Customizing Data Entry Behavior

A number of features, behaviors, and even the appearance of the Log-In and Data Entry screens can be configured depending on configuration settings, user preferences, and special layout editing tools. This section provides an overview of these features; more detail on each feature is available in later sections.

For more information, see:

• Define Data Entry Configuration Settings
  
• Configuring Additional Data Entry User Preferences
  
• Configuring Privileged Update
  

Define Data Entry Configuration Settings

Data entry configuration settings, such as whether univariate validation failures alert the First-Pass and Second-Pass data entry operators, can be set at the local database level, the study level, or the user level.

Data entry configuration settings can be set at the:

• Database Level through the Maintain Installation Configuration window; see Configure Database-Level Data Entry Settings

• Study Level through the Maintain Study Configuration window (via Maintain Clinical Study States window); see Configure Study-Level Data Entry Settings

• User Level through the Maintain Oracle Accounts window; see Configure User-Level Data Entry Settings

As the configuration level becomes more specific, from database to study to user, its settings usually take precedence over the more general level. At the local database level, each setting is either enabled or disabled. At the study and user levels, each setting is either enabled, disabled, or not set. If the value of a setting is "Not Set" it serves as a "pass-through" to the next higher level value for that setting. Initially, all values at the study- and user-level are set to "Not Set" so that the database level, which is set up during installation, is in effect until you modify the settings for a given study or user.

Study-level configuration settings affect all users who have access to that study, except when user-level configuration or Study/Site security settings are set up for a user. If a setting at this level has a value of Not Set, all users who access the study use the database-level setting, unless the value for the setting at the user level is Enabled or Disabled for a specific user.

Note:

Study-level settings of configuration parameters are not replicated during study replication. Each local database defines its own configuration settings.

Note that certain privileges that are assigned via the Study and/or Site Security windows take precedence over user-level data entry configuration settings.

The settings available at each level are identical; the only difference is the availability of the "Not Set" value at the study- and user-levels. See Table 5-1 for a complete list of settings.

For more information , see:

• Configure Database-Level Data Entry Settings
  
• Configure Study-Level Data Entry Settings
  
• Configure User-Level Data Entry Settings
  

Configure Database-Level Data Entry Settings

Local database configuration settings are maintained in the Maintain Installation Configuration window. You can customize the configuration settings for the local database by changing the default shipped values for the configuration settings.

At the local level, configuration settings are either enabled, disabled, or have a numeric value, as applicable. Table 5-1 describes each setting.

To change the local settings:

1. Navigate to Admin, DE Admin, and then select DE Config Settings. The Maintain Installation Configuration window opens.

2. Navigate to the configuration setting that you want to modify, and change its value. The default page height and width settings allow numeric values within upper and lower bounds. The other settings can be set to either enabled or disabled.

3. Click Save to commit changes.

Table 5-1 Local Database-Level Data Entry Configuration Settings

Configuration Parameter	Description	Values	Default setting
Second-Pass Comparison Failure Alert	(Oracle Clinical only) Controls whether the data entry operator is notified when a first-pass/second-pass comparison error occurs. When this setting is not enabled, the operator is in "silent" mode during second-pass data entry, and any first/second pass comparison failures that occur must be resolved during comparison reconciliation.	Enabled/ Disabled	Enabled
Manual Discrepancy in Browse	(Oracle Clinical only) Whether the data entry operator can create or modify a manual discrepancy (operator comment) in browse mode (only applicable if the user has access to Browse mode).	Enabled/ Disabled	Enabled
Resolve Discrepancies in Data Entry	(Oracle Clinical and RDC) Whether the data entry operator has authority to resolve discrepancies during data entry, that is, the permission to set a discrepancy to closed status.	Enabled/ Disabled	Enabled
Privileged Update	(Oracle Clinical and RDC) Whether the data entry operator can perform the following while in update mode: update data for locked RDCMs and RDCIs, override protected repeating defaults, and exceed the Maximum # of Repeats to a Repeating Question Group, even when Enforce Repeats is set (Oracle Clinical only).	Enabled/ Disabled	Disabled
List of Values for Thesaurus Questions	(Oracle Clinical only) Whether a list of values is available for thesaurus questions based on external dictionaries.	Enabled/ Disabled	Disabled
Univariate Failure Alert	(Oracle Clinical) Whether the data entry operator is notified when a univariate validation error occurs. When this setting is disabled, the operator is in "silent" discrepancy mode. Univariate discrepancies are still created in "silent" mode, but the operator is not notified of their creation. RDC Onsite does not use this setting. Instead, it uses a configuration setting in the RDC Administration tool, which can be over-ridden by the end user, if Preferences are made available	Enabled/ Disabled	Enabled
Initiate DE session using DCI Book	(Oracle Clinical only) Whether DCI book sequencing is the default sequencing mode during log-in and data entry.	Enabled/ Disabled	Enabled
Unenrolled patient alert	(Oracle Clinical only) Whether the data entry operator is notified when a received DCI is logged in for a patient not enrolled in the study.	Enabled/ Disabled	Enabled
Prevent Second-pass Entry by First-pass operator	(Oracle Clinical only) Whether Oracle Clinical prevents the data entry operator who did first-pass entry on a given RDCI from performing second-pass entry on the same RDCI.	Enabled/ Disabled	Disabled
Browse accessible data only	(Oracle Clinical only) Determines if data entry operators can browse data.	Enabled/ Disabled	Disabled
DCI and DCM Date Required	(Oracle Clinical and RDC) The data entry must enter the DCI and DCM Visit date.	Enabled/ Disabled	Enabled
Default height for Data Entry page in DCM	(Oracle Clinical only) Default value for the Data Entry Page Height for DCMs. This setting determines only the value that is supplied as the default, which can be overridden during DCM definition.	Number between 10 and 60	22
Default width for Data Entry page in DCM	(Oracle Clinical only) The default value for the Data Entry Page Width for DCMs. This setting determines only the value that is supplied as the default, which can be overridden during DCM Definition.	Number between 10 and 240	80

Configure Study-Level Data Entry Settings

If you require that a particular study have different data entry configuration settings from those set at the local database level, you can change the settings at the study level by modifying the Clinical Study State record for that study. Study-level configuration settings override local database-level configuration settings for that study.

The study-level configuration settings are identical to the local database-level data entry configuration settings, but at the study level, an additional value, "Not Set", is available for all configuration settings. If a setting is not set, it is not defined and the next higher configuration setting takes effect. Because study-level settings take precedence over database-level, by default, all study-level configuration settings are set to "Not Set", which results in the local-level settings taking effect. See Table 5-1 for a listing of the settings.

Values for each non-numeric setting are available from the list of values and can be either "Enabled", "Disabled", or "Not Set". The default page height and width settings allow numeric values within upper and lower bounds.

To change a study-level data entry configuration setting:

1. Navigate to Conduct, Security, and then select Clinical Study States. The Maintain Study States window opens.

2. Query for the study you want to update.

3. Open the Special menu and select DE Configs. The Maintain Study Configuration window opens.

4. Make the necessary changes to the configuration settings that you want to modify.

5. Save the changes and click Back to return to the Maintain Clinical Study States window, or click Back without saving to abandon your changes.

Changes at this level affect all users working in the study, unless user-level data entry configuration settings are defined for a user. See Configure User-Level Data Entry Settings for information on modifying these settings.

Configure User-Level Data Entry Settings

User-level settings affect all studies to which the user has access.

If you require that a user have different data entry configuration settings from those set at the study or the database level, you can change specific settings at the user level that supersede those higher level settings.

The user-level configuration settings are identical to the study- and database-level data entry configuration settings. As with the study level settings, an additional value of Not Set is available for all nonnumeric settings. If a setting is Not Set, the next higher configuration setting takes effect. Because user-level settings take precedence over database-level, by default they are set to Not Set, which results in the local-level settings taking effect. Table 5-1 has a complete list of settings.

Note:

The DCI and DCM Date Required setting is inactive at the user-level (see the table in Configure Database-Level Data Entry Settings for more details).

Values for each nonnumeric setting are available from the list of values and can be either Enabled, Disabled, or Not Set. The default page height and width settings allow numeric values within upper and lower bounds.

To change user-level data entry configuration settings, follow this procedure:

1. Navigate to Admin, Users, and then select Oracle Accounts. The Maintain Oracle Accounts multi-view window displays.

2. Query the user record you want to modify.

3. Open the Special menu and select DE Configs. The Maintain User Configuration window displays.

   To define a user-level configuration setting, change the value of the configuration setting in this window to any value other than not set. You can change the value of a configuration setting without changing all of them.

4. Change any setting, as needed.

5. Save the changes and then click Back to return to the Maintain Oracle Accounts form, or click Back without saving to abandon your changes.

Configuring Additional Data Entry User Preferences

Oracle Clinical supplies a set of default values for user preferences, which are displayed in Table 5-2. These preferences remain in effect for all data entry operators unless operators override the defaults and save their own values (see Chapters 3 and 4 in Oracle Clinical Conducting a Study).

To change the default values for user preferences:

1. Navigate to Admin, DE Admin, and then select DE User Prefs. The Maintain Installation Preferences window opens.

2. Navigate to the user preference that you want to modify, and change its value. Values for each user preference are represented either as check boxes or as a list of values.

3. Click Save as Default to save the changes, and then click Exit to close the window.

Table 5-2 Local Data Entry User Preference Settings

User Preference	Description	Values	Default Setting
Auto Skip	On fields that have been defined as Auto Skip fields in DCM definition, determines whether the cursor automatically skips to the next field when the current field is filled to its predefined length.	Enabled/Disabled	Enabled
Auto Fill	Applicable only for fields that have lists of values (DVG- or thesaurus-based). Determines whether entering a few unique characters of a valid value will result in the system's filling in the rest of the value upon navigation out of the field.	Enabled/Disabled	Enabled
Univariate Beep	Determines whether an audible signal will accompany the Univariate validation failure pop-up window. Not applicable if the Univariate validation failure alert configuration setting is disabled.	Enabled/Disabled	Enabled
Comparison Beep	Determines whether an audible signal accompanies the First-Pass/Second-Pass Comparison Failure pop-up window. Not applicable if the second-pass comparison failure alert configuration setting is disabled.	Enabled/Disabled	Enabled
End of Form Beep	Determines whether you receive an audible beep when you reach the end of a form.	Enabled/Disabled	Enabled
Data Entry Input Format	For all log-in and data entry tasks, for DCI and DCM dates and data entry fields of type date, determines how date formats are applied to interpreting data that is input to the field. Must be the same as data entry display format (see below), unless display format is standard. standard format (see below) is always accepted.	us (mm-dd-yyyy) european (dd-mm-yyyy) swedish (yyyy-mm-dd)	US
Data Entry Display Format	For DCI and DCM Dates, the Display Format configuration determines the date format used for displaying dates. For data entry fields, the format is controlled by the date order of the DCM, which is either DYNAMIC or is one of the four date formats (US, EUROPEAN, SWEDISH, or STANDARD).If the DCM's date order is DYNAMIC, data entry fields that are dates are displayed using the same data entry configuration Display Format setting used for DCI and DCM dates. Otherwise, data entry fields are displayed using the format indicated by the Date Order for the DCM.Additionally, whether the day and month portion of a data entry field date is displayed is controlled by the Date Time Format of the DCM question on which it is based. There are four possible Date Time Formats for a date field: DMY (day, month, and year are displayed), MY (day is not displayed), and Y (only year is displayed). NOTE: Although user-level settings generally override database-level settings, when a data type discrepancy is raised for a date field, the resulting warning message displays the discrepant date in the format specified at the database level. Therefore, Oracle recommends that you always specify STANDARD (DD-MON-YYYY) as the Data Entry Display Format at the database level. The other possible values can be misconstrued: US (MM-DD-YYYY), European (DD-MM-YYYY), and Swedish (YYYY-MM-DD).	US (MM-DD-YYYY) European (DD-MM-YYYY) Swedish (YYYY-MM-DD) Standard (DD-MON-YYYY)	US
RDCI Sort Order	For query sequencing, determines the ordering for the RDCIs retrieved by a query for data entry processing.	Document Number Patient - Visit - DCI Name - DCI Date Entry Order	Entry Order

Configuring Privileged Update

Users with privileged update can perform the same tasks on a locked document that they can on an unlocked document. in all data entry modes: log in, first pass, second pass, update, reconciliation, and key changes.

Within RDC, enabling privileged update means that the user can take any action consistent with the study- or site-security privileges assigned to the user's name. For RDC purposes, privileged update can only be assigned through the data entry configuration settings.

In Oracle Clinical you can assign privileged update through data entry configuration settings and through study/site security.

• If Privileged Update is not enabled for a user through the data entry configuration settings, you can use the UPD_LOCK_OC privilege to grant Privileged Update access to a user. The advantage of this approach is that you can grant the privilege for a specific site within a study, while the Data Entry Configuration settings allow specification only at the database, study, or user level.

• If Privileged Update is enabled through the data entry configuration settings, the UPD_LOCK_OC privilege assigned through study/site security is not applicable.

For more information , see:

• Set Privileged Update Using Configuration Settings
  
• Set Privileged Update Using Study/Site Security
  

Set Privileged Update Using Configuration Settings

By default, privileged update is not enabled for a user. In most circumstances, you set the Privileged Update data entry configuration setting at the user level. To do this, see Configure User-Level Data Entry Settings.

• To set privileged update at the study level, see Configure Study-Level Data Entry Settings.

• To set privileged update at the local database level, see Configure Database-Level Data Entry Settings.

These settings apply to Oracle Clinical and RDC users.

Set Privileged Update Using Study/Site Security

For Oracle Clinical users only, when Privileged Update is not enabled for a user in the data entry configuration settings, you can grant Privilege Update access by assigning the user the UPD_LOCK_OC privilege for a particular study or site within a study.

Navigate to Admin, Users and Roles, Study Security or Site Security.