Executing Procedures

Procedures are executed as part of every batch validation, usually scheduled to run at regular Intervals. You can also execute a single procedure or batch validation at any time:

Executing a Single Procedure

You can explicitly execute a single Active Procedure at any time. When you do, the system runs the Procedure over all patients in the current study, not just those patients for whom data has been added or modified (as in batch validation).

The output file displays the number of discrepancies created during this run, the number that remain current and the number that have become obsolete since the last run. The number remaining current reflects the total number of open discrepancies in the study that have been generated by this Procedure.

View discrepancies created by the Procedure from the Special menu (Show Prod Discrep), or from the Definition menu, select Data Validation, then Discrepancy Database.

You can execute a single Procedure from two locations in Oracle Clinical: the Procedures window and the Execute Single Procedure PSUB window. To execute a Procedure against a Test database, you must execute it from the Procedures window.

For more information , see:

Execute a Single Procedure from the PSUB Window

From the Conduct menu, select Data Validation, then Execute Single Procedure, and do the following:

  1. From the list of values, choose the Procedure you want to run.
  2. From the list of values, choose the version sequence number of the Procedure you want to run.
  3. From the list of values, choose Y to run the Procedure in Debug mode, which lets you view the individual values as they are validated in the .out file. The default value is N.
  4. Click Submit Job.

To check on the job's progress and see the .out and .log files, click Job Status.

Execute a Single Procedure from the Procedures Window

From the Definition menu, select Validation Procedures or Derivation Procedures, then Procedures (or Prov Procedures or Procedures w Edit; the menu path you see depends on your privileges) and do the following:

  1. In the Procedure Definitions window, select the Procedure you want to execute. You can also execute a Procedure from any of the child windows.
  2. From the Special menu, choose Execute in Prod (or Execute in Test to run against a test data database). A dialog box appears.
  3. If you want to run the Procedure in Debug mode, which lets you view the individual values as they are validated in the .out file, choose Yes. A message appears, giving you the batch job ID number.

To check on the job's progress and see the .out and .log files, open the PSUB form (from the Conduct menu, select Data Validation, then Execute Single Procedure) and click Job Status.

Executing Batch Validation

You can schedule batch validation to run at regular Intervals (such as nightly) or once at a particular time, or you can manually invoke a batch validation at any time. By selecting Data Validation from the Conduct menu, and then Batch Validation Session, you open a PSUB window. You do not need to enter information in this window. All Procedures in the current study are automatically run every time you run a batch validation.

For further information on batch validation, see Chapter 4, "Using the Discrepancy Database" in Oracle Clinical Conducting a Study. For information on submitting batch validation and viewing its output file, see Chapter 3, "Submitting batch jobs and reports" in Oracle Clinical Getting Started.

In this section:

Facts About Procedure Execution During Batch Validation

  • During batch validation, Oracle Clinical runs all Derivation Procedures before any Validation Procedures.

  • Batch validation always executes incrementally; that is, it processes only data that has changed since the last batch validation run.

  • Oracle Clinical detects changes made in the definition of the length of a DCM Question and automatically regenerates any Active Procedure that references that Question before executing the Procedure.

    That is, the procedure is regenerated if and when it needs to be executed in a subsequent batch validation run because data has been modified for one or more patients in fields referenced by the Procedure. The Procedure is then run on patients with modified data.

  • Whenever a derivation calculation is re-executed, Oracle Clinical compares the resulting value with any existing value for the response. If the new value differs, Oracle Clinical creates a new version of the response and records DATA CHANGE or DERIVATION CHANGE, depending on whether the recalculation resulted from a change to data or to the derivation calculation.

  • A study-specific parameter (the study's Second Pass Required option) controls if data that has only completed first-pass entry participates in derivation.

Batch Validating TMS Derivation Procedures

Oracle Clinical executes derivation procedures before TMS processing in batch validation runs. This feature enables you to perform the following processes on TMS derivation procedures:

  • You can derive a value from TMS into an Oracle Clinical derived Question in the first TMS portion of batch validation, and derive related TMS values for the derived Oracle Clinical Question during the second TMS portion of the same batch validation.

  • You can use an Oracle Clinical derivation procedure to derive a value in Oracle Clinical, and send that value to TMS for processing during the second TMS portion of the same batch validation.

These are examples of how this feature can be useful:

  • you would like to derive values from two different dictionaries for a single verbatim term.

  • You would like to substitute the original collected term with another term, leaving the original response intact; for example, in a historic study or a study conducted by a company you have acquired.

Note that you cannot have more than two levels of derivation for TMS Questions. The TMS code only handles the following scenario:

  • TMS parent Question

  • Derived Question (This Question is in turn used as a parent Question.)

  • Derived Question

You cannot create a fourth derived Question.

See the Oracle Thesaurus Management System User's Guide for more information.

Procedures and Frozen-status Patients

Oracle Clinical runs Derivation Procedures even for patients whose status is Frozen; in these cases, recalculation can take place when:

  • an existing Procedure is changed

  • a new Procedure is created

  • an existing, unchanged Procedure is explicitly executed over all patients, and calculation is based on external data that has changed

  • a patient was frozen before having new or modified data processed by batch validation

Derivation Procedures containing validation expressions may produce discrepancies for patients with a status of Frozen.