Creating DCFs

There are two approaches to creating DCFs. You can create them by specifying criteria for the discrepancies you want the DCF to include, or you can individually select a group of discrepancies with the grouping utility in the Maintain Discrepancy Database window (see Creating a DCF for a Hand-Selected Group of Discrepancies). This section describes creating DCFs by specifying criteria for discrepancies and Adding Multivariate Discrepancy's Procedure Variables to a DCF.

Before you can create a DCF, you must set a review status for each of the discrepancies you want to include in it. From the Conduct menu, select Data Validation, then select Maintain Discrepancy Database.

See introductory information at Using Data Clarification Forms and Description of Fields.

To create a DCF:

1. Open the Maintain Data Clarification Form window. From the Conduct menu, select Data Validation, then select Data Clarification Forms.

2. Click the Create DCF button. The Create DCF window dialog box opens.

3. Specify which discrepancies you want to include in the DCF in terms of their Discrepancy Review Status (see Discrepancy Status Codes):

   • Discrepancy Status for Distribution. (For example, Investigator REVIEW.) Discrepancies with this status (that also fulfill other selection criteria) appear on printed reports for this DCF as well as the Discrepancies window of the Maintain Data Clarification Forms window.

   • Discrepancy Status for Non-distribution. (For example, PASSIVE REVIEW.) Discrepancies with this status (that fulfill other selection criteria) do not appear on any printed reports for this DCF, though they do appear in the Discrepancies window of the Maintain Data Clarification Forms window.

   • Discrepancy Resolution for Resolved Status. (For example, RESOLVED or IRRESOLVABLE.) Normally resolved discrepancies are released from the DCF and do not appear in reports, though they are displayed in the Discrepancies window of the Maintain Data Clarification Forms window. Entering a value in this field allows you to create a DCF Report containing resolved discrepancies for review.

4. Choose to include or exclude discrepancies of system status OBSOLETE; set the Exclude Obsolete? box. If selected, obsolete discrepancies are excluded from the DCF.

5. Limit the scope of the DCF by setting specific values. The system limits the lists of values for each field according to the discrepancy statuses you entered. For example, the Specific Investigator field list of values lists only the Investigators identified in discrepancies that match the review and resolution status codes you specified in Step 3. Set at least one of the parameters listed in the substeps 5.a and/or 5.b:

   1. Select a specific Investigator, site, and/or patient position. The system limits the lists of values to Investigators, sites, and patient positions with the same status codes you specified in step 3.

   2. Choose one: Patient, Patient Visit, DCM, or Discrepancy. The system limits the lists of values to patient visits, DCMs, or discrepancies with the same status codes you specified in step 3.

6. In the Owning User field, enter a user identifier to be responsible for the DCF. The system sets the field to the current user by default, but you can choose any user in the system who has the necessary database privileges.

7. Describe the DCF in the Description field. The system displays this freeform text in all subsequent displays of the DCF.

8. Select standard header and footer text identifiers from their lists of values. (F9 or the List Values button in the toolbar)

9. Finish:

   • Click the Create button to create at least one new DCF with all of the current settings. Oracle Clinical creates one DCF for each patient whose records match the criteria.

   • Click the Back button to close the Create DCF dialog box without saving the DCF.

   • Click the Clear button to erase all your settings but remain in the dialog box.

     See Setting the DCF Status.

See also:

• Adding Multivariate Discrepancy's Procedure Variables to a DCF