Batch Validation in an Integrated OC/TMS Environment

This section includes:

• OC and TMS Data Exchanged During Batch Validation
  
• Running Only the TMS Portion of Batch Validation
  
• Batch Validation Execution Order
  
• Effect of TMS Errors on Batch Validation
  

OC and TMS Data Exchanged During Batch Validation

Oracle Clinical Batch Validation runs on a single study, usually on a regular schedule such as nightly.

When Oracle Clinical and TMS are integrated, the Batch Validation job finds data that is new or changed in each system since the last Batch Validation and sends the relevant data to the other system. During the same Batch Validation job, TMS Autoclassification and Synchronization run in TMS on new Oracle Clinical data, and derived information, omissions, and Actions associated with that same data are sent back to Oracle Clinical.

During Batch Validation:

• Oracle Clinical sends new parent question responses, plus their key information, to TMS. If responses have been deleted in Oracle Clinical, the deletions are sent to TMS.

• Oracle Clinical sends responses whose question set definition has been changed.

• Oracle Clinical sends discrepancies newly given a status of TMS EVALUATION.

• TMS sends the derived values specified in the parent question's question set to questions whose parent question response has been classified, reclassified, or declassified in TMS.

• TMS sends derived values to questions corresponding to high-level TMS omissions that have been resolved in TMS.

• In the Oracle Clinical Discrepancy Database, Batch Validation resolves any discrepancies associated with question responses/verbatim terms that have been manually in TMS.

• In the Oracle Clinical Discrepancy Database, Batch Validation applies any Actions that have been assigned to omissions in TMS to the discrepancy associated with the original question response. The Action Text is displayed in Oracle Clinical as the Internal Comment for the discrepancy.

• Batch validation creates Oracle Clinical discrepancies for any terms TMS was unable to classify automatically (omissions). If First Review is set to TMS, these discrepancies have a status of TMS IN PROGRESS; if First Review is set to Oracle Clinical, they have a status of UNREVIEWED.

Running Only the TMS Portion of Batch Validation

Running only the TMS portion of Batch Validation may be useful when you are recoding a large amount of data but do not want to run other components of Batch Validation (such as Oracle Clinical Procedures). For example, if you have upgraded your dictionary version and anticipate a large number of terms to be processed.

To run only the TMS portion of Batch Validation, open Oracle Clinical. From the Conduct menu, select Data Validation, then TMS Derivation.

Note:

The TMS Derivation job runs the TMS portion of Batch Validation once, not twice as in the full Batch Validation job.

Batch Validation Execution Order

Batch Validation runs TMS processing twice, before and after running all validation and derivation procedures defined in Oracle Clinical for the study.

See Using a Derived Question as a Parent Question for information on how to use this feature.

Batch validation includes the following processes in the following order, for a single study:

1. Sends data from Oracle Clinical to TMS for processing, including Synchronization and Autoclassification. (See Synchronization and Autoclassification for more information.)
2. Returns data from TMS to Oracle Clinical, creating and resolving TMS-related discrepancies in Oracle Clinical.
3. Runs all Oracle Clinical validation procedures, creating and resolving discrepancies.
4. Runs all Oracle Clinical derivation procedures, generating values for derived question responses.
5. Sends a limited set of data—parent question values derived during the current Batch Validation (if any)—to TMS for processing.
6. Returns data specified in the derived parent questions' question sets to Oracle Clinical.

See OC and TMS Data Exchanged During Batch Validation for an explanation of which data is exchanged.

Effect of TMS Errors on Batch Validation

You can control whether Batch Validation fails altogether or just displays a warning if it encounters a serious problem during TMS processing by setting a reference codelist value in Oracle Clinical; see OCL_STATE.

If the long value is active and set to Warn for the short value TMS_FAIL_BV_ACT in the OCL_STATE local reference codelist in Oracle Clinical, then if Batch Validation encounters a serious error during its TMS processing, it will give a warning but it will not cause the entire Batch Validation job to fail. Serious errors include:

• a SQL error

• data corruption

• serious setup issue

If the long value is inactive or set to anything other than Warn, Batch Validation will fail if it encounters a serious error during TMS processing.

If Batch Validation encounters a less serious error during TMS processing, it will issue a warning but not fail, regardless of the long value set for TMS_FAIL_BV_ACT. For example, less serious errors include:

• No value set for the local reference codelist TMS_OPTIONS.

  Batch validation displays the following error message: "Reference codelist for First Review Flag not found."

• The dictionary specified for a question set used in the study is not included in any TMS domain element for the study in Oracle Clinical.

  Batch validation displays the following error message: "No dict. for Question Set: question_set_name."

• The domain specified in the study's TMS domain element is not part of a valid dictionary/domain combination (as defined in the TMS Define Domains window) for one of the following: the dictionary specified in the domain element, or the dictionary specified for a question set used in the study.

  Batch validation displays the following error message: "No Domain for Question Set: question_set_name."