4 Configuring Discrepancy Management

A discrepancy is any data that falls outside of an expected range of values or is otherwise flagged during the edit check process as an error. Examples of a discrepancy are an invalid date, an age greater than the maximum age for the study, and inconsistent information across CRFs.

Discrepancy management is the process that systematically addresses discrepancies generated within a study. For each discrepancy assigned to a user role, a user must identify the cause, assess the error, and determine the appropriate action. The user can choose to resolve the discrepancy or route it to another user. Correcting and managing discrepancies ensures that the data is complete, accurate, and compliant with the study protocol.

Using Oracle Clinical, you configure several features that help users manage discrepancies while entering and modifying data in the RDC application.

For more information, see:

• Tools for Configuring Discrepancy Management
  
• Defining the Reasons for Discrepancies
  
• Defining the Review Statuses for Discrepancies
  
• Configuring the Access Statuses for Discrepancies
  
• Configuring the Actions Allowed against Discrepancies
  
• Defining the Resolution Reasons for Discrepancies
  
• Preventing Update to OTHER Discrepancies