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Greenlight Guru (releasing soon)
Near real-time import of data in standard ODM format from Greenlight Guru to Clinical One.
Integration Details:
Data Flow: Inbound
Mode: API
Source Format: ODM
Target format: JSON
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Additional costs may be applied. Contact vendor for additional information.
Next Steps:
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Subject creation in Clinical One
- Import of subject data from Greenlight Guru to Clinical One
- Subject status updates
Available Data Points
- ePRO
- eConsent
Medable
Import of data from Medable to Clinical One using direct Clinical One APIs.
Integration Details:
This integration is built by Medable using direct Clinical One API approach, where captured data is pushed from Medable application directly into Clinical One.
The integration does not run on Digital gateway and IMO.
Data Flow: Inbound
Mode: API
Source Format: JSON
Target format: JSON
Configuration Service:
NA.
Next Steps:
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Subject creation in Clinical One
- Import of subject data from Medable to Clinical One
Available Data Points
- ePRO
- eConsent
- eCOA
Medrio
Near real-time import of data in standard ODM format from Medrio to Clinical One.
Supporting Documentation:
Integration Details:
Data Flow: Inbound
Mode: API
Source Format: ODM
Target format: JSON
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Additional costs may be applied. Contact vendor for additional information.
Next Steps:
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Subject creation in Clinical One
- Import of subject data from Medrio to Clinical One
Available Data Points
- ePRO
- eConsent
- eCOA
ObvioHealth
Near real-time import of data in standard ODM format from ObvioHealth to Clinical One.
Supporting Documentation:
Integration Details:
Data Flow: Inbound
Mode: API
Source Format: ODM
Target format: JSON
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Additional costs may be applied. Contact vendor for additional information.
Next Steps:
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Subject creation in Clinical One
- Import of subject data from ObvioHealth to Clinical One
Available Data Points
- ePRO
- eConsent
- eCOA
PMD SmartSupplies
A clinical inventory management system (CIMS) that allows customers to track their clinical inventory, supply stock levels, etc.
Supporting Documentation:
Integration Details:
Data Flow: Outbound
Mode: sFTP
File type: XML
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps:
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Kit status changes at depots and sites
- Kit request transfer from depot to depot
- Kit receipt transfer from depot to depot
Available Data Points
- Kit number
- Lot number and Status
- Source and Destination depot
- Shipment date
- Expected date
- Kit and Lot
IBM Clinical Development
Send Clinical One RTSM data to IBM EDC for screening, randomization, subject completion, subject withdrawal, and study drug dispensation.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: API
File type: TXT
Configuration Service:
B92665: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 70 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Screening/Screenfail
- Randomization
- Visit Complete
- Completion/undo Completion
- Withdrawal/Undo Withdraw
- Kit Replacement
Available Data Points
- Demography
- Randomization
- Dispensation/Replacement
- Withdraw/ScreenFail reasons
- Completion details
- Scheduled Visit details
InForm
Synchronize study subject data between Oracle Clinical One Platform and Oracle InForm.
Supporting Documentation
Integration Details
Data Flow: Outbound from Clinical One
Mode: Web Service
File type: ODM
Configuration Service:
B92665 Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 70 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Screening/Screenfail
- Randomization
- Visit Complete
- Completion/undo Completion
- Withdrawal/Undo Withdraw
- Kit Replacement
- Data Updates
- Subject Transfer
Available Data Points
- Demography
- Randomization
- Dispensation/Replacement
- Withdraw/ScreenFail reasons
- Completion details
- Scheduled Visit details
Medidata Rave
Outbound subject data integration from Clinical One RTSM to Medidata Rave ensures you have a complete set of subjects for whom data is to be collected.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: Web Service
File type: XML
Configuration Service:
B92665: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 70 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Screening/ScreenFail
- Randomization
- Visit Complete
- Completion/Undo Completion
- Withdrawal/Undo Withdraw
- Kit Replacement
- Code Break
Available Data Points
- Demography
- Randomization
- Dispensation/Replacement
- Withdraw/ScreenFail reasons
- Completion details
- Scheduled visit details
- Code break details
Oracle’s Siebel CTMS (report)
Allows you to obtain an accurate overview of your subject’s activity in a study and send data to your CTMS system.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: sFTP
File type: TXT
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events & Data Points
For additional report details click HERE.
The details will include available modes, roles that can run this report, and field descriptions that are included in this report.
Veeva CTMS
Automatically send subject enrollment data to Veeva Vault for better monitoring of subject enrollment information.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: Web Service
File type: XML
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration..
Available Events
- Screening (Status and Screened Date)
- Screenfail (ScreenFailed Status and ScreenFailed Date
- Inscreening Status with blank screenfailed date (Undo screenfail)
- Pre-Screening status with blank screenfailed date (Undo Screenfailed without screening)
- Randomization (Status and Randomized Date)
Available Data Points
- Site ID
- Subject ID
- Status
- Screening Date
- Randomization Date.
Verified Clinical Trials
Send subject data from Clinical One RTSM to VCT through Oracle sFTP to ensure subjects are not participating in multiple trials concurrently.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: sFTP
File type: Comma delimited .txt
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Subject visits-Configurable
- Subject sites-Configurable
Available Data Points
- Cumulative Subject data with latest subject’s status and visit only.
- Sites and visits can be configured or all sites and all visits can be sent.
Multi-IWR Interface
Import data in standard ODM format from an external vendor to Clinical One using the Digital Gateway Builder web service.
Supporting Documentation
Integration Details
Data Flow: Inbound
Mode: API
File type: Subject/data files
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Subject data from IWR to Clinical One
- Subject lab data from an external lab vendor to Clinical One
Available Data Points
- Enroll
- Screen/Screen Failure
- Visit Complete
- Data Update
- Lab test results and associated data
CDISC Lab Intake
Load lab data into the Oracle Clinical One Platform that adheres to the Clinical Data Interchange Standards Consortium (CDISC) Laboratory Data Model (LAB) standard.
Supporting Documentation
Integration Details
Data Flow: Inbound
Mode: sFTP
File type: ASCII .txt comma or pipe delimited
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- NA
Available Data Points
-
The following can be populated pending study design.
- Visits
- Forms
- Form Items
Data Intake
Load generic data such as subject and questionnaire data into Clinical One forms.
Supporting Documentation
Integration Details
Data Flow: Inbound
Mode: sFTP
File type: ASCII .txt comma or pipe delimited
Configuration Service:
B92664: Oracle Life Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.
The Oracle Life Sciences Clinical One Digital Gateway Configuration Service includes remote services related to the configuration of a standard integration between Clinical One and a Separate Software Application. For more information, review the Service Description and Metrics.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- NA
Available Data Points
-
The following can be populated pending study design.
- Visits
- Forms
- Form Items
CRF Submit
Initiate PDF archive and history report requests and retrieve the output in the Clinical One Platform user interface. You can include the output created with CRF Submit in submissions to regulatory authorities and to archive study data.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: NA
File type: PDF or CSV.
Configuration Service:
NA
Next Steps
Users assigned the appropriate Clinical One permissions can access the Archives tab under Reports & Archives.
Review the CRF Submit access table in Descriptions of permissions in Oracle Clinical One Platform for more information.
Available Request Types
- Submission
- Archival
- Blank
- Custom
Available Reports
- Download log
- Site Confirmation
Analytics & Reports Datasets
Allows developers to make Oracle Clinical One Platform API calls to extract clinical data, metadata, and administrative data by accessing Clinical One Platform services.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: Web Services
File type: JSON format
Configuration Service:
NA
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- NA
Available Data Points
- Clinical data, metadata, and administrative data
Oracle's Siebel Clinical Trial Management System (CTMS) – Site Integration
Send site details from a protocol in Oracle Siebel CTMS to Clinical One for automatic site creation.
Supporting Documentation
Integration Details
Data Flow: Inbound
Mode: API
File type: XML
Configuration Service:
Available via Oracle consulting services.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Site, from CTMS to Clinical One
Available Data Points
- Site details including account type, site address and shipment information, & site status.
Note:This CTMS offering consists of the Source Data Validation Integration, Subject Visit Integration, Site Integration, and the SVT integration. You only need to implement what is necessary for your organization.
Oracle's Siebel Clinical Trial Management System (CTMS) – Study Version Template (SVT) Integration:
Send study version and corresponding study design metadata for a study running in a particular mode from Clinical One to Oracle Siebel CTMS
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: API
File type: XML
Configuration Service:
Available via Oracle consulting services.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Study design – All versions
Available Data Points
- Visits, Visit Schedule, & Form Items by version.
Note:This CTMS offering consists of the Source Data Validation Integration, Subject Visit Integration, Site Integration, and the SVT integration. You only need to implement what is necessary for your organization.
Oracle's Siebel Clinical Trial Management System (CTMS) – Subject Visit (SV) Integration
Send incremental subject, subject status, and clinical data from Clinical One to Oracle Siebel CTMS.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: API
File type: XML
Configuration Service:
Available via Oracle consulting services.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Screening/Screenfail
- Randomization
- Withdrawal status
- Screenfail/Undo Screenfail
- Completion/undo Completion
- Withdrawal/Undo Withdraw
Available Data Points
- Only Date items and items with value 'Yes' are integrated.
- Only Visit completed with Visit Date and Subject Status is integrated.
Note:This CTMS offering consists of the Source Data Validation Integration, Subject Visit Integration, Site Integration, and the SVT integration. You only need to implement what is necessary for your organization.
Oracle's Siebel Clinical Trial Management System (CTMS) – Source Data Verification (SDV)
Send Source Data Validation (SDV) data from Clinical One to Oracle Siebel CTMS.
Supporting Documentation
Integration Details
Data Flow: Outbound
Mode: API
File type: XML
Configuration Service:
Available via Oracle consulting services.
Next Steps
Reach out to your Oracle point of contact if you want to use this integration.
Available Events
- Scheduled visits
- Unscheduled visits
- Adverse Events.
Available Data Points
- Visit Verified
- Visit Verified date
- Event name
Note:This CTMS offering consists of the Source Data Validation Integration, Subject Visit Integration, Site Integration, and the SVT integration. You only need to implement what is necessary for your organization.