Managing the TMS/Oracle Clinical Workflow

You can choose to review discrepancies/omissions first in either Oracle Clinical or TMS.

Regardless of whether you set First Review to Oracle Clinical or TMS, during Batch Validation all Oracle Clinical question responses collected since the last Batch Validation and marked for processing by TMS (see Defining a Parent Question) are sent to TMS and inserted into the TMS SOURCE_TERMS TABLE with all their associated key data. Batch validation triggers TMS Synchronization and Autoclassification.

During Autoclassification, TMS searches for an exact match to a dictionary term or an existing VTA linking the same Oracle Clinical response/TMS verbatim term to a dictionary term.

For each term that is automatically classified:

• In TMS, the verbatim term is associated with a VTA linking it to a dictionary term.

• During the next Batch Validation, TMS sends to Oracle Clinical all the derived data defined in the question set variables.

  Note:

  If TMS is unable to derive a related term in one of the requested dictionary levels, it creates a high-level omission within TMS and sends all the derived values possible back to Oracle Clinical. When the high-level omission is resolved in TMS, TMS sends the remaining derived value(s) to Oracle Clinical. See Resolving High-Level Omissions.

For each term that cannot be automatically classified:

• TMS creates an omission.

• During the next Batch Validation, Oracle Clinical creates a discrepancy.

• Manual intervention is required; the workflow depends on whether First Review is set to TMS or Oracle Clinical. (See Setting First Review.)

Normally you will want to handle omissions in TMS, because there you can specify how to handle the same verbatim term automatically in the future. However, you may prefer to check the data in Oracle Clinical first to correct any errors and send the data back to TMS for Autoclassification after it has been corrected.

A description of the workflow for First Review in TMS and First Review in Oracle Clinical follows.

This section includes:

• First Review in TMS
  
• First Review in Oracle Clinical
  
• Setting First Review
  

First Review in TMS

If a term cannot be automatically classified and First Review is set to TMS, Batch Validation creates the Oracle Clinical discrepancy of category type Missing_PT with a status of TMS IN PROGRESS, which cannot be changed within Oracle Clinical.

You must handle the omission in TMS. You have the following options:

• Manual Classification
  
• Applying an Action
  
• Sending a Discrepancy Message
  

Manual Classification

To classify a term manually after it fails Autoclassification, you must do one of the following:

• Create a new VTA to link the verbatim term to a dictionary term. I

• Add a new company term to the dictionary and create a VTA linking the verbatim term to the new term.

After you have manually classified a verbatim term, the next Batch Validation:

• Sends to Oracle Clinical all the derived data defined in the question set variables.

  Note:

  If TMS is unable to derive all the data requested, it creates a high-level omission within TMS and sends all the derived values possible back to Oracle Clinical. When the high-level omission is resolved in TMS, TMS sends the remaining derived value(s) to Oracle Clinical. See Resolving High-Level Omissions.

• Gives the discrepancy a review status of CLOSED and a resolution status of:

  • VTA CREATED if the omission was resolved in TMS by creating a new VTA.

  • DT CREATED if the omission was resolved by creating a new dictionary term.

Applying an Action

If you cannot classify a verbatim term because of a flaw in the term, you can assign an Action to the term to send a message back to Oracle Clinical requesting a modification to the verbatim term. For example, Oracle Clinical may send a question response/verbatim term to TMS that includes two terms, such as "headache and nausea." Because TMS does not support combined verbatim terms, you might want to apply an Action to this verbatim term with the text "please split this term." During the next TMS Synchronization, the system sends this message back to Oracle Clinical as a comment associated with the discrepancy for the question response.

When the you apply an Action to an omission, the next Batch Validation:

• Changes the status of the discrepancy according to the status specified in the definition of the TMS Action. Normally this is INV REVIEW (Investigator Review) to indicate that the investigator must take the next step in resolving the discrepancy, but it could be any valid status.

• Inserts a message in the discrepancy's Comment field requesting clarification or other modification of the verbatim term.

In Oracle Clinical, the person responsible for resolving the discrepancy must make the requested change, if appropriate, and change the discrepancy's review status to TMS EVALUATION. During the next Batch Validation, the updated term is sent back to TMS for Autoclassification and the discrepancy's status is changed to TMS IN PROGRESS.

See Defining and Using Actions for more information.

Sending a Discrepancy Message

You can send a message to Oracle Clinical regarding a single source term in the Classify VT Omissions window. A Discrepancy Message is not predefined; you enter text specifically for a particular source term. See Applying a Discrepancy Message.

First Review in Oracle Clinical

If a term cannot be automatically classified and First Review is set to Oracle Clinical, Batch Validation creates Oracle Clinical TMS discrepancies with a status of UNREVIEWED. You can then review each discrepancy and correct any errors. After correction (or at any time), set the discrepancy status to TMS EVALUATION. The next Batch Validation will change its status to TMS IN PROGRESS and pass it to TMS for Autoclassification. Corrected terms may be successfully auto. If not, an omission is created and you must handle it in TMS (see First Review in TMS).

Setting First Review

Two settings determine which system handles the First Review, both set in Oracle Clinical: the Review Before TMS? setting in the Question Sets window and the FIRST_REVIEW short value in the TMS_OPTION reference codelist. The interaction between the two settings is as follows:

• If the reference codelist value is NO (so TMS manages omissions), the value set in the Question Set window is ignored.

• If the reference codelist value is YES (so Oracle Clinical manages omissions), clearing the Review Before TMS? box overrides the database setting and directs omissions to TMS.

In other words, to have Oracle Clinical do the first review of omissions, you must set both the reference codelist value to YES and select Review Before TMS? in the Question Set window. All other setting combinations result in a first review by TMS.