InFrm On Demand Single Trial Services Descriptin Versin 7.5 Effective Date: 14-December-2017 This is the Services Descriptin fr Oracle InFrm On Demand Single Trial ( Schedule ) t Yur Study Order fr Oracle InFrm On Demand Single Trial services ( Study Order ). This Schedule describes the services prvided by Oracle (the Services ) fr the Trial listed in the Study Order. Additinal services rdered in Yur Study Order (e.g., integratin services, etc.) may be described in ther schedules. Further details f the Services are shared at the cmmencement f the Services. Table f Cntents 1.0 OVERVIEW OF SERVICES... 2 2.0 OPTIONAL SERVICES... 2 3.0 DEPLOYMENT AND ENVIRONMENTS... 2 4.0 USERS AND ACCESS BY USERS... 3 5.0 DELIVERABLES AND CUSTOMER DEPENDENCIES... 3 6.0 ACCEPTANCE OF DELIVERABLES... 7 7.0 FASTSTART... 8 8.0 FASTFORWARD... 8 9.0 FASTLOCK... 9 10.0 ORACLE CLOUD POLICIES AND PILLAR DOCUMENTATION... 9 11.0 SERVICE LEVEL TARGETS... 9 Versin 7.5 14-Dec-2017 Page 1 f 9
1.0 Overview f Services InFrm is a web-based data cllectin system designed fr clinical studies. Oracle will prvide Yu with Services fr Yur Trial in three phases: FastStart, FastFrward, and FastLck. The activities related t these Services are bunded by the parameters in the Study Order and described in mre detail belw. During the FastStart phase ( Study Setup ), Oracle prvides Services related t prject initiatin and applicatin set-up tasks t prepare the InFrm Services envirnment fr user acceptance testing. During the FastFrward phase ( Study Cnduct ), Oracle prvides Services related t user acceptance testing, InFrm prgram usage, and the management f cntracted changes. The FastFrward phase starts at the delivery f the InFrm prgram fr user acceptance testing and cncludes upn cnfirmatin by Yu f Database Lck. During FastLck ( Study Clsure ), Oracle prvides Services leading t decmmissin f the InFrm Services envirnment. Regulatry Cmpliance: Infrmatin n Oracle s practices fr certain regulatry standards applicable t the 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. 2.0 Optinal Services In additin t the standard Services that Oracle prvides t Yu, ptinal services are als available, such as: Custm Requests Custm requests will be per qutatin and may include services such as database imprts, database exprts, custm reprts, etc. Electrnic submissin-ready PDF files One set n encrypted media cntaining all trial data. Submissin-ready utput will include the data as requested by Yu as utlined belw under Archives fr Yur Trial. IVRS Integratin - The IVRS Integratin Slutin integrates InFrm GTM Trial data with external vendr Interactive Vice Respnse Systems (IVRS) and Interactive Web Respnse Systems (IWRS) t screen and enrll patients, perfrm randmizatin, add/update clinical patient data and transfer patient data. Dedicated Hsting Envirnment A hsting service which can be rdered based n Yur hsting needs. Additinally, when a cntracted InFrm trial reaches a threshld f 5 millin data items cnsumed, Yu must pay fr increased hsting fees. Such fees will be calculated and cntracted as a Dedicated Hsting Envirnment. 3.0 Deplyment and Envirnments 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 ). 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. Yu may als cntact Oracle fr additinal training ptins, mre infrmatin is here. Versin 7.5 14-Dec-2017 Page 2 f 9
4.0 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 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 subinvestigatrs). Identity and Access Management Service (IAMS): Oracle Health Sciences Identity and Access Management Service (IAMS) prvides Oracle single sign-n (SSO) functinality 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 in 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. 5.0 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: Specificatins These are written by the Oracle prject team t 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 fr which Oracle and Yu are respnsible, as applicable. Team List This dcument is created and maintained by the Oracle Prject Manager. It describes the team members, their respnsibilities, and their cntact infrmatin. 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 Applicatin Release fr G-Live This is the Prductin release by Oracle f the cnfigured InFrm prgram in the Prductin instance f Yur InFrm Services envirnment that Yur apprved Users may access. Changes and Fixes t the Prductin InFrm Prgram Related dcuments are created by Oracle and apprved by Yu. Database Extracts These database extracts may be used by Yu t analyze and reprt n Yur data captured by the cnfigured InFrm applicatin. It is Yur respnsibility t request an exprt nline and t dwnlad the extract. Archives fr Yur Trial 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. Versin 7.5 14-Dec-2017 Page 3 f 9
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. A decmmissining package (i.e. archival study database and assciated files related t hsting the Prductin instance including integratins, if any) will be sent t yu after decmmissining. Archival dcumentatin related t Oracle services (e.g. trial build specificatins, change rders, dcument fr trial fix, and service request tickets) will be sent t Yu via Oracle sftp peridically during the Services Perid. Help Desk Supprt User supprt will be accessible via email r via lcal phne numbers (tll-free where available at Oracle s discretin). User Management Tl (UMT) Nn-Prductin Envirnment The latest generally available release 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. Maintenance f the Clud Services Oracle will maintain the Clud Services, including upgrades, in accrdance with the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin. 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 www.racle.cm/cntracts. 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 cnfiguratin Versin 7.5 14-Dec-2017 Page 4 f 9
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. Upgrades and migratins are scheduled with Yu and are perfrmed during business hurs fr UAT instances. Maintenance f the Training instance 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 Optinal services as described in the parameters table in the Study Order. Yur respnsibilities fr a given prject 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. 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. If Yu require a Training instance fr Yur Trial, Yu are respnsible fr requesting that Oracle deply a Training instance. Delivering clear and cmplete requirements in accrdance with the agreed timeline planning. These may include frm, edit check, Trial cnfiguratin, and database requirements. Versin 7.5 14-Dec-2017 Page 5 f 9
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. Acceptance f the cnfigured InFrm prgram fr release t the UAT instance and fr release t the Prductin instance. Prviding names f individuals wh will require access t the UAT instance. 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. This includes capturing UAT 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). 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 if Oracle is cntracted t prvide End User Help Desk supprt. 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 Database 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 Services fr cllectin and reprting f serius adverse events, Yu remain respnsible fr ensuring that all applicable regulatry bligatins are met. Reviewing and apprving dcuments related t Prductin instance changes and fixes. Apprving the InFrm prgram Database Lck. 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 Versin 7.5 14-Dec-2017 Page 6 f 9
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 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 submitting Yur PDF archive requirements and requesting that Oracle generate any PDFs Yu and/r Yur Sites may require during the Trial and/r fllwing Database Lck, within 7 calendar days f Database Lck and prir t Yur Request fr Decmmissin. Yu are respnsible fr reviewing the archival PDFs and signing and returning t Oracle a Request fr Decmmissin within 30 calendar days f receipt f the archival PDFs. 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 The FastLck phase is expected t take a ttal f 90 calendar days between Yur cnfirmatin f Database Lck and decmmissin, during which the Trial will cntinue t be available in a read-nly status. Shuld this timeframe extend beynd 90 calendar days due t delays n Yur part, Oracle reserves the right t charge additinal fees as utlined in the Study Order. 6.0 Acceptance f Deliverables Upn cmpletin f any deliverable, Oracle may prvide a cpy theref t Yu. Yu will be respnsible fr any additinal review and testing f such deliverable in accrdance with any mutually agreed review criteria r specificatins. If the deliverable des nt cnfrm with any such review criteria r specificatins, unless stated therwise in Yur bligatins abve, Yu shall 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 shall use reasnable effrts t prmptly cure any such deficiencies. After Versin 7.5 14-Dec-2017 Page 7 f 9
cmpleting such cure, Oracle shall resubmit the deliverable fr Yur review and testing as set frth abve. Upn accepting any deliverable submitted by Oracle, Yu shall 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 shall be deemed accepted at the end f the Acceptance Perid. 7.0 FastStart FastStart cnsists f activities prir t the availability f the cnfigured InFrm prgram fr user acceptance testing (UAT). Prject Management Create a prject plan detailing Trial tasks and milestnes. Crdinate Oracle prject team effrts. Track and keep Yu infrmed f Trial/prject prgress. Change Order initiatin, as needed. Endeavr t archive key milestnes, fr example: Release fr User Acceptance Testing (UAT) Study Design and Build Lead discussins t understand and dcument Yur Trial requirements Cnfigure r build Trial cmpnents in supprt f the mutually agreed Trial requirements Frmal Testing Cnduct an independent test f Yur Trial by testing Trial cmpnents against the mutually agreed Trial requirements Help Desk If Oracle is cntracted t prvide End User Help Desk supprt, Set up sites and users in the InFrm prgram. Manage user accunts in the InFrm prgram. 8.0 FastFrward FastFrward cnsists f activities frm availability f the cnfigured InFrm prgram fr user acceptance testing thrugh cnfirmatin by Yu f cmpletin f Database Lck. Prject Management One (1) User Acceptance Testing (UAT) findings meeting. Status meetings (telecnference) at mutually agreed intervals and times Change Order initiatin, as needed. Discussin regarding Change Order deliverables, as needed. User Acceptance Testing Assess and address any design that Yu find in UAT that des nt supprt the mutually agreed Trial requirements If required, deply the new build t the UAT envirnment fr Yu t re-test Yur findings Help Desk If Oracle is cntracted t prvide End User Help Desk supprt, Prvide Help Desk supprt via email r via lcal phne numbers (tll-free where available at Oracle s discretin). Versin 7.5 14-Dec-2017 Page 8 f 9
Set up sites and users in the InFrm prgram and manage user accunts. Deliver an (End-User) Satisfactin Survey questinnaire. Escalate calls t Yu, as apprpriate. Study Hsting and Applicatin Management Add user accunts t the Training instance with passwrds that will expire accrding t the parameters defined in the Prductin instance and as per Oracle s standards. 9.0 FastLck FastLck services cnsist f thse relating t the management f the Prductin instance frm cnfirmatin by Yu f cmpletin f Database Lck t Trial decmmissin. Prject Management Liaise with Yur team fr activities needed t clse ut the Trial. If applicable, prgress Yur archive requirements as described under Deliverables Frmal Testing If applicable, perfrm frmal testing f the archival PDFs Help Desk Mdify end-users t Read Only status. Study Hsting and Applicatin Management Decmmissin and recycle trial envirnment. 10.0 Oracle Clud Plicies and Pillar Dcumentatin The Services are subject t the Oracle Clud Hsting and Delivery Plicies and Oracle Industry Clud Services pillar dcumentatin, which may be viewed at www.racle.cm/cntracts. 11.0 Service Level Targets InFrm On Demand has the fllwing service level targets: Recvery Time Clud Service Objective (RTO) Recvery Pint Objective (RPO) Target System Availability Oracle Health Sciences InFrm On Demand 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. Versin 7.5 14-Dec-2017 Page 9 f 9