Managing Discrepancies

Your organization must set up a process for resolving discrepancies, and create a review status for each stage of the process. Each person who completes one stage of the process must update the review status of the discrepancy in the Discrepancy Database. Oracle Clinical provides tools for you to use in the review process, including these special functions available from the Special menu from the Maintain Discrepancy Database window:

• Scanned CRF images. If your organization has set up this feature, from the Special menu, select Get Image to see an image of the actual paper CRF used to collect the data that led to this discrepancy. (To set up this link initially, your system administrator must modify the procedure OCL_CLIENT_PACK.PASSKEYS database function to call the imaging system. See the Interfacing from Oracle Clinical manual.)

• Show RDCM information. If you have the necessary database privileges, you can view a discrepancy's DCM responses directly from the Maintain Discrepancy Database window. From the Special menu, select Show RDCM Info.

• Audit RDCIs. View the history of changes to Received DCM(S) and Received DCI(S) involved in a discrepancy, including the original and update timestamps, comments, and owners.

• Data Clarification Forms. You can group similar discrepancies for a single patient together on a Data Clarification Form and send them out for review. See Using Data Clarification Forms.

• CRF Page Tracking. You can associate the discrepancy with the page number of the physical Case Report Form where the discrepant response was recorded. See Including CRF Page Numbers With Discrepancies.

If you determine that a discrepancy was caused by entering incorrect data, and you have the necessary privileges, you can go to the Data Entry window in Update mode directly from the Maintain Discrepancy Database window and update the data. See Browse and Update Patient Data.

You can also create discrepancies manually. See Entering Manual Discrepancies.

This section contains the following topics:

• Discrepancy Status Codes
  
• Browse and Update Patient Data
  
• Entering Manual Discrepancies
  
• Including CRF Page Numbers With Discrepancies
  
• Maintaining Data Clarification Form (DCF) Information
  
• Modifying Groups of Discrepancies
  
• Group-Updating Review Status
  
• Group-Updating CRF Page Numbers
  
• Group-Inserting Standard Text
  
• Group-Marking for Passive Review
  
• Creating a DCF for a Hand-Selected Group of Discrepancies