First-Pass Data Entry

Select the First-pass menu option to complete the initial entry of the data from a Case Report Form (CRF). Before entering the CRF data into the DCI the header information must be logged in and the status of the DCI marked "Received." DCIs in this state are sometimes referred to as Received DCIs, or RDCIs. If your study is set up to accommodate it (the Allow First Pass from Login flag is checked in the Maintain Study States window. To access it, select Conduct, then Security, then Clinical Study States), you can choose to do the data entry in the same operation as logging in the header or as a separate operation.

To complete first-pass data entry as a separate operation:

1. Select Data Entry then, select First-Pass Entry.

2. Find the RDCI to complete:

   1. Complete the fields to locate the appropriate RDCI, such as Patient and Visit.

   2. Execute the Query.

   3. If the query finds multiple RDCIs, use Next Record to locate the right one.

      The system returns only RDCIs with a status of received or pass 1 started.

      If a DCI book displays, it completes some fields automatically from the row that is highlighted. If you need a different DCI book, you can place your cursor in the Book field, invoke a list of values, and choose a different one.

3. Select Next Block to invoke the first DCM.

   The system displays the RDCM window under the RDCI header window. If there is more than one RDCM for the RDCI (see the indicator 1 of X in the first line of the RDCM window), scroll to the RDCM for which you want to enter data, using Next Record and Previous Record.

4. Select Next Block to move to the data entry window for the given RDCM. 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.

   The system also checks that the RDCI and its RDCMs are of the appropriate status for the First-Pass Data Entry task. Standard starting statuses for performing first-pass data entry are received and pass 1 started, and the default behavior of the system is to query only RDCIs having these statuses.

   You can explicitly query 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 data that has become available for outside access (externally accessible data) cannot be modified except in Update mode (see Updating Accessible Data).

   Note:

   For DCMs that have had PASS 1 completed, you are not allowed to modify a DCM and the data for the DCM unless all of these conditions apply:

   • you are the same person who entered it

   • you are modifying the DCM or its data within the time frame specified by the long value of the JUSTENTERP1TIME row in the reference codelist OCL_DE_CONFIG (Refer to the Oracle Clinical Administrator's Guide.)

   • either PASS 2 is required or, if PASS 2 is not required, the document has not been batch validated. Note that the system populates the accessible time for documents that do not require PASS 2.

   The cursor is positioned in the first field available for data entry. Default values, if they exist, are displayed in each field.

5. Enter data from the CRF into the appropriate fields.

   Respond to any univariate validation failures as described in the section Validating Data Entry.

   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.

6. To complete first-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.

   • Discard – Exits the window and discards all pending changes.

   • Save Incomplete – Saves pending changes, and exits the window with the RDCM in an incomplete state with a status of pass 1 started.