Setting Up Integration Between CTMS and Oracle Clinical One
This chapter describes how to integrate CTMS with Oracle Clinical One.
The data in a clinical study is created across many applications. Each application needs this data and hence there is a need to create the same data manually in each application. This involves a lot of effort, and it’s time consuming. To avoid this overhead and to reduce manual errors, we need to integrate these applications. Once we integrate the applications, when data is created in one application, it automatically creates the same data in another application based on the configured rules by using REST API protocols.
You can use the REST APIs for:
- Inserting SVT from External Application to Siebel Clinical
- Querying Sites in Siebel Clinical
- Querying Item Library in Siebel Clinical
- Upserting Source Data Verification in Siebel Clinical
- Marking Visits as Planned or Unplanned
- Using Inbound Subject API in Siebel Clinical
It is advisable to create Subject Visit Template (SVT) using "Inserting SVT from External Application to Siebel Clinical" API before using other APIs as this ensures that all required fields for functioning of other APIs are correctly set.
Using the Insert SVT API first, will take care of setting of new fields introduced as part of Clinical One Integration in CTMS such as ClinicalItem, FormId, Repeating Number etc.
For more information about the REST APIs, see the "Using Siebel REST API For Siebel Clinical" chapter of the REST API Guide.
Terms used in context of Integration between CTMS and Oracle Clinical One
EDC Item Library
The “LS Clinical EDC Item Library View” is available under Administration - Clinical -> Visit Templates.
When a new SVT is inserted using APIs in Siebel Clinical, as part of the process the unique Activities (identified by Clinical Item + Form Id) are inserted under the “EDC Item Mapping” view from each Template Version.
Refresh Activity
This button is available at Administration Clinical->Visit Templates->Template Versions.
By Default, when an SVT is inserted from Clinical One, the Template Versions are inserted as 'Approved' and hence cannot be edited.
For those Template Versions, Refresh Activity button will remain disabled.
This button is enabled for the versions which are not in Approved status.
If the user wants to make any changes (such as adding payment information, whether to mark the activity for integration or not, etc.) to the activities received from Clinical One, it can be done in the “EDC Item Mapping” view. Once updates are done in this view, the user can click the Refresh Activity button.
If the Refresh Activity Button is clicked:
- It will keep only those activities in the current version which are marked as 'Integrated' in the “EDC Item Mapping” view. Other activities will be deleted from the current version.
- It will copy the Payment Amount from the activity in EDC Item Mapping to Visit activity in Template versions.
This gives the flexibility of customizing any Template version in Siebel Clinical on top of Template Versions flown from Clinical One.
Repeating Number Concept
There are fields called 'Repeating' and 'Repeating Max Count' which are available at SVT->Versions->Visits level, which indicates that this visit can be repeated for the specified number of times.
When any subject is created and scheduled, there are subject visits which are created based on the SVT template used at the site.
If there is a requirement to create any more dynamic or on-the-fly visits, it can be created using Inbound Subject API as described in the REST API Guide.
This API can be used to copy a visit by its Clinical Item and update the Repeat Number as appended in the Name of the Payload.
Dynamic Visits or On-the-fly Visits
If there is a need to create any additional visits other than already created by Subject Scheduling, Inbound API can be used to create such visits.
When dynamic Visits are created, it has Repeat Number > 0.
This also results in the creation of CRF Records corresponding to these Dynamic Visits.