Configuring Study-Level DCI Form Settings

Once you have enabled DCI Form definition and collection, you configure default generation settings such as default layout templates and header prompt text.

You can configure the default generation settings for a study in the DCI Form Local Study Settings form. To open the form, log in to Oracle Clinical and navigate to Design, then open the DCI Form Local Study Settings menu item.

About the DCI Form Local Study Settings Form

The DCI Form Local Study Settings form organizes the configuration settings into categories. The following list describes the settings by category. (See section, "DCI Form local database settings" in the Oracle Clinical Administrator's Guide for more information.)

• An unlabeled column that contains plus (+) or minus (-) symbols. Clicking a cell in this column displays or hides a category's settings.
• Setting This column contains several general configuration categories and their configuration settings. You must click the plus symbol to the left of a category to display its settings. The categories are headings: you do not set any values in the category rows.
• Value This column displays the current values for the settings. If a cell is blank, its value has not been set.
• An unlabeled column that includes list of value (LOV) buttons for list of values-controlled settings. If a setting does not have an list of values, its LOV cell is inactive.
• Inherit From Local DB Setting, if selected, indicates that a setting is using the default setting set at the local database level. If you enter a value different from the default value, the system deselects this field.

  If you are unable to deselect a setting's Inherit From Local DB Setting box or change a value for a setting, the system is preventing you from changing the value because it is enforcing the default value at the local database level. See the Oracle Clinical Administrator's Guide for more information about database-level DCI Form configuration.

  Note:

  Changing the database-level setting does not override study settings already in effect. It enforces settings for studies that are created after the change.
• Local DB Value displays the default values.

For more information, see:

• Configuring Local Studies
  

Configuring Local Studies

The following sections describe each of the DCI Form Local Study Settings form's configuration categories:

• DCI Form Runtime
  
• General
  
• Graphic Layout Editor/Updater
  
• Graphic Layout Generator - General
  
• Graphic Layout Generator - DCMs
  
• DCI Form Generation Defaults
  
• Default Settings for Showing DCM Header Fields
  
• Default DCM Header Field Prompts
  
• Version Migration
  
• Patient Data Report
  
• Validation
  
• Options in Group Verify dialog
  
• Options in Group Approve dialog
  
• Source Data Verification Plan Defaults
  

DCI Form Runtime

The settings in this category are:

• Disable Delete CRF Icon Select Y to disable the CRF icon in the RDC Onsite Data Entry window. Select N to enable it. When the icon is enabled, users can click it to delete the CRF and its data.

• Display Label for DCM Question Select the source for the label of each field in each DCM; either the SAS label, the Question name, or the default prompt of the corresponding Question definition.

• Display Visit Owning Interval on MPC Page? If set to Y, the multipatient casebook page in RDC Onsite displays the Interval—phase, period, or subperiod—of which each visit is a part.

• Enable Entry of Investigator Comments If set to Y, Investigator comments are allowed in RDC Onsite.

• Label for Customizable Patient Identifier If you are using a customizable patient identifier and you would like to display a label other than Reference (the default) for the field in the Patient Positions table in RDC Onsite, enter the label text you prefer.

• Page Labeling Compatible with Page Tracking? If set to Y, the page label in a physical page uses the same syntax as the page identification in the page tracking system. This setting applies only to studies that use Page Tracking; see Using CRF Page Tracking for more information.

• Represent Disabled Blocks as This setting applies to studies using conditional in-form branching. The possible settings are:

  • Hidden The horizontal section of the form representing the conditional target block is completely hidden, as if the form is ‘collapsed' or folded. If there are questions that appear on the form after the conditional blocks, those questions appear immediately after the conditional source question. For multi-page forms, the locations of page breaks are preserved relative to questions in the form. Therefore, when blocks are hidden, questions from the next page are not moved to fill the resulting additional blank space on the page.

  • Greyed The horizontal section of the form representing conditional target block is visible but inactive.

• Suppress Change Reason for New Responses If set to Y, the data entry user is not prompted for a Change Reason the first time a response is entered.

• Suppress Change Reason Prompt for New Investigator Comment If set to Y, the Investigator is not prompted for a Change Reason the first time he or she enters a comment on a particular response.

• Use Customizable Patient Identifier? If set to Y, the system displays the Reference field in the Patient Positions table in RDC Onsite. You can change the label for the field using the Customizable Patient Identifier Label setting.

General

There is one setting for this category: Default Unplanned Use Allowed for DCIs not in Book. This setting controls the default value for the Unplanned Use Allowed for DCIs Not in Book field on the DCI Book Constraints form. If this field is set to Y, then unplanned use of any DCIs defined in the study is allowed. Otherwise, the only DCIs available for unplanned use are those that are already used in the book and which are so designated.

This setting affects only new DCI Books. Changing the setting does not change the DCI Book Constraint setting for an existing DCI Book.

See Defining DCI Book Constraints for more information on constraining DCI usage.

Graphic Layout Editor/Updater

There is one setting for this category: Enforce Length as Field Size. If set to Y, the layout editor does not allow the user to drag the field to make it shorter than the character length defined for the Question. When set to Y, if you increase the Question's length in the Study DCM Questions window, the system sets the Needs Update flag for the layout.

Note:

This setting has no effect if the generated size of the field is based on the Question's DISPLAY LENGTH instead of LENGTH, per the DCM Question Attribute for Determining Field Width setting; see Graphic Layout Generator - DCMs.

Graphic Layout Generator - General

The settings in this category are:

• Default Checkbox Check Style Click the LOV cell to choose a default symbol for check marks. This setting populates the Checkbox Style field in the startup dialog for the DCM Graphic Layout Generator. You can choose a check, circle, cross, or square.

• Default Checkbox Shape Click the LOV cell to choose a default box shape. This setting populates the Checkbox Shape field in the startup dialog for the DCM Graphic Layout Generator. You can choose between a circle and a square.

• Default Checkbox Size Click the LOV cell to choose a default box size, in points. There are 72 points per inch, or about 28 points per centimeter. (You specify the list of values by populating reference codelist DCIF CHECKBOX SIZE.)

• Default Landscape Form Layout Template This attribute determines the default Form Layout Template during DCI Layout generation, if no portrait Form Layout Templates are large enough. The DCM Layout generation defaults to the Portrait Form Layout Template.

• Default Portrait Form Layout Template Click the LOV cell to choose a default portrait Form Layout Template from the listed choices.

• Field Font Size Click the LOV cell to choose a monospaced font size, in points. There are 72 points per inch, or about 28 points per centimeter. (You specify the list of values by populating reference codelist DCIF FONT TYPESIZE.)

• Field Font Typeface This list is based on the DCIF Typefaces table, which is not modifiable. The only choice is Courier.

  Note:

  The Layout Editor does not support the Symbol font. The generated layout may show boxes instead of characters.

• Prompt Font Size The prompt is an entry field's label. Click the LOV cell to choose a font size, in points. There are 72 points per inch, or about 28 points per centimeter. (You specify the LOV by populating reference codelist DCIF FONT TYPESIZE.)

• Prompt Font Typeface This list is based on the DCIF Typefaces table which is not modifiable. The choices include Courier New, Arial, Times New Roman and Symbol.

Graphic Layout Generator - DCMs

This category has one setting: DCM Question Attribute for Determining Field Width. Select the Question attribute to use to determine the size of the field for each Question's response:

• If set to Length, the display area accommodates the maximum number of characters allowed for the Question, without scrolling. If the page is not wide enough to accommodate the field on one line, the layout generator changes it to a multi-line field.

• If set to Display Length, the display area may not be large enough to see the full response at one time. If the page is not wide enough to accommodate the field, the layout generator will extend the field to the page margin, but will not change it to a multi-line field.

  The user can scroll to view or edit the overflow of text that might occur. A Patient Data Report (PDR) that includes such a field displays the entire value in the ancillary pages of the report.

  Note:

  See also the Enforce Length as Field Size setting here: Graphic Layout Editor/Updater.

DCI Form Generation Defaults

The settings in this category are:

• Default Landscape Page Definition Select a default page size for horizontal pages: either US letter (OCL_USL_L) or A4 (OCL_A4_L).

• Default Portrait Page Definition Select a default page size for vertical pages: either US letter (OCL_USL_P) or A4 (OCL_A4_P).

  Note:

  These settings have the same list of values, which is populated by the DCIF PAGE DEFINITION installation reference codelist. Be careful to select a landscape value for the landscape setting and a portrait value for the portrait setting.

See Creating DCI Form Page Definitions for more about Page Definitions.

Default Settings for Showing DCM Header Fields

You control the default display of DCM header fields in this category. These settings can be overridden at the DCI module level.

Note that you use next category, Default DCM Header Field Prompts, to define default text for these fields' labels.

The settings in this category are:

• Default for Show Blank Flag? Set to Y to enable displaying an indicator to set DCMs to Blank status in DCM headers.

• Default for Show Comment? The DCM header data comments are available only in the Oracle Clinical Data Entry subsystem. You cannot modify the field in RDC Data Entry. Set this option to Y only if you want to produce Patient Data Reports that show RDCM header comments entered in through Oracle Clinical Data Entry.

• Default for Show Data Comment? The DCM header data, which is the same as internal comments, is only available in the Oracle Clinical Data Entry subsystem. You cannot modify the field in RDC Data Entry. Set this option to Y only if you want to produce Patient Data Reports that show RDCM header data comments entered in through Oracle Clinical Data Entry.

• Default for Show Lab? Set to Y to enable displaying and entering the lab for an RDCM by default if the DCM has any lab Questions. If there are no lab Questions for a DCM, Show Lab is set to N for DCI Modules regardless of this setting.

• Default for Show Qualifying Value? Set to Y to enable displaying the DCM qualifying value in the DCM header. If a DCM has no Qualifying Question or has a Qualifying Question with no default value, Show Qualifying Value has a value of N for the DCI Module record, regardless of the value of this setting.

• Default Visit Display Code This setting determines whether and how the subevent is displayed with the visit name. Note that the user cannot directly enter the subevent number, regardless of the option you choose. The user selects the subevent (or just the visit) from a list of values in the Visit Name field. The information is displayed in the format you select here:

  • NAME ONLY The system displays only the Visit Name.

  • NAME+SUB# The system displays the Visit Name and Subevent Number in one field with a dot (.) separator; for example, CHECKUP.1.

  • NAME/SUB # The system displays the Visit Name and Subevent Number in separate fields.

    Note:

    If you do not want to display any visit information, set the next setting, Hide Visit by Default? to Y.

• Hide Visit by Default? Set this value to Y to hide the visit identifier by default. The system sets the Visit Display setting in the DCI Modules form to HIDDEN, overriding the previous setting. Exceptions: if there is no defined Clinical Planned Event (CPE, or visit), or the Use DCI Date setting is not selected in the DCI Modules form, the Visit must be displayed; the Visit Display setting for the DCM defaults to the Default Visit Display Code setting (above) and the user is prevented from setting it to HIDDEN.

Default DCM Header Field Prompts

You can control the default display prompts of DCM Header fields in this category. You control the display of these definitions in the previous category, Default Settings for Showing DCM Header Fields.

The settings in this category are:

• (Internal) Comment Prompt Enter the prompt text for an internal comment field.

• Blank Flag Prompt Enter the default prompt text to identify a header indicator that a DCM is blank.

• Data Comment Prompt Enter the default prompt text to identify a DCM header Data Comment field.

• Date Prompt Enter the default prompt text to identify a DCM header Date field.

• Generate DCM Header Divider? Enter Yes to include a line between a DCM Header and the DCM.

• Lab Prompt Enter the default prompt text to identify a DCM header Lab Identifier field.

• Length for (Internal) Comment Prompt Enter a number that indicates the maximum number of characters a Comment field can hold.

• Length for Data Comment Enter a number that indicates the maximum number of characters a Data Comment field can hold.

• Length of Visit Name Enter a number that indicates the maximum number of characters a Visit Name field can hold.

• Subevent Prompt Enter the default prompt text to identify a DCM Subevent Identifier field.

• Time Prompt Enter the default prompt text to identify a Time field.

• Visit Name Prompt Enter the default prompt text to identify a Visit Name field.

• Visit Name+Sub# Prompt Enter the default prompt text to identify a combination Visit Name and Subevent Identifier field.

Version Migration

If the data definitions that comprise a DCI Form change after a study has gone into production, you need to create a new layout version and migrate data to the new version.

The settings in this category are:

• Allow Migration of Approved Documents? Set this value to Yes if under some circumstance the system should migrate an RDCI to a new layout version. Set this value to No to prevent all RDCIs from migrating to new layout versions.

• Allow Migration of Classic RDCIs? If you have data you collected in the character-based layout system, and you have created DCI Form layouts for the corresponding DCIs to DCI Form layouts, set this value to Yes if you want the system to render its RDCIs in the new DCI Forms layouts. Set this value to No if you do not want these RDCIs to be viewed in RDC Onsite.

  Note:

  For instructions on completing this restriction, see the section "Allowing Access to CRFs Entered via Oracle Clinical" in the Oracle Clinical Remote Data Capture Onsite Administrator's Guide .

• Allow Migration of Locked Documents? Set this value to Yes if you want to allow the system to migrate locked RDCIs to new layout versions.

• Default Reason to Retain Approval Verification Select the default reason to supply if approvals or verifications are retained during DCI Form version migration. If User Override to Reverse Approvals? or User Override to Reverse Verifications? is set to N, the user running the migration cannot specify a different reason (these settings are covered below).

  You must create the available values in the APPROVE VERIFY RETAIN CODE installation reference codelist.

• Default Reason to Reverse Approval/Verification Select the default reason to supply if approvals or verifications are reversed during DCI Form version migration. If User Override to Reverse Approvals? or User Override to Reverse Verifications? is set to N, the user running the migration cannot specify a different reason (these settings are covered below).

  You must create the available values in the APPROVE VERIFY REVERSE CODE installation reference codelist.

• Default Setting for Reverse Approval Status If set to Y, DCI Form version migration changes approved RDCIs' approval status to unapproved. If set to N, DCI Form version migration keeps approved RDCIs' approval status as approved.

• Default Setting for Reverse Verification Status If set to Y, DCI Form version migration changes verified RDCIs' approval status to unverified. If set to N, DCI Form version migration keeps verified RDCIs' approval status as verified.

• Last Migrateable Entry Status Specify highest status at which version migration is allowed. The possible statuses are, in order from lowest to highest, with the Oracle Clinical term given first and the RDC equivalent following:

  • Received (Blank)

  • (not applicable) (Created)

  • Pass 1 Started (Entry Started)

  • Pass 1 Complete (Entry Complete)

  • Batch Loaded (not applicable)

  • Pass 2 Pending (not applicable)

  • Pass 2 Started (not applicable)

  • Pass 2 Complete (not applicable)

  In addition to these statuses, the keyword ALL allows RDCIs at any status to migrate, and the keyword NONE disallows any RDCI from migrating.

• User Override to Reverse Approvals? If set to Y, the user running Form Version Migration can specify whether the particular execution of Form Version Migration should reverse the status of all approved RDCIs migrated.

• User Override to Reverse Verifications? If set to Y, the user running Form Version Migration can specify whether the particular execution of Form Version Migration should reverse the status of all verified RDCIs migrated.

Patient Data Report

The settings in this category are:

• Bookmark Ancillary Data Section If set to Y, the system generates bookmarks for the Ancillary Data sections of the Patient Data Report (PDR).

• Bookmark Subevents If Y, the system generates bookmarks for Visit Subevents in the PDR.

• Bookmark Title for Ancillary Data Section Specify a title to be used for bookmarks to the ancillary data section for a CRF (if Bookmark Ancillary Data Section is set to Y). The default value is "Ancillary Data Section". In the bookmark, the system appends the word for followed by the bookmark label of the CRF to the value specified. Therefore with the default value the bookmark text is "Ancillary Data Section for CRF bookmark label."

• Exclude Overflow for Hidden Protected Repeating Defaults The blank casebook report (patient-specific and not patient-specific) includes all default text for repeating Questions in the ancillary pages. Set to Y if you do not want to include text for repeating default Questions if they are hidden.

• Include Approval Information If set to Y, approval information for the CRF is included in the ancillary data section. A line appears under the title of the report stating that the document was approved, who it was approved by and the date and time of approval. If the CRF is approved but has no other ancillary data, the ancillary data page is included with just the approval information.

• Include Audit History for Fields Not Displayed in CRF If set to Y, the audit history for CRF fields not displayed in the CRF is displayed at the end of the Ancillary Data Section. It is not attached to a superscript but lists all audit information for fields that are not displayed on the form—for example, if the blank flag was changed for a CRF but the blank_flag is not displayed in the form. If set to N, the audit history is not displayed for undisplayed fields.

• Include TOC in Page Numbering If set to Y, the cover page and table of contents are counted when determining PDR page numbers. For example, if CONMED is the first domain, and the cover page and table of contents each consisted of one page, CONMED would begin on page 3 if Include TOC in Page Numbering is set to Y and on page 1 if it is set to N.

• PDR Bookmark Data Domain Select DCI if you want Patient Data Report bookmarks to be at the DCI level, or DCM if you want bookmarks at the DCM level. Enforce Local DB Setting is checked and cannot be unchecked. The setting cannot be changed at the study level. The default value is DCI.

Validation

This category contains one value: Execute TMS validation during site/patient validation?. The Validate Patient job, which is run from RDC, includes running TMS-related derivation Procedures on the whole study. A user who runs the Validate Patient job is recorded as creating these derived responses for all sites and patients in the study. This may be a problem if the user does not have privileges for all sites in the study.

If set to Y, TMS-related Procedures are executed for the whole study during site and patient validation.

If set to N, TMS-related Procedures are not executed at all during site and patient validation. However the TMS-related Procedures are included in Batch Validation.

Options in Group Verify dialog

The LOV of each of following settings consists of the four possible combinations of CHECKED vs. UNCHECKED and UPDATEABLE vs ENFORCE:

• CHECKED, ENFORCED: Check box is checked and user cannot change it

• CHECKED, UPDATEABLE: Check box is checked but user can change it

• UNCHECKED, ENFORCED: Check box is unchecked and user cannot change it

• UNCHECKED, UPDATEABLE: Check box is unchecked but user can change it

Exclude batch-loaded CRFs

Batch-loaded CRFs are not included in the Verify action.

Exclude CRFs with discrepancies

CRFs with one or more discrepancies are not included in the Verify action.

Exclude non-migrated CRFs

Non-migrated CRFs are not included in the Verify action.

Include CRFs for this visit only

This setting applies only if the action is invoked from the multi-patient casebook page and it applies to both the Verify and the Undo Verification dialogs.

Options in Group Approve dialog

The LOV of each of following settings consists of the four possible combinations of CHECKED vs. UNCHECKED and UPDATEABLE vs ENFORCE:

• CHECKED, ENFORCED: Check box is checked and user cannot change it

• CHECKED, UPDATEABLE: Check box is checked but user can change it

• UNCHECKED, ENFORCED: Check box is unchecked and user cannot change it

• UNCHECKED, UPDATEABLE: Check box is unchecked but user can change it

Exclude batch-loaded CRFs

Batch-loaded CRFs are not included in the Approve action.

Exclude CRFs with discrepancies

CRFs with one or more discrepancies are not included in the Approve action.

Exclude non-migrated CRFs

Non-migrated CRFs are not included in the Approve action.

Include CRFs for this visit only

This setting applies only if the action is invoked from the multi-patient casebook page and it applies to both the Verify and the Undo Verification dialogs.

Include verified CRFs only

Only verified CRFs are included in the Approve action.

Source Data Verification Plan Defaults

Use these settings to set default values for site-level SDV plans created for this study. These settings can be overridden at the study site level in the SDV Site Planing tab in Remote Data Capture by a user with the necessary privileges.

To set the defaults for a study, access Design, and then DCI Form Local Study Settings. To make the changes for the database, access Admin, and then DCI Form Local Database Settings.

Exclude batch-loaded CRFs?

When checked, indicates that even if a patient is identified as requiring 100% SDV, batch-loaded CRFs for that patient should not be presented in the RDC Surround as requiring SDV. The default is UNCHECKED.

Exclude non-migrated CRFs

When checked, indicates that even if a patient is identified as requiring 100% SDV, CRFs for that patient that were entered via RDC Classic or Oracle Clinical and that have not been migrated to a DCI Form Version should not be presented in the RDC Surround as requiring SDV.

Initial Patients for 100%SDV

The number of initial patients to be automatically selected for 100% SDV. Use a number between 0 and 999.

Patient auto-select rate for 100%SDV

The rate at which newly SDV eligible patients should be tagged for SDV. For example, if the rate is 20%, every fifth patient is selected.

See Setting Up Partial Source Data Verification for more information.