6 Customizing Data Entry Behavior

6.1.1 Defining the DCI Form Runtime Settings at the Database Level

To define the DCI Form Runtime settings at the database level: 

1. Open Oracle Clinical.

2. Navigate to Admin and select DCI Form Local Database Settings.

3. Expand the DCI Form Runtime node. See Figure 6-1.

   Figure 6-1 DCI Form Runtime Settings for RDC

   
   Description of ''Figure 6-1 DCI Form Runtime Settings for RDC''
   
   

4. Change the value of the settings you want. The sections that follow provide provide more information about each setting.

5. Select the Enforce Local DB Setting check box to always use this value as the default value.

   If not selected, a user who has privileges to the DCI Form Study Database Settings form at the study level can override the default values.

   Note that the Enforce Local DB Setting check box is always selected for the Suppress warning for non-migrated CRFs setting because you cannot change its value at the study level.

6. Save your changes.

6.1.2 Defining Report Settings at the Study Level

To define the DCI Form Runtime settings at the study level: 

1. Open Oracle Clinical.

2. Navigate to Design and select DCI Form Local Study Settings.

3. Expand the DCI Form Runtime node.

4. Deselect the Inherit From Local DB Setting check box for any value you want to change.

5. Change the value of the settings you want. The sections that follow provide more information about each setting.

6. Save your changes.

6.1.3 Enabling HTML Data Entry for RDC

To allow RDC to collect data by presenting HTML forms to the user, you must configure the correct settings in Oracle Clinical. You enable data entry with DCI Forms at the study level. If you do not enable this setting, RDC does not display the study to the user.

To enable a study to use HTML data entry:  

1. Open Oracle Clinical.

2. Navigate to Conduct, Security, and then select Clinical Study States.

3. Query for your study.

4. Select the study from the results of your query.

5. Enable the DCI Forms Entry Enabled? check box.

6. Save your changes.

6.1.4 Displaying the Visit-Owning Interval on the Casebooks Page

Use the Display Visit Owning Interval on MPC Page? setting to customize the spreadsheet heading on the RDC Casebooks page.

• If set to Y, the spreadsheet heading on the Casebooks page displays the name of the interval — phase, period, or subperiod — along with the name of the current visit.

  
  Description of the illustration ''interval_mcp_page.gif''
  
  

• If set to N, the spreadsheet heading on the Casebooks page displays only the name of the current visit. The default value is N.

6.1.5 Allowing Investigator Comments

Use the Enable Entry of Investigator Comments setting to specify whether the RDC application allows users to enter and update investigator comments.

• If set to Y, RDC allows the entry of investigator comments. Users with UPDATE privileges can add investigator comments to a response field and update existing investigator comments. All users can review investigator comments in the Data Entry window and on the Review Investigator Comments page.

• If set to N, RDC does not allow the entry of any investigator comments by any user, regardless of privileges.

6.1.6 Adding a Customized Reference Field to the Search Pane

You can customize the RDC application to include an additional patient-level search field on the Home page and the Casebooks page.

This patient attribute field:

• Lets you search for a particular patient or a set of patients based on the contents of the field

• Can be up to 25 alphabetic, numeric, and special characters

• Supports wildcard searches (%)

To configure the customized field, you need to:

• Specify values for two DCI Form Runtime settings that define a label for the field and enable the customized field

• Write a procedure to populate the Patient Positions table with the user-entered value

ocl_utils.update_pat (
  rxcpdstd.v_mode,
  rxcpdstd.patients_rec.patient_position_id,
  rxcpdstd.patients_rec.reported_sex,
  rxcpdstd.patients_rec.reported_birth_date,
  rxcpdstd.patients_rec.reported_initials,
d.reportedPatientRef)

6.1.7 Controlling the Display of Conditional Blocks within a CRF

When defining the questions for a CRF (that is, DCM questions), you can associate one or more conditions with a question. You can define a data response value so that when the user enters that value, other questions and fields become active, and the cursor automatically moves to a specified question within the same CRF. This action is called conditional branching.

With conditional branching, you can define a path through the CRF based on the responses enter. For example, you can use conditional branching to bypass pregnancy-specific questions if the patient is male.

You can the Represent Disabled Blocks As setting to control how RDC displays the conditional blocks within a CRF. You can choose one of the following options:

• Select Greyed if you want RDC to gray out the section in the CRF with the conditional questions. In this case, the user can see the section, but the questions remain disabled until a response value triggers the condition defined for the source question.

• Select Hidden if you want RDC to completely hide the section in the CRF with the conditional questions. The next expected questions, if any, are displayed in the same area, so there is no empty space. The section remains hidden until a response value triggers the condition defined for the source question.

  For multi-page CRFs, RDC preserves the locations of page breaks relative to the questions in the form. Therefore, when conditional blocks are hidden, questions from the next CRF page are not moved to fill the resulting additional blank space on the page.

6.1.8 Suppressing Prompts and Warnings

You can use the DCI Form Runtime settings to suppress the:

• Change reason prompt for new responses

• Change reason prompt for new investigator comments

• Warning for non-migrated CRFs

6.2.1 Manually Assigning Patients to DCI Books Using Oracle Clinical

To use Oracle Clinical to manually assign patients to DCI Books: 

1. Open Oracle Clinical.

2. Navigate to Design, Patient Positions, and then select Patients.

3. Select your study from the list of clinical studies.

4. Click Patient Positions to open the Patient Positions form.

5. Scroll to the right of the form.

6. Enter the DCI Booknames for one or more patients.

6.2.2 Automatically Assigning the DCI Book upon Initial Data Entry

As an alternative to pre-assigning DCI Books by manually updating the Patient Positions table, you can specify that RDC automatically assign each patient to a book upon initial data entry.

Automatic book assignment works as follows:

• You provide instructions, if necessary, to your RDC users as to what book to use for initial data entry.

  • If only one book is active in a study at a time, no instructions are necessary.

  • If you have multiple active books defined, instructions are needed. When first invoked, the RDC Casebooks page always displays the default casebook you specified at study definition time. RDC uses this casebook for entering data for unassigned patients. However, the user can select another casebook on the Casebooks page.

• When an RDC user enters and saves the first CRF for a patient, RDC automatically assigns the patient to the book in context; that is, RDC updates the Patient Positions table for that patient. Note that the assignment is ONLY made if the patient is currently unassigned.

• Once a patient is assigned to a casebook, RDC enforces use of the casebook for future data entry. The user can no longer change the casebook used simply by changing the casebook in context on the RDC Casebooks page.

To set up automatic book assignment at study definition time: 

1. Open Oracle Clinical.

2. Define the DCI Book that RDC uses by default for entering data for patients.

   1. Navigate to Definition, DCIs, and then select DCI Books.

   2. Select the Default check box for the DCI Book to use as the default.

   3. Save your changes.

3. Turn on automatic book assignment.

   1. Navigate to Admin, Reference Codelists, and then select Local Codelists.

   2. Query for the OCL_STATE local reference codelist. (Enter OCL_STATE in the Name field, and then press F8 to execute the query.)

   3. Scroll to the BOOK_ASSIGN short value.

   4. Set the long value to Y.

      When set to Y, RDC automatically assigns the DCI Book you defined as the default for the study to each patient when data is first entered for the patient.

   5. Save your changes.

6.2.3 Allowing Patient Book Assignments to Change

If you make use of a patient book assignment, you may expect the book assignment to change during the course of the study. The following are two examples where this may be the case:

• You define a new DCI Book to account for a protocol amendment. On a site-by-site basis, you update the Patient Positions table to assign patients to the new book.

• You use a Screening book for initial data entry, and based on responses in the Screening CRFs, you assign the patient to one of the arms (casebooks) of a multi-arm study.

To allow a change in the patient or book assignment: 

1. Open Oracle Clinical.

2. Navigate to Admin, Reference Codelists, and then select Local Codelists.

3. Query for the OCL_STATE local reference codelist.

   1. Enter OCL_STATE in the Name field.

   2. Press F8 to execute the query.

4. Scroll to the BOOK_CHANGE short value.

5. Set the long value to ALLOW.

6. Save your changes.

6.5.1 Accessing the Codelists to Customize the Change Reason Values

You customize the list of change reasons presented in RDC by using the following installation reference codelists:

• DATA CHANGE REASON TYPE CODE — Use this codelist to customize the list of acceptable change reasons for updates made to response or data fields, that is any field except a header field.

• RDCI CHANGE REASON TYPE — Use this codelist to customize the list of acceptable change reasons for updates made to header fields such as Visit date, Visit time, CRF comment, blank flag, lab, or qualifying value.

To access the codelists for customizing the change reasons: 

1. Open Oracle Clinical.

2. Navigate to Admin, Reference Codelists, and then select Installation Codelists.

3. Query for the codelist you want to modify.

Table 6-3 lists the initial values in the Data Change Reason Type Code codelist.

6.5.1.3 Identifying Change Reasons NOT for Use in RDC

RDC data entry uses the same change reason reference codelists that are referenced by Oracle Clinical data entry. To mark any change reason that should not be used in RDC, specify NOTRDC in the Long Value field for the appropriate change reason entry. Figure 6-2.

Note that the NOTRDC setting applies only to RDC. Specifying NOTRDC for a change reason does not affect the use of the change reason in Oracle Clinical data entry or in pre-4.5.3 versions of RDC data entry.

Figure 6-2 DATA CHANGE REASON TYPE CODE Codelist

Description of ''Figure 6-2 DATA CHANGE REASON TYPE CODE Codelist''

6.5.2 Making a Reason for Change Optional for Updates to RDCI Comments in Accessible Documents

As described earlier in Section 6.5, "Defining the List of Allowable Change Reasons," RDC requires users to specify a change reason whenever they update data in a CRF previously saved as complete. As soon as the user updates a field and navigates away from it (by tab or mouse click), RDC displays the Reason for Change dialog box. The user must select one of your pre-defined reasons from the list.

You can suppress the change reason prompt when the user updates RDCI comments in accessible documents.

You can, however, choose to make a change reason optional for updates to RDCI comments in accessible documents.

To suppress the Reason for Change dialog box: 

1. Open Oracle Clinical.

2. Navigate to Admin, Reference Codelists, and then select Local Codelists.

3. Query for the OCL_DE_CONFIG reference local codelist.

   1. Enter OCL_DE_CONFIG in the Name field.

   2. Press F8 to execute the query.

4. Scroll to the COMMCHGREAS_REQ short value.

5. Set the long value to N to make a change reason optional for updates to RDCI comments in accessible documents.

6. Save your changes.

6.6.1 Setting Date Formats at the Database Level

To modify date preferences at the local database level: 

1. Open Oracle Clinical.

2. Navigate to Admin, DE Admin, and then select DE User Prefs.

3. Set your preferences for the Data Entry Display Format and the Data Entry Input Format.

4. Click Save as Default to save your changes.

   
   Description of the illustration ''depref.gif''
   
   

5. Redeploy RDC for the changes to take effect. See "Redeploying RDC with Customizations" for instructions.

6.6.2 Setting Date Formats for Individual Users

To modify the date preferences for an individual user: 

1. Open Oracle Clinical.

2. Navigate to Admin, Users and Roles, and then select Oracle Accounts.

3. Press F7 to open the query screen.

4. Enter name of user or enter an account name.

5. Press F8 to display all users that match your specified search criteria. Navigate to the applicable user.

6. Open the Special menu, and then select DE Prefs.

Users can also override the display and entry format by clicking the Preferences link in RDC. This method permanently changes the preference for the user and has the same effect as setting it through Oracle Accounts.

You can customize the RDC application to not display the Preferences link. See Section 3.3.2, "Hiding the Preferences Links" for more information.