System Validations Performed During Update Mode

When you open an RDCI, the system verifies the following conditions:

• the patient record is not frozen

• the RDCI is not locked

• the Data Entry form for the DCM is ready for data entry

• the data is accessible, defined as:

  • If second-pass is required for the study, status must be pass 2 complete.

  • If second-pass is not required for the study, status may be pass 1 complete or higher.

Unsuccessful validations produce an error message which instructs you how to proceed.

Successful validation results in the appropriate Data Entry window appearing under the RDCI and RDCM windows. The window is populated with all the saved responses from the Data Entry process. Fields are color-coded to indicate the presence of univariate discrepancies, Investigator comments, and operator comments (manual discrepancies). For more explicit description of the color codes, read Indicators of an Existing Discrepancy.

As you update a value in a response field, the system performs a univariate validation check. If it validates, the system requires a reason for the change.