Access Your Data

The details on this page will help you to learn more about how to visualize study data using analytics, share data with your study team, and how to integrate your Clinical One system using pre-built and one-off integrations.

Let's get Started

Visualize study data using analytics

Share data with your study team

Use a pre-built data integration

Develop your own data integration

Work with your Oracle project manager to make sure the Oracle Clinical One Analytics are fully deployed in your organization's environment. Remember that you can use Oracle Clinical One Analytics whether you are working in a brand new or existing study.

Work with your user administrator to make sure you and other sponsor users are assigned the appropriate permissions in Oracle Clinical One Platform.

For step-by-step instructions on how to provision a sponsor user in Oracle Clinical One Platform, see Create study user accounts. For permissions typically assigned to a data manager or other sponsor users, see Examples of study roles.

Read about the predefined datasets, corresponding permissions, and what tasks you can perform when working with analytics.

Get started with datasets and visualizing data | Dataset descriptions | Use cases

You don't have to create a custom dataset from scratch because they are already predefined in your Oracle Clinical One Analytics environment. However, you have control over what you choose to visualize or export from that dataset.

Select a dataset to work with

You can visualize Oracle Clinical One Platform clinical data and add your visualizations into a dashboard that can be shared with analysts and statisticians on your study team.

Create a data visualization

You can run reports on real data while in production mode or on mock data when in testing and training mode. When your reports are ready you can download them in CSV or PDF format or view them in HTML.

Run and download a report or data extract | Generate an Oracle CRF Submit archive or report

Clinical One includes a wide variety of reports for you to select from. Don't forget that your access to certain reports may be restricted due to your study role.

Report descriptions | Data extract descriptions | Oracle CRF Submit archives and reports

Some reports can be customized to better suit your needs. For example, you can add more subject data to your Subject Events report.

Add customized fields to a report

Supply Systems

EDC Systems

InForm
Medidata Rave

CTMS Systems

Duplicate Patient Checking

IWR Systems

CTMS Systems

Oracle's Siebel TMMCS

mHealth/DCT - Medable (Contact your Customer Success Manager (CSM) for information)

Wearables/Devices
eConsent/eCOA/ePRO
Telehealth

Labs/General Subject Data

CDISC Lab Intake
Data Intake

Data Review/Management & SDTM

Data Management Workbench

Metadata Repository - Nurocor (Contact your Customer Success Manager (CSM) for information)

Automated Study Setup

Risk Based Monitoring - Remarque (Contact your Customer Success Manager (CSM) for information)

Site SDV Level re-calibration

Central Coding
CRF Submit
Analytics & Reports Datasets
InForm & Argus

To keep your data secure, working with our REST APIs requires you to authenticate with Clinical One. You must also ensure that you have permissions to access the data you need without risking the integrity of your trial.
Learn more: Set up your authentication and accounts

REST APIs offer access to Clinical One services. Developers need to be familiar with, and have the tools needed to work with REST APIs. They should also have a basic understanding of Clinical One and the data they are working with. Most importantly, they need to have appropriate credentials to access the needed data and test out their systems.
Get started as a developer

Clinical One offers a range of services that are accesible through REST APIs. You can search our API documentation to find the APIs and examples you need.
Search APIs

Want to take it for a spin? We offer use cases to help you better understand how you can use REST APIs to integrate you applications or migrate your data.
See our use cases

Almac Global Depot Network

Allows you to automate, distribute, and track shipments more effectively.

Supporting Documentation:

Integration Details:

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps:

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Shipment Requests
Automated Shipment Response-Confirmed
In Transit Status

Available Data Points

Request: Shipping Site Address, Site contact information, Site investigation information, & Shipment Order Details

Response: Shipment Order, Tracking Number and Shipment Date, and Shipment Status

Fisher Clinical Services

Automate, distribute, and track initial shipments to sites, resupply shipments and manual shipments.

Supporting Documentation:

Integration Details:

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps:

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Shipment Requests
Shipment Response-Date Shipped, Courier for InTransit status

Available Data Points

Request: Shipping Site address, Site contact information, Site Investigator Information, & Shipment Order details

Response: Shipment Order, Tracking number and Shipment Date and Shipment Status

PMD SmartSupplies:

A clinical inventory management system (CIMS) that allows customers to track their clinical inventory, supply stock levels, etc.

Supporting Documentation:

Integration Details:

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps:

If you are interested in using this integration, work with your Customer Success Manager (CSM).

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

Catalent Clinical Supply Services:

Lets you effectively manage shipments and forecast your clinical supply needs ensuring you have the right number of supplies available at a site at all times.

Supporting Documentation:

Integration Details:

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps:

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Shipment Requests
Shipment Response-Confirmed
In Transit Status
Received

Available Data Points

Request: Shipping Site Address, Site contact information, Site Investigator information, & Shipment Depot & Order Details

Response: Shipment Order, Tracking number and Shipment Date and Shipment Status, & Shipment Delivery

Catalent Clinical Supply Services:

Lets you effectively manage shipments and forecast your clinical supply needs ensuring you have the right number of supplies available at a site at all times.

Supporting Documentation:

Integration Details:

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps:

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Shipment Requests
Automated Shipment Response-Confirmed
In Transit Status

Available Data Points

Request: Shipping Site Address, Site contact information, Site investigation information, & Shipment Order Details

Response: Shipment Order, Tracking Number and Shipment Date, and Shipment Status

What's New?

Added: Ability to share alerts of events

SAP Custom

Lets you effectively manage shipments and forecast your clinical supply needs ensuring you have the right number of supplies available at a site at all times.

Supporting Documentation:

Integration Details:

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps:

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Shipment Requests
Automated Shipment Response-Confirmed
In Transit Status

Available Data Points

Request: Shipping Site Address, Site contact information, Site investigation information, & Shipment Order Details

Response: Shipment Order, Tracking Number and Shipment Date, and Shipment Status

What's New?

Added: Ability to share alerts of events

Sharp ERP Shipment:

Synchronize shipment and tracking data between Sharp's Supply Management system and Clinical One RTSM.

Supporting Documentation:

Integration Details:

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps:

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Shipment Requests
Shipment Response-Date Shipped, Courier for InTransit status

Available Data Points

Request: Shipping Site address, Site contact information, Site Investigator Information, Shipment Order details, Lot Number, & Kit Type

Response: Shipment Order, Tracking number and Shipment Date and Shipment Status

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

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Screening/Screenfail
Randomization
Visit Complete
Completion/undo Completion
Withdraw/Undo Withdraw
Kit Replacement

Available Data Points

Demography
Randomization
Dispensation/Replacement
Withdraw/ScreenFail reasons
Completion details
Scheduled Visit details

iMednet EDC

A two-way integration capable of sending screening data from iMednet EDC to Clinical one, and randomization data from Clinical One to iMednet EDC.

Supporting Documentation

Integration Details

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Screening (from iMednet to Clinical One)

Randomization (from Clinical One to iMednet)

Available Data Points

Screening:
Site ID, Subject ID, and 3 other data points, sent from iMednet EDC to Clinical One after a subject is screened in iMednet EDC.

Randomization:
Randomization Date, Randomization Number, and other data points, sent from Clinical One to iMednet EDC after the subject is randomized in Clinical One.

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

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events & Data Points

For additional report details click HERE. The details will include available modes, roles that 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

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

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

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

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

Configuration Service:

B92664: Oracle Health Sciences Clinical One Digital Gateway Configuration Service, up to 40 Data Points.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

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

Trial Management and Monitoring Cloud Service (TMMCS) – Site Integration:

Send site details from a protocol in Siebel TMMCS to Clinical One for automatic site creation.

Supporting Documentation

Integration Details

Configuration Service:

Contact your Customer Success Manager (CSM) for information.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Site, from TMMCS to Clinical One

Available Data Points

Site details including account type, site address and shipment information, & site status.

Trial Management and Monitoring Cloud Service (TMMCS) – Subject Visit Template Integration:

Send study version and corresponding study design metadata for a study running in a particular mode from Clinical One to Siebel TMMCS

Supporting Documentation

Integration Details

Configuration Service:

Contact your Customer Success Manager (CSM) for information.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Study design – All versions

Available Data Points

Visits, Visit Schedule, & Form Items by version.

Trial Management and Monitoring Cloud Service (TMMCS) – Subject Visit Integration:

Send incremental subject, subject status, and clinical data from Clinical One to Siebel TMMCS.

Supporting Documentation

Integration Details

Configuration Service:

Contact your Customer Success Manager (CSM) for information.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Screening/Screenfail, Randomization, Withdrawal status, Screenfail/Undo Screenfail, Completion/undo Completion, & Withdrawal/Undo Withdraw

Available Data Points

Date items and items with value 'Yes'. Visit completed with Visit Date and Subject Status.

Trial Management and Monitoring Cloud Service (TMMCS) – Source Data Validation:

Send Source Data Validation (SDV) data from Clinical One to Siebel TMMCS.

Supporting Documentation

Integration Details

Configuration Service:

Contact your Customer Success Manager (CSM) for information.

Next Steps

If you are interested in using this integration, work with your Customer Success Manager (CSM).

Available Events

Scheduled visits, Unscheduled visits, and Adverse Events.

Available Data Points

Visit Verified, Visit Verified date, and Event name