Group-Marking for Passive Review

Passive Review is a status that allows you to reduce the number of discrepancy queries and the number of discrepancies on a DCF by associating one or more discrepancies with a primary discrepancy. You can then include all the discrepancies in a single query. When you create the DCF, do not include discrepancies marked as Passive Review in the printed DCF.

Example

If you have a page with three lab results and all three lab results are missing, you would have three discrepancies such as:

• AST lab units missing, please provide.

• ALT lab units missing, please provide.

• RBC lab units missing, please provide.

You could send three queries, but to save time, money, and paper you could choose to send only one query such as: Page 7 all lab units are missing, please provide.

To do this, mark the second two discrepancies for passive review associated with the first discrepancy as the primary discrepancy. Then create a DCF, include all three discrepancies in the DCF, but mark the primary discrepancy's status as For Distribution and the other discrepancies' status as Not For Distribution. When you print the DCF, only the primary discrepancy appears, but all three are included in the electronic DCF.

When the answer to the query returns, you can update the data for all three discrepancies.

Note:

You may want to add a status called PASSIVE, for example, to the DISCREPANCY REV STATUS CODE specifically for this purpose. You must also assign user roles to the code in the

To associate discrepancies with a primary discrepancy:

1. In the Maintain Discrepancy Database multi-record view, make a note of the ID of the primary discrepancy and its current review status.
2. Select the secondary discrepancies and the primary discrepancy in the Maintain Discrepancy Database window; see Selecting a Group of Records to Change.
3. Click the Group Action on Selected Records button located the upper right corner of the Master section.

   The Discrepancy Group Functions dialog box opens.

4. Click the Mark for Passive Review radio button and then click OK. The Discrepancy Association and Passive Review dialog box opens.
5. Enter the ID of the primary discrepancy. A list of values is available.
6. Enter a review status for the primary discrepancy. You can set a new review status for it here. A list of values is available.
7. Enter a passive review status for the secondary discrepancies or leave it as the default value: Passive Review. A list of values is available.
8. Click OK to save changes and return to the Maintain Discrepancy Database window. You must press Save again there to save the changes to the database.

   OR

   Click Back to return to the Maintain Discrepancy Database window without saving your changes.

Note:

If you are using V3.1-style Procedures in your study, you can avoid creating secondary discrepancies by defining your Validation Procedures so that they do not process variables (Questions) with univariate discrepancies. See Validation and Derivation Procedures in the Oracle Clinical Creating a Study manual.