Subject Visit (SV) Integration

This incremental integration based on the subject number runs on a schedule to identify events that occurred in a study since the last run. The integration then sends completed visit, form, and item data, subject status transitions for any subject event, and information for planned visits to CTMS.

This integration runs third if all four (4) CTMS integrations have been implemented.

Table 2-8 Details

Type of integration	Data flow	Frequency
Multiple file	One-way, from Oracle Clinical One Platform to CTMS.	Scheduled

Overview

• You can find a list of supported Oracle Clinical One Platform events and their actions in the table below.
• Once the integration process completes, the subject data from Oracle Clinical One Platform is present in CTMS under each site, located in Site Management/{Target Site}/Subjects.

  Note:

  Data corresponding to these events is processed in the order of occurrence. Also, event processing for multiple subjects is done in parallel.
• If the integration job fails to process an event, future jobs for the subject are blocked until the current job is fixed or canceled. This ensures that data stays in sync in the target system.

Table 2-9 Supported events

Event	Action
Pre-screening	Subject information is sent to CTMS along with the visit completion date. The Encounter Date in CTMS is equivalent to the Visit Complete date in Oracle Clinical One Platform. Note: The Encounter Date is updated to the screening date once the subject is screened.
Screening	A subject with the same subject number and a status of Screening is created in CTMS after the subject is screened in Oracle Clinical One Platform.
Enrolling	This event is configured for non-randomization studies. If used, the Enrolled status is sent to CTMS after the subject is screened in Oracle Clinical One Platform.
Subject Number Change	Updates the subject number for the current subject in CTMS with an updated subject number from Oracle Clinical One Platform.
Randomization	Status transition and randomization data, including randomization date, randomization number, and cohort name, are sent to CTMS after a subject is randomized in Oracle Clinical One Platform.
Withdraw	Sends subject status transitions for Subject withdraw and Undo Subject Withdraw.
Screen Fail	Sends subject status transitions for Screen Fail and Undo Screen Fail.
Completion	Sends subject status transitions for Subject Complete and Undo Subject Complete
Subject Transfer	Sends subject status transitions for Subject transfer.
Visit Dump	Sends visit and item completion dates when the visit is completed or items are updated in Oracle Clinical One Platform. This includes visits completed during Screening, Randomization, SubjectComplete, SubjectWithdraw, and SubjectTransfer.
Visit Schedule Note: For CTMS SV Visit schedule, sub integration would get the list of future visits from the current state of subject in the study.	A subject’s visit schedule can change based on previous visits, their treatment arm, or the completion of a form question by choosing a particular option. The sub-integration retrieves the planned visits for the subject and marks the corresponding visits as planned in CTMS.

Pre-requisites: the following should be confirmed before running the integration

• Sites in CTMS are active and associated with an approved study version.
• Study versions for the site in CTMS and the site in Oracle Clinical One Platform match.

Integration user and roles

An integration user needs to be created and assigned to a custom role that includes the following permissions.

• Answer Queries
• Edit Supply Settings, Blinded Groups, Label Groups and Resupply Strategies (Unblind)
• Integrate Subject Data
• View Form Data for Subjects

For more information about permissions, see Descriptions of permissions in Clinical One

Exceptions

• Subject Visit information for Adverse Events is not sent.

Configuration

Working with the customer, the Oracle integration team creates a Configuration Setup Details Document (CSDD), which details the configuration specifications defined for integrations between Oracle Clinical One Platform and CTMS.