Oracle Health Sciences. InForm Direct Cloud Service Service Descriptions and Metrics

Transcription

1 Oracle Health Sciences InFrm Clud Service Service Descriptins and Metrics December 14, 2017 Table f Cntents Metric Definitins... 2 Patient... 2 Site... 2 Trial... 2 Service Descriptins fr Clud Services... 3 Oracle Health Sciences InFrm Clud Service, InFrm Direct Clud Service per Trial... 3 Clud Service Set Up... 3 InFrm Clu d Service... 3 InFrm Direct Clud Service Oracle Health Sciences InFrm Clud Service End User Help Desk per Site Oracle Health Sciences InFrm Clud Service Central Cding Per Trial Oracle Health Sciences InFrm Clud Service Medicatin Adherence Insights (MAI) per Patient per Trial Oracle Health Sciences Design Envirnment Clud Service (DECS) per Trial Service Descriptins fr Cnfiguratin Services InFrm Clud Service Trial Build per Trial InFrm Clud Service Study Prject Management per Trial InFrm Clud Service Study Prject Management and Advisry Services per Hur per Trial Central Cding Cnfiguratin per Trial Lab Nrmals Management Tl Cnfiguratin per Trial InFrm Integratin Cnfiguratin Standard File-Based Integratin* per Integratin per Trial InFrm CRF Submit Additinal Runs Each Acceptance f Deliverables Retired Offerings Oracle Health Sciences InFrm Multi-Trial Hsting per Trial [RETIRED] InFrm Integratins Cnfiguratin Direct Data Lader (DDL) ** [RETIRED] Oracle Health Sciences InFrm Clud Service Lab Nrmals Management Tl (LNMT) [RETIRED] Oracle Health Sciences InFrm Clud Service InFrm Integratin [RETIRED] Oracle Health Sciences InFrm Clud Service Service Descriptins Page 1

2 Metric Definitins Patient Patient is defined as a persn receiving healthcare related treatment such as receiving drugs, medical devices r alternate treatment/therapies and/r enrlled/participating in a clinical study. Fr the purpses f licensing, the maximum number f Patients enrlled in the study must be cunted. The quantity stated fr Patients excludes screen-failed patients (i.e. patients wh have nt received medicatin). The terminlgy Patient is used interchangeably with Subject. Site Site is defined as a single lcatin frm which the Service will be accessed (e.g., an investigatr site r a custmer lcatin). Trial Trial is defined as each research prject, study r prcedure created, mdified, tracked and/r cnducted by a spnsr using the Oracle prgram(s) r Service(s). Regulatry Cmpliance Infrmatin n Oracle s practices fr certain regulatry standards applicable t the Oracle Health Sciences InFrm Clud Services r delivery f Trial Build and Cnfiguratin Services as described in this Service Descriptin may be viewed at supprt.racle.cm. References therein t Oracle's design, develpment, testing, r validatin as they relate t Trial Build and Cnfiguratin Services apply nly where Yu have rdered Trial Build r ther Cnfiguratin services frm Oracle. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 2

3 Service Descriptins fr Clud Services Oracle Health Sciences InFrm Clud Service, InFrm Direct Clud Service per Trial Clud Service Set Up Yur InFrm Services envirnment will be deplyed in a hsting facility and will be maintained and managed by Oracle. The deplyment f the Services envirnment will cnsist f an instance fr prductin use ( Prductin instance ), a nn-prductin instance fr user acceptance testing ( UAT instance ), and if requested by Yu, a nn-prductin instance fr training ( Training instance ). The Prductin instance is the instance which will be used t capture the clinical data ( Data ). Data may be referred t as Yur Cntent in Yur respective agreement with Oracle fr the clud services. The UAT instance will be used t perfrm user acceptance testing prir t prductin g-live and will be used t test changes and fixes after prductin g-live. The Training instance may be used by Yu t cnduct training in additin t the nline training prvided. Yu may als cntact Oracle fr additinal training ptins fr which there may be additinal cst. Mre infrmatin is available here. InFrm Clud Service InFrm Clud Service - Users and Access by Users Yur use f the Services is limited t persnnel related t Yur Trial as authrized by Yu. Nrmally this cnsists f tw main grupings f persnnel: spnsr and Site. The spnsr grup typically cnsists f persnnel frm Yur cmpany and may als include ther sub-cntracted persnnel (such as Cntract Research Organizatin persnnel, mnitrs, and data managers). The Site persnnel typically cnsist f the Site crdinatrs (clinical research crdinatrs) and study investigatrs (principal investigatrs and sub-investigatrs). Identity and Access Management Service (IAMS): Oracle Health Sciences Identity and Access Management Service (IAMS) prvides Oracle single sign-n (SSO) functinality fr InFrm Clud Service fr IAMS-enabled versins f InFrm. IAMS manages identity and access requests by Users and rles. IAMS uses carse-grained authenticatin t evaluate if Users have been assigned privileges t pen an InFrm page that they are trying t access. Fr IAMS-enabled versins f InFrm, Users may access an InFrm page t which they are prvided privileges using a single sign-n accunt. Once an InFrm page is accessed by a User using a single sign-n accunt, the User will autmatically be signed int such InFrm page fr future access. IAMS is supprted fr develpment, UAT, and Prductin instances in newly deplyed envirnments f InFrm 6.1 r later. IAMS will nt be supprted fr Training instances. Fine-grained privilege access cntrl features may be accessed thrugh the InFrm prgram as described in the InFrm prgram dcumentatin. InFrm Clud Service - Deliverables and Custmer Dependencies The deliverables fr a given prject are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables and entitlements listed belw. Sme cmmn deliverables and entitlements that apply t prjects include: Validatin Package If Yu build Yur wn Trials, this dcumentatin may be used by Yu t perfrm Installatin Qualificatin (IQ), Operatinal Qualificatin (OQ) and/r Perfrmance Qualificatin (PQ) fr the InFrm prgram. It is Yur respnsibility t request the package frm Oracle if desired. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 3

4 InFrm Prgram Release fr UAT This is the initial release by Oracle f the cnfigured InFrm prgram in the UAT instance f Yur InFrm Services envirnment that Yu may use t cnduct user acceptance testing activities. InFrm Prgram Release fr G-Live This is the release by Oracle f the cnfigured InFrm prgram in the Prductin instance f Yur InFrm Services envirnment that Yur apprved Users may access. Database Extracts These database extracts may be used by Yu t analyze and reprt n Yur data captured by the cnfigured InFrm prgram. It is Yur respnsibility t request an exprt nline and t dwnlad the exprt. Authrized Users may btain a database extract in ne f tw ways: Archives fr Yur Trial Practively lg int InFrm and generate an extract as needed Request Oracle t schedule the extract generatin Yu may request up t nce per day fr Yur Trial in this manner InFrm Trials with Archive Generatr Fr InFrm Trial(s) with Archive Generatr enabled n the InFrm Prtal, Yu and Yur Sites must request and dwnlad any archive PDFs, archive reprts, and study submissin PDFs ( Archive Generatr Files ) that Yu r Yur Sites may require fr Yur Trial thrugh Archive Generatr. Yu, and Yur Sites, are respnsible fr fulfilling the bligatins stated in the Services Descriptin with regard t requesting and dwnlading Archive Generatr Files thrugh Archive Generatr. There is n limit n the number f self-service dwnlads which may be requested by Yu and Yur Sites thrugh Archive Generatr during the Trial up t Yur Request fr Decmmissin. Files created using Archive Generatr will be deleted r therwise rendered inaccessible by Oracle upn the earlier f 120 days after they were generated r decmmissining f the Clud Service. The Archive Generatr Files will nt be available fr dwnlad after such time. Additinally, Archive Generatr, including the Archive Generatr Files, will nt be available after decmmissin. Yur Request fr Decmmissin cnfirms bth Yur and Yur Sites acceptance f the Archive Generatr Files. InFrm Trials withut Archive Generatr Fr InFrm Trial(s) withut Archive Generatr enabled n the InFrm Prtal, Yu may request that Oracle generate Yur PDFs up t tw times during the Trial thrugh Yur Request fr Decmmissin. Oracle may generate and deliver the PDFs t Yu n encrypted physical media. Yu, and Yur Sites, are respnsible fr fulfilling the bligatins stated in the Services Descriptin with regard t requesting PDFs. These archive files are intended t dcument the Data as it existed in Yur Prductin instance f the cnfigured InFrm prgram. Generatin f additinal set(s) f utput with different utput requirements, such as a subset f Data fr auditing purpses, is nt cvered by this Services Descriptin and must be rdered separately. Online Training fr Named Trials fr InFrm Users and fr User Management Tl (UMT) Users The list f available nline curses is prvided in the Oracle Health Sciences Online Training fr Oracle Health Sciences InFrm Clud Service Data Sheet User Management Tl (UMT) Nn-Prductin Envirnment The latest generally available release Oracle Health Sciences InFrm Clud Service Service Descriptins Page 4

5 f UMT will be released in the UMT nn-prductin envirnment prir t release in the UMT prductin envirnment. Yur UMT Users are entitled t access the latest generally available release f UMT in the UMT nn-prductin envirnment t try new features, t update spnsr internal standard perating prcedures, and t train spnsr end users t perfrm cmmn trial administratin tasks (including imprt f Users, Sites, and rles) prir t accessing the latest generally available release f UMT in the UMT prductin envirnment. The UMT nn-prductin envirnment has n cnnectivity t InFrm r Identity and Access Management Service (IAMS). The latest GA release f UMT will be deplyed in the UMT nn-prductin envirnment at Oracle s discretin, apprximately three weeks t 60 days prir t release in the UMT prductin envirnment. Clinical Develpment Analytics (CDA) If requested by Yu, Oracle will deply the Oracle Health Sciences Clinical Develpment Analytics (CDA) integratin package int the InFrm Trial database t help supprt integratin f the Trial with cmpatible versins f CDA that Yu have licensed and deplyed utside f the Oracle Clud Services envirnment. Lab Nrmals Management Tl If requested by Yu, Oracle will deply Lab Nrmals Management Tl (LNMT) with Yur InFrm Trial. LNMT must be cnfigured by Yu, r Oracle may assist with Yur cnfiguratin f LNMT fr an additinal fee. InFrm Integratin If requested by Yu, Oracle will deply Standard File-Based Integratins with Yur InFrm Trial. A Standard File-Based Integratin integrates InFrm Trials with certain external systems via a flat file transfer. The integratin(s) must be cnfigured by Yu, r Oracle may assist with Yur cnfiguratin(s) f the integratin(s) fr an additinal fee. Reprt Extractr If requested by Yu, Oracle will deply Reprt Extractr fr Yu t use with Yur InFrm Trial(s). Oracle will initially cnfigure Reprt Extractr t cnnect t up t 200 f Yur InFrm Trials. Initial cnfiguratin may include cnfiguratin f Reprt Extractr fr up t 20 Cgns Reprts r SQL bjects, which must be develped by Yu, r Oracle may assist with Yur develpment f Cgns Reprts r SQL bjects fr an additinal fee. Design f the Cgns Reprts r SQL bjects must cnfrm t Reprt Extractr requirements and specificatins. After initial cnfiguratin f Reprt Extractr by Oracle, Yu will be respnsible fr any further cnfiguratin changes. Maintenance f the Clud Services Oracle will maintain the Clud Services in accrdance with the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, including upgrades. Upgrades are applied per InFrm server and all Trials n the same server are upgraded at the same time. Migratins will be in accrdance with the Oracle Health Sciences Clud Services GA and EOL Dates dcument, which is available at Migratins typically include a Trial mve t a new server. Oracle will crdinate change management requests required fr upgrades and migratins. Maintenance f the Prductin instance Upgrades and migratins are scheduled with Yu and are perfrmed during the maintenance windw. Maintenance f the UAT instance Upn request, Oracle will update the UAT instance with a fresh extract f the Prductin instance each time a change r fix t the InFrm prgram in the Prductin instance requires testing. This invlves remving the UAT instance (including UAT Data) and replacing it with a fresh extract f the Prductin instance cntaining all the Data as it exists in the Prductin instance. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 5

6 Upgrades and migratins are scheduled with Yu and are perfrmed during business hurs fr UAT Trials. Maintenance f the Training instance If requested by Yu, Oracle will set up a Training instance using Trial implementatin files similar t thse used fr the Prductin instance. Yu may request that the Training instance be updated t reflect subsequent changes r fixes within the Prductin instance. Cpying Data frm the Prductin instance t the Training instance is nt allwed. Upgrades and migratins are scheduled with Yu and are perfrmed during business hurs fr Training instances. Prductin instance backups The terms f the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin apply fr the purpse f Prductin instance backups. Backups are nt intended fr and cannt be used fr purpses f archiving a Trial. Oracle will make the fllwing backups f Yur Data hsted by Oracle in the Prductin instance. Daily backups f hsted applicatin system and database files. On fur-hur intervals, backups are made f the Oracle Database Archive files where applicable. Daily replicatin f backups t an ffsite facility. A decmmissining package (i.e. archival Trial database and assciated files related t hsting the Trial Prductin instance including integratins, if any) will be sent t yu after decmmissining. Archival dcumentatin related t Oracle services will be sent t Yu via Oracle sftp peridically during the Services Perid. Yur respnsibilities related t the abve services are dependent upn the cmpnents included in the prject, including but nt limited t: If Yu require a Training instance fr Yur Trial, Yu are respnsible fr requesting that Oracle deply a Training instance. If Yu build Yur wn Trials, (i) the initial Trial build related t prject initiatin and prgram set-up tasks t prepare the InFrm prgram fr user acceptance testing; and (ii) any pst g-live fixes and changes. In accrdance with Yur standard perating prcedures and/r wrk instructins, testing the InFrm prgram (e.g., cnducting user acceptance testing) as well as creating and testing Yur wn test cases. In accrdance with Yur standard perating prcedures and/r wrk instructins, ensuring packages and scripts are adequately tested befre sending them t Oracle fr deplyment n Yur UAT and Prductin instances. Fr any packages r scripts submitted by Yu, it is Yur respnsibility t examine the implementatin lgs fr ptential errr messages and take apprpriate actin. Nte that a successful ticket cmpletin means the script cmpleted with r withut errrs. Fr integratin f Yur InFrm Trials t Clinical Develpment Analytics (CDA), Yu are respnsible fr submitting a request fr the deplyment f the CDA integratin package t each InFrm Trial. Fr CDA deplyed n Yur premise, Yu will als need t prvide necessary netwrk cnnectivity t Oracle Health Sciences InFrm Clud Service Service Descriptins Page 6

7 supprt this integratin (e.g. VPN, MPLS, ther such netwrk cnnectivity) which may need t be rdered separately. Adding Site and User infrmatin int User Management Tl (UMT) and/ r fr the initial creatin f the Sites and Users prviding a cmpleted Oracle template listing the Site and User infrmatin t be laded int UMT. Perfrming testing and training in the UMT nn-prductin envirnment in accrdance with Yur standard perating prcedures and/r wrk instructins as well as creating and testing Yur wn test cases. Ensuring that all users are trained prir t accessing the system. This includes maintaining all training recrds. All Data management activities fr the Trial, including but nt limited t dictinary cding, query reslutin, Serius Adverse Event ( SAE ) recnciliatin, and Trial lck. Managing and verseeing third party vendrs (e.g., lab vendrs, external partners, Yur subcntractrs, etc.). If Oracle will nt supply End User Help Desk supprt then Yu must ensure Yur End User Help Desk vendr is aware they need t administer Oracle users where apprpriate. While InFrm may be used t assist in adverse event ntificatin, InFrm is nt designed t be a cmprehensive safety case handling system. Shuld Yu decide t use the Clud Service fr cllectin and reprting f serius adverse events, Yu remain respnsible fr ensuring that all applicable regulatry bligatins are met. Wrking with Oracle t upgrade the cntract t prvide a dedicated envirnment if nt rdered as such at the utset and Yur usage exceeds the limits defined belw. Archives fr Yur Trial Fr InFrm Trial(s) with Archive Generatr enabled n the InFrm Prtal, Yu and Yur Sites are respnsible fr requesting and dwnlading any Archive Generatr Files Yu and/r Yur Sites may require during the Trial and/r fllwing Database Lck, prir t Yur Request fr Decmmissin. Yu may chse t initiate the creatin f Sites Archive Generatr Files n behalf f Yur Sites, hwever Yu are respnsible fr ensuring that Yur Sites dwnlad their Archive Generatr Files directly using Archive Generatr. Archive Generatr Files will be deleted r therwise rendered inaccessible by Oracle upn the earlier f 120 days after they were generated r decmmissining f the Clud Service. N Archive Generatr Files will be available fr dwnlad after such time. Archive Generatr, and the Archive Generatr Files, will nt be available after decmmissin. Yu are respnsible fr making Yur Sites aware f the services and their bligatins hereunder. If at any time there is a failure in the strage drive that stres Archive Generatr Files and strage cannt be restred after cmmercially reasnable effrt, then Yu are respnsible fr regenerating the files using Archive Generatr. Yur Request fr Decmmissin cnfirms bth Yur and Yur Sites acceptance f the Archive Generatr Files. Yu are respnsible fr ensuring that Yu d nt submit Yur Request fr Decmmissin until Yu and Yur Sites have requested, dwnladed, and Oracle Health Sciences InFrm Clud Service Service Descriptins Page 7

8 reviewed the Archive Generatr Files that Yu and Yur Sites require. It is recmmended that Yu request Database Lck and that the final Archive Generatr Files be requested and dwnladed by Yu and Yur Sites in a manner that permits sufficient time fr review prir t the end f the Services Perid. Yu are respnsible fr executing any extensins t Yur rder that Yu and Yur Sites may require due t Yur failure t submit Yur Request fr Decmmissin by the end f the Services Perid. Fr InFrm Trial(s) withut Archive Generatr enabled n the InFrm Prtal, Yu and Yur Sites are respnsible fr requesting that Oracle generate any PDFs Yu and/r Yur Sites may require during the Trial and/r fllwing Database Lck, prir t Yur Request fr Decmmissin. It is recmmended that Yu request Database Lck and PDFs at least ninety (90) days prir t the end f the Services Perid t allw time fr PDF generatin and Yur review prir t submissin f Yur Request fr Decmmissin. Yu are respnsible fr executing any extensin t Yur rder resulting frm Yur failure t submit Yur Request fr Decmmissin by the end f the Services Perid. Yu are respnsible fr making Yur Sites aware f the services and their bligatins hereunder. Yu are als respnsible fr distributing PDFs, as apprpriate. Reviewing and accepting the fllwing deliverables within sixty (60) calendar days f delivery by returning t Oracle the designated Oracle frms within such acceptance perid. If Yu fail t prvide written ntice f nn-acceptance t Oracle within the acceptance perid, as prvided abve, the deliverables shall be deemed accepted as f the end f the acceptance perid and Oracle may permanently delete r therwise render inaccessible the deliverables and Yur Trial data in Yur instance(s): the decmmissining package relevant archival dcumentatin related t Oracle services Distributing the decmmissining package and archival dcumentatin, as apprpriate. Submitting Yur Request fr Decmmissin prir t the end f the Services Perid. If Yu require additinal time beynd Yur Services Perid, Yu will be required t execute an extensin t Yur cntract. If Yu fail t meet Yur bligatin t submit the Request fr Decmmissin prir t the end f the Services Perid and Yu have nt rdered an extensin t the Services Perid, Yur Trial will be decmmissined upn the end f the Services Perid. If Yu submit the Request fr Decmmissin at least thirty (30) days prir t the end f the Services Perid, then, fllwing Yur written request, Oracle will prvide Yu with a refund f any recurring fees actually paid t Oracle fr the perid fllwing Oracle s receipt f Yur Request fr Decmmissin. If Yu build Yur Trials, Yu are respnsible fr submitting a ticket t request decmmissin. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 8

9 Users f the InFrm Clud Service and InFrm Direct Clud Service are authrized t access the fllwing mdules: InFrm prgram InFrm Adapter InFrm Prtal InFrm Publisher InFrm Reprt Extractr (RE) Lab Nrmals Management Tl (LNMT) User Management Tl (UMT) User Management Interface Usage Limits: The InFrm Clud Service and InFrm Direct Clud Service are subject t usage limits based n: Number f Patients defined in Yur rder The fllwing usage limits apply per licensed metric: Metric Database Strage File Strage Bandwidth Included with Clud Service Patient/Trial standard hsting 25 GB N/A N/A 1 Trial pack (Prductin, UAT, Training *) Patient/Trial dedicated hsting 2,000 GB N/A N/A 1 Trial pack (Prductin, UAT, Training *) * A Training instance will be prvided if requested by Yu. Service Level Targets: The InFrm Clud Service and InFrm Direct Clud Service have the fllwing service level targets: Clud Service Recvery Time Objective (RTO) Recvery Pint Objective (RPO) Target System Availability Oracle Health Sciences InFrm Clud Service 90 days 48 hurs 99% The Service Level Targets d nt apply t the nn-prductin instance(s). The Target System Availability des nt apply in the event f a declared disaster. The Recvery Time and Recvery Pint Objectives d nt apply t custmizatins r third party sftware. Oracle uses cmmercially reasnable effrts t cmplete Cgns reprting installatins within 5 business days frm the date the request is submitted. Third Party License Requirements: InFrm Clud Service includes Cgns reprting in the Prductin and UAT instances. Cgns reprting is nt available fr Training instances. The use f IBM Cgns Reprt Studi is nt included in this service and needs t be licensed by Yu separately. Oracle Clud Plicies The Services are subject t the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, which may be viewed at Oracle Health Sciences InFrm Clud Service Service Descriptins Page 9

10 InFrm Direct Clud Service InFrm Direct is an InFrm Clud Service ffering that excludes reprting. Specifically this excludes: installatin f Cgns in Yur hsted Services envirnment (including access t Cgns custm reprting tl) access t the 28 built-in standard reprts access t reprting Ad hc clinical and peratinal data mdel InFrm Direct Clud Service prvides full access t Data Viewer fr clinical data review and Reprting Data Extract (RDE) fr clinical data analysis. Yu have the ptin t build Yur wn reprts and upn Yur request Oracle can prvide an extract f the Review/InFrm Schema fr this purpse. Yu may als purchase cnsulting services frm Oracle t assist Yu build Yur reprts, including custm reprts. Oracle Health Sciences InFrm Clud Service End User Help Desk per Site Users f the InFrm Clud Service End User Help Desk may use the Services t perfrm the fllwing activities: Rutine User Management InFrm user activatin/inactivatin requests InFrm user terminatin/un-terminatin InFrm Site r user additin r change InFrm user passwrd change Management f UMT accunts Change f InFrm Trial cnfiguratin settings Creatin/change f rights, rles and grups Change f Trial versin InFrm Clud Service End User Help Desk is available in the fllwing languages during nrmal Oracle business hurs in the GMT time zne, except where nted: English (available 24x7) Spanish French German Italian Japanese (available nrmal Oracle business hurs in the JST time zne) Usage Limits: The InFrm Clud Service End User Help Desk is subject t usage limits based n: Number f Sites defined in Yur rder Service Level Targets: The Clud Service End User Help Desk has the fllwing service level targets: Severity Level 1 issues will be respnded t within ne hur f the User lgging a ticket. Fr the purpse f InFrm Clud Service End User Help Desk, Severity Level 1 is a catastrphic issue Oracle Health Sciences InFrm Clud Service Service Descriptins Page 10

11 impacting multiple system Users f an active Prductin system. The issue may be perceived as presenting ptential data integrity risks. Oracle Clud Plicies The Services are subject t the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, which may be viewed at Oracle Health Sciences InFrm Clud Service Central Cding Per Trial Users f Clud Service Central Cding are authrized t access the fllwing mdules r functinalities: Central Cding Central Cding purchased per Trial allws Yur Trial t cnnect t Central Cding fr Yur use f the Central Cding prgram: Fr the exchange f relevant data including verbatim terms indicatin and rute f administratin frm the InFrm Trial T return cdes, terms, cder name, and dictinary used in Central Cding Users and Access by Users The Services may be accessed nly by persnnel invlved in cding activity fr Yur Trial. Oracle will grant User Manager and User Administratr rles fr Central Cding t Yu. Yu will then be able t create individual end user accunts fr Yur persnnel in the Central Cding applicatin. Oracle will nt create individual end user accunts fr Yu. Identity and Access Management Service (IAMS): Oracle Health Sciences Identity and Access Management Service (IAMS) prvides Oracle single sign-n (SSO) functinality fr Central Cding fr IAMS-enabled versins f Central Cding. IAMS manages identity and access requests by Users and rles. IAMS uses carse-grained authenticatin t evaluate if Users have been assigned privileges t pen a Central Cding page that they are trying t access. When accessing Central Cding using a single sign-n accunt, users will autmatically be signed int ther IAMS-enabled HSGBU Clud Services, e.g. the InFrm Clud Service page fr future access. IAMS is supprted fr UAT and Prductin instances in newly deplyed envirnments f Central Cding r later. IAMS will nt be supprted fr Training instances. Fine-grained privilege access cntrl features may be accessed thrugh the Central Cding prgram as described in the Central Cding prgram dcumentatin. Deliverables and Custmer Dependencies Fr a new Central Cding deplyment, Oracle will prvide the fllwing cmmn deliverables that apply t prjects: Tw instances f the Central Cding prgram One nn-prductin UAT instance fr user acceptance testing and ne Prductin instance fr prductin use Central Cding must be cnfigured by Yu, r Oracle may assist with Yur cnfiguratin f Central Cding fr an additinal fee. Validatin Package If Yu build Yur wn Trials and Central Cding integratin, Yu may request frm Oracle a Validatin Package dcument fr Yur Central Cding integratin. The Oracle Health Sciences InFrm Clud Service Service Descriptins Page 11

12 Validatin Package may be used by Yu t perfrm Installatin Qualificatin (IQ), Operatinal Qualificatin (OQ) and/r Perfrmance Qualificatin (PQ) fr the Central Cding integratin. Online training fr Central Cding fr the named Trials fr Central Cding users The list f available nline curse(s) fr Central Cding is prvided in the Oracle Health Sciences Online Training fr Oracle Health Sciences InFrm Clud Service Data Sheet Yur respnsibilities related t the abve services are dependent upn the cmpnents included in the prject, including but nt limited t: It is Yur respnsibility t include Central Cding items (such as dictinary versin, cder/apprver name, etc.) in the InFrm ecrf design requirements fr thse ecrf s that are t be integrated with Central Cding in rder t ensure that the InFrm Clud Service decmmissining package includes all relevant Central Cding infrmatin. A Central Cding database extract is specifically excluded. Third Party Licensing Requirements Yu are slely respnsible fr licensing any dictinaries used (e.g., MedDRA r WHODD) and must maintain a valid license t such dictinaries fr the duratin f the Services Perid. Such dictinaries are cnsidered materials prvided by Yu fr purpses f the infringement indemnificatin bligatins f the applicable agreement gverning use f the Clud Services. Dictinaries need t be licensed separately. Oracle will use reasnable effrts t attempt t verify with the apprpriate licensing authrity (e.g., MSSO r WHO) that Yu have a valid license prir t lading the dictinary in the Central Cding envirnment and n an annual basis. Hwever, this des nt alleviate Yur bligatins t maintain a valid license t such dictinaries. Oracle may suspend access t the Clud Services immediately if Yur dictinary licenses have expired. In such an event, Yu remain respnsible fr payment bligatins hereunder. Usage Limits: This Clud Service is subject t usage limits based n: Number f Trials defined in Yur rder The fllwing usage limits apply per licensed metric: Metric Database Strage File Strage Bandwidth Included with Clud Service Central Cding Trial 60GB N/A N/A ne Prductin and ne UAT instance Service Level Targets: This Clud Service has the fllwing service level targets: Clud Service Recvery Time Objective (RTO) Recvery Pint Objective (RPO) Target System Availability InFrm Clud Service Central Cding 90 days 48 hurs 99% The Service Level Targets d nt apply t the nn-prductin instance(s). The Target System Availability des nt apply in the event f a declared disaster. The Recvery Time and Recvery Pint Objectives d nt apply t custmizatins r third party sftware. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 12

13 Oracle Clud Plicies The Services are subject t the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, which may be viewed at Oracle Health Sciences InFrm Clud Service Medicatin Adherence Insights (MAI) per Patient per Trial The Medicatin Adherence Insights (MAI) ptin fr InFrm integrates Data frm the Prteus Digital Health Feedback System (DHFS) with InFrm Trials. Fr purpses f the InFrm Clud Service, including the MAI, Data frm the Prteus DHFS shall be cnsidered Yur Data. Users and Access by Users Yur use f the InFrm Clud Service, including the MAI and Data frm the Prteus DHFS, is limited t persnnel related t Yur Trial as authrized by Yu. Secure Data Transfer Prcedure Data transfer prcedures between the Prteus DHFS data center and the InFrm Services envirnment cnfrm t the Oracle Industry Clud Secure Data Transmissin Standard. Changes t the Oracle Industry Clud Secure Data Transmissin Standard supersede any Data transfer mechanisms described fr the InFrm Clud Service. Data is transferred frm the Prteus DHFS data center t Yur InFrm Services envirnment via a set f secure (SSL based) and authenticated web service calls. Errr Handling Oracle Medicatin Adherence Insights Web Services If there is a cnnectivity r ther issue between Yur InFrm Services envirnment and the Prteus DHFS data center (fr example due t Prteus web services r due t the InFrm server), then Oracle Custmer Supprt may wrk directly with Prteus fr purpses f reslving the issue. InFrm Imprt After Yu imprt r Data is therwise transferred frm Prteus DHFS int the InFrm Services envirnment, the standard audit lg will be generated t indicate the status f the imprt r transfer. The audit lg, alng with the cpy f the Data file, will be stred in persistent Data strage, and viewable n the Adherence Data Lg Viewer page within the InFrm Prtal. Clud Services Deliverables and Dependencies The deliverables fr a given prject are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: End User Help Desk T supprt MAI fr Yur users f the InFrm Clud Service. MAI Release fr UAT Install the cnfigured MAI integratin in a UAT instance that Yu may use t cnduct user acceptance testing activities. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 13

14 MAI Integratin Release fr G Live Deply the MAI integratin in the Prductin instance. Maintenance f the Clud Services Maintenance f the Clud Services is prvided in accrdance with the service descriptin fr Oracle Health Sciences InFrm Clud Service. Remve the UAT MAI integratin cnfiguratin instance. Decmmissin - Decmmissin and recycle the envirnment. Yur respnsibilities fr a given prject are dependent upn the cmpnents included in the prject. Yur respnsibilities and bligatins include, but are nt limited t: Yu must cntract directly with Prteus Digital Health ("Prteus") fr the Prteus DHFS. Oracle will use reasnable effrts t crdinate with Prteus, but Yu are ultimately respnsible fr interacting with Prteus and ensuring all cmpnents f the Prteus DHFS are available fr usage during the Trial. Enrlling Patients participating in the Trial using the Prteus DHFS Acquiring, frm Prteus, training and supprt f the Prteus DHFS fr Yur Site, persnnel and Patients. Oracle des nt prvide any training and supprt fr the Prteus DHFS. Ensuring n prtected health infrmatin ( PHI ) is placed int Yur InFrm Services envirnment as that term is defined by the Health Insurance Prtability and Accuntability Act ( HIPAA ) f 1996, as amended, unless prir t delivery t Oracle Yu have de-identified the PHI in accrdance with 45 C.F.R (b)(1) ( Statistical De-Identificatin ) r 45 C.F.R (b)(2) ( Remval f Identifiers ). The Prteus DHFS, including maintenance, manufacturing, distributin, and use, is the sle respnsibility f Yu and Prteus. Yu and Prteus are respnsible fr crrecting and resubmitting incmplete, inaccurate r crrupted Data and recrds. Clud Service Assumptins The availability and perfrmance f imprting r therwise transferring Data int InFrm frm Prteus is dependent n Prteus, including the Prteus data center, which can be impacted by Patient interactin with the Prteus DHFS (e.g., nt wearing the patch sensr). MAI Cnfiguratin The Medicatin Adherence Insights (MAI) ptin fr InFrm uses standard integratin capabilities and frms t integrate Data frm the Prteus DHFS with InFrm Trials. MAI Cnfiguratin - Deliverables and Custmer Dependencies The deliverables fr a given prject are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: Requirements Definitins Dcument (RDD) Dcumenting Yur frm requirements related t the MAI integratin. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 14

15 Specificatins Dcumenting the design specificatins f the MAI integratin cnfiguratin. Specificatins may include frm data element mappings, data types, data element restrictins, and ntificatin infrmatin. One design iteratin is included fr the design specificatins. Prject Plan Creating and maintaining a prject plan. It will detail the tasks, timelines, and milestnes that Oracle and Yu are respnsible fr, as applicable. Cmmunicatin Plan Creating and maintaining a cmmunicatin plan that describes the team members, their respnsibilities, and their cntact infrmatin. MAI InFrm ecrf Dcument and implement the standard frms in InFrm t accmmdate the MAI integratin. Cnfiguratin Cnfigure MAI integratin in supprt f the requirements and integratin specificatins. Testing Perfrm smke testing. Dcument the test cases needed fr this cnfiguratin, and perfrm frmal testing f the MAI integratin. User Acceptance Testing (up t 1 rund) Install and cnfigure the MAI integratin in Yur UAT instance. One (1) user acceptance testing findings meeting. Respnd t questins that Yu raise in user acceptance testing. If required, update the MAI integratin and deply the updated cnfiguratin t the UAT instance fr Yu t re-test. If additinal runds f user acceptance testing are required, the Change Order prcess will be fllwed (including additinal fees and time). Deplyment Once user acceptance testing is cncluded, deply the MAI integratin in Yur Prductin instance. Fixes t the Prductin MAI integratin Related dcuments are created by Oracle and prvided t Yu. Yur respnsibilities fr a given prject are dependent upn the cmpnents included in the prject. Yur respnsibilities include but are nt limited t: Crdinating with Oracle with regard t Yur MAI cnfiguratin. Ensuring the MAI cnfiguratin cnfrms t Yur requirements and specificatins. Delivering t Oracle clear and cmplete requirements in accrdance with the agreed timeline planning, including withut limitatin Data mapping, data restrictins, r ntificatins. If final requirements are nt available, Yu and Oracle may mutually agree t begin the cnfiguratin f the MAI integratin with draft requirements, but this apprach may be subject t additinal fees. Specificatins fr Data t be integrated by MAI integratin must be identified and any update required in standard MAI frms must be finalized befre cnstructin f the InFrm Trial. Prviding input int the creatin and maintenance f the prject plan as requested by Oracle. Negtiating in gd faith an estimated timetable fr any revised r additinal milestne dates that are intrduced after the initial timeline agreement. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 15

16 Ensuring that all key stakehlders, decisin-makers, and team members are present and/r invlved with all key meetings and deliverables (i.e., planning and review f the MAI integratin specificatins, user acceptance testing, etc.). Ensuring that all key stakehlders, decisin-makers, and team members adhere t the agreed timelines. Ensuring specificatins meet the regulatry requirements fr the Trial. Acceptance f requirements specificatins in a timely manner. Acceptance f the cnfigured MAI integratin fr release t UAT and fr release t g-live. Testing the MAI integratin (user acceptance testing) t Yur wn standard perating prcedures and/r wrk instructins and fr creating and testing Yur wn test cases. This includes capturing user acceptance testing feedback that is clear, reprducible, and actinable in the Oracle-prvided template. If changes intrduced during user acceptance testing are required, the change management prcess will be fllwed (including additinal fees and time). Ensuring that all users are trained prir t accessing the system. This includes maintaining all training recrds. Reviewing and apprving dcuments related t Prductin MAI integratin changes and fixes. Usage Limits: Medicatin Adherence Insights is subject t usage limits based n: Number f Patients defined in Yur rder The fllwing usage limits apply: Metric Database Strage File Strage Bandwidth Included with Clud Service Patient N/A N/A N/A ne Prductin and ne UAT instance Service Level Targets: The Clud Service has the fllwing service level targets: Clud Service Recvery Time Objective (RTO) Recvery Pint Objective (RPO) Target System Availability Medicatin Adherence Insights 90 days 48 hurs 99% The Service Level Targets d nt apply t the nn-prductin instance(s). The Target System Availability des nt apply in the event f a declared disaster. The Recvery Time and Recvery Pint Objectives d nt apply t custmizatins r third party sftware. Oracle Clud Plicies The Services are subject t the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, which may be viewed at Oracle Health Sciences InFrm Clud Service Service Descriptins Page 16

17 Oracle Health Sciences Design Envirnment Clud Service (DECS) per Trial Yur Oracle Health Sciences Design Envirnment Clud Service (DECS) envirnment will be deplyed in a hsting facility and will be managed by Oracle. The deplyment f the DECS envirnment will cnsist f Central Designer and InFrm. The purpse f this DECS envirnment is t build and test Yur InFrm Trial prir t deplyment t a Prductin instance. The DECS envirnment is nt intended t perfrm in a manner cnsistent with an Oracle Prductin instance designed fr hsting live clinical Trials r live data. Yu may nt lad any prtected health infrmatin (PHI) r similarly sensitive persnal infrmatin that impses specific data security bligatins fr the prcessing f such data int the DECS envirnment. Users and Access by Users Yur use f the DECS is limited t persnnel related t Yur Trial as authrized by Yu. Nrmally this cnsists f persnnel frm Yur Cmpany and may als include ther sub-cntracted persnnel such as Cntract Research Organizatin persnnel. It is Yur respnsibility t ensure that anyne wh is authrized by Yu t access the envirnment has a unique and individual accunt prvisined in rder t enable apprpriate audit trails. Deliverables and Custmer Dependencies Oracle respnsibilities and deliverables under Design Envirnment Clud Service include: Respnsibilities Cnfigure Yur dedicated virtual netwrk (VLAN). Cnfigure firewall and F5 cntent switch rules fr Hypertext Transfer Prtcl Secure (HTTPS) access t Oracle Prgrams. Manage Dmain Name Service (DNS) inside f DECS envirnment Install and cnfigure virtual servers and physical Oracle database servers (where applicable) and the assciated Strage Area Netwrk (SAN) and tape strage devices. Install and cnfigure Infrm and Central Designer and related Oracle database instance. Patch perating system and databases, where applicable. Create table spaces t be used with required applicatins Create perating system and database accunts required t install required applicatins Install and manage Anti-virus sftware n Windws servers Maintain database instance availability Manage database system table spaces Mnitr system availability, file system usage, perating systems, CPU usage, and memry usage Backups Backup media is nt intended fr use as a Trial archive r fr any purpses ther than as a means f data prtectin at a secure ff-site lcatin and t prvide the ability fr recvery activities t ccur in the event f a disaster. Oracle will make the fllwing backups fr the purpses f DECS: Daily backups f hsted applicatin system and database files. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 17

18 Prir t handver t Yu, perfrm DECS envirnment functinal verificatin check after initial prvisining and after upgrades. Prvide Yu with DECS envirnment dcumentatin Perfrm patches and majr and minr upgrades f the Central Designer instance (including data migratin where applicable). Cnduct regular maintenance f the DECS envirnment, including upgrades t new releases f the Oracle Prgrams as described in the Ordering Dcument, including the Service Specificatins, upn request r as determined by Oracle. Prvisin additinal instances and upgrades f InFrm servers within DECS that are required t accmmdate upgrades fr Oracle hsted InFrm Trials. This prvisining is intended fr majr and minr upgrades fr interim perids f up t 12 mnths. Upn cmpletin f upgrades t Oracle hsted InFrm Trial, the server(s) required during the upgrade perid will be decmmissined. Prvisin additinal instances and upgrades f Central Designer servers within DECS that are required t accmmdate upgrades fr Central Designer. This prvisining is intended fr majr and minr upgrades fr interim perids f up t 3 mnths. Upn cmpletin f upgrades t Central Designer, the server(s) required during the upgrade perid will be decmmissined. Prvide technical supprt fr the Oracle Prgram as set frth in the Ordering Dcument. Online training fr Central Designer users. The list f available nline curse(s) fr Central Designer is prvided in the Oracle Health Sciences Online Training fr Oracle Health Sciences InFrm Clud Service Data Sheet. In additin t the activities abve, the fllwing activities t prvisin, set-up and maintain InFrm within the DECS apply: Wrk with Yu t prvisin the VPN frm DECS envirnment t Yur premise Cnfigure firewall and F5 cntent switch rules t secure remte access 1 t Yur virtual servers and the Oracle database server frm Yur facilities. Prvisin Yur administratr accunts in perating system Prvisin Yur administratr accunts in database Prvide Yu with access t URI Manager tl Any data migratins between InFrm versins and upgrades within DECS are excluded. Deliverables Oracle deliverables fr the DECS envirnment include: Central Designer prgram usage that cmprises f the required virtual applicatin server setup and hsting, and prerequisite Oracle database. InFrm prgram usage that cmprises f the required virtual applicatin server test envirnment setup and hsting and prerequisite Oracle database. 1 Nte: Secure remte access currently defined as Hypertext Transfer Prtcl Secure (https) and either secure shell (ssh) r terminal service access t the prgrams and servers in the VLAN. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 18

19 Yu are respnsible fr the fllwing activities related t DECS: Building and testing the InFrm Trial design (this includes and is nt limited t frm design, visit structure design and prgramming f edit checks) in accrdance with Yur standard perating prcedures and/r wrk instructins as well as creating and testing Yur wn test cases. Ensuring that all users are trained prir t accessing this envirnment fr DECS activities. This includes maintaining all training recrds. Prvisining and maintenance f all applicatin administratr and user accunts fr Yur users within the Oracle Prgrams Includes prvisining f accunts fr Oracle as required fr supprt Includes management f passwrd plicies and cmplexity Requesting sftware upgrades Yu agree that the DECS envirnment is nt certified under the Health Insurance Prtability and Accuntability Act (HIPAA) security standard and Oracle shall nt be respnsible fr cmpliance under this standard. Yu shall cmply with all laws t the extent that such laws are applicable t Yur use and receipt f this service. Perfrmance f the InFrm prgram and prerequisite Oracle database will vary based n Yur cnfiguratin and use. Yu shuld use the InFrm prgram and Oracle database cnsistent with Oracle dcumentatin and recmmended practices. In additin t the activities abve, Yu will be respnsible fr the fllwing activities fr InFrm within the DECS: Wrk with Oracle t prvisin the IPSEC site t site VPN frm Yur premise t the DECS Prvisining required perating system accunts fr Yur users using the Oracle prvided custmer administratr accunt Prvisining required database accunts (e.g. t deply Trials r lad data) using the Oracle prvided custmer administratr accunt Deplying InFrm Trial servers and enable Trial servers t the Internet via URI Manager Tl Managing InFrm Trial servers (start/stp/delete/cnfigure) Managing InFrm Trial server system cnfiguratin Cpying Trial metadata design files (e.g. Central Designer deplyment package, XML files) t InFrm server as needed Maintaining Trial server data Lading InFrm data extracts when desired including transferring extract files, creating Trial specific table spaces (as required) and lading data Drpping InFrm data in database as required Managing file system space as necessary Ensuring required data is nt deleted Oracle Health Sciences InFrm Clud Service Service Descriptins Page 19

20 Ensuring that the database r perating systems are nt restarted Ensuring that perating system, database, r applicatin security hardening is nt relaxed Yu shall als have the right t dwnlad and self-hst and use the InFrm prgram and prerequisite Oracle database slely in cnnectin with Yur rder fr DECS. Yu may nt use the InFrm prgram and prerequisite database fr any ther purpse including deplyment f Trials int the Prductin instance. Yur right t use the InFrm prgram and Oracle database shall cterminate with Yur rder fr DECS and at terminatin Yu shall n lnger use the InFrm prgram and Oracle database and shall uninstall the InFrm prgram and Oracle database frm Yur system. Yu may dwnlad the InFrm prgram and prerequisite Oracle database at the fllwing URL: Yu acknwledge that Oracle is under n further delivery bligatin under this Service Descriptin r Yur rder. Yu are slely respnsible t ensure prper installatin and cnfiguratin f the InFrm prgram and prerequisite Oracle database and Yu are respnsible fr all related csts fr cnfiguratin and installatin. Users f the Oracle Health Sciences Design Envirnment Clud Service are authrized t access the fllwing mdules: Central Designer InFrm and the fllwing InFrm integratin prduct InFrm Adapter Nte: Use f Cgns reprting with InFrm is excluded. Usage Limits: Oracle Health Sciences Design Envirnment Clud Service is subject t usage limits based n: One Trial The fllwing usage limits apply: Metric Database Strage File Strage Bandwidth Included with Clud Service Trial N/A N/A N/A One DECS envirnment Service Level Targets: The Clud Service has the fllwing service level targets: Clud Service Recvery Time Objective (RTO) Recvery Pint Objective (RPO) Target System Availability DECS (Central Designer cmpnent) 90 Days 48 hurs 99% DECS (InFrm cmpnent) Oracle Clud Plicies N/A N/A (data is nt stred ffsite) 99% (infrastructure nly) The Central Designer cmpnents f the Design Envirnment Clud Service are subject t the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, which may be viewed at The InFrm cmpnents f the Design Envirnment Clud Service are subject t the Oracle Health Sciences Design Envirnment Clud Service, Service Level Guide, which may be viewed at Oracle Health Sciences InFrm Clud Service Service Descriptins Page 20

21 Service Descriptins fr Cnfiguratin Services InFrm Clud Service Trial Build per Trial InFrm Clud Service Trial Build services relate t the Infrm prject initiatin and prgram set-up tasks t ready the InFrm prgram fr user acceptance testing. The deliverables fr InFrm Clud Service Trial Build services are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: Specificatins Dcument the design f the InFrm prgram cnfiguratins. Specificatins may include EDC frm cntent, rules and edit checks, InFrm prgram cnfiguratins, and database requirements. Prject Plan This plan will be created and maintained by the Oracle Prject Manager. It will detail the tasks, timelines, and milestnes that Oracle and Yu are respnsible fr, as applicable. Team List Dcument and maintain a list f Oracle team members, their respnsibilities, and their cntact infrmatin. Cnfiguratin Cnfigure r build Trial cmpnents in supprt f the mutually agreed Trial requirements. Test Cnduct an independent test f Yur Trial by testing study cmpnents against the mutually agreed Trial requirements. User Acceptance Testing (up t 1 rund) One (1) user acceptance testing findings meeting. Respnd t questins that Yu raise in user acceptance testing. If required, deply a new cnfiguratin t the UAT instance fr Yu t re-test Yur findings. If additinal runds f user acceptance testing are required, the Change Order prcess will be fllwed (including additinal fees and time). Once user acceptance testing is cncluded, install the Trial in Yur Prductin instance. Fixes t the Prductin InFrm Prgram Related dcuments are created by Oracle and apprved by Yu. Changes t the Prductin InFrm Prgram The Change Order prcess will be fllwed (including additinal fees if applicable). Related dcuments are created by Oracle and apprved by Yu. Yur respnsibilities fr InFrm Clud Service Trial Build are dependent upn the cmpnents included in the prject. Examples include but are nt limited t: Regulatry Cmpliance Yu are respnsible fr the fllwing: Ntifying Oracle f any requirements r respnsibilities impsed n Oracle arising frm regulatry apprvals granted t Yu thrughut the Services Perid. Oracle will cperate with Yur effrts t determine whether use f the standard Oracle Services ffering is cnsistent with thse requirements. Additinal fees may apply t any additinal wrk that is required t be perfrmed by Oracle t cmply with such requirements. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 21

22 Ensuring that specificatins meet the regulatry requirements fr the Trial including such requirements laid ut in the Prtcl and subsequent Prtcl Amendments. Ensuring that any required regulatry apprvals are in place prir t mving the cnfigured Trial Build t Prductin r enabling Yur Site Users t access the Services. This applies t the initial release and any subsequent releases that may ccur as a result f mdificatins t the cnfigured Trial Build. Prviding the final clinical prtcl and, as applicable, any subsequent final prtcl amendments. Yu remain slely respnsible fr Yur regulatry cmpliance in cnnectin with Yur use f the Services. Testing the InFrm prgram (user acceptance testing) in accrdance with Yur wn standard perating prcedures and/r wrk instructins as well as creating and testing Yur wn test cases. This includes capturing user acceptance testing feedback that is clear, reprducible, and actinable in the Oracle-prvided template. If changes are intrduced fllwing finalizatin f the dcumented requirements, the change management prcess will be fllwed (including additinal fees and time, as apprpriate). Delivering clear and cmplete requirements in accrdance with the agreed timeline planning. These may include frm, edit check, Trial cnfiguratin, and database requirements. Prviding input int the creatin and maintenance f the prject plan as requested by the Oracle Prject Manager. Negtiating in gd faith an estimated timetable fr any revised r additinal milestne dates that are intrduced after the initial timeline agreement. Ensuring that all key stakehlders, decisin-makers, and team members are present and/r invlved with all key meetings and deliverables (e.g. requirements discussin and user acceptance testing, etc.) and that they adhere t the agreed timelines. Reviewing and apprving dcuments related t Prductin InFrm prgram changes and fixes. InFrm Clud Service Trial Build Assumptins: A Frm is cnsidered t be re-used frm a client library r previus InFrm Trial when n changes are required. There are certain updates that can be made t a re-used frm (at the discretin f the Oracle frm designer): updating the year range fr a date field deleting items that d nt impact rules, reprts r integratins, r minr updates t text that d nt impact rules, reprts r integratins. The quantities stated in the Study Order fr Ttal, Unique, and Re-Used ecrf pages and fr Rules represent Oracle s estimate f the effrt invlved t build the ecrf based n the parameters that Yu prvided t Oracle prir t executin f the Study Order. A different cmbinatin f frms, rules, and re-use may be necessary as the Trial build prceeds, and this may require additinal effrt. Yu agree t enter int a Change Order with Oracle fr any such additinal effrt, which must be executed prir t Trial g-live. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 22

23 InFrm Clud Service Study Prject Management per Trial Applies either t Trials built by Oracle r t Trials built by Yu. InFrm Clud Service Study Prject Management prvides prject management services fr an InFrm SaaS Trial during the Services Perid. Prject Management services include crdinatin f prfessinal services requests and cmmunicatins and Trial prject planning (prject plan cntaining key milestnes t be mutually agreed with Yu). InFrm Clud Service Study Prject Management specifically excludes cntractual additins, such as Change Orders A Prject Manager will be assigned as the primary cntact t Yu fr Services activity. InFrm Clud Service Study Prject Management and Advisry Services per Hur per Trial Study Prject Management and Advisry Services applies either t Trials built by Oracle r t Trials built by Yu. Oracle will prvide these Services up t the number f hurs defined in the Study Order. Once the number f hurs purchased has been utilized, additinal hurs may be purchased. Hurs nt used n r befre the end f the Services Perid expire withut refund and are nt available fr future use r use fr ther services by Yu. Hurs are restricted t Services perfrmed by Prject Management (PM), Design Cnsultant (DC) & Technical Cnsultant (TC) rles. InFrm Clud Service Study Prject Management and Advisry Services may include assistance with the fllwing as mutually agreed: Assisting Yu with questins regarding: Trial design, frm design, wrkflw and rule design, deplyment packages, data extract setup and data extract usage. PM services may include crdinatin f prfessinal services requests and cmmunicatins, prject planning and prject status reprting. A Prject Manager will be assigned as the primary cntact t Yu fr Services activity. Assumptins: Services will be delivered frm the lcatin f the Oracle staff emplyee. Services can be applied nly t the specific Trial cntracted fr in the Study Order. Yu must request use f the services hurs by cntacting Yur Oracle Prject Manager assigned t the Trial. Oracle requires lead time f at least 2 business days t respnd t a request fr cnsumptin f these hurs. Study Prject Management and Advisry Services specifically excludes: Custmizatins related t the Trial build. Change Orders related t the Trial build. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 23

24 Central Cding Cnfiguratin per Trial Includes the cnfiguratin f Central Cding with ne (1) InFrm integrated Trial. The deliverables fr a given prject are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: Initial Set Up Initial set-up including defined rights and rles. Demnstratin Demnstratin f the Central Cding prgram fr use during requirements gathering and specificatins. Requirements In crdinatin with Yu, dcumentatin f requirements in the Central Cding Cnfiguratin specificatin fr the setup and integratin f ne (1) InFrm Trial with Central Cding. Cnfiguratin Cnfiguratin f the Central Cding prgram in tw instances, ne Central Cding UAT instance and ne Central Cding Prductin instance, based n the Cnfiguratin Specificatin including: Cding Algrithm Cding definitins fr up t tw standard cding dictinaries Assignment rules based n the agreed specificatin fr cding wrk teams Cnfiguratin f synnym lists and stpwrd lists Cnfiguratin f ne (1) integrated InFrm Trial with the InFrm Adapter and assciated Central Cding jb scheduler and Cnfiguratin f a versin f MedDRA and WHODD standard dictinaries in the Central Cding prgram (subject t Yur separate licensing requirements fr such dictinaries). Dictinary Upgrades Up t 32 hurs f assistance fr standard dictinary upgrades f MedDRA and WHODD. Upgrades may be requested up t tw (2) times per calendar year and will be perfrmed per a mutually agreed schedule. This includes any required impact analysis in preparatin fr an upgrade assuming ttal Oracle effrt per upgrade des nt exceed 32 hurs. Central Cding Upgrades Per mutually agreed schedule. Any Central Cding mappings required fr the InFrm Clud Service Trial Build will be the respnsibility f the party building the Trial, which may be Oracle fr InFrm Trials where Trial Build services are rdered in the applicable Study Order r Custmers wh are respnsible fr Trial Builds. Lab Nrmals Management Tl Cnfiguratin per Trial The Lab Nrmal Management Tl (LNMT) fr InFrm is designed t allw spnsrs t cmpare lab Data entered int InFrm with lab nrmal ranges. The assciatin f subject lab results and the defined Lab Nrmal Ranges is specific t the Trials leveraging the LNMT. A cmmn ecrf design practice must be used in designing the lab ecrf s fr capturing lab data. In cnjunctin with the ecrf design, a set f edit checks that are Trial specific are used t aut generate InFrm queries. LNMT includes functinality t extract the lab results data frm the InFrm ecrf s, cmpare them against the pre-defined nrmal ranges, and insert/update the results back t the riginal InFrm ecrf. This is an autmated prcess that is scheduled t run in batch. The batch can be scheduled t run as frequently as hurly. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 24

25 Prerequisites: ecrfs must be designed using LNMT specificatins All Lab Tests and Units are pre-identified fr each Trial fr entering nrmal ranges thrugh the LNMT User Interface. Deliverables and Custmer Dependencies The deliverables fr a given prject are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: Requirements These are written by the Oracle prject team t dcument Yur specific data integratin needs fr the LNMT prgram. Specificatins These are written by the Oracle prject team t dcument the design f the LNMT prgram cnfiguratin. Specificatins may include frm data element mappings, data types, data element restrictins, and ntificatin infrmatin. One design iteratin is included fr the design specificatins. Prject Plan This plan will be created and maintained by the Oracle Prject Manager. It will detail the tasks, timelines, and milestnes that Oracle and Yu are respnsible fr, as applicable. Cmmunicatin Plan This dcument is created and maintained by the Oracle Prject Manager. It describes the team members, their respnsibilities, and their cntact infrmatin. Cnfiguratin Cnfigure LNMT prgram cmpnents in supprt f the requirements and integratin specificatins. Testing Perfrm smke testing. Dcument the test cases needed fr this cnfiguratin, and perfrm frmal testing f the LNMT prgram. User Acceptance Testing (up t 1 rund) Install and cnfigure the LNMT prgram in Yur UAT envirnment. One (1) user acceptance testing findings meeting. Respnd t questins that Yu raise in user acceptance testing. If required, deply a new cnfiguratin t the UAT instance fr Yu t re-test. If additinal runds f user acceptance testing are required, the Change Order prcess will be fllwed (including additinal fees and time). Once user acceptance testing is cncluded, install and cnfigure the LNMT prgram in Yur Prductin instance. Fixes t the Prductin LNMT Prgram Related dcuments are created by Oracle and apprved by Yu. Yur respnsibilities fr a given prject are dependent upn the cmpnents included in the prject. Examples include but are nt limited t: Delivering clear and cmplete requirements in accrdance with the agreed timeline planning. These may include data mapping, data restrictins, r ntificatins. If final requirements are nt available, Yu and Oracle may mutually agree t begin the cnfiguratin f the LNMT prgram with draft requirements. This latter apprach may be subject t additinal fees. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 25

26 Prviding input int the creatin and maintenance f the prject plan as requested by the Oracle Prject Manager. Negtiating in gd faith an estimated timetable fr any revised r additinal milestne dates that are intrduced after the initial timeline agreement. Ensuring that all key stakehlders, decisin-makers, and team members are present and/r invlved with all key meetings and deliverables (i.e., planning and review f the LNMT prgram specificatins, user acceptance testing, etc.). Ensuring that all key stakehlders, decisin-makers, and team members adhere t the agreed timelines. Ensuring specificatins meet the regulatry requirements fr the Trial. Acceptance f requirements specificatins in a timely manner. Acceptance f the cnfigured LNMT prgram fr release t UAT and fr release t g-live. Testing the LNMT prgram (user acceptance testing) t Yur wn standard perating prcedures and/r wrk instructins and fr creating and testing Yur wn test cases. This includes capturing user acceptance testing feedback that is clear, reprducible, and actinable in the Oracle-prvided template. If changes intrduced during user acceptance testing are required, the change management prcess will be fllwed (including additinal fees and time). Ensuring that all users are trained prir t accessing the system. This includes maintaining all training recrds. Reviewing and apprving dcuments related t Prductin LNMT prgram changes and fixes. InFrm Integratin Cnfiguratin Standard File-Based Integratin* per Integratin per Trial * Previusly named Integrated Vice Respnse System (IVRS) InFrm Integratin Cnfiguratin includes cnfiguratin f a Standard File-Based Integratin fr InFrm, which integrates InFrm Trials with external systems via a flat file transfer. This feature requires crdinatin between the study spnsr, Vendr r ther surce f electrnic data, and Oracle. There are three pssible cnfiguratins f the Standard File-Based integratin: inbund integratin, utbund integratin, and tw-way integratin. Inbund integratin is imprting Data frm the external system t InFrm via a flat file. Outbund integratin is exprting Data frm InFrm and transferring it t the external system r t Yu via a flat file. Tw-way integratin includes inbund and utbund integratin. The inbund integratin prcess encmpasses the imprt data flw frm the external system t the InFrm Service. The prcess cnsists f the fllwing steps: 1. Site Users will enter Data thrugh the external system, such as creating and randmizing subjects and adding r updating clinical Data fr a subject via the telephne r web interface. 2. Once this infrmatin is submitted, the external system will initiate a prcess t extract the Data int an Oracle specified Data frmat (MedML r pipe-delimited frmat) and transmit thse files acrss an sftp cnnectin t the Oracle sftp server. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 26

27 3. Once the Data is received at Oracle, the Data is thereafter recrded int the InFrm Trial database. 4. InFrm users can nw view this Data within InFrm. The utbund integratin prcess encmpasses a single data flw between the external system and InFrm system where InFrm is the sending system. The prcess cnsists f the fllwing steps: 1. Site Users will enter Data int the InFrm system. 2. Once this Data is submitted, InFrm will generate a data file (in an agreed upn frmat) and transmit the files acrss a secure sftp cnnectin t the Oracle hsted sftp server. 3. The Data is thereafter received and prcessed by the external system. The Tw-way integratin prcess cnsists f bth the inbund integratin and utbund integratin prcesses cnfigured n a single Trial. Prerequisites Specificatins fr Data t be laded must be incrprated int the Trial and frm layut at the beginning f the InFrm Trial prject. Crdinatin is required between study spnsr, the external system vendr, and Oracle. Oracle will use reasnable effrts t crdinate with the external system vendr, but Yu are ultimately respnsible fr interacting with such vendr. Uplad f Data files t a secure server frm the external Vendr system is necessary. In additin, manual review and crrectin f rejected files by Yu and the external system vendr is required. Inbund data files must match the frmat described by Oracle. Outbund data file frmat must be mutually agreed upn. Assumptins & Limitatins Pricing includes the integratin f a maximum f 20 data fields spread acrss up t 5 unique InFrm Frms. Yu must ensure that the external system vendr adheres t the apprved cnfiguratin specificatin and prvides necessary files fr user acceptance testing. Perfrmance is dependent n the number and size f files being imprted in a given interval. Yu (and the external system vendr) are respnsible fr crrecting and resubmitting rejected recrds if recrds are rejected due t Trial r external system prblems. Data File Requirements The fllwing requirements must be met fr all Data files generated by the external system vendr and transferred t Oracle fr imprt int InFrm. Data files must be frmatted accrding t the Oracle s MedML file frmat r pipe-delimited frmat (Screening, Enrllment, and Patient Transfer cannt be dne using pipe-delimited frmat). Data files shuld cntain incremental recrds. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 27

28 Separate Data files must be created fr each Trial visit-frm cmbinatin. Fr example, if there are tw frms that will receive upladed Data fr a given Trial, the vendr will create tw separate Data files fr transfer t Oracle. If the same frm is used fr several visits, a separate data file is required fr each instance f this frm. Recrd must cntain the Subject number, Subject initials (r equivalent f what is cllected if initials are nt used), and Site number in rder t be laded. Recrd will be rejected if Subject number, Subject initials, r Site are incrrect r if Subject is nt enrlled. Screening failures can be laded if identified. MedML frmat has tags t accmmdate screening, enrllment, adding patient data, editing patient data, and transferring patient. Examples f each are utlined belw. MedML frmat has a tag called DUPLICATEORDER which is a number specifying the rder in which patients with the same patient initials are enrlled. This tag is required when tw r mre patients with same initials are present at a Site. The value f this tag can be supplied by the Vendr, OR autmatically calculated by the external applicatin. Example fr this is utlined belw. If the external system will generate the DUPLICATEORDER value, there is a requirement that screen and enrll transactins must be sent within the same file. File Naming Cnventins Data files sent by the external system vendr t Oracle must adhere t specific file naming cnventins in rder t satisfy the fllwing requirements fr uniqueness and the rder f prcessing. Many files may be received int ne directry n the specified Oracle sftp server frm the external system. Many files may be received at the same date/time. Files fr a given Subject must be prcessed in a specific rder (ex. Adding data t demgraphy befre inclusin/exclusin.) Data Transfer Prcedure All Data transfer prcedures dcumented here cnfrm t the Oracle Industry Clud Secure Data Transmissin Standard. Changes t the Oracle Industry Clud Secure Data Transmissin Standard supersede any Data transfer mechanisms described in this dcument. The external system must transmit the MedML data files acrss a secure SFTP channel t the specified Oracle sftp server. Data will be sent t a Trial specific inbund flder n the Oracle sftp server. The flder structure will adhere t the Oracle standard. A Windws service n the system that hsts the InFrm Trial will pll the flder n the Oracle sftp server fr any new Data files. Once a file is fund, the file will be cpied frm the Oracle sftp server, prcessed and laded int the apprpriate InFrm Trial. The audit infrmatin fr the imprt and a cpy f the riginal Data file will be maintained in persistent data strage, and viewable n the Lg Viewer page within the InFrm Prtal. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 28

29 Secure FTP (sftp) Access All Data file access must be dne using sftp in accrdance with the Oracle Industry Clud Secure Data Transmissin Standard. Changes t the Oracle Industry Clud Secure Data Transmissin Standard supersede any file access mechanisms described in this dcument. External system vendrs must have a supprted sftp client t lgin t Oracle s hsted sftp server at sftp.webcrf.net and transmit files. Oracle currently supprts the fllwing sftp clients: SecureFX frm Vandyke Sftware (preferred client) WS_FTP Pr Versin 9 frm IPSwitch Putty Cmmand line client Win SCP External system vendrs will be granted named user accunts with access privileges t the apprpriate Trial flders. Accunts will be created accrding t Oracle s SFTP Service Plicy. External system vendr user accunts can access multiple Trial flders. If a vendr accunt is assciated with mre than ne Trial flder, then the vendr s transfer prcess will be required t navigate t the apprpriate flder after lgin. This navigatin can be dne thrugh use f the apprpriate cmmands depending upn the sftp client. Errr Handling Oracle SFTP server SFTP prvides authenticatin, Data cmpressin, and file integrity algrithms t help cnfirm that the file received is the same as the file that was sent. If there is a cnnectivity issue t the Oracle sftp server (either frm the external system vendr r frm the InFrm server), then Oracle Custmer Supprt may assist with reslutin. InFrm Imprt In terms f imprting Data int InFrm, audit lgs will be generated fr every imprt indicating success r failure. The audit lg alng with the cpy f the Data file will be stred in persistent Data strage and viewable n the Lg Viewer page within the InFrm Prtal. Deliverables and Custmer Dependencies The deliverables fr a given prject are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: Requirements These are written by the Oracle prject team t dcument Yur specific Data integratin needs fr the Standard File-Based integratin. Specificatins These are written by the Oracle prject team t dcument the design f the Standard File-Based integratin cnfiguratin. Specificatins may include external-t-infrm frm Data element mappings, Data types, Data element restrictins, and ntificatin infrmatin. Prject Plan This plan will be created and maintained by the Oracle Prject Manager. It will detail the tasks, timelines, and milestnes fr which Oracle and Yu are respnsible, as applicable. Cmmunicatin Plan This dcument is created and maintained by the Oracle Prject Manager. It describes the team members, their respnsibilities, and their cntact infrmatin. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 29

30 Cnfigure Standard File-Based integratin cmpnents as defined in the requirements and integratin specificatins. Testing Perfrm smke testing t validate the designs. Dcument the test cases needed fr the cnfiguratin, and perfrm frmal testing f the Standard File-Based Integratin. Cnduct an independent validatin f the Standard File-Based integratin cnfiguratin by testing cmpnents against apprved specificatins. User Acceptance Testing (up t 1 rund) Install and cnfigure the Standard File-Based integratin in Yur UAT instance. One (1) user acceptance testing findings meeting. Respnd t questins that Yu raise in user acceptance testing. If required, deply a new cnfiguratin t the UAT instance fr Yu t re-test. If additinal runds f user acceptance testing are required, the Change Order prcess will be fllwed (including additinal fees and time). Once user acceptance testing is cncluded, install and cnfigure the Standard File-Based integratin in Yur Prductin instance. Fixes t the Prductin Standard File-Based integratin Related dcuments are created by Oracle and apprved by Yu. Update the UAT instance with a fresh extract f the Prductin instance and cnfiguratin f the Standard File-Based integratin nly if required, each time a Trial fix r Trial Change Order needs t be tested. Yur use and Oracle s maintenance f the UAT instance is limited t the implementatin f fresh extracts when a Trial fix r Trial Change Order related activities are required. Yur respnsibilities fr a given prject are dependent upn the cmpnents included in the prject. Examples include but are nt limited t: Delivering clear and cmplete requirements in accrdance with the agreed timeline planning. These may include Data mapping, Data restrictins, r ntificatins. If final requirements are nt available, Yu and Oracle may mutually agree t begin the cnfiguratin f the integratin with draft requirements. This latter apprach may be subject t additinal fees. Prviding input int the creatin and maintenance f the prject plan as requested by the Oracle Prject Manager. Negtiating in gd faith an estimated timetable fr any revised r additinal milestne dates that are intrduced after the initial timeline agreement. Ensuring that all key stakehlders, decisin-makers, and team members are present and/r invlved with all key meetings and deliverables (i.e., planning and review f the Standard File-Based integratin specificatins, user acceptance testing, etc.). Ensuring that all key stakehlders, decisin-makers, and team members adhere t the agreed timelines. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 30

31 Ensuring specificatins meet the regulatry requirements fr the Trial. Acceptance f requirements specificatins in a timely manner. Acceptance f the cnfigured Standard File-Based integratin fr release t UAT and fr release t g-live. Testing the Standard File-Based integratin (user acceptance testing) t Yur wn standard perating prcedures and/r wrk instructins and fr creating and testing Yur wn test cases. This includes capturing user acceptance testing feedback that is clear, reprducible, and actinable in the Oracle-prvided template. If changes intrduced during user acceptance testing are required, the change management prcess will be fllwed (including additinal fees and time). Ensuring that all users are trained prir t accessing the system. This includes maintaining all training recrds. Reviewing and apprving dcuments related t Prductin Standard File-Based integratin changes and fixes. Yu are respnsible fr managing the relatinship and cmmunicatin with the IVR Vendr that is necessary t implement the Standard File-Based integratin. InFrm CRF Submit Additinal Runs Each InFrm CRF Submit Additinal Runs are nly available fr InFrm Trials withut Archive Generatr enabled n the InFrm Prtal. Deliverables and Custmer Dependencies The deliverables are dependent upn the requirements. Sme cmmn deliverables that apply t requests include: Requirements These are written, with Yur input, by the Oracle prject team t dcument Yur needs. Trial Data in either an Archive Prtable Data Frmat ("PDF") file r a Submissin Ready PDF file, as specified by Yu in the requirements dcument. These are intended t dcument the Data as it existed at the time the Trial was lcked in the Prductin instance f the cnfigured InFrm Trial. Generatin f additinal set(s) f utput with different utput requirements, such as a subset f Data fr auditing purpses, is nt cvered by this Service. Yur respnsibilities are dependent upn the requirements. Examples include but are nt limited t: Delivering clear and cmplete requirements in accrdance with the agreed timeline planning. Yu must cmplete and return t Oracle a CRF Submit requirements dcument fr each request fr PDF files t select required Data elements t be included in the files and selectin f utput types. Distributing archival PDFs and Trial Archival Package (TAP), as apprpriate. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 31

32 Acceptance f Deliverables Upn Oracle s cmpletin f any deliverable, Yu will be respnsible fr any additinal review and testing f such deliverable in accrdance with any mutually agreed review criteria r test scripts. If the deliverable des nt cnfrm with any such review criteria r test scripts, Yu will have five (5) business days after Oracle s submissin f the deliverable ( Acceptance Perid ) t give Oracle written ntice which shall specify the deficiencies in detail. Oracle will use reasnable effrts t prmptly cure any such deficiencies. After cmpleting such cure, Oracle will resubmit the deliverable fr Yur review and testing as set frth abve. Upn accepting any deliverable submitted by Oracle, Yu must prvide Oracle with written acceptance f such deliverable. If Yu fail t prvide written ntice f any deficiencies within the Acceptance Perid, as prvided abve, such deliverable will be deemed accepted at the end f the Acceptance Perid. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 32

33 Retired Offerings Oracle Health Sciences InFrm Multi-Trial Hsting per Trial [RETIRED] The Services fr this ffering are described in the InFrm Clud Service sub-sectins abve entitled Clud Service Set Up InFrm Clud Service Users and Access by Users InFrm Clud Service Deliverables and Custmer Dependencies Service Level Targets Third Party License Requirements Oracle Clud Plicies Users f InFrm Multi-Trial Hsting are authrized t access the fllwing mdules*: InFrm prgram InFrm Prtal User Management Tl (UMT) User Management Interface InFrm Publisher InFrm Adapter *Multi Trial Sftware Usage rights must be purchased separately Usage Limits: The Oracle Health Sciences InFrm Multi-Trial Hsting Service is subject t usage limits based n: Number f Trials defined in Yur rder The fllwing usage limits apply per licensed metric: Metric Database Strage File Strage Bandwidth Trial 25 GB N/A N/A # f Instances included with Clud Service 1 Trial pack ( UAT, Training and Prductin) InFrm Integratins Cnfiguratin Direct Data Lader (DDL) ** [RETIRED] ** DDL n lnger available fr purchase frm August 2014 The Direct Data Lader (DDL) fr InFrm ITM is designed t facilitate the lading f Data files received frm third party vendrs directly int the InFrm ITM Reprting Database. DDL accepts flat files via Oracle s sftp server, prcesses thse files and imprts the Data int the InFrm reprting database. The imprted Data is accessible via InFrm ad-hc reprts, custm reprts, and reprting database extracts. DDL file prcessing and lading cnsists f the fllwing steps: Data files frm external vendrs must be upladed t a designated sftp directry n the Oracle sftp server fr each Trial. The DDL Service detects each upladed file and mves it int the prcessing queue. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 33

34 Files are prcessed in a FIFO manner. File prcessing includes preliminary checks and any errrs fund during the preliminary checks are lgged and made available t Users via the DDL user interface. After the preliminary checks are run and errneus recrds are filtered ut, the remaining Data is laded int InFrm Reprting. ntificatin can be cnfigured t reprt the lad status t a predetermined list f addresses. Laded Data is accessible via InFrm ad-hc reprting, custm reprts, and reprting database extracts. Recrds that fail t lad are lgged and accessible via the DDL administratin tab within the InFrm prtal. Prerequisites Crdinatin is required between Yu and the third party vendr t ensure the Data files prvided adhere t the DDL external Data file requirements and are cnsistent with cnventins agreed upn between Yu and the vendrs. Specificatins fr Data t be laded must be incrprated int the Trial and frm layut. Assumptins & Limitatins External Data will nt be laded int InFrm cre. Laded Data will nt be viewable within ecrfs Sites will nt see Data in InFrm Rules will nt be applied t Data The laded Data will be available within the Clinical Data Mdel fr reprting purpses (bth AdHc and Custm) using the InFrm Reprting functinality The laded Data will be available within the InFrm reprting database extract. DDL des nt prvide facilities fr editing Data all crrectins will be the respnsibility f the Data supplier. DDL will display nly the latest Data laded frm a Data prvider in reprting. There will nt be an audit trail in InFrm reprting. DDL pricing includes the integratin f a maximum f 5 distinct Data file frmats and assciated ecrf s. A maximum f 10 histrical Data files may be archived fr retentin purpse. (This des nt include Data imprted int the reprting database) Perfrmance is dependent n the number and size f files being imprted in a given interval. If Yu/data file supplier cannt meet the DDL base requirements, Oracle may prvide prgramming services at additinal cst. Data File Requirements The fllwing requirements must be met fr all Data files generated by the Data file supplier and transferred t Oracle fr imprt by DDL. Data files must be received in ASCII text frmat. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 34

35 If a file is cmpressed in zip frmat then the zip file must cntain single Data file withut any directries/flders. (The ptinal cmpressed file passwrd will be cnfigurable within the applicatin.) A Data recrd must nly exist n a single line. A field delimiter is cnfigurable within the applicatin. Mst cmmn delimiters are pipe " " and cmma "," with ptinal qutes fr values that cntain cmma within text. Empty fields in a recrd must be designated by tw cnsecutive delimiters. Every recrd must cntain the same number f fields. Each Data recrd in the Data file must cntain fields that cnstitute a key t uniquely identify each recrd. Data file may be cumulative (All unchanged, changed and new recrds must exist in the Data file t be upladed.) Data file may be incremental (The incming file will cntain recrds that were created, changed, r deleted between the last and current Data transfers. Recrds that were nt included in the incremental transfer are assumed t be unchanged by the applicatin.) The applicatin supprts transactin type flags with each Data recrd signifying Insert, Update, Delete, and Retransmit transactins. This will allw supprt fr incremental CDISC transfers where transactin flags are: "I" fr Insert "U" fr Update "M" fr Delete "R" fr Retransmit When a transactin specified by a transactin type flag cannt be perfrmed then an errr will be generated. The applicatin ptinally can prcess Insert and Delete transactins sent in the same Data file. Data types supprted are: Text, Integer, Flat, and Date File Naming Cnventins Data files sent by the Data file supplier t Oracle must adhere t specific file naming cnventins in rder t satisfy the requirements fr uniqueness and the target destinatin fr prcessing. The Data file name must be ASCII case insensitive. A file name must cntain the EDT name separated frm the ther file name cmpnents by an underscre. Enfrcing the existence f the Trial name within the file name can be ptinally selected by setting an apprpriate cnfiguratin setting. Data Transfer Prcedure All Data transfer prcedures dcumented here cnfrm t the Oracle Industry Clud Secure Data Transmissin Standard. Changes t the Oracle Industry Clud Secure Data Transmissin Standard supersede any Data transfer mechanisms described in this dcument. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 35

36 The Data file supplier must transmit the Data files acrss a secure SFTP channel t the specified Oracle sftp server. Data will be sent t a Trial specific flder n the Oracle sftp server. The flder structure will adhere t the Oracle standard. The DDL Windws Service n the machine that hsts the InFrm Trial will mnitr this flder n the Oracle sftp server fr any new Data files. Once a file has cmpleted uplading it will be cpied frm the Oracle sftp server, prcessed and laded int the apprpriate Trial specific DDL Data repsitry. The cmpressed versin f the riginal Data file will be archived in persistent Data strage, and viewable n the DDL Lg Viewer page within the InFrm prtal. Secure FTP (sftp) Access All Data file access must be dne using sftp in accrdance with the Oracle Industry Clud Secure Data Transmissin Standard. Changes t the Oracle Industry Clud Secure Data Transmissin Standard supersede any file access mechanisms described in this dcument. Each instance will be assciated with a secure FTP lcatin unique t each Vendr r Data file type fr the delivery f Data files t be imprted by DDL Data file suppliers must have a supprted sftp client t lgin t Oracles hsted sftp server at sftp.webcrf.net and transmit files. Oracle currently supprts the fllwing sftp clients: SecureFX frm Vandyke Sftware (preferred client) WS_FTP Pr Versin 9 frm IPSwitch Putty Cmmand line client Win SCP All Data file suppliers will be granted named user accunts with access privileges t the apprpriate Trial DDL flders. Accunts will be created accrding t Oracle s SFTP Service Plicy. Data supplier user accunts can access multiple Trial flders. If a data supplier accunt is assciated with mre than ne Trial flder, then the Data supplier s transfer prcess will be required t navigate t the apprpriate flder after lgin. This navigatin can be dne thrugh use f the apprpriate cmmands depending upn the sftp client. Errr Handling Oracle SFTP server SFTP prvides authenticatin, Data cmpressin and file integrity algrithms t help cnfirm that the file received is the same as the file that was sent. If there is a cnnectivity issue t the Oracle sftp server (either frm the Data supplier r frm the InFrm server), then Oracle Custmer Supprt may assist with reslutin. DDL Imprt Fr the imprt f Data int DDL data repsitries in the reprting database, audit lgs will be generated fr every imprt indicating success r failure. The audit lg alng with the cpy f the Data file will be stred in persistent Data strage, and viewable n the DDL Lg Viewer page within the InFrm prtal. The prgram can be cnfigured t send ntificatins fr success and errr. Deliverables and Custmer Dependencies The deliverables fr a given prject are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: Oracle Health Sciences InFrm Clud Service Service Descriptins Page 36

37 Data Requirements These are written by the Oracle prject team t dcument Yur specific Data file cnfiguratin needs fr the DDL Integratin. It will als include the necessary external Data type definitins necessary t accmmdate the DDL Integratin. Vendr Requirements These are written by the Oracle prject team t dcument the vendr specific cnfiguratin needs fr the DDL Integratin including user access and ntificatin ptins. Generate design specificatins frm Yur-supplied requirements. One design iteratin is included fr the design specificatins. Prject Plan This plan will be created and maintained by the Oracle Prject Manager. It will detail the tasks, timelines, and milestnes that Oracle and Yu are respnsible fr, as applicable. Cmmunicatin Plan This dcument is created and maintained by the Oracle Prject Manager. It describes the team members, their respnsibilities, and their cntact infrmatin. Cnfigure DDL cmpnents as defined in the design specificatins. Create Trial ecrf cnfiguratins crrespnding t the specified Data file(s). Create external Data type specificatin files (EDTs) crrespnding t the specified Data file(s). Create secured FTP file directries accrding t the cnfiguratin specified in the Vendr specificatin requirements dcument. Testing Perfrm smke testing t validate the designs. Dcument the test cases needed fr this cnfiguratin, and perfrm frmal testing f the DDL prgram. Cnduct an independent validatin f the DDL prgram cnfiguratin by testing cmpnents against apprved specificatins. User Acceptance Testing (up t 1 rund) Install and cnfigure the DDL prgram in Yur UAT instance. One (1) user acceptance testing findings meeting. Respnd t questins that Yu raise in user acceptance testing. If required, deply a new cnfiguratin t the UAT instance fr Yu t re-test. If additinal runds f user acceptance testing are required, the Change Order prcess will be fllwed (including additinal fees and time). Once user acceptance testing is cncluded, install and cnfigure the DDL prgram in Yur Prductin instance. Fixes t the Prductin DDL prgram Related dcuments are created by Oracle and apprved by Yu. Update the UAT instance with a fresh extract f the Prductin instance and cnfiguratin f DDL nly if required, each time a Trial fix r Trial Change Order needs t be tested. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 37

38 Yur use and Oracle s maintenance f the UAT instance is limited t the implementatin f fresh extracts when Trial fix r Trial Change Order related activities are required. Archival Dcumentatin This is a package f dcumentatin that was maintained by Oracle during the curse f the Trial. After the DDL prgram is decmmissined, this package is sent t Yu fr archiving. Yur respnsibilities fr a given prject are dependent upn the cmpnents included in the prject. Examples include but are nt limited t: Yu are respnsible fr managing the relatinship and cmmunicatin with the Data file supplier(s). Yu and Data file suppliers are respnsible fr crrecting and resubmitting rejected recrds if recrds are rejected due t Trial r Data supplier versights. Delivering clear and cmplete requirements in accrdance with the agreed timeline planning. These may include frm, Trial cnfiguratin, and database requirements. If final requirements are nt available, Yu and Oracle may mutually agree t begin Trial design with draft requirements. This latter apprach may be subject t additinal fees. Prviding input int the creatin and maintenance f the prject plan as requested by the Oracle Prject Manager. Negtiating in gd faith an estimated timetable fr any revised r additinal milestne dates that are intrduced after the initial timeline agreement. Ensuring that all key stakehlders, decisin-makers, and team members are present and/r invlved with all key meetings and deliverables (i.e., planning and review f the DDL prgram specificatins, user acceptance testing, etc.). Ensuring that all key stakehlders, decisin-makers, and team members adhere t the agreed timelines. Ensuring specificatins meet the regulatry requirements fr the Trial. Acceptance f design specificatins in a timely manner. Acceptance f the cnfigured DDL prgram fr release t UAT and fr release t g-live. Testing the DDL prgram (user acceptance testing) t Yur wn standard perating prcedures and/r wrk instructins and fr creating and testing Yur wn test cases. This includes capturing user acceptance testing feedback that is clear, reprducible, and actinable in the Oracle-prvided template. If changes intrduced during user acceptance testing are required, the change management prcess will be fllwed (including additinal fees and time). Ensuring that all users are trained prir t accessing the system. This includes maintaining all training recrds. Managing and verseeing third party vendrs (i.e., lab vendrs, Yur external partners, etc.). Reviewing and apprving dcuments related t Prductin DDL prgram changes and fixes. Database Extracts These database extracts may be used by Yu t analyze and reprt n Yur Data captured by the cnfigured DDL prgram. It is Yur respnsibility t request an exprt nline and t dwnlad it t a secure lcatin. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 38

39 Oracle Health Sciences InFrm Clud Service Lab Nrmals Management Tl (LNMT) [RETIRED] Users f the Clud Service Lab Nrmals Management Tl (LNMT) are authrized t access the fllwing mdules r functinalities: Users and Access by Users Assciatin f Lab Results in a Trial with Lab Nrmal Ranges The Services are intended t be used by persnnel invlved in the management f Yur Trial as authrized by Yu. Deliverables The deliverables fr a given prject are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: LNMT Prgram Release fr UAT This is the initial release by Oracle f the cnfigured LNMT prgram in a UAT instance f the Prductin envirnment that Yu may use t cnduct user acceptance testing activities. LNMT Prgram Release fr g-live This is the Prductin release by Oracle f the cnfigured LNMT prgram that Yur Users may access. Maintenance f the instances Oracle will maintain the instances in accrdance with the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, including prduct upgrades t new releases and in-place upgrades and migratins in accrdance with the Oracle Health Sciences Clud Services GA and EOL Dates dcument, which is available at Upgrades are applied per InFrm server and all Trials n the same server are upgraded at the same time. Migratins typically include a Trial mve t a new server. Oracle will crdinate change management requests required fr upgrades and migratins. Maintenance f the Prductin instance Upgrades and migratins are scheduled with Yu and are perfrmed during the maintenance windw fr Prductin Trials. Maintenance f the UAT instance Upn request, Oracle will update the UAT instance with a fresh extract f the Prductin instance each time a change r fix t the prgram needs t be tested by Yu. This invlves remving the UAT instance (including UAT Data) and replacing it with a fresh extract f the Prductin instance cntaining all the Data as it exists in Prductin instance. Upgrades and migratins are scheduled with Yu and are perfrmed during business hurs fr UAT Trials. Remve the UAT LNMT prgram cnfiguratin instance. Decmmissin and recycle the Trial envirnment. Oracle Health Sciences InFrm Clud Service Service Descriptins Page 39

40 Usage Limits: The InFrm Clud Service Lab Nrmals Management Tl is subject t usage limits based n: Number f Trials defined in Yur rder The fllwing usage limits apply per licensed metric: Metric Database Strage File Strage Bandwidth # f Instances included with Clud Service Trial N/A N/A N/A ne Prductin and ne UAT instance Service Level Targets: The Clud Service Lab Nrmals Management Tl has the fllwing service level targets: Clud Service Recvery Time Objective (RTO) Recvery Pint Objective (RPO) Target System Availability Lab Nrmals Management Tl (LNMT) 90 days 48 hurs 99% Oracle Clud Plicies The Services are subject t the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, which is part f the Service Specificatins f Yur rder and may be viewed at Oracle Health Sciences InFrm Clud Service InFrm Integratin [RETIRED] Yur InFrm Integratin will be deplyed and will integrate Yur main InFrm Trial with any f the cntracted integratins belw. These cntracted integratins may be cnfigured by Oracle r by Yu as cntracted. Standard File-Based Integratin* Direct Data Lader (DDL)** * Previusly named Integrated Vice Respnse System (IVRS) ** DDL n lnger available fr purchase frm August 2014 The InFrm Clud Service InFrm Integratin as described belw may als be purchased independently f the specific integratin types listed immediately abve. Users and Access by Users The Services are intended t be used by persnnel related t Yur Trial as authrized by Yu. Nrmally this cnsists f three main grupings f persnnel: spnsr, Site, and Patient. The spnsr grup typically cnsists f persnnel frm Yur cmpany and may als include ther sub-cntracted persnnel such as Cntract Research Organizatin persnnel, Mnitrs, and Data Managers. The Site persnnel typically cnsist f the Site Crdinatrs (Clinical Research Crdinatrs) and study Investigatrs (Principal Investigatrs and Sub-Investigatrs). The Patient ppulatin is nt expected t interact with the Integratin. Deliverables The deliverables fr an InFrm Integratin are dependent upn the cmpnents included in that prject. Nt all prjects will prduce all f the deliverables listed belw. Sme cmmn deliverables that apply t prjects include: Oracle Health Sciences InFrm Clud Service Service Descriptins Page 40

41 Release fr UAT This is the initial release by Oracle f the cnfigured Integratin in a UAT instance f the Prductin envirnment that Yu may use t cnduct user acceptance testing activities. Release fr g-live This is the Prductin release by Oracle f the cnfigured Integratin that Yur apprved end-users may access. Maintenance f the instances Oracle will maintain the instances in accrdance with the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, including prduct upgrades t new releases and in-place upgrades and migratins in accrdance with the Oracle Health Sciences Clud Services GA and EOL Dates dcument, which is available at Upgrades are applied per InFrm server and all Trials n the same server are upgraded at the same time. Migratins typically include a Trial mve t a new server. Oracle will crdinate change management requests required fr upgrades and migratins. Maintenance f the Prductin instance Upgrades and migratins are scheduled with Yu and are perfrmed during the maintenance windw fr Prductin Trials. Maintenance f the UAT instance Upn request, Oracle will update the UAT instance with a fresh extract f the Prductin instance each time a change r fix t the MAI prgram needs t be tested by Yu. This invlves remving the UAT instance (including UAT Data) and replacing it with a fresh extract f the Prductin instance cntaining all the Data as it exists in Prductin instance. Upgrades and migratins are scheduled with Yu and are perfrmed during business hurs fr UAT Trials. Remve the UAT Integratin cnfiguratin instance. Decmmissin and recycle the Trial envirnment. Usage Limits: The InFrm Clud Service InFrm Integratin is subject t usage limits based n: Number f Trials defined in Yur rder The fllwing usage limits apply per licensed metric: Metric Database Strage File Strage Bandwidth # f Instances included with Clud Service Trial N/A N/A N/A Implementatin n ne Prductin and ne UAT Trial fr each integratin purchased Service Level Targets: The Clud Service InFrm Integratin has the fllwing service level targets: Clud Service Recvery Time Objective (RTO) Recvery Pint Objective (RPO) Clud Service InFrm Integratin 90 days 48 hurs 99% Target System Availability Oracle Clud Plicies The Services are subject t the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, which is part f the Service Specificatins f Yur rder and may be viewed at Oracle Health Sciences InFrm Clud Service Service Descriptins Page 41