. Performance is dependent on the number and size of files being imported in a given interval. You (and the external system vendor) are responsible for correcting and resubmitting rejected records if records are rejected due to Trial or external system problems. Data File Requirements The following requirements must be met for all Data files generated by the external system vendor and transferred to Oracle for import into InForm. Data files must be formatted according to the Oracle s MedML file format or pipe-delimited format (Screening, Enrollment and Patient Transfer cannot be done using pipe-delimited format). Data files should contain incremental records. Separate Data files must be created for each Trial visit-form combination. For example, if there are two forms that will receive uploaded Data for a given Trial, the vendor will create two separate Data files for transfer to Oracle. If the same form is used for several visits, a separate data file is required for each instance of this form. Record must contain the Subject number, Subject initials (or equivalent of what is collected if initials are not used), and site number in order to be loaded. Record will be rejected if Subject number, Subject initials or site are incorrect or if Subject is not enrolled. Screening failures can be loaded if identified. MedML format has tags to accommodate screening, enrollment, adding patient data, editing patient data and transferring patient. Examples of each are outlined below. MedML format has a tag called DUPLICATEORDER which is a number specifying the order in which patients with the same patient initials are enrolled. This tag is required when two or more patients with same initials are present at a site. The value of this tag can be supplied by the Vendor, OR automatically calculated by the external application. Example for this is outlined below. If the external system will generate the DUPLICATEORDER value, there is a requirement that screen and enroll transactions must be sent within the same file. Page 30 of 39

31 File Naming Conventions Data files sent by the external system vendor to Oracle must adhere to specific file naming convention in order to satisfy the following requirements for uniqueness and the order of processing. Many files may be received into one directory on the specified Oracle sftp server from the external system, Many files may be received at the same date/time. Files for a given Subject must be processed in a specific order (ex. Adding data to demography before inclusion/exclusion.) Data Transfer Procedure All Data transfer procedures documented here 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 in this document. The external system must transmit the MedML data files across a secure SFTP channel to the specified Oracle sftp server. Data will be sent to a Study specific inbound folder on the Oracle sftp server. The folder structure will adhere to the Oracle standard. A Windows service on the system that hosts the InForm Trial will poll the folder on the Oracle sftp server for any new Data files. Once a file is found, the file will be copied from the Oracle sftp server, processed and loaded into the appropriate InForm Trial. The audit information for the import and a copy of the original Data file will be maintained in persistent data storage, and viewable on the Log Viewer page within the InForm Portal. Secure FTP (sftp) Access All Data file access must be done using sftp in accordance with the Oracle Cloud for Industry (OCI) Secure Data Transmission Standard. Changes to the OCI Secure Data Transmission Standard supersede any file access mechanisms described in this document. External system vendors must have a supported sftp client to login to Oracle s hosted sftp server at sftp.webcrf.net and transmit files. Oracle currently supports the following sftp clients: SecureFX from Vandyke Software (preferred client) WS_FTP Pro Version 9 from IPSwitch Putty Command line client Win SCP External system vendors will be granted named user accounts with access privileges to the appropriate Trial folders. Accounts will be created according to Oracle s SFTP Service Policy. External system vendor user accounts can access multiple Trial folders. If a vendor account is associated with more than one Trial folder, then the vendor s transfer process will be required to navigate to the appropriate folder after login. This navigation can be done through use of the appropriate commands depending upon the sftp client. Page 31 of 39

32 Error Handling Oracle SFTP Server SFTP provides authentication, Data compression and file integrity algorithms to help confirm that the file received is the same as the file that was sent. If there is a connectivity issue to the Oracle sftp server (either from the external system vendor or from the InForm server), then Oracle Customer Support may assist with resolution. InForm Import In terms of importing Data into InForm, audit logs will be generated for every import indicating success or failure. The audit log along with the copy of the Data file will be stored in persistent Data storage, and viewable on the Log Viewer page within the InForm Portal. 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 Standard File-Based integration. Specifications These are written by the Oracle project team to document the design of the Standard File-Based integration configuration. Specifications may include external to InForm form Data element mappings, Data types, Data element restrictions, and notification information. 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. Configure Standard File-Based integration components as defined in the requirements and integration specifications. Testing o Perform smoke testing to validate the designs. o Document the test cases needed for this configuration, and perform formal testing of the Standard File-Based Integration. o Conduct an independent validation of the Standard File-Based integration configuration by testing components against approved specifications. UAT (up to 1 round) o Install and configure the Standard File-Based integration Application 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 Standard File-Based integration Application in Your Production instance. Fixes to the Production Standard File-Based integration Application o Related documents are created by Oracle and approved by You. o Update the UAT instance with a fresh extract of the Production instance and configuration of the Standard File-Based integration only if required, each time a Trial fix or Trial Change Order needs to be tested. o Your use and Oracle s maintenance of the UAT instance is limited to the implementation of fresh extracts when a Trial fix or Trial Change Order related activities are required. Page 32 of 39

33 Decommission Provide associated project documents to You. This will include a copy of the Study Lifecycle Records pertaining to the Standard File-Based integration configuration. 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 integration with draft requirements. This latter approach may be subject to additional fees. 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 Standard File- Based integration 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 Standard File-Based integration for release to UAT and for release to go-live. Testing the Standard File-Based 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 Standard File-Based integration changes and fixes. You are responsible for managing the relationship and communication with the IVR Vendor that is necessary to implement the Standard File-Based integration. InForm Integrations Configuration - Direct Data Loader (DDL) ** ** DDL no longer available for purchase from August 2014 The Direct Data Loader (DDL) for InForm ITM is designed to facilitate the loading of Ddata files received from third party vendors directly into the InForm ITM Reporting Database. DDL accepts flat files via Oracle s sftp server, processes those files and imports the Ddata into the InForm reporting database. The imported Ddata is accessible via InForm ad-hoc reports, custom reports, and reporting database extracts. DDL file processing and loading consists of the following steps: Page 33 of 39

34 Data files from external vendors must be uploaded to a designated sftp directory on the Oracle sftp server for each Trial. The DDL Service detects each uploaded file and moves it into the processing queue. Files are processed in a FIFO manner. File processing includes preliminary checks and any errors found during the preliminary checks are logged and made available to Users via the DDL user interface. After the preliminary checks are run and erroneous records are filtered out, the remaining Data is loaded into InForm Reporting. notification can be configured to report the load status to a predetermined list of addresses. Loaded Data is accessible via InForm ad-hoc reporting, custom reports, and reporting database extracts. Records that fail to load are logged and accessible via the DDL administration tab within the InForm portal. Prerequisites Coordination is required between You and the third party vendor to ensure the Data files provided adhere to the DDL external Data file requirements and are consistent with conventions agreed upon between You and the vendors. Specifications for Data to be loaded must be incorporated into the Trial and form layout. Assumptions & Limitations External Data will not be loaded into InForm core. o Loaded Data will not be viewable within ecrfs o Sites will not see Data in InForm o Rules will not be applied to Data o The loaded Data will be available within the Clinical Data Model for reporting purposes (both AdHoc and Custom) using the InForm Reporting functionality o The loaded Data will be available within the InForm reporting database extract. DDL does not provide facilities for editing Data all corrections will be the responsibility of the Data supplier. DDL will display only the latest Data loaded from a Data provider in reporting. There will not be an audit trail in InForm reporting. DDL pricing includes the integration of a maximum of 5 distinct Data file formats and associated ecrf s. A maximum of 10 historical Data files may be archived for retention purpose. (This does not include Data imported into the reporting database) Performance is dependent on the number and size of files being imported in a given interval. If You/data file supplier cannot meet the DDL base requirements, Oracle may provide programming services at additional cost. Data File Requirements The following requirements must be met for all Data files generated by the Data file supplier and transferred to Oracle for import by DDL. Data files must be received in ASCII text format. If a file is compressed in zip format then the zip file must contain single Data file without any directories/folders. (The optional compressed file password will be configurable within the application.) Page 34 of 39

35 A Data record must only exist on a single line. A field delimiter is configurable within the application. Most common delimiters are pipe " " and comma "," with optional quotes for values that contain comma within text. Empty fields in a record must be designated by two consecutive delimiters. Every record must contain the same number of fields. Each Data record in the Data file must contain fields that constitute a key to uniquely identify each record. Data file may be cumulative (All unchanged, changed and new records must exist in the Data file to be uploaded.) Data file may be incremental (The incoming file will contain records that were created, changed, or deleted between the last and current Data transfers. Records that were not included in the incremental transfer are assumed to be unchanged by the application.) The application supports transaction type flags with each Data record signifying Insert, Update, Delete, and Retransmit transactions. This will allow support for incremental CDISC transfers where transaction flags are: o "I" for Insert o "U" for Update o "M" for Delete o "R" for Retransmit When a transaction specified by a transaction type flag cannot be performed then an error will be generated. The application optionally can process Insert and Delete transactions sent in the same Data file. Data types supported are: Text, Integer, Float, and Date File Naming Conventions Data files sent by the Data file supplier to Oracle must adhere to specific file naming conventions in order to satisfy the requirements for uniqueness and the target destination for processing. The Data file name must be ASCII case insensitive. A file name must contain the EDT name separated from the other file name components by an underscore. Enforcing the existence of the Trial name within the file name can be optionally selected by setting an appropriate configuration setting. Data Transfer Procedure All Data transfer procedures documented here 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 in this document. The Data file supplier must transmit the Data files across a secure SFTP channel to the specified Oracle sftp server. Data will be sent to a Trial specific folder on the Oracle sftp server. The folder structure will adhere to the Oracle standard. The DDL Windows Service on the machine that hosts the InForm Trial will monitor this folder on the Oracle sftp server for any new Data files. Once a file has completed uploading it will be copied from the Oracle sftp server, processed and loaded into the appropriate Trial specific DDL Data repository. The Page 35 of 39

36 compressed version of the original Data file will be archived in persistent Data storage, and viewable on the DDL Log Viewer page within the InForm portal. Secure FTP (sftp) Access All Ddata file access must be done using sftp in accordance with the Oracle Cloud for Industry (OCI) Secure Data Transmission Standard. Changes to the OCI Secure Data Transmission Standard supersede any file access mechanisms described in this document. Each instance will be associated with a secure FTP location unique to each Vendor or Data file type for the delivery of Ddata files to be imported by DDL Data file suppliers must have a supported sftp client to login to Oracles hosted sftp server at sftp.webcrf.net and transmit files. Oracle currently supports the following sftp clients: SecureFX from Vandyke Software (preferred client) WS_FTP Pro Version 9 from IPSwitch Putty Command line client Win SCP All Data file suppliers will be granted named user accounts with access privileges to the appropriate Trial DDL folders. Accounts will be created according to Oracle s SFTP Service Policy. Data supplier user accounts can access multiple Trial folders. If a data supplier account is associated with more than one Trial folder, then the Data supplier s transfer process will be required to navigate to the appropriate folder after login. This navigation can be done through use of the appropriate commands depending upon the sftp client. Error Handling Oracle SFTP Server SFTP provides authentication, Data compression and file integrity algorithms to help confirm that the file received is the same as the file that was sent. If there is a connectivity issue to the Oracle sftp server (either from the Data supplier or from the InForm server), then Oracle Customer Support may assist with resolution. DDL Import For the import of Data into DDL data repositories in the reporting database, audit logs will be generated for every import indicating success or failure. The audit log along with the copy of the Data file will be stored in persistent Data storage, and viewable on the DDL Log Viewer page within the InForm portal. The application can be configured to send notifications for success and error. 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: Page 36 of 39

37 Data Requirements These are written by the Oracle project team to document Your specific Data file configuration needs for the DDL Integration. It will also include the necessary external Data type definitions necessary to accommodate the DDL Integration. Vendor Requirements These are written by the Oracle project team to document the vendor specific configuration needs for the DDL Integration including user access and notification options. Generate design specifications from Your-supplied requirements. 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. Configure DDL components as defined in the design specifications. o Create Study ecrf configurations corresponding to the specified Data file(s). o Create external Data type specification files (EDTs) corresponding to the specified Data file(s). Create secured FTP file directories according to the configuration specified in the Vendor specification requirements document. Testing o Perform smoke testing to validate the designs. o Document the test cases needed for this configuration, and perform formal testing of the DDL Application. o Conduct an independent validation of the DDL Application configuration by testing components against approved specifications. UAT (up to 1 round) o Install and configure the DDL Application 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 DDL Application in Your Production instance. Fixes to the Production DDL Application o o Related documents are created by Oracle and approved by You. Update the UAT instance with a fresh extract of the Production instance and configuration of DDL only if required, each time a Trial fix or Trial Change Order needs to be tested. o Your use and Oracle s maintenance of the UAT instance is limited to the implementation of fresh extracts when Trial fix or Trial Change Order related activities are required. Archival Documentation This is a package of documentation that was maintained by Oracle during the course of the Trial. After the DDL application is decommissioned, this package is sent to You for archiving. Your responsibilities for a given project are dependent upon the components included in the project. Examples include but are not limited to: You are responsible for managing the relationship and communication with the Data file supplier(s). You and Data file suppliers are responsible for correcting and resubmitting rejected records if records are rejected due to Trial or Data supplier oversights. Delivering clear and complete requirements in accordance with the agreed timeline planning. These may include form, Trial configuration, and database requirements. If final requirements are not available, You and Oracle may mutually agree to begin Trial design with draft requirements. This latter approach may be subject to additional fees. Providing input into the creation and maintenance of the project plan as requested by the Oracle Project Manager. Page 37 of 39

38 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 DDL 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 design specifications in a timely manner. Acceptance of the configured DDL application for release to UAT and for release to go-live. Testing the DDL 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). Ensuring that all users are trained prior to accessing the system. This includes maintaining all training records. Managing and overseeing third party vendors (i.e., lab vendors, Your external partners, etc.). Reviewing and approving documents related to Production DDL application changes and fixes. Database Extracts These database extracts may be used by You to analyze and report on Your Data captured by the configured DDL application. It is Your responsibility to request an export online and to download it to a secure location. CRF Submit Additional Runs Deliverables and Customer Dependencies The deliverables are dependent upon the requirements. Some common deliverables that apply to most requests include: Requirements These are written, with Your input, by the Oracle project team to document Your needs. Trial Data in either an Archive Portable Data Format ("PDF") file or a Submission Ready PDF file, as specified by You in the requirements document. o These are intended to document the Data as it existed at the time the Trial was locked in the Production instance of the configured InForm Trial. o 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 Service. Your responsibilities are dependent upon the requirements. Examples include but are not limited to: Delivering clear and complete requirements in accordance with the agreed timeline planning. You must complete and return to Oracle a CRF Submit requirements document for each request for PDF files to select required Data elements to be included in the files and selection of output types. Distributing archival PDFs and Trial Archival Package (TAP), as appropriate. Page 38 of 39

39 Acceptance of Deliverables Upon Oracle s completion of any deliverable, You will be responsible for any additional review and testing of such deliverable in accordance with any mutually agreed review criteria or test scripts. If the deliverable does not conform with any such review criteria or test scripts, You will have five (5) business days after Oracle s submission of the deliverable ( Acceptance Period ) to give Oracle written notice which shall specify the deficiencies in detail. Oracle will use reasonable efforts to promptly cure any such deficiencies. After completing such cure, Oracle will resubmit the deliverable for Your review and testing as set forth above. Upon accepting any deliverable submitted by Oracle, You must provide Oracle with written acceptance of such deliverable. If You fail to provide written notice of any deficiencies within the Acceptance Period, as provided above, such deliverable will be deemed accepted at the end of the Acceptance Period. Page 39 of 39