Second-Pass Data Entry

Second-pass data entry ensures that the data entered during the first-pass was entered correctly and verifies that it agrees with the CRF. If the study specifies that second-pass data entry is required the data is not accessible until second-pass entry is complete.

You can decide to perform second-pass data entry even if it is not required. For instance, you might do first-pass data entry when you receive faxed CRFs, and second-pass entry when the actual CRFs arrive with Investigator corrections.

If this requirement is toggled on, data becomes internally accessible after both first-pass and second-pass are complete. If this requirement is toggled off, data is "internally accessible" after second-pass is completed. Data that is internally accessible and has been batch validated is considered to be "externally accessible," which means data extract views will display the data.

The study administrator also defines two configuration settings that particularly affect the behavior of the Data Entry form in second-pass: Second-Pass Comparison Failure Alert, and Prevent Second-Pass Entry by First-Pass Operator. A second pass can require a total re-entry of each response, or may be satisfied with sight verification, depending on the DCM question definition.

To complete second-pass data entry:

1. Select Data Entry then, select Second-Pass Entry from the Oracle Clinical main menu.

   If you are going directly from first- to second-pass entry, select Change Tasks and then Second-Pass Entry from the dialog that displays.

2. As in first-pass data entry, you can use either query or DCI book query sequencing to drive the order of the RDCIs for which you enter data.

   As in first-pass, Oracle Clinical validates the following criteria:

   • Patient record is not frozen.

   • Received DCI is not locked.

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

   Standard starting statuses for performing second-pass data entry are pass 1 complete and pass 2 started.

   You can only continue entry for a later-than-standard status if the accessible timestamp for the RDCI is more recent than the last time batch validation was executed for the study. This restriction guarantees that accessible data cannot be modified except in Update mode.

   Note:

   For a PASS 2 COMPLETE DCM, the system does not permit you to modify either the DCM or its data unless both of the following conditions are present:

   • You are modifying the DCM or its data within the time frame specified by the long value of the JUSTENTERP2TIME row in the reference codelist OCL_DE_CONFIG. (Refer to the Oracle Clinical Administrator's Guide.)

   • The document is not externally accessible.

   The cursor is positioned in the first field available for data entry. If a question has been defined as second-pass sight-verifiable a value is displayed in that field. All other fields lacking default values are blank. Enter data for all fields except those defined as sight-verifiable.

   Note:

   In second-pass data entry, the data entry window initially displays the default value for repeating or nonrepeating questions, even if a different value was entered during first-pass data entry. But for default repeat values the entered value is displayed; these are considered "sight verified" by definition.

   Note:

   If a field contains the word "ATTACHMENT" in uppercase followed by a version number and text, it represents an Extended Text Question that supports up to 10,000 characters. You cannot view the rest of the text or enter or update the response here. You can enter and update responses to these questions only in Oracle Clinical Remote Data Capture (RDC) Onsite.

   If you are unable to enter text in an empty field, it may be because it is an Extended Text Question.

3. To complete second-pass entry, either Save or Exit.

   If you have made changes, the Changes Pending dialog box offers the options:

   Cancel—places you back in Data Entry and allows you to continue data entry.

   Discard—exits the window and discards all pending changes.

   Save Incomplete—saves pending changes and exits with the status of the RDCM as pass 2 started.