Oracle Health Sciences. Central Coding Cloud Service Service Descriptions and Metrics

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1 Central Cding Clud Service Service Descriptins and Metrics August 17, 2016 Table f Cntents Metric Definitins... 2 Instance... 2 Hsted Named Health Science User... 2 Hsted Named Health Sciences Read Only User... 2 Service Descriptins... 3 Central Cding Clud Service Instance... 3 Retired Offerings... 5 Central Cding On Demand ( Central Cding Service ) Instance... 5 Central Cding Clud Service Service Descriptins Page 1

2 Metric Definitins Instance Instance is defined as a single deplyment f the Oracle Prgram. Fr details f deplyment specific t the Oracle prgram please refer t service descriptins/entitlements. Hsted Named Health Science User Hsted Named Heath Sciences User is defined as an individual authrized by Yu t access the Clud Services, regardless f whether the individual is actively accessing the Clud Services at any given time. Hsted Named Health Sciences Read Only User Hsted Named Heath Sciences Read Only User is defined as an individual authrized by Yu t have read-nly access t the Health Sciences Clud Services such as running queries r reprts fr which Yu als acquired nn read-nly access, regardless f whether the individual is actively assessing the Clud Services at any given time. Central Cding Clud Service Service Descriptins Page 2

3 Service Descriptins Central Cding Clud Service Instance Users f the Central Cding Clud Service are authrized t access the fllwing mdules r functinalities: Central Cding A purchased Instance f Central Cding allws multiple Trials t cnnect t that Instance fr the use f the Central Cding prgram fr the exchange f relevant data including verbatim terms indicatin and rute f administratin frm the InFrm Trials 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(s). Oracle will grant User Manager and User Administratr rles t the Central Cding Custmer. The Custmer will then be able t create individual end user accunts fr their persnnel in the Central Cding prgram. Oracle will nt create individual end user accunts fr the Custmer. Deliverables Fr a new Central Cding deplyment, Oracle will prvide the fllwing cmmn deliverables that apply t mst prjects: One Instance f the Central Cding includes ne UAT Envirnment and ne Prductin Envirnment 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, this Validatin Package dcumentatin may be used by Yu t perfrm Installatin Qualificatin (IQ), Operatinal Qualificatin (OQ) and/r Perfrmance Qualificatin (PQ) fr the Central Cding integratin. It is Yur respnsibility t request the Validatin Package frm Oracle if desired. Online training fr Central Cding fr the named Trial(s) fr Central Cding Users. The list f available nline curse(s) fr Central Cding is prvided in the Online Training fr InFrm Clud Service Data Sheet As part f Decmmissining a Trial, Oracle will prvide Yu with a full Central Cding database extract (i.e. shwing data fr all Trials in Yur Central Cding database). If there is a need t separate ut the data fr a specific Trial frm the full Central Cding database extract prvided (e.g. in rder fr Yu t distribute t a third party) this separatin and distributin is Yur respnsibility. Central Cding Clud Service Service Descriptins Page 3

4 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 Central Cding Clud Service. Dictinaries must 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 Instance and n an annual basis. Hwever, this des nt alleviate custmer bligatins t maintain a valid license t such dictinaries. Oracle may suspend access t the Central Cding Clud Service immediately if Yur dictinary licenses have expired. In such an event, Yu remain respnsible fr payment bligatins hereunder. Usage Limits: The Central Cding Clud Service is subject t usage limits based n: Number f purchased Instances The fllwing usage limits apply per licensed metric: Metric Database (Recrds) File (GB) Bandwidth Central Cding Instance* 250GB N/A N/A # f Instances included with License 2 (ne Prductin Envirnment supprts up t 50 Trials and ne UAT Envirnment supprts up t 50 Trials) Hsted Named Heath Sciences User ** N/A N/A N/A N/A Hsted Named Heath Sciences Readnly User N/A N/A N/A N/A *Yu will need t purchase anther Instance f Central Cding shuld yu deply mre than 50 Trials ** Minimum f ne User required fr use f Clud Services Service Level Targets: The Central Cding Clud Service has the fllwing service level targets: Clud Service Recvery Time Objective (RTO) Recvery Pint Objective (RPO) Target System Availability Central Cding 90 days 48 hurs 99% Oracle Clud Plicies: Yur rder fr this Oracle Clud Service is subject t the Oracle Clud Hsting and Delivery Plicies, which may be viewed at Central Cding Clud Service Service Descriptins Page 4

5 Retired Offerings Central Cding On Demand ( Central Cding Service ) Instance Users f the Central Cding Service are authrized t access the fllwing mdules r functinalities: Central Cding A purchased Instance f Central Cding allws multiple Trials t cnnect t that Instance fr the use f the cding applicatin fr the exchange f relevant data including verbatim terms indicatin and rute f administratin frm the InFrm Trials 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 t the Central Cding custmer. The custmer will then be able t create individual end user accunts fr their persnnel in the Central Cding applicatin. Oracle will nt create individual end user accunts fr the custmer. Deliverables Fr a new Central Cding deplyment, Oracle will prvide the fllwing cmmn deliverables that apply t mst prjects: One Instance f the Central Cding includes ne UAT envirnment and ne Prductin envirnment 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, this Validatin Package dcumentatin may be used by Yu t perfrm Installatin Qualificatin (IQ), Operatinal Qualificatin (OQ) and/r Perfrmance Qualificatin (PQ) fr the Central Cding integratin. It is Yur respnsibility t request the Validatin Package frm Oracle if desired. Online training fr Central Cding fr the named Trial(s) fr Central Cding users. The list f available nline curse(s) fr Central Cding is prvided in the Online Training fr InFrm Clud Service Data Sheet As part f decmmissining a Trial, Oracle will prvide Yu with a full Central Cding database extract (i.e. shwing data fr all Trials in Yur Central Cding database). If there is a need t separate ut the data fr a specific Trial frm the full Central Cding database extract prvided (e.g. in rder fr Yu t distribute t a third party) this separatin and distributin is Yur respnsibility. Central Cding Clud Service Service Descriptins Page 5

6 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 Central Cding Services. Dictinaries must 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 Instance and n an annual basis. Hwever, this des nt alleviate custmer bligatins t maintain a valid license t such dictinaries. Oracle may suspend access t the Central Cding Services immediately if Yur dictinary licenses have expired. In such an event, Yu remain respnsible fr payment bligatins hereunder. Usage Limits: The Central Cding Service is subject t usage limits based n: Number f purchased Instances The fllwing usage limits apply per licensed metric: Metric Database (Recrds) File (GB) Bandwidth Central Cding Instance* 250GB N/A N/A # f Instances included with License 2 (ne Prductin Envirnment supprts up t 50 Trials and ne UAT Envirnment supprts up t 50 Trials) Hsted Named Heath Sciences User ** N/A N/A N/A N/A Hsted Named Heath Sciences Readnly User N/A N/A N/A N/A *Yu will need t purchase anther Instance f Central Cding shuld yu deply mre than 50 Trials ** Minimum f ne User required fr use f Clud Services Service Level Targets: The Central Cding Service has the fllwing service level targets: Clud Service Recvery Time Objective (RTO) Recvery Pint Objective (RPO) Target System Availability Central Cding 90 days 48 hurs 99% Oracle Clud Plicies: Yur rder fr this Oracle Clud Service is subject t the Oracle Clud Hsting and Delivery Plicies, which may be viewed at Central Cding Clud Service Service Descriptins Page 6

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