3 Create other integrations

Automate and distribute shipments using the Almac Global Depot Network

This workflow applies to shipments when you use an integration with the Almac global depot network for shipments, and it applies to all types of shipments, including the initial shipment to a site, a resupply shipment that is generated automatically when resupply runs, and a manual shipment.

Integration user details

Integration set up includes the creation of a study level integration user account, which is assigned the Clinical supply manager template role, or a custom role that includes the same permissions. The integration user account is created using the email address of one of your organization's Clinical Supply Managers. The email address associated with the integration user receives integration notifications, which can include content resulting in unblinding. Make sure the appropriate email address is configured for the integration user account to avoid unblinding issues.

For information about how to set up this integration, contact your Oracle Project Manager.

Workflow for a shipment when you use an integration with Almac

Note:

If you need to update a shipment after the shipment request has been sent to the depot, you must contact Almac directly. If you make any updates to shipments from within Oracle Clinical One Platform, the changes won't be sent to the depot.
  1. When a new shipment is raised, the status of the shipment changes to Pending. This activity is automated.
  2. When the shipment request is sent to the depot, the status of the shipment changes to one of the following:
    • Confirmed, if the depot received the request.
    • Invalid, if an issue occurred with the request.

    Both status changes are automated.

  3. For a confirmed shipment, after the depot fulfills the shipment, the ship date and tracking number are set, and the status of the shipment changes to In Transit. The setting of the ship date, tracking number, and status change are all automated.
    For an invalid shipment, a clinical supply manager should cancel the shipment and do one of the following:
    • Allow the resupply process to create a new shipment the next time inventory runs.
    • Create a new manual shipment.
  4. A site receives the shipment and marks the shipment as received, changing its status to Received.

What if an order is sent to Almac in error?

If a shipment request is sent in error or kits need to be added or removed, the clinical supply manager must contact Almac and request the shipment's cancellation. Once Almac cancels the order in their system, the shipment status changes to Invalid in Oracle Clinical One Platform. To allow the resupply process to create a new shipment the next time inventory runs, the clinical supply manager must also explicitly cancel the shipment in Oracle Clinical One Platform.

Note:

Almac will only be able to cancel the order if the shipment hasn't been sent yet.

Prerequisites for sending the depot order form to Almac-managed depot facilities

To make sure depot users at an Almac-managed depot facility get this email notification in their inbox, in Oracle Clinical One Platform, on the Depots tab, check that the Almac-managed depots are correctly defined and their Depot IDs match the exact names of the depot facilities. Additionally, make sure the email field for depots managed by the Almac Global Depot Network is left blank. The integration is configured to send emails to the appropriate recipients.

Automate and distribute shipments using Catalent Clinical Supply Services

This workflow applies to shipments when you use an integration with Catalent Clinical Supply Services for shipments, and it applies to all types of shipments, including the initial shipment to a site, a resupply shipment that is generated automatically when resupply runs, and a manual shipment.

Integration user details

Integration set up includes the creation of a study level integration user account, which is assigned the Clinical supply manager template role, or a custom role that includes the same permissions. The integration user account is created using the email address of one of your organization's Clinical Supply Managers. The email address associated with the integration user receives integration notifications, which can include content resulting in unblinding. Make sure the appropriate email address is configured for the integration user account to avoid unblinding issues.

For information about how to set up this integration, contact your Oracle Project Manager.

Prerequisites for clinical supply managers

  1. Shipment ID prefixes created in Oracle Clinical One Platform must consist only of numbers. When you set the prefix on the Supply Settings tab, in the Shipment Settings section, choose one of the following options:
    • Use Depot ID: If Depot IDs have been defined using numbers only
    • Enter Prefix: Enter a prefix and make sure the value consists only of numbers
    • None: If no prefix is used.
  2. To make sure depot users at a Catalent-managed depot facility are notified by email about an order, in Oracle Clinical One Platform, on the Depots tab, check that the email field for depots managed by Catalent Clinical Supply Services is left blank. The integration is configured to send emails to the appropriate recipients.
  3. Catalent expects protocol values between 5 and 30 characters long, therefore the value for Study Title in Oracle Clinical One Platform must be defined accordingly.

Workflow for a shipment when you use an integration with Catalent Clinical Supply Services for shipments

  1. When a new shipment is raised, the status of the shipment changes to Pending in Oracle Clinical One Platform. This activity happens both manually or automatically, depending on how the resupply conditions are set in the study.
  2. When the shipment request is acknowledged by the depot, the status of the shipment changes to Confirmed in Oracle Clinical One Platform. This activity is automated.
  3. The depot adds a ship date and a tracking number to the shipment, if available. The status of the shipment changes to In Transit in Oracle Clinical One Platform. These updates are automated.
  4. The following updates can happen both automatically or manually, depending on how the integration is configured:
    • If the integration is configured to support this and the courier provides the information: Catalent Clinical Supply Services receives delivery information from the courier. The integration sets the status of the shipment to Received in Oracle Clinical One Platform. The status of all the kits included in the shipment automatically changes to Available.

      Additionally, the Date Received is updated in Oracle Clinical One Platform to reflect the date the integration processed the delivery file. This date may not always match the date at which the shipment is delivered by Catalent Clinical Supply Services.

    • If the integration isn't configured to interpret the delivery as a receipt: A site user must manually mark the shipment as Received in Oracle Clinical One Platform.

Note:

If you need to update (add or remove kits from a shipment) or cancel a shipment after the shipment request has been sent to the depot, you must contact Catalent Clinical Supply Services directly. If you make any updates to shipments from within Oracle Clinical One Platform, the changes won't be sent to the depot. When the shipment is marked as Received, this status update applies to the entire shipment and all its kits are presumed Available. Therefore, all the kits in the shipment, including kits added after the original request, are updated once the shipment is received.

What if an order is sent to Catalent Clinical Supply Services in error?

If a shipment request is sent in error or kits need to be added or removed, the clinical supply manager must contact Catalent Clinical Supply Services and request the shipment's cancellation. Once Catalent Clinical Supply Services cancels the order in their system, the shipment status changes to Invalid in Oracle Clinical One Platform. To allow the resupply process to create a new shipment the next time inventory runs, the clinical supply manager must also explicitly cancel the shipment in Oracle Clinical One Platform.

Note:

Catalent Clinical Supply Services will only be able to cancel the order if the shipment hasn't been sent yet.

Automate and distribute shipments using Fisher Clinical Services

This workflow applies to shipments when you use an integration with Fisher Clinical Services, and it applies to all types of shipments: the initial shipment to a site, a resupply shipment that is generated automatically when resupply runs, and a manual shipment.

Integration user details

Integration set up includes the creation of a study level integration user account, which is assigned the Clinical supply manager template role, or a custom role that includes the same permissions. The integration user account is created using the email address of one of your organization's Clinical Supply Managers. The email address associated with the integration user receives integration notifications, which can include content resulting in unblinding. Make sure the appropriate email address is configured for the integration user account to avoid unblinding issues.

For information about how to set up this integration, contact your Oracle Project Manager.

Workflow for a shipment when you use an integration with Fisher Clinical Services

  1. When a new shipment is raised, the status of the shipment changes to Pending. This activity is automated.
  2. For a confirmed shipment, after the depot fulfills the shipment, the ship date is set, and the status of the shipment changes to In Transit. The setting of the status and shipment details defined with each integration, such as shipment date, courier and tracking number, are both automated.
  3. A site receives the shipment and marks the shipment as received, changing its status to Received.

Note:

If you need to update a shipment after the shipment request has been sent to the depot, you must contact Fisher Clinical Services directly. If you make any updates to shipments from within Oracle Clinical One Platform, the changes won't be sent to the depot.

Integrate screening and randomization data using iMednet EDC

Use this web service based, two-way integration, between Mednet EDC and Oracle Clinical One Platform RTSM to integrate subject screening and randomization data.

Integration data flow

iMednet EDC to Oracle Clinical One Platform RTSM

Subjects are first screened in iMednet EDC. A schedule, configured in Oracle Clinical One Platform, calls Mednet API's to retrieve subjects who are marked Ready for Randomization. Screening data is returned to Oracle Clinical One Platform to automatically screen subjects.

Oracle Clinical One Platform to iMednet EDC

Once a subject has been randomized in Oracle Clinical One Platform, randomization data is returned to the iMednet EDC system.

Available events and data points

  • Available events: Screening and Randomization.
  • Available data points for Screening: Subject statuses, Site ID, Subject ID, and 3 other data points defined by the project team.
  • Available data points for Randomization: Randomization date, Randomization Number, Dispensed and replaced kits, and other data points defined by the project team.

Other integration details

  • Data sent to Oracle Clinical One Platform completes the screening process in which iMednet data points populate all required items in the screening visit. Other items can be present at the screening visit, but they cannot be required, or the integration will not be able to complete the screening process.
  • Site ID/Name must match in both systems.
  • If a subject is transferred to a new site in either system, the integration is no longer able to sync data, and jobs start failing.
  • The integration in Oracle Clinical One Platform does not monitor or log any job failures once the data is sent via the Mednet APIs. The customer needs to work with Mednet to resolve any data import issues or failures. No data is stored by the integration for future retries.
  • When a subject is screened in Oracle Clinical One Platform, the visit date for the screening visit defaults to the current date and time.

How can I configure this integration?

For more information about how to set up this type of integration, reach out to your Oracle project manager, or find additional details at Access Your Data under Use a pre-built data integration.

Load lab results and other data into Oracle Clinical One Platform

There are two types of data intake integrations available through the Oracle Clinical One Digital Gateway that can be utilized to load data into forms in Oracle Clinical One Platform.

CDISC Lab Data Intake

Load lab data into Oracle Clinical One Platform that adheres to the Clinical Data Interchange Standards Consortium (CDISC) Laboratory Data Model (LAB) standard, ensuring the data being loaded is done so in accordance with the industry's standard for transmitting electronic data related to drug development.

Data for this integration can be loaded into flat, repeating and multi-section forms assigned to a scheduled visit, unscheduled visit or cycle visit.

Note:

Data loaded into hidden items does not adhere to the CDISC LAB standard.

For more information about this integration, reach out to your Oracle Customer Success Manager (CSM) or Oracle Project Manager.

Generic Data Intake

Load generic data such as subject and questionnaire data into Oracle Clinical One Platform forms.

Data for this integration can be loaded into flat and repeating forms assigned to a scheduled visit, unscheduled visit or cycle visit.

For more information about this integration, contact your Oracle Customer Success Manager (CSM) or Oracle Project Manager.

Data Intake integration overview

  • Forms are created during study design that are to be populated through a data intake integration.
  • The integration is configured using the integration template.
  • Data files (ASCII .txt comma or pipe delimited), are placed on the Oracle sFTP server by the vendor which are picked up once detected by the Oracle Clinical One Digital Gateway.
  • The Oracle Clinical One Digital Gateway validates and incrementally processes the file, then uploads the data into the appropriate forms.
  • Queries are automatically raised as per the rules that have been predefined in the study design.

Data Intake integration error handling

  • If data does not conform to the expected format defined for an integration or if data points do not match the options defined in Oracle Clinical One Platform such as study name, visit, form, or subject id the job will fail and displays the appropriate error message and remediation details.
  • If a Data Intake integration attempts to populate a form in a skipped visit, a visit manually skipped by a user, the import job fails, and data does not integrate. To resolve this, a user must undo the skipped visit followed by the vendor placing the file on sFTP for re-import.
  • Scheduled visits can be loaded out-of-order except for branch visits. Integration jobs will fail if sending data out-of-order for any branch visit (non-cycled and cycled). For example, if a branch has Day1 -> Day2 visits then the Day2 visit cannot be loaded before Day1 is completed.

Send subject and kit event data to Oracle InForm

Study data from Oracle Clinical One Platform synchronizes directly in Oracle InForm.

For information about how to set up this integration, please reach out to your Oracle Project Manager.

All data on scheduled and unscheduled events (including unscheduled dispensation data) is sent to Oracle InForm at the intervals defined in the integration schedule. For more details on what types of data you can integrate, see below.

When integrating date fields between Oracle Clinical One Platform and Oracle InForm, make sure a date rule is created in Oracle Clinical One Platform to prevent data that is not accepted by Oracle InForm from being collected. Otherwise, the integration fails with no possible workaround. Learn how to prevent this error and make sure your integrations with Oracle InForm won't fail.

Subject event data

Type of data Notes

Screen a subject.

You choose the data to send.

Screen fail a subject and undo screen failure

  • For screen failure, the screen failure date and reason along with any other relevant information related to the screen failure event are sent to Oracle InForm. You can map these fields to any form you use to collect the screen failure reason. The status for the subject in Oracle InForm isn't changed.
  • For undo screen failure, the screen failure date is updated to blank in Oracle InForm. The status for the subject in Oracle InForm isn't changed.

Randomize a subject

You choose the data to send.

Update a form for a subject.

You choose the data to send.

Complete a subject's visit.

You choose the data to send.

Transfer a subject.

You choose the data to send.

Withdraw a subject and undo withdrawal.

  • For subject withdrawal, the withdrawal form in Oracle InForm is updated with the withdrawal date and reason, as well as any other relevant information.
  • For undo subject withdrawal, the completion date and other details that were sent are cleared out in Oracle InForm. Oracle Clinical One Platform retains the information in the withdrawal form.

Complete a study for a subject and undo study completion.

  • For a study completion, the completion date and any other relevant information for a subject completion event is sent to Oracle InForm.
  • For undo study complete, the completion date and other details that were sent are cleared out in Oracle InForm. The information in the study completion form in Oracle Clinical One Platform remains.

Kit event data

Type of data Notes

Replace a kit that was damaged or lost

Data about replaced kits and new kits that are dispensed is sent to Oracle InForm and included in a visit form. The new information includes dispensation date, original kit number and new kit number, amongst others.

Re-dispense a conserved kit.

The conserved kit number and any other relevant data can be sent to Oracle InForm and included in a visit form.

Form data

Type of data Notes

Apply, update, or clear a data flag.

In Oracle InForm, data flags correspond to the Reason Incomplete options available in the user interface for incomplete form answers. In Oracle InForm the Data Entry Flag is collected in the item comment section. Clicking the Comments icon in Oracle InForm displays the Reason Incomplete options, equivalent to those in Oracle Clinical One Platform. The Reason for Change from Oracle Clinical One Platform is featured on the Comment field above the Reason Incomplete options.

These are the default configurations in Oracle InForm. Make sure these settings are configured appropriately, so that data flag information can be sent from Oracle Clinical One Platform to Oracle InForm.
  • The Require a comment setting (when entering N/A, Unknown, or Not Done) in Oracle InForm is set to No.
  • The Display Comment Text Boxes setting is set to Yes.

Send subject event data to a third-party electronic data capture system

You can send subject event data from Oracle Clinical One Platform to a third-party EDC system, based on the configuration settings you specify in the Oracle Clinical One Platform.

For information about how to set up this integration, please reach out to your Oracle Project Manager.

Which data can Oracle Clinical One Platform share with a third-party electronic data capture system?

All event data is sent to a third-party EDC system at the intervals defined in the integration schedule.

Note:

For this type of integration, you must not apply data flags to any form fields in a Oracle Clinical One Platform study. Including data flags in an integrated study will cause integration failures.
  • Screen a subject

    You choose the data to send.

  • Screen fail a subject, and undo screen failure
    • For screen failure, the screen failure date and reason along with any other relevant information related to the screen failure event are sent to the third-party EDC system. You can map these fields to any form you use to collect the screen failure reason. The status for the subject in the third-party EDC system isn't changed.
    • For undo screen failure, the screen failure date is updated to blank in the third-party EDC system. The status for the subject in the third-party EDC system isn't changed.
  • Randomize a subject

    You choose the data to send.

  • Complete a subject's visit

    You choose the data to send.

  • Withdraw a subject, and undo withdrawal
    • For subject withdrawal, the withdrawal form in the third-party EDC system is updated with the withdrawal date and reason, as well as any other relevant information.
    • For undo subject withdrawal, the completion date and other details that were sent are cleared out in the third-party EDC system. Oracle Clinical One Platform retains the information in the withdrawal form.
  • Code break

    If a user performed a code break in Oracle Clinical One Platform, Oracle Clinical One Platform sends the date and time when the code break was performed to the third-party EDC system.

  • Kit replacement

    When a kit is replaced, the dispensed kit information is updated with the replacement kit information on the specified form and item in the third-party EDC system.

Send subject enrollment information to Veeva Vault CTMS

The integration between Oracle Clinical One Platform and Veeva Vault CTMS allows you to better monitor subject enrollment information.

For information about how to set up this integration, please reach out to your Oracle Project Manager.

What type of information can Oracle Clinical One Platform share with Veeva Vault CTMS?

For example, this integration can automatically send updates to Veeva Vault CTMS whenever a subject is screened or randomized in Oracle Clinical One Platform and their state changes accordingly.

Track kit status and location in SmartSupplies PMD

The integration between Oracle Clinical One Platform and SmartSupplies PMD lets you automatically track the status and location of kits from your clinical inventory, making sure you always have the right amount of supplies available at your sites at all times.

Integration user details

Integration set up includes the creation of a study level integration user account, which is assigned the Clinical supply manager template role, or a custom role that includes the same permissions. The integration user account is created using the email address of one of your organization's Clinical Supply Managers. The email address associated with the integration user receives integration notifications, which can include content resulting in unblinding. Make sure the appropriate email address is configured for the integration user account to avoid unblinding issues.

For information about how to set up this integration, contact your Oracle Project Manager.

What type of information can Oracle Clinical One Platform share with SmartSupplies PMD?

This integration automatically sends updates to SmartSupplies PMD whenever one of these changes occurs in Oracle Clinical One Platform:
  • A kit's status is updated
  • A kit's location is updated (including kits whose location is updated from one depot to another).