4 Integrating TMS with Oracle Clinical
When Oracle Clinical and Oracle Thesaurus Management System (TMS) are fully integrated, you can classify the raw patient data entered in Oracle Clinical to standard terms from dictionaries such as MedDRA and WHO-Drug.
After a response is collected to a question that is marked for processing by TMS, during the next Batch Validation the response is sent to TMS as a verbatim term. TMS tries to classify the verbatim term using Autoclassification. If that is not possible, TMS creates an omission that must be handled manually and, during the next Batch Validation, Oracle Clinical creates a discrepancy for the response.
After the verbatim term is classified, during the next Batch Validation TMS returns the classification and any other information you have defined (such as term ID, alternate code, or user-defined details) to Oracle Clinical as derived question response values in the same RDCM as the original collected question response. If a discrepancy had been associated with the response, it is automatically resolved.
In addition, Oracle Clinical passes information about the context of each collected question response to TMS, where you can use it to help with manual classification and other tasks. This key information—Patient, Study, Project, DCM, Investigator, Visit, Document Number and Discrepancy ID—remains stored in TMS (see Defining External System Information in TMS for more information). If you reclassify a verbatim term in TMS, during the next Batch Validation the system uses the key information to update the derived responses for each occurrence of the term/question response in Oracle Clinical.
To set up Oracle Clinical for integration with TMS, you must define parent questions to collect the response in Oracle Clinical, derived questions to receive values from TMS, and question sets to link the two and specify the information to be retrieved from TMS. You must also associate TMS domains with Oracle Clinical studies or projects.
To define these objects, you must have access to Oracle Clinical windows that appear only when TMS is installed with Oracle Clinical. The following table shows the privilege required to view each window.
Table 4-1 TMS-Related Windows in Oracle Clinical
| Window | Oracle Clinical Navigation Path | Privilege Required |
|---|---|---|
|
Question Sets |
From the Glib menu, select Question Sets, then choose Question Sets |
rxc_gl_full |
|
Qry Question Sets |
From the Glib menu, select Question Sets, then choose Qry Question Sets |
rxc_any |
|
TMS Domain Elements |
From the Plan menu, select TMS Domains |
tms_define_priv |
|
Qry TMS Domains |
From the Plan menu, select Qry TMS Domains |
rxc_any |
Note:
You must also have TMS superuser privileges or the drop-down list to select a dictionary in the TMS Domain Elements window will be empty; see Defining a New User for information on granting superuser privileges.
This section includes:
- Managing the TMS/Oracle Clinical Workflow
- Batch Validation in an Integrated OC/TMS Environment
- Setting Up Data Collection in Oracle Clinical
- Linking an Oracle Clinical Study to TMS
- Accessing Oracle Clinical Data in TMS
- Setting Integration Reference Codelist Values
Parent topic: Setting Up and Administering TMS