| Oracle® Clinical Creating a Study Release 4.6.2 E18820-01 |
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PDF · Mobi · ePub |
| Oracle® Clinical Creating a Study Release 4.6.2 E18820-01 |
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PDF · Mobi · ePub |
This chapter outlines the process of producing Graphic Layouts. It includes the following topics:
In Oracle Clinical, the term layout means the graphic and typographic representation of a data collection definition. (See "Data Entry and Report Layout Design" for a comparison of the graphic-based layout system to the character-based system.) Here are some of the Graphic Layout system's advantages:
You can use Graphic Layouts to produce these outputs:
You can create DCI Forms for the RDC Data Entry Option.
You can print out formatted blank CRFs.
You can produce formatted Patient Data Reports (PDRs).
You lay out DCMs and DCIs separately in order for these data collection definitions to retain their flexibility for re-use.
If you revise a Graphic Layout after you start collecting data—for instance, if you add a Question or modify the layout—you can create a new layout version. (See "Maintaining Form Layout Versions".)
These are the main Graphic Layout terms:
DCM Graphic Layouts are DCM definitions that include visual formatting. The Questions in a DCM Graphic Layout are collected into blocks.
DCI Graphic Layouts contain DCM Graphic Layouts and header and footer information.
DCI Forms are used to generate the CRF for RDC Onsite HTML data entry window and the PDF Patient Data Report (PDR) and Blank Casebook Report. A DCI Form can contain up to 2000 objects.
Note:
Each page must fit on a printed page or you will not be able to see all the data in the Patient Data Report. The system converts the layout separately for the PDF reports and HTML data entry. There are likely to be small differences in pixel counts. When you create a layout, test both uses.Form Layout Templates contain DCI Graphic Layouts and define the areas for DCIs, headers, and footers.
Page Definitions determine the overall dimensions of a CRF or PDR printed page or window.
Objects are text and graphic elements like fields, lines, boxes, and prompts. There are input objects you inherit from the DCIs and DCMs, and static objects you add to a layout.
Figure 11-1, "Graphic Layout Process Workflow" is a diagram of the basic process for creating DCI Forms.
As an introduction to the Graphic Layout system, here are steps that utilize default values and starter definitions to produce a basic DCI Form. See Figure 11-1, "Graphic Layout Process Workflow".
Enable DCI Forms in a study: Navigate to Conduct, Security, and Clinical Study States, and select the DCI Form Definition Enabled and DCI Forms Entry Enabled boxes for a study; see "Enabling DCI Forms".
Create or select an active DCM; see "Defining DCMs".
Generate a DCM Graphic Layout: In the DCM window, select Special, then choose Graphic Layout, then Generate Default from Scratch. Accept the defaults and click Generate. The system creates a Graphic Layout definition of the DCM; see "Generating Default DCM Graphic Layouts".
Alternatively, if you already have a character layout, select Generate Default From Character Layout.
You can now edit the DCM Layout; see "Editing DCM Graphic Layouts". While in the editor you can generate a preview of the layout; see "Previewing DCM Graphic Layouts".
In the DCMs window, click the Graphic Layout tab, select the DCM's Available? box, and Save.
If necessary, create a default DCI, or add the DCM to an existing DCI; see "Defining DCIs".
Generate a default DCI Graphic Layout from the DCI (see "Generating Provisional DCI Layouts"):
From the Special menu, select DCI Layout, then Generate Provisional Layout. The Attributes for DCI Graphic Layout Generation dialog box opens that includes several modifiable settings that are explained later.
Click the Generate button. The system creates a definition of the DCI's data and formatting characteristics. You can now edit your DCI Layout; see "Maintaining DCI Graphic Layouts".
At this point, you can generate a preview of the blank CRFs that you can print.
Generate a DCI Form: Select the DCI with the DCI Layout you generated in the last step, and navigate to Special, DCI Layout, and Generate Provisional DCI Form. Click Generate. The system creates the DCI Form.
Select your DCI and click the DCI Form Versions button. If this is the first time you have generated a DCI Form from this DCI, it is Version 1. Change its Status value from P(rovisional) to A(ctive), save, and click the Back button.
If necessary, add your DCI to a DCI Book.When you are satisfied with the form, change the Book's Status to A(ctive); see "Defining DCMs".
Figure 11-1 Graphic Layout Process Workflow
This section introduces the DCI Form's graphic terrain by describing its parts. When you generate a DCI Form, you render the set of nested data definitions as graphic representations. Each representation fits into an area. From the interior to the edges, here are the relationships of the areas:
Questions fit into blocks in DCM Layouts.
DCM blocks fit into DCM regions of DCI Layouts.
DCI Layouts inherit the dimensions of their associated Form Layout Templates. Form Layout Templates define the dimensions that can hold the header, footer and DCM regions.
The DCI Form Generator positions Form Layout Templates into DCI Form Page Definitions. The Page Definition specifies the size of the page. The Binding Offset determines the positioning of the Form Layout Template within the page.
The following sample DCI Form Layout illustrates the layout areas of a DCI Form based on a starter DCI Form Page Definition in portrait orientation (OC_USL_P), and the default US_USL_P Form Layout Template. Because of the difference in size between the Page Definition and the Form Layout Template, it has top and bottom margins of 36 points (1/2 of an inch) each, and side margins of 54 points (3/4of an inch) each.
A Page Definition is the paper size in print, or the overall form size on screen. Oracle Clinical provides starter definitions for the standard paper sizes. However, you can define pages for custom paper sizes or to fit on a particular screen device. In Figure 11-2, the visible part of the Page Definition is light gray, and extends to the edges of the illustration. This section describes how to create them.
You maintain Page Definitions in the DCIF PAGE DEFINITION Installation Codelist: From the Admin menu, select Reference Codelists, choose Installation Codelists, and query DCIF PAGE DEFINITION.
You define a page's dimensions by entering a codelist long value with this syntax:
HEIGHT:x WIDTH:x BINDING OFFSET:x
In the above syntax line, x is a value in points.
The only available unit of measure for Page Definitions is points. Points have these properties:
There are 72 points to an inch, 28.3 points to a centimeter.
A standard A4 page is 494.4 by 842 points.
A standard US letter (8 1/2 inches by 11 inches) page is 612 by 792 points.
Points and screen measurements have a relative correspondence. A layout appears much larger on a monitor screen set to 1280 by 1024 pixels than it does on a screen set to 1600 by 1200 pixels. Although all units of measure—including point measurements—are relative on the screen, they are absolute in print.
Oracle Clinical provides starter Page Definitions that you can in any DCI Form based on standard A4 and US Letter page sizes. There are landscape and portrait orientation definitions for each page size. Their names indicate their page size and orientation. The starter pages have no binding offsets, which means that the DCI Form Generator centers Form Layout Templates inside them. These are the Page Definition names and the long values that define them:
OC_USL_P HEIGHT:792 WIDTH:612 BINDING OFFSET:0
OC_USL_L HEIGHT:612 WIDTH:792 BINDING OFFSET:0
OC_A4_P HEIGHT:842 WIDTH:595.4 BINDING OFFSET:0
OC_A4_L HEIGHT:595.4 WIDTH:842 BINDING OFFSET:0
A DCI Form's margin area is equal to the difference between the Page Definition size and the Form Layout Template size. Most organizations standardize on a particular page size, so determining the margins in a layout most likely requires defining the size of your Form Layout Templates. See "Sizing Form Layout Templates" for sizing Form Layout Templates.
When you generate a DCI Form, the DCI Form Generator subtracts the Form Layout Template's width from the layout's designated DCI Form Page Definition width. It then divides the difference by two to determine the width of the left and right margins. In Figure 11-2, the example has side margins 54 points (3/4 inches) each. A standard U.S. letter is 612 points wide. The starter Form Layout Template OC_USL_P is 504 points wide. This leaves 108 points difference in the width, or 54 points in each long margin. For portrait orientation, you can shift the margin to the left or right. See "Setting Binding Offsets".
The system performs the same operation on the height. In Figure 11-2, the example has a Page Definition height of 792 points and a Form Layout Template height of 720 points. The difference is 72 points, so the top and bottom margins are each 36 points high. For landscape orientation, you can shift the margin up or down. See "Setting Binding Offsets".
You can shift the template along one axis by changing the Page Definition's Binding Offset value. The binding offset parameter enables you to increase the gutter space in a PDR DCI form. The list of eligible Page Definitions for a DCI Layout or PDR generation is limited to Page Definitions with binding offsets that fit.
The DCI Form Generator subtracts the offset value from the Portrait Page Definition's short dimension, then re-centers the Form Layout Template on the reduced axis. Therefore, adding a binding offset requires changing the offset value in the Page Definition and adjusting a dimension of a Form Layout Template.
The binding offset is always along the long dimension of the Page Definition, regardless of the page orientation. You can use positive or negative values. If you define a square page with a binding offset, the system offsets the Form Layout Template to the left or right.
For portrait orientation layouts, a positive offset value shifts the Form Layout Template toward the right side of the page, increasing the left margin. A negative value shifts the Form Layout Template toward the left side of the page, increasing the right margin. For example, if the left margin is 26 without an offset, an offset of negative six (-6) changes the left margin to 20 points.
For landscape orientation layouts, a positive offset value shifts the Form Layout Template toward the top of the page, increasing the bottom margin. A negative value shifts the template toward the bottom of the page, increasing the top margin. For example, if the top margin is 40 without an offset, an offset of 10 changes the top margin to 30 points.
You enable the definition of DCI Forms and data entry using DCI Forms at the study level by logging in to Oracle Clinical and opening the Clinical Study States form: Navigate to Conduct, Security, and then Clinical Study States. Query and select your study, then select its DCI Forms Definition Enabled? and DCI Forms Entry Enabled? boxes. Save your work and exit.
Note:
You must download the latest version of the Oracle Clinical PDF Plugin from My Oracle Support, as described in the Oracle Clinical Installation Guide, to use the Annotated Layout feature.You can enable the definition of DCI Forms by default for all studies on a local database through a local database setting. If you do this, when you create a study through Easy Study Design, you do not have to enable the study in the Clinical Study States window. From the Admin menu, select DCI Form Local Database Settings, then DCI Form Definition. Set DCI Forms Definition Enabled to Yes. See the Oracle Clinical Administrator's Guide for a description of local database configuration.
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.
The following sections describe each of the DCI Form Local Study Settings form's configuration categories:
The settings in this category are:
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. Select Greyed if you want conditional fields that are not expected for a patient to be displayed but inactive. Select Hidden if you do not want such fields to be displayed at all. In this case, the next expected fields, if any, are displayed in the same area, so that there is no empty space.
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.
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.
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".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.
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.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.
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.
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.
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 migrate its 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 to continue to represent the RDCIs in the character-based layout system.
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.
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.
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.
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.
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. If a user runs the Validate Patient job, he or she 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.
Set to N, TMS-related Procedures are not executed at all during site and patient validation. However they are included, as always, in Batch Validation.
There are two configuration and generation procedures you perform at this stage of implementation.
DVGs provide a set of named values for a Question. You associate DVGs to Questions in the DCM Questions window (from the Definition menu, select DCMs, choose DCMs, click the DCM Question Groups button, and then the DCM Questions button). Depending on how you define certain DVG attributes, the values for the DVGs display as single boxes, sets of boxes, or—during RDC Onsite data entry—as single box pull-down lists. Navigate to Glib, then Discrete Value Grps, and then Discrete Value Groups. Select the DVG in the Discrete Value Groups window and attend to the fields in the fifth row of the form. For more information, see "Layout Options".
The DCI Modules window has DCI Forms settings. To maintain the controls, navigate to Definition, then DCIs, choose DCIs, select the DCI, and click the DCI Modules button. On the far side of the sliding canvas, there is a group of settings that fall under the title, DCM Header Generation. See "Adding DCMs to DCIs"
A DCM Graphic Layout is a definition that describes the location of static labels, masks, and graphics, and prompts and fields that make up a DCM. The definition is editable in the DCM Graphic Editor. DCM Graphic Layouts comprise the data entry section of a DCI Graphic Layout.
This section describes enabling and generating DCM Graphic Layouts from your DCM definitions to use in DCI Forms at the study level. See "Defining DCMs" for information about maintaining DCMs.
The Default Layout Generator creates a file that describes the DCM's Questions in the DCM and their locations within the confines of its associated Form Layout Template values. You cannot generate a default layout if there are no Questions in a DCM or from a retired DCM.
The Default Generator lays the DCM's Questions out left to right, top to bottom, adding more blocks as necessary. No text or field may span a block boundary. Each Question Group starts on a new line. The blocks are numbered consecutively in descending order from the top.
You invoke the graphic Default Layout Generator from the Special menu, by selecting Graphic Layout. These are your choices:
Choose this menu option to generate a new default layout. If you have already edited a layout, the generator returns a message so that you know. If you continue, the generator creates a new default version of the layout that does not include your manual changes. However, the system does not overwrite your previous layouts. They still exist as earlier layout versions, and you can still use them.
In the DCM window, from the Special menu, select Graphic Layout, then choose Generate Default from Scratch. The Attributes for DCM Layout Generation dialog box opens, displaying default values. You can accept the defaults.
The Form Layout Template value sets the dimensions of your DCM's work area. (For the starter portrait templates, a P stands for Portrait, L for Landscape orientation.) The Block Width, Standard/Max Allowed Height and First Block Height are adjustable within the confines of the template. They determine the areas of the Questions in the DCM. The Checkbox Shape and Checkbox Size fields control the display of DVG boxes.
Click the Generate button.
You can now perform several operations:
You can edit your DCM Layout: From the Special menu, select Graphic Layout, then choose Edit. See "Editing DCM Graphic Layouts" for DCM-specific editing instructions.
You can generate a preview of the layout: Select Action, then Print Preview.
If you have enabled automatic PDF Annotations and have full Adobe Acrobat installed with the Oracle Clinical Acrobat plug-in, you can generate the annotations: Select Action, then Print Annotated CRF. The Print Preview window opens where you can click the Annotated CRF button to open the Annotation window. See Chapter 12, "Annotating CRFs" for more information about setting the values in this window.
Note:
Under some circumstances when creating more than one annotated CRF in a session, the browser incorrectly displays the annotations from a previous layout. You can tell if it is a "stale" version because when you select Annotate, the CRF is already populated with annotations. If your DCI Form has the wrong annotations, stop the Acrobat.exe process from the Windows Task Manager's Processes tab and regenerate the layout.If you laid out this DCM in the character-based layout system, you can migrate it to the graphic system by choosing Special, and then the Graphic Layout menu option. The system has algorithms to translate a character-based DCM Layout definition to a graphic-based system definition.
If you have updated one or more DVGs or DVG subsets used by Questions in a DCI DCM, you can update an existing DCI Layout to reflect the changes without generating another default layout. Run the Update from DVG Definition utility from the DCMs window: From the Special menu, select Graphic Layout, then Update from DVG Definition. The utility propagates changes to the following properties:
Active Values
Display Type Code
Checked Flag Value
Note:
The utility does not propagate any changes related to check box layout. To propagate changes to check box properties, you must generate a new default layout.From the Special menu, select Graphic Layout, then choose Edit to edit the Graphic Layout for the selected DCM. For complete instructions about editing graphic DCM Layouts, see "Editing DCM Graphic Layouts".
Navigate to Definition, then DCMs, choose DCMs, select your study, and then choose the Graphic Layout tab. Find the DCM and, if necessary, its Subset and Layout. This window displays related information about the state of a DCM, including:
Available? Before you can generate a DCI Graphic Layout that uses a DCM Layout, you must generate the DCM Layout and select the Available? box for the DCM. You cannot select this box if the DCM requires editing, verification, or if there are pending post-edit updates.
Edited? A check mark here indicates that a Graphic Layout has already been generated and that layout work has already been saved. This is a read-only field.
Needs Editing/Verification? A check mark here indicates that either the layout is invalid or there have been post-edit updates to the data definitions. To test a layout's validity, from the Layout Editor, select File, then choose Validate; see "Validating Layouts".
Post Edit Updates? A check mark here indicates that there have been changes to the DCM's data definition that impact the DCM Layout. The system selects this field if you add a Question, change whether a Question is collected or displayed, remove a Question, or change the number of repeats for a Question. If selected, you must review and save the layout from the Layout Editor. This is a read-only field.
When definitional updates are made that impact layouts, Oracle Clinical sets the flags as follows:
The DCM layout is selected for Needs Edit /Verification.
The DCM is not selected as Available.
Affected DCI layouts are selected as Needs Regeneration.
Data entry continues to make use of the DCM/DCI layouts in the existing, active form version. The newly edited layouts do not go into use in data entry until a new form version is generated; see "Maintaining Form Layout Versions".
When you edit the layout to synchronize it with the definitions and successfully validate and save the layout, the system sets the flags as follows:
The Needs Edit / Verification settings for the DCM layout is not selected.
The Edited setting for the DCM layout is selected.
The Available setting for the affected DCM layout remains unselected. (You must manually set this value). The setting cannot be selected if the Needs Edit /Verification is selected.
The Needs Regeneration? setting for the DCI layout remains selected.
A DCI Graphic Layout is a graphic description of a DCI used for input in generating an HTML data entry form and PDF template for the Patient Data Report and Blank Casebook Report. This section describes how to generate and edit a DCI Graphic Layout. The Maintain DCIs window has all of the tools to create initial DCI Graphic Layouts. You can also work from the Provisional window. To open Maintain DCIs, navigate to Definition, DCIs, and DCIs. See "Defining DCIs" for information about maintaining DCIs.
The Maintain DCIs window and the DCI Modules window display the status values for a DCI's Graphic Layouts. This section describes these displays.
The Maintain DCIs window has three tabs: General, Page Tracking, and DCI Layout. The parameters related to DCI Forms are on the DCI Layout tab. On this tab, you can view a summary of the status of the layouts for the DCI Form version record. You cannot change the values here. These are the values on the DCI Layout tab:
Active Layout Version # The version number of the active layout. If the field is empty, the DCI has no active layout. This field is read-only.
# of Retired Layouts Displays the current number of retired versions of the layout for this DCI
PDR Page Definition Page Definition of the Provisional Layout the generator uses when it creates a Patient Data Report. The field is empty if there is no Provisional Layout.
DCI Form Page Definition Page Definition to be used when DCI Form is generated
Prov. Layout Version # Version number of the Provisional Layout. The field is empty if there is no Provisional Layout.
Needs Regeneration? There is a check mark in this field if the DCI Form Layout must be generated or regenerated. This is set if the DCI Module definition has changed since the last DCI Form Layout was generated, or if there have been definitional changes to its DCM definitions.
Needs Edit? There is a (Y) in this field if you have to edit the provisional form layout before you can generate a DCI Form. Post-edit updates can also set this flag.
Post-Edit Layout Updates? If there have been any changes to the data definitions that comprise a DCI since the last edit, the system sets this value to Y. Conversely, if there have been no changes, this value is blank.
Prov DCI Form Generated? If a DCI Form corresponding to the Provisional Layout has been generated, the system sets this value to Y.
To generate a default Provisional DCI Graphic Layout, follow these instructions
Navigate to Definition, DCIs, then Provisional DCIs. Choose a study that is enabled for DCI Forms. (See "Enabling DCI Forms".)
Select a DCI that has DCMs that are available for DCI Forms. (Set the DCMs' Available? box on the Graphic Layout tab of the Maintain DCMs window.)
From the Special menu, select DCI Layout, then choose Generate Provisional Layout. The Attributes for DCI Graphic Layout Generation dialog box opens. Here are the parameters you can modify:
Unit of Measurement: You cannot change to another measure here. (You set Unit of Measurement for the local database. Navigate to Admin, and DCI Form Local Database Settings. See the Oracle Clinical Administrator's Guide.)
You can choose another template. The list only displays templates that can accommodate the largest DCM block size in the DCI.
The PDR Page Definition is the page size for printouts of the DCI Form's Patient Data Report and viewing and printing the layout. The list of values displays the definition's name, height, width, and binding offset. The list excludes definitions where either height or width are smaller than the associated Form Layout Template's height or width dimensions, or if the binding offset would cause the form layout template to touch or overlap the edge of the Page Definition. You can change the value of the PDR Page Definition after the DCI Form is generated if necessary. See "Setting Binding Offsets".
The DCI Form Page Definition for Page Definitions for DCI Forms. The list only includes definitions where both height and width are at least two points larger than the Form Layout Template's height and width.
The Checkbox Shape determines the shape for all boxes generated. You can change this value for all the DVG Questions in the group.
Checkbox Size: You can choose from a list of values. (You specify the list of values by populating reference codelist DCIF CHECKBOX SIZE.) You can change the size of individual boxes in the layout editor, but not the shape.
Click the Generate button. The system creates or overwrites the Provisional Layout for the DCI.
When you have a default DCI Graphic Layout, you can generate the DCI Form that will be used for RDC data entry and for the generation of Patient Data Reports. (If you want to edit the layout first, navigate to Special, Graphic Layout, and Edit Graphic Layout. See "Editing Layouts" for general editing instructions, or "Editing DCI Graphic Layouts" for DCI-specific editing instructions.) The DCI must be provisional and its DCI Graphic Layout must be valid before you can create a DCI Form.
DCI Forms are stored in the database in two formats: one in HTML to be used for data entry in RDC Onsite and another in PDF to be used for generating the Patient Data Report and Blank Casebook Report. DCI Form refers to both representations.
To generate a DCI Form:
From the Maintain Provisional DCIs window, select the DCI. Navigate to Special, DCI Layout, and Generate Provisional DCI Form.
The system prompts you for a Reports Server. If you have difficulty connecting, compare your error message to the topic descriptions in the "Troubleshooting Graphic Layout Problems".
Click Generate. The DCI Form Generator, which resides on the Reports Server, transforms the DCI definition into both an HTML and a PDF-readable definition. The system creates a new version of the DCI Form.
Note:
Each CRF page must fit on a printed page or you will not be able to see all the data in the Patient Data Report. The system converts the layout separately for the PDF reports and HTML data entry. There are likely to be small differences in pixel counts. When you create a layout, test both uses.You can generate formatted Patient Data Reports of received data from both Oracle Clinical and RDC. From Oracle Clinical, navigate to Conduct, Conduct Reports, Data Validation, then Graphic Patient Data Report. The Blank Casebook Report can be generated only from RDC Onsite or the command line. Parameters allow you to customize the output. For information about the parameters, see the Oracle Clinical Remote Data Capture Onsite User's Guide .
Oracle Clinical stores your DCI Graphic Layouts and their associated DCI Form records, if any, as DCI Form Layout Versions (FLVs). You can have multiple FLVs for a DCI. You set their status in the Maintain DCI Form Versions window. The window displays the details and history of all DCI Graphic Layouts and associated DCI Form generations for a selected DCI. To access the Maintain Form Versions window, navigate to Definition, DCIs, and DCIs. Select a DCI and click the DCI Form Versions button.
You can have multiple versions of DCI Graphic Layouts and if their associated DCI Forms. You create new versions when you want to change the layout of a DCI Form that has already been replicated or used to collect production data. This is useful when a protocol amendment requires you to add or delete Questions. You can also make use of this capability to change to otherwise refine the layout, including changing the header and footer.
The DCI Forms Versions window is inactive if any of these criteria are true:
The selected DCI Layout has the status Retired
If you are in Locate DCI mode
If you are in Query-only mode
If DCI Form definition is not enabled for the study. (If the DCI Form Definition Enabled? box is not selected. See "Configuring Local Studies".)
These rules apply when changing the status of a form layout version:
You can change the status to Active if the DCI is Active and the DCI Form has been generated for the Provisional FLV.
You can change the status to Provisional only if there is no production data entered against the FLV, none of the other versions have the status Provisional, and the study has been replicated by design or by disconnected replication (not applicable for GLIB DCIs), and the FLV is not retired.
You can change the status to Retired only if production data has been collected using this FLV or the study definition has been replicated via regular or disconnected replication (excluding for Global Library Level DCIs for the last condition).
If you change an Active version to Provisional or Retired, a warning dialog box stating, "Warning: You need an active version for deriving the current version in RDC and Form Version Migration. Continue? [Yes] [No]." If you select No, the system changes the status back to the previous status.
If you change a Retired or Provisional FLV to Active and an Active FLV exists and the above conditions do not prevent you from doing so, a dialog box states, "Changing status to Active will retire existing active form layout version. [OK] [Cancel]." If you choose OK, the system retires the Active version, and activates the current version. Otherwise no action is taken.
This window maintains DCI Layout and DCI Form versions. For a Provisional DCI Layout, you can change DCI Layout Status, Description, Page Definitions for Printing, and DCI Form Generation. From this window you can perform all of the DCI Form activities that you can perform from the DCI window, including to generate DCI Layouts, edit or browse DCI Layouts, generate DCI Provisional Forms, and delete Provisional and Active layouts. In addition, you can copy from an existing DCI Form version record to create a new DCI Form version, you can change the PDR Page Definition, and you can specify a description for a DCI Form version. There are rules that govern these activities. The system prevents you from violating the rules. The following section describes these rules.
A DCI Form version can have one of three statuses: P (Provisional); A (Active); or R (Retired). Across all of a DCI's versions, here are the rules about status assignment:
Only one DCI Form version can have the Provisional status.
Only one version can be Active.
There can be any number of retired versions.
You can only edit the version you can update.
If the DCI is Active, you can change the form version status to Active.
Each time you generate a DCI Form, the system creates a new version and gives it the next available number.
The system chooses the PDR Page Definition when you print the PDR Report or blank CRFs. When a PDR is printed, the individual Received DCIs are printed using the Page Definition defined for the DCI Form version associated with that RDCI. The current form version is associated with the RDCI at the time of data collection and can be changed by migrating data. Migrating data is covered in the next section.
You can control the migration of patients to a specific DCI Form version of a DCI by assigning the patients to DCI Books. The DCI Books specify the preferred version for its DCIs through the DCI Book Constraints window. (For more information on version constraints and setting preferred versions, see "Defining DCI Book Constraints". You control the migration by assigning only the patients you want to migrate to a modified book. The preferred version of the DCI Book also controls the version of the form to be used for data entry in a new CRF. See "Running Form Version Migration" for instructions on executing the migration.
A DCI's preferred version setting in its DCI Book constraints specifies the target version for the migration. By assigning only specific patients to the DCI Book that is being migrated, you can control what patients are migrated to what version. It is possible to set up different DCI Books to point to different versions so that some patients are migrated to one version while other patients assigned to a different DCI Book are migrated to different versions. This is particularly useful for controlling migration on a site-by-site basis.
Migration and assignment of a DCI Book to a patient must occur at the location that owns the patient. However, the generation and creation of DCI Form versions, creating DCI Books, and defining DCI Book constraints occurs at the study owning location. Version migration is a cooperative effort between sponsor and site.
There are two ways to assign a patient to a DCI Book:
You can automatically assign patients to a DCI Book when data is entered using a DCI Book, depending on how the BOOK_USAGE and the OCL_STATE reference codelists are configured.
Patients can be initially assigned or changed to a book through the Maintain Patient Positions window.
Depending on the study migration settings, all or some of the received data assigned to the DCI Book migrates, even though the data was entered against other DCI Books.
The following are examples of some of the possibilities available with version migration.
Example 11-1 Migrating Classic-Mode Received Data for All Patients
A study has a DCI Form version for a DCI named EXERCISE with Active status. You want to be able to update, browse, and/or report study data using DCI Forms. Here is EXERCISE DCI's history:
Before its DCI Form was created, EXERCISE was assigned to a classic-mode DCI Book.
Data continues to be collected using both RDC Classic and RDC Onsite data entry.
None of the patients are assigned to a DCI Book.
The DCI Form version and related definition data has been replicated to all locations.
To enable viewing EXERCISE DCI data in RDC Onsite, perform these steps at each site:
From the Design menu, select DCI Form Local Study Settings, and set the Allow Migration of Classic RDCIs? field for the study to Y.
Assign the patients for that location to a DCI Book that includes the DCI EXERCISE. You can assign all patients to the same DCI Book or to different DCI Books, as long as the DCI Book contains the DCI EXERCISE. If a DCI Book contains additional DCIs that you do not want migrated, create a DCI Book without those DCIs and assign the patient(s) to that DCI Book. If there are multiple versions of the DCI Form version, make sure that the preferred version on the DCI Book constraint window points to the desired version.
Run the Migrate utility for each DCI Book that includes the EXERCISE DCI and is assigned to a patient. (See "Running Form Version Migration".) This action migrates all of the classic and graphic received data (for the classic entered and non-classic entered data) for all patients assigned to the specified DCI Book.
Schedule to run the Migrate utility on a continuing basis to migrate any data that is entered through Classic mode.
Example 11-2 Adding a Question to a DCI Form and Selectively Rolling Out the Change
You decide to add a Question named PREGNANCY to a DCM named AE and remove Question SMOKING. The AE DCM is used in several DCIs and DCI Books. There is already RDC received data entered via DCI Forms. No patients are assigned to a DCI Book. You want to roll this out for new entry to all locations, but you want to migrate existing data only at the current location. Because data has already been collected, you need to create a new DCI Form version. Here are the steps:
From the DCMs window, navigate to the DCM Questions window.
Mark the SMOKING Question as not collected in subset.
Add the PREGNANCY Question to the DCM.
Edit the Graphic Layout to include the new Question to the DCM.
Edit the Graphic Layout to include the PREGNANCY Question. If also doing Classic data entry, modify the character layout.Set Available to Y on the Graphic Layout tab.
For each DCI that uses the DCM where you want to incorporate Question PREGNANCY, if you want to incorporate the new Question:
If no Provisional Form Version exists, either (1) generate a new Provisional Form layout or (2) copy an existing form version to serve as a basis for the new Provisional Form Version.
Edit the existing Provisional Form layout or the one created by the previous step. This will automatically incorporate the new Question.
Verify you want to use the new layout.
Generate the DCI Form version.
Make the DCI Form version active. No changes should be needed for the DCI Book Constraints: by default, the preferred version for the DCI Book Constraint is CURRENT.
Replicate the definition to each location. The system collects new data using the new DCI Form version.
At the current location, assign the patients for that location to a DCI Book that includes the relevant DCI. There must be a DCI Book Constraint record for the DCI. If it is an unplanned DCI, Unplanned Use Allowed must be checked.
Migrate data for the specified DCI Book. (See "Running Form Version Migration".)
Example 11-3 Changing a Header
You decide to add a logo, include Investigator, and reposition existing fields in the header of an existing DCI Form for which there is received data. All patients are assigned to the same DCI Book that includes the DCI. A DCI Book constraint specifies the CURRENT version for the DCI. All data has been collected through a DCI Form.
To create a new DCI Form version and migrate the data:
Modify or create a Form Layout Template to incorporate the changes.
Generate a new Provisional Form Layout Version for the DCI. If you created a new Form Layout Template, specify the new Form Layout Template.
Generate the DCI Form version.
At each location, replicate the new definition and migrate the data based on that DCI Book. (See "Running Form Version Migration".)
The Form Version Migration window has controls to retain or reverse approvals or verifications for CRFs that are being migrated to a new form version. Before the patch, form version migration reversed all approvals and verifications. With the new controls on the Form Version Migration window, you can indicate whether a form version migration warrants either re-approving or re-verifying, the affected CRFs.
You can also set default settings at the database and study levels.
There are two reference codelists that provide the set of possible Reasons for retaining or reversing approvals and verifications. APPROVE VERIFY RETAIN CODE populates a list of reasons for retaining a book's approvals and verifications, and APPROVE VERIFY REVERSE CODE populates a list of reasons for reversing a book's approvals and verifications.
You can provide a single, generic reason for each codelist, as described in the following section. Or, you can use these codelists to characterize the types of form changes that do and do not require reversal of verifications and approvals. For example, perhaps a new label for a field requires re-approval, but the addition of a field does not.
In the Form Version Migration window, if the user applies the same action (Retain or Reverse), to both Verifications and Approvals, then Oracle Clinical populates the same reason to both Verifications and Approvals. The user can change either reason.
To modify the list of reasons for retaining a book's approvals and verifications:
In Oracle Clinical, select Admin, then Installation Codelists.
Query APPROVE VERIFY RETAIN CODE in the Name field. The upgrade includes one entry:
Short Name: DFLT_RETAIN_R You cannot change this value.
Long Value: The default text is: (Sample) Form update does not warrant reversal.You can change this text.
Description: You can add a description in this field.
Add more entries. Both the Short and Long values appear in the list of values displayed in the Form Version Migration window.
To modify the list of reasons for reversing a book's approvals and verifications:
Query APPROVE VERIFY REVERSE CODE in the Name field. The upgrade includes one entry:
Short Name: DFLT_REVERSE_R You cannot change this value.
Long Value: The default text is: (Sample) Form update requires reversal.You can change this text.
Description: You can add a description in this field.
Add more entries. Both the Short and Long values appear in the list of values displayed in the Form Version Migration window.
This section describes configuring approval and verification retention options at the database and study level.
Configuring Default Settings at the Database Level
If you have Superuser or Administrator privileges, you can set the default Retention or Reversal policy for approvals and verifications at the database level:
In Oracle Clinical, select Admin, then DCI Form Local Database Settings. Then click on the Version Migration plus symbol. The Version Migration category includes the following new settings:
Default reason to retain approval/verification Choose an entry from the list of values. The list of values draws from the APPROVE VERIFY RETAIN CODE reference codelist.
Default reason to reverse approval/verification Choose an entry from the list of values. The list of values draws from the APPROVE VERIFY REVERSE CODE reference codelist.
Default setting for Reverse Approval Status Select Y or N.
Default setting for Reverse Verification Status Select Y or N.
Last Migrateable Entry Status Choose the data entry mode from the list of values Choose a data entry status from the list of values.
User Override to Reverse Approvals? Select Y or N. If you choose Y, the user executing the form version migration can change the default reversal or retention policy for approvals.
User Override to Reverse Verifications? Select Y or N. If you choose Y, the user executing the form version migration can change the default reversal or retention policy for verifications.
Save.
Configuring Approval and Verification Settings at the Study Level
You can enable or disable approvals and verifications at the study level:
In Oracle Clinical, select Design, then DCI Form Local Study Settings. Then click on the Version Migration plus symbol. The Version Migration category includes the following new settings:
Default reason to reverse approval/verification Choose an entry from the list of values. The list of values draws from the APPROVE VERIFY REVERSE CODE reference codelist.
Default reason to reverse approval/verification Choose an entry from the list of values. The list of values draws from the APPROVE VERIFY REVERSE CODE reference codelists.
Default setting for Reverse Approval Select Y or N.
Default setting for Reverse Verification Status Select Y or N.
Last Migrateable Entry Status Choose the data entry mode from the list of values Choose a data entry status from the list of values.
User Override to Reverse Approvals? Select Y or N.
User Override to Reverse Verifications? Select Y or N.
Save.
In Form Version Migration window you can retain or reverse Approvals and Verifications in the existing DCI book response data.
Migration occurs for all patients assigned to the selected DCI Book.
Migration occurs for all patients assigned to the selected DCI Book, and all CRFs entered using a DCI where the (new) form version is later than the version used for the initial data entry.
The following graphic shows the new controls for verifications and approvals in the Form Version Migration window:
To run a form version migration:
In Oracle Clinical, select Definition, then DCIs, and finally, Migrate Form Version by Book. The Migrate Forms Version by Book window opens.
If necessary, you can change the study by clicking the Change Study button.
Select the DCI Book from the DCI Book Name list of values.
If available, choose to retain or reverse Approvals in the DCI Book, and choose a reason from the list of values. If you cannot override the default settings, you are prevented at the database or study levels.
If available, choose to retain or reverse Verifications in the DCI Book, and choose a reason from the list of values. If you cannot override the default settings, you are prevented at the database or study levels.
Note:
If you choose to retain both Approvals and Verifications, upon choosing a reason in either field, Oracle Clinical automatically chooses the same reason in the other field. You can change the reason to another choice, if necessary. The same happens for reversals: If you choose to reverse both Approvals and Verifications, upon choosing a reason in either field, Oracle Clinical automatically chooses the same reason in the other Reason field. You can change the reason to another choice, if necessary. If you choose to retain Approvals but reverse Verifications, or vice versa, then you must choose a reason for both approvals and verifications.Select Test Run to perform a test run of the migration. Oracle Clinical returns the number of RDCIs eligible for migration. It does not commit the form migration to the database. To execute the Form Version Migration, unselect Test Run.
Click Submit Job to queue the migration job.
You can click the Job Status button to check on the job's progress.
DCI and DCM Graphic Layouts inherit their shape from its DCI Form Layout Template. It defines the work area, which is the area between the header and footer, and the size of the header and footer when previewing the layout or when generating the DCI Form. This area is used for the DCM and response related fields when generating the DCM and DCI Layouts. The contents of this area can be edited in the DCM or DCI Layout Editor.
You maintain DCI Form Layout Templates at the Global Library level. You can generate different definitions of your templates to accommodate different page sizes and orientations. From the Glib menu, select Form Layout Templates, and choose Maintain Form Layout Templates. (For provisional work, navigate to Maintain Prov Form Layout Templates.) The Form Layout Template window has two tabs: The Form Layout Templates tab displays the values for one template; the Multi Form Layout Templates tab displays a scrolling list of all available templates.
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Note: When you edit a Form Layout Template, the changes do not cascade to existing DCM Layouts, DCI Layouts, or DCI Forms. |
The status controls the availability of the Form Layout Template. Set to A (Active) if you are ready to use. You cannot edit the layouts of active Form Layout Templates. To edit an active Form Layout Template, change the status to P, edit the layout, then change it back to A. Set the status to R (Retired) if you don't want the layout to be available for use and you don't want to allow editing of the layout.
Oracle Clinical 4.6 includes four starter templates:
OC_A4_L: Suitable for positioning on the ISO A4, Landscape (horizontal orientation) Page Definition
OC_A4_P: Suitable for positioning on ISO A4 Portrait (vertical orientation) Page Definition
OC_USL_P: Suitable for positioning on standard US Letter (8 1/2 x 11 in.) Portrait Page Definition
OC_USL_L: Suitable for positioning on US Letter Landscape Page Definition
You cannot modify any of the starter templates. You have to make copies of them. To begin making your own templates, select a starter template that most closely resembles your needs and copy it.
To copy a template follow these instructions:
From the Glib menu, select Form Layout Templates, then click Maintain Form Layout Templates or Maintain Prov Form Layout Templates.
Select an existing template to be the basis of your new template.
From the Special menu, select Copy Form Layout Template. A dialog box titled Copy Form Layout Templates opens.
Choose a template from the list of values in the Copy from Template field. In this section, the template you choose here is called the parent template.
Name your new template in the Copy to Template field.
Click the OK button to create the copy.
You can then adjust how the default generator arranges and sizes different parts of the DCI in your template. The next section describes these tasks.
Unlike DCM and DCI Graphic Layouts, you cannot save an invalid Form Layout Template. Oracle Clinical separates the saving process from the validation process for layouts so that you can work on them over more than one session. Check the Form Layout Template's validity by selecting File, then Validate. If you receive any errors, the error message box includes descriptions of them. Correct the errors and try validating the template again.
The three types of layouts, DCM, DCI, and the Form Layout Template, have their own editors. However, all three editors use many of the same layout tools. This section describes these tools.
This section describes the Graphic Layout Editor interface. Figure 11-3, "Graphic Layout Editor Interface" is the screenshot of a DCI Layout session. The interface is identical for the other Graphic Layout editors. It has a column of numbers along the left border. The following list describes the areas of the layout editor adjacent to the numbers.
Figure 11-3 Graphic Layout Editor Interface
The topmost bar is the Windows title bar. In a layout session, the title bar displays the name of the layout.
Row two is the main menu.
The third row is the main toolbar. It includes these icons:
Save: Click the floppy disk icon to save your latest work.
Exit: Click the doorway icon to close your session. The editor prompts you if there is unsaved work.
Selector: Click the arrow icon to turn your mouse pointer into an object selector.
Create Label: Click the T icon to create a free form text label.
Rectangle: Click the rectangle icon to create a rectangle.
Rounded Rectangle: Click the rounded rectangle icon to create a rectangle with rounded corners.
Horizontal Line: Click the straight horizontal line icon to create a horizontal line.
Vertical Line: Click the straight vertical line icon to create a vertical line.
Free Form Line: Click the diagonal line icon to create line at any angle.
Insert Image: You can import a graphic image into your layout. The graphic must be a .gif or .jpeg file. You store graphics for this purpose in a location you specify on the Application Server's registry variable RDC_DCIF_IMAGES, which is set during installation. Click the Insert Image icon in the toolbar. A dialog box opens. You can either enter a graphic file name or click the Browse button to see a list of graphic files in the images directory and select a file, then click OK.
Note:
If the registry variable RDC_DCIF_IMAGES_VALIDATE is set to Y, you must have access to the network location for the directory specified in the RDC_DCIF_IMAGES variable and you must select a file from that directory. In addition, the network location must be inside the firewall.Zoom: Adjust the size of the layout on your screen by dropping down the Zoom button and selecting a magnification value.
Arrange: There are six icons for arranging or aligning multiply selected objects.
Row four is the font formatting toolbar. (See "Formatting Label and Prompt Text".)
Row five is the ruler. You can change it to centimeters, inches, or points. The ruler marks the position of the mouse pointer with a pale line. In this screen shot, you can see lines on the ruler at about five horizontal inches by two vertical inches.
Workspace. The appearance of the workspace depends on your template configuration. Note the vertical line five inches from the left side of the workspace. This represents the defined right margin of this DCI Layout.
Status bar: The status bar is divided into cells. The cells display geometric information:
The third cell from the left displays the coordinates of the upper-left corner of the selected object.
The fourth cell displays the dimensions of a selected object.
The fifth cell displays the coordinates of the mouse pointer, including the current block or page number. If the mouse pointer is outside the borders of the template, the block or page number displays as x.
You can change a template's unit of measure to inches, centimeters, or points. To change the unit of measure, select the View menu option Unit of Measurement. There are 72 points in an inch. There are 25.4 points in a centimeter. You set the unit of measurement each time you open the layout, or you can change the unit of measure permanently in the Maintain DCI Form Settings window. (From the Admin menu, select DCI Form Settings window.)
The editor includes an option to display a superimposed grid of geometrically arranged dots over the workspace. The grid can simplify positioning objects. You display and set the grid's properties from the View menu. To turn the grid display on, select the Show Grid box in the View menu.
You can set the editor to align an object to the grid when you move it with a mouse drag operation. To enable this feature, select the Snap to Grid box in the View menu.
You can change the distance between the points on the grid. Select the View menu option Set Grid Size. A dialog box opens with entries for changing the grid height and grid width. Note that the values do not have to be the same value, so you can create a rectangularly-spaced grid. This might be useful if you are laying out lines of regularly-sized text or rows of Questions.
This section describes the types of objects in a layout. Layout objects include any item in the layout, including lines, prompts, checkboxes, Questions, boxes, and graphic images.
Note:
A DCI Form, which is the generated version of a complete layout, can contain up to 2000 objects. If you exceed this number, the generation of the DCI Form Version may fail. If your layout approaches 25 pages or about 4 MB, you are approaching this limit.A layout inherits the data collection objects, or input objects, from its DCMs, DCIs, or layout templates. When you open a default layout, it contains only input objects, arranged according to the data definitions and the Default Generator's layout algorithms. An input object has these three parts:
Field: A field is the response area for collecting data. It is the expression of a login or Question field. It has no visual expression. When you print out a blank CRF, the field is invisible. When you print out a PDR, the data is printed at the location of the field. In RDC Onsite, you enter data in the field.
Mask: The mask is the visualization object that indicates the location and shape of a field on paper or the screen.
Prompt: The prompt is text that identifies the input object.
When you move the mask, the prompt and the field automatically follow. But you can select and modify them individually. The field can be difficult to select independently because it occupies the same territory as its mask. Changing the mask to a line or reducing its size can simplify selecting its field.
You can add objects that are not associated with any input objects. These can be graphics, labels, or geometric shapes.
Flex fields are read-only fields that you can add to the headers and footers of a Form Layout Template. You customize flex fields to display values. The system determines the value of a flex field at run time by a flex field function that you customize. See "Customizing Flex Fields" in the Oracle Clinical Administrator's Guide for instructions on customizing and enabling flex fields.
To insert a flex field, select the Insert menu and then choose Insert Flex Field. A dialog box opens displaying any available flex fields. (The dialog box limits you to ten available flex fields.) Check one or more flex fields and click Ok. The Form Layout Template editor inserts the selected flex fields into the non-display section of the header and footer. You can then drag and drop a flex field into the header or footer areas of the Form Layout Template. The Insert Flex Field operation has the following characteristics:
To remove a flex field once it is part of the layout, drag and drop it into the non-display section.
Once you add a flex field to a Form Layout Template, you cannot un-check it.
You can edit the flex field object's label text in the layout.
There are four ways to select objects. Selected objects display pull handles, which are small black squares at the corners and midpoints of the object's boundaries.
To select one response field, field label, or text object: with the selection tool, click inside the borders of the object. For a box object, either position the point of the selector over the border of the box and left-click, or position the cursor inside the box and click-drag in a diagonal direction.
To select all the objects in an area of the layout: Click-drag the selector in a diagonal direction across the area.
You can Control-click to select or deselect objects regardless of their geographic location in the layout. If you are Control-clicking a box, note that you must position the mouse pointer of the selector tool directly over its border.
If your installation enables spell checking, you can check the spelling of words in text objects in the body of a layout. See the Oracle Clinical Installation Guide for instructions to enable this option.
Note:
Spell check works for any English values if they are represented as single-byte text instead of multi-byte text.
You can check the spelling of one selected text object. Select the object, then navigate to Edit and choose either the Spell Check Current or the Find Next Misspelling option. The following sections describe these two options.
Choose the Spell Check Current menu option to check the spelling of a selected field. If there is a word that is not in the spell checker's dictionary, (an unrecognized word), a dialog box opens allowing you to choose from the following options:
The Replace With field allows you to choose a near match from the Suggestions list.
You can choose to ignore the item.
You can add a new spelling to the dictionary by clicking the Learn button.
You can choose to Replace All of the same occurrences of the word in the layout to the value in the Replace With field.
The Spell Check Current operation has the following characteristics:
When the spell checker finds no unrecognized words in the selected text object, the checker returns the message "No Error".
If you did not select a word when you invoked this menu option, you receive an error message.
If you have selected more than one object of any type, you receive an error message.
The option checks all of the words in the object.
When you act upon an unrecognized word, the checker looks for other words that are not in the dictionary. When there are no other unrecognized words, the checker returns the message, "No Error".
When there are no more unrecognized words, the dialog box closes automatically. The spell checker does not look for misspellings in the next text object; it only acts on the selected text object.
You can check for unrecognized words continuing from your selected position. Navigate to Edit, then choose Find Next Misspelling. This operation processes each text object in turn, starting with the nearest text object after the current selected text object. The Find Next Misspelling operation has these characteristics:
The operation searches for unrecognized words in text objects starting from the currently selected object and proceeding left to right down the layout.
If you have selected more than one object, the operation starts checking from the upper-most, left-most object in the selection.
If the operation finds an unrecognized word in an off-screen text object, it scrolls the layout to display the object.
If the operation finds an unrecognized word in an off-screen text object, it scrolls the layout to display the unrecognized word.
If there are no unrecognized words in the text objects after the selected object to the end of the layout, the operation starts searching for words in text objects with unrecognized words at the beginning of the layout.
When there are no unrecognized words in the entire layout, then the checker returns the message "No error."
If the operation finds a text object with an unrecognized word, it behaves in the same manner described in the "About the Spell Check Current Option".
This section describes the several methods for positioning objects. You can use them in conjunction with the Snap to Grid option for positioning objects to specified increments. (See "Setting Grid Options".)
Note on Extended Text Question Display:
RDC Onsite automatically displays a yellow icon to the right of each Extended Text Question response field. This icon is not displayed in the Graphic Layout Editor. Be sure to leave space for it (approximately 15 points) so the icon does not overlap adjacent fields.RDC Onsite displays only part of Extended Text Question responses in the CRF. It displays the number of characters defined as the Question length, minus 24. If additional characters have been entered, it also displays an ellipsis (...). (The 24 characters are reserved for the extended text prefix, even though the prefix is not displayed in RDC Onsite.) The full text—up to 10,000 characters—is displayed only in a pop-up window that you do not need to design in the Graphic Layout Editor.
Note that the icon is also not visible in Print Preview from the Graphic Layout Editor.
You can move an individual object or a group of selected objects with the mouse. For a rectangle object, place the tip of the mouse pointer on the perimeter of the rectangle. (Try to avoid the midpoints and corners, which are the locations of the grab handles.) Click and hold while you drag the rectangle to a new position. For any other type of object, place the tip of the mouse pointer within the object's perimeter, then click and hold while you drag the object to another position. To move multiple selected objects, click and hold on any one of the selected objects, then drag. The editor moves all selected objects.
You can move one or more selected objects with the keyboard arrows. This approach can allow more precise positioning than you can achieve with the mouse.
You can specify an object's coordinates in the Properties dialog box. Select Edit, then Properties. This approach does not rely on a mouse's graphic resolution limitations, so you can arrange objects to within 0.1 point (or 0.001 centimeter, or 0.001 inch). You can position individual or grouped objects. Note that if you enter any value that violates the general layout parameters, the box closes but makes none of your changes.
The coordinates are the position of the upper-left corner of the object's boundary. The X Position value indicates the left edge of the object's distance from the left side of the block. The Y Position value indicates the object's distance from the top of block (not the top of the template).
The Graphic Layout Editor has six tools for systematically aligning groups of selected objects by the objects' axes or borders. You invoke the tools either from the Arrange menu or from toolbar icons. Position the mouse pointer over a toolbar icon to read a description of how it aligns selected objects.
Oracle Clinical has two Arrange menu options for distributing selected objects:
Distribute Horizontally: This menu option redistributes all selected objects so that the amount of horizontal space between each object is the same. The left-most and right-most objects retain their positions and the spaces between the intervening objects are equal.
Distribute Vertically: This menu option redistributes all selected objects so that the amount of vertical space between each object is the same. The top-most and bottom-most objects retain their positions and the spaces between the intervening objects are equal.
These distribution options work differently according to which of a field's objects you select:
If you select a field's visualization object, the distribution options treat all of that field's objects (prompt, input object, and visualization object), as a single entity and keeps their relative positions to each other the same.
If you select a field's visualization object and input object, the distribution options treat all of that field's objects (prompt, input object, and visualization object), as a single entity and keeps their relative positions to each other the same.
When you only select a field's prompt, the distribution options move the prompt independent of its visualization object.
When you only select a field's input object, the distribution options move the it independently from its visualization object.
You can group objects together so that they remain in the same relative position to each other. Grouping reduces the risk of inadvertently moving one arranged object without another, and to simplify moving groups of objects. For example, if you create a graphic and text that you want to treat as a unit, by grouping them, when you move one, the other moves with it. Grouping works for any set of selected objects. To group objects, select them, then select the Arrange menu option, Group. The Group menu item is only active when you have selected more than one ungrouped object.
You can ungroup grouped objects if you decide to change their relative positions. To ungroup objects, select them, then select the Arrange menu option, Ungroup. The Ungroup menu option is only active when you select a grouped object.
You can freeze one or more objects so that they cannot change position or size. Freezing objects prevents them from being inadvertently moved or resized. To freeze objects, select them, then select the Arrange menu option, Freeze. The Freeze menu option is only active when you select a grouped object.
You can unfreeze objects if you decide to move them or resize them. To unfreeze objects, select them, then select the Arrange menu option, Unfreeze. The Unfreeze menu option is only active when you select frozen objects.
You can change the height and width of rectangles and text objects, and the lengths of text fields. You can also systematically resize a group of selected items in one operation.
Select the object to expose its pull handles (small black boxes at the midpoints and corners of the object). Place the point of the mouse pointer over a pull handle. Click and hold while you drag the pull handle at least one character length.
Note:
If a field collects the response to a number Question that includes a decimal point, you must enlarge the box in order to avoid truncating data. The system does not automatically allow space to display the decimal point.For example, if a Question is defined as a number with length 1,2 and a response of 3.56 is entered, if you do not manually enlarge the response field rectangle the value is truncated to 3.5.
In a single-line response field, if the text box is too short to display all the characters in a response, the text scrolls left and right so that you can view the entire response. If you set a text box's Multiline property to Yes, you can cause the response to 'wrap' at the right-hand boundary of the text box. If the height of the multiline text box is insufficient to view all rows of the response, the text scrolls up and down.
Users entering text responses can use the Enter key to start a new paragraph in a multiline text box.
To make a text box multiline:
Select the text box.
In the Edit menu, select Properties. The Edit Properties window opens.
In the Multiline field, select Yes.
Click OK.
Notes:
Unlike single line text fields, multiple line text boxes do not resize in response to a change in font. If you do not leave enough room, the DCI form may cut off part of the entry.In the Layout Editor, the text dimensions may not render to exactly the same text dimensions that appear in the generated DCI form. Use the Print Preview function to see how they will appear in the generated DCI form. If the form cuts off text, adjust the height of the bounding object in the Layout Editor.
You can select multiple objects using Shift+click or Ctrl+click and then use the options in the Resize menu to change the widths of the selected objects to a uniform size. The options are:
Resize to Smallest Width makes all selected objects the same width as the selected object with the shortest width
Resize to Average Width makes all selected objects the same width as the the average of all of their widths
Resize to Largest Width makes all selected objects the same width as the selected object with the largest width
You can specify an object's size in the Properties dialog box. Select Edit, then Properties. This approach does not rely on a mouse's graphic resolution limitations, so you can size objects to within 0.1 point (0.001 centimeter, or 0.001 inch). Note that this approach does not work for grouped objects.
If you select an object, you can review and modify many of its attributes. Select the object so that you can see its pull handles, then open the Properties menu item from the Edit menu. An Edit Properties dialog box opens. If the selected object is a field, the dialog box indicates parameters it inherits from its definition.
You can also perform several movement and sizing operations by entering new values in the dialog box. This is an alternate approach to positioning objects that does not rely on a mouse's graphic resolution limitations. However, note that if you enter any value that violates the general layout parameters, the box closes but makes none of your changes.
If the values for a property of a multiple selection are the same for all selected objects, the editor displays the value. Otherwise the Property field is blank. If a property is not applicable to any of the objects, the Property field is inactive.
The Graphic Layout Editor gives you the option to alter the appearance of a field's visualization object, or mask. Masks superimpose graphics that represent field areas on paper or on the screen. Figure 11-4, "Masks" illustrates the four masks available for fields: line, box, box set, and comb. There are also square and circle masks available for DVG box fields. You can change box masks between squares and circles. (The editor deactivates square and circle selections if the mask you have selected is not for a box field.)
You can also choose for a field to have no visualization object at all.
You can change a mask from one shape to another, and from no mask to another. To change the format of a mask, first select it so that you can see the pull handles. From the Format menu, select the Visual Appearance menu option, and then select one of its options. Choose the None menu option to have no visualization object associated with the field: Only the input object is visible.
You resize a box or a line by selecting it and dragging its pull handles. The box set and comb masks have expanded controls described in the next section.
The comb and box set masks create cells for each of the characters in a response. The editor has an expanded set of controls to refine their appearance.
The box set and comb masks work well for paper renderings and for auto-populated fields in Form Layout Templates. However, if an end user enters data into an RDC DCI Form field with a box set or comb mask, the characters do not necessarily line up with the mask's cells. This is because the character spacing in a field is independent of the shape of its mask.
This section describes defining the appearance of a comb or box set mask. The process is the same for both masks.
Select a mask by positioning the tip of the mouse pointer on the border of a mask.
Navigate to Format, then Visual Appearance, and select Box Set or Comb. A Transform dialog box opens. You can also change the format of an existing Box Set or Comb by selecting the object and navigating to Format and then Format Mask.
In the Format String field, compose a string of characters to represent the cells in the mask. The total number of characters you enter in this field determines the mask's number of cells. Note that the mask can have a long string of C characters in it by default, so be sure you account for all of them. This list describes the behavior of the different characters:
The uppercase C character is a control character. The editor creates an empty cell with a border for each C in your string.
The Space character is a control character. The editor creates an empty space with no cell borders for each space in your string. Spaces have their own width control (see Step 6 below).
For any other character, the editor removes the border from that cell and prints the character instead.
Adjust the height of the mask:
If you are creating a comb mask, there are two height controls. Adjust the height of the interior vertical lines by entering a value in the Inner Height field. The first and last vertical lines are border lines, and you set their height in the Outer Height field. You can make them larger to give the mask the appearance of a start and an end. You control the height of the comb borders in between with the Height value.
If you are creating a box set mask, you set the vertical height of the box set in the Height field.
Adjust the cell width. Although you can drag the pull handles to change the dimensions of a mask, for combs and box sets this approach can be haphazard, especially if you format several masks to have the same appearance. Enter a value in the Width field to set all of the cells in the mask to a specific length.
If you include spaces in your format string, you can set their width independently of the other cells' widths. Enter a value in the Width of Space field. This allows you to narrow the width of the empty spaces in your mask without narrowing the other cells.
Click OK to save your settings.
Figure 11-5, "Mask Settings and Resulting Masks" illustrates box set and comb settings, with the resulting mask below each of their dialog boxes.
Figure 11-5 Mask Settings and Resulting Masks
The font type and size for labels and prompts are set at the database and study levels; see "Configuring Study-Level DCI Form Settings". If you have the required privileges you can check or change these settings in the Design menu path. For a default layout, the DCM graphic layout editor displays labels and prompts using the font settings in the DCI Form Settings window.
You can override the font type, size, and emphasis characteristics of the text in individual labels and prompts from the editor's text format toolbar, which is a row of icons between the main toolbar and the ruler.
Notes:
If you regenerate the layout, these manual changes are lost.You cannot change the default font settings of field text.
For each of these operations, select a label or prompt outline so that you can see its pull handles. Use Control-click to select more than one object to format at the same time. After you make a change, double-click in the middle of a prompt or label to refresh the layout editor view. You can make these text format changes:
Change Font Type: Click the first icon on the Font toolbar. This icon has the font type name of a selected label or prompt (Arial, for instance), as its title. A menu opens displaying available fonts. Select a font, and the menu collapses. Double-click the label or prompt to refresh the screen.
Change the Font Size: Click the icon next to the font-type icon. The icon displays the font size of a selection as its title. A menu opens, displaying available font sizes. Select a font size, and the menu collapses. Double-click the label to refresh the screen.
Toggle Bold Emphasis: Click the B icon in the Font toolbar to change a normal weight selection to bold weight, or a bold weight selection to normal weight. Double-click the label or prompt to refresh the screen.
Toggle Italic Emphasis: Click the I icon in the Font toolbar to change a normal slant selection to an italicized object, or an italicized selection to normal slant. Double-click the label or prompt to refresh the screen.
|
Notes: You cannot add bold or italic emphasis to text formatted with the Symbol font. If you do, the emphasized text is invisible.If you move from one label or prompt to another , the font definition you see in the toolbar applies to the previously selected label or prompt until you change the settings for the currently selected field. |
The editor retains a record of the state of the layout before your most recent editing action, and a record of its state when you last saved it.
To return your layout to its state before your most recent edit, from the Edit menu, select Undo (where the menu displays the type of last action you made). You can change it back to your last action by selecting Edit, then Redo.
To return the state of your layout to the last saved version, select Edit, then Revert. This option enables you to start over without having to exit the layout editor.
A data entry form has a cursor visitation order: the order in which the response fields become active as a data entry operator completes them. The default Layout Generator assigns visitation order values to each field from left to right, top to bottom, or according to the objects' Disp Seq# definitions. Until you use a layout editor's Order utility, fields retain their default visitation order values, even if you move them in the layout editor. If a default or modified layout does not have the most efficient or intuitive visitation order, you can resequence the values.
To display a layout's cursor visitation order, choose Order, then Display. The DCM Layout Editor replaces each response field's Question name with its cursor visitation order value. To simplify reordering, the values are multiples of ten. For instance, the DCM's first active field has a value of 10, and the next field in the visitation order has a value of 20. (You cannot adjust the visitation order from this menu path. See the following sections for changing the visitation order.) The system replaces the layout toolbar with the ordering mode toolbar.
There are three visitation ordering tools, each described in the following sections.
Note:
You cannot insert the visitation order value of a Question into the visitation order sequence of a repeating Question Group unless it is a member of the repeating Question Group.When the system generates the default layout, it assigns a visitation order to the fields from left to right, from top to bottom. You can assign this same visitation order scheme to a rearranged layout. The row/column visitation order might suffice for data entry, or you can use it as a starting point for further manipulation with one of the other ordering tools. From the Order menu, select Order Current Page by Row/Column. With this tool you remain in layout mode. (To view the results, from the Order menu, select Display. To return to the layout after viewing the visitation order, click in the toolbar.)
Use the Order by Clicking tool to set the visitation order by clicking each successive field in the layout: click once in the field you want to be first, then click once in each successive field in the new order. As you click each field, the system automatically adjusts the order values of the remaining fields. Note that once you have clicked as many times as there are fields, continued clicking assigns the last sequence number with each click.
When you finish ordering, click the door-close button in the toolbar to return to layout mode. Or, if you are unsatisfied with the results of your pass through the fields, click the door-close button. You can then reopen the Order by Clicking tool (or Order by Entering Sequence Numbers, described next), and start again.
You can select a field and change its visitation order by entering a value. From the Order menu, select Order by Entering Sequence Number. You select a field and enter a number, and the system adjusts the values of all other fields accordingly. You can either enter the values manually or with the plus and minus incrementing buttons, described in the next sections.
To insert a field's visitation between two consecutively ordered fields, assign the inserted field the greater value. (You can also assign a value between the two values.) The system renumbers the fields to the new sequence. As an example, a rearranged layout might have a visitation order like:
| Field | Visitation Order |
|---|---|
| WEIGHT | 10 |
| HEIGHT | 30 |
| BIRTHDATE | 20 |
To sequence the visitation order of these fields from top to bottom, change the value of HEIGHT from 30 to 20 (or, for instance, to 15), and select another field. The system reorders the fields to:
| Field | Visitation Order |
|---|---|
| WEIGHT | 10 |
| HEIGHT | 20 |
| BIRTHDATE | 30 |
The Order by Entering Sequence Numbers tool also includes plus and minus buttons in the toolbar that you can use to change individual sequence values. You select a field, then click either button to change its value by one value. In the example in the previous section, to change HEIGHT from 30 to 20, you would select 30, then click the minus button. The results are the same as manually entering 20.
You can save your edit work at any time even if it violates its layout and definition rules. Oracle Clinical separates the saving process from the validation process for layouts so that you can work on them over more than one session. However, you cannot make a layout active until it is valid. You can test a layout's validity by selecting the Validate option from the File menu.
This section describes editor activities that are exclusive to DCM Graphic Layouts. To edit a default DCM Graphic Layout, select the DCM in the Maintain DCMs window and navigate to Special, Graphic Layout, and Edit. The editor opens in a separate window. Since you cannot save any work you do in the Maintain DCMs window, a reminder message opens over it.
Figure 11-7, "DCM Graphic Layout Editor" is a screen-shot of a DCM in the layout editor. The DCM has only one block, so the area below the light gray line marks the lower boundary of the valid working area of the layout. Also note that the Not Laid Out button is active in the toolbar. This indicates that this DCM has new objects that were not in the DCM before the last generation.
The remainder of this section describes editor tasks that are specific to laying out DCMs. For comprehensive instructions about using the editor tools, see "Editing Layouts".
A generated DCM Graphic Layout consists of one or more blocks. The Default Generator creates as many default-sized blocks as it takes to hold all of the Questions in the DCM. When you add a DCM to a DCI, blocks are the smallest divisible unit that you can add to a page. If you have a very long DCM that spans pages, the breaks between the pages happen at the block level.
You identify a block by its number in the layout. The topmost block is Block 1, and each block below it takes the next higher number. If you add or delete blocks, the editor renumbers the remaining blocks: if you delete Block 1, the former Block 2 becomes the new Block 1. You can determine which block you are working in by checking on the right side of the taskbar. There is a display of the block number of the pointer's current position, and its block coordinates. If the pointer is below the last block or outside the work area, the block value is x. If you select an object, the taskbar displays its block number, the block's maximum height setting, and the selected object's coordinates.
You can insert an empty block among existing blocks. Inserting a block between other blocks can simplify moving groups of objects, and allow you to leave laid out blocks intact while you move other objects around them. When you insert a block, the size of the block will default to the maximum height.
To insert a block, select Block, then Insert. A dialog box opens where you enter the number of the block the new block follows, and the height of the block. Inserting a block increments the block numbers of the blocks that follow the new block.
You can divide a block into two blocks. Dividing blocks into smaller blocks can help reduce the length of layouts targeted for DCI Forms. You can then arrange some blocks from successive DCMs on one DCI Form page. To divide a block, scroll down the layout until the top ruler is at the position in the work area where you want to divide a block. Next, select Block, then Insert Block Divider. The height of the block is the height between two block dividers.
If you have a block that contains no input objects, you can delete it from the layout. Determine the block number to delete by positioning your pointer over it and reading its number on the right side on the taskbar at the bottom of the editor, then select Block, and Delete Block. The Delete a Block dialog box opens. Enter the block number and click OK.
You can change the dimensions of your work area within the confines of the DCM's associated Form Layout Template. Select Block, then Set Block Size. The Set Block Size dialog box opens, displaying the current maximum allowed height and width values, in points. Make your changes and click OK. Changing the height has delayed consequences, the width changes the width immediately.
Changing the height has two consequences:
When you save, if any of the blocks are larger then the specified maximum height, you receive an error message.
When you insert a block, the size of the block defaults to the maximum height. If you choose a number that is larger than the values the DCM inherits from its associated Form Layout Template, you receive an error message.
This section describes the DCM Graphic Layout Editor's two utilities for editing repeating Question Groups.
Note:
All repeats of a repeating Question Group must be contained in the same block.If a DCM has repeating Questions you can distribute all of them to a specific height in one operation. In addition to making their appearance uniform, this tool can also be helpful to compress the area they consume. Select any ungrouped object among the repeating Questions. Then select Arrange, and choose Set Height Per Repeat. A dialog box opens showing the maximum height. The height you are setting is the line height, which is the distance from the bottom of one line of type to the bottom of the next.
The editor has a utility for handling cursor visitation order in repeating Questions. Cursor visitation is the sequence of selected fields as you tab through an RDC DCI Form. (See "Setting Cursor Visitation Order" for a complete explanation.) By default, if you change the cursor visitation order of one repeating Question, all of the repeating Questions in the group automatically adjust to the same order. For instance, if you have 3 repeats of 4 Questions with this ordering sequence, and you view their cursor visitation order, the Question sequence might look like this:
If you change the Question with order of 60 to have an order of 70 (and 70 to 60), the editor adjusts the other Questions to have the same relative repeating order:
Automatic ordering occurs in locked mode. In locked mode, you cannot change the sequence for one repeating Question sequence without changing the sequence in all of the others. You can change from the locked mode to unlocked mode, which allows you to order each Question manually. Unlocked ordering enables you to sequence a Question from another group into the sequence of repeating Questions. To change from locked mode to unlocked mode, select the Order menu option and deselect the Lock Ordering of Repeats box. You can then reorder the visitation order of the repeating Questions. You can relock the cursor visitation order by selecting the Lock Ordering of Repeats box.
If new Questions are added to a DCM after you have edited its layout, Oracle Clinical stores the new Question objects in the layout editor's Not Laid Out area so that they do not disrupt your existing work. The Not Laid Out area is only accessible when there are new objects. When you add new Questions, the system sets the Needs Edit and Needs Update flags. You move them to the DCM Layout by cutting and pasting. Follow these instructions to move new objects into your DCM Layout:
Click the Not Laid Out button on the DCM Graphic Layout toolbar.
Select the new objects. You do not have to select all of the objects at once.
Cut the objects: Select Edit, then Cut, or use the keyboard shortcut Control-X.
Return to the DCM Layout by clicking the Laid Out button in the toolbar. The Not Laid Out area closes.
Paste the cut objects onto the DCM: Select Edit, then Paste, or use the keyboard shortcut Control-V.
When you move all of them from the Not Laid Out area, the DCM becomes valid.
If you remove Questions from a DCM that has a layout, the system checks the DCM version's Needs Edit? value. When you reopen the DCM's layout in the editor, the deleted Questions are gone, leaving the area they occupied empty.
You can preview either an HTML or PDF representation of your layout without creating a completely functional DCI Form. The preview shows all of the layout's masks and prompts. Previewing a layout the first time requires that you associate the layout with a DCI template: Select Block, then choose Set DCI Layout Template. Click the list of values (...) button to view a list of available Form Layout Templates. Choose a suitable template and click OK.
The Oracle Clinical Report Server has a transform tool for converting DCI Form objects into PDFs or HTML files, and opening the result in your browser. Note that the operation might take a while, and that there is no indication that anything is happening in the meantime.
This section describes editing activities that are exclusive to DCI Graphic Layouts. Select Special, then Graphic Layout, and Edit Graphic Layout. While in the editor you can generate a preview of the layout: Select Action, and then Print Preview.
You can copy an existing DCI Form version record from the DCI Form Version window. The DCI Form version record includes the DCI Layout. Follow these instructions:
Navigate to DCIs, then choose DCIs. Locate the DCI with the layout you want to copy.
Click the Form Versions button. The Maintain DCI Form Versions window opens.
Select the desired DCI Form version to copy.
From the Special menu, select DCI Layout, then choose Create Provisional Layout as Duplicate.
In the editor, a DCI Graphic Layout is a column composed of one or more pages. The DCI's DCM blocks are stacked into the column. Blocks do not span page boundaries, so you manipulate the blocks and the pages to make the most economical use of your layout area. Like blocks, the editor numbers pages in a top-down sequence. If you add or delete a page, the editor renumbers the remaining pages in the column. When you position the mouse pointer over a page, the editor displays its number in the right side of the taskbar, which is the bottom panel of the layout editor's window.
You can add pages to your DCI Layout to make it more suitable for data entry and printing. If you have one page in your layout, you can add a page after page one. In the DCI Graphic Layout Editor, select Page, then Insert. A dialog box opens. Enter a number and click OK. The editor renumbers the blocks so that they are in sequence.
You can delete pages if they contain no input objects. Determine the page number of the candidate page by positioning the mouse pointer over it and reading the Page value in the taskbar at the bottom of the editor window.
If you change a DCM Graphic Layout that is used by a DCI Graphic Layout, the system sets the DCI Graphic Layout's Needs Edit/Needs Update flag. The next time you modify the DCI Layout, the system replaces the old DCM Graphic Layout with the modified one.
If a DCM has header fields such as Qualifying Questions or displayed comments, you can change their cursor visitation order within the DCM header. The cursor visitation order is independent between DCM headers. You control the display of the DCM headers in the DCI Modules window (see "Configuring DCI Modules' Graphic Layout Settings". Choose a visitation order method from the Order menu. See "Setting Cursor Visitation Order" for more information.
Oracle Clinical separates the saving process from the validation process for DCI Layouts so that you can work on them over more than one session. You can test a DCI's validity at any time by selecting File, then Validate. If there are no violations the test returns a "No errors" message. If the layout is invalid, the editor returns a message that describes the nature of each violation. A DCI Layout is invalid if any of its objects exceed the layout's boundaries or if there are any objects in the Not Laid Out area. If you try to save an invalid layout, the editor notifies you and asks if you want to save the layout anyway.
This section describes editing activities exclusive to Form Layout Templates. To open a Form Layout Template in the Graphic editor, follow these instructions:
Open the Maintain Form Layout Templates window (from the Glib menu, select Form Layout Templates), or the Maintain Provisional Form Layout Templates window (from Prov Form Layout Templates, select Maintain Form Layout Templates).
Select the template to edit.
Open Special, then select Edit Form Layout Template. An editor session opens as an additional window.
Figure 11-8 The Template Editor's Header Workspace
When you edit a template, you do not view the entire template at one time. You view either the header or the footer. You toggle between the header and footer workspaces by clicking the footer or header icon on the toolbar, or from the View menu, choose Show Footer or Show Header. Figure 11-8, "The Template Editor's Header Workspace" shows the header workspace, so to change to the footer workspace you would click the icon labeled Footer (or the View menu's Footer option). The template editor always opens to the header workspace.
The template editor opens displaying the header workspace. The left side of the work area is the left margin of the template. The top of the work area is the top margin of the template. The work area contains two regions, separated by a horizontal line. In Figure 11-8, "The Template Editor's Header Workspace", the mouse pointer rests on the separator, 4.5 cm from the top of the workspace. (You can change these dimensions from the Block menu. See "Sizing Form Layout Templates".)
The horizontal line is a separator that marks the lower boundary of the header. The work space above the separator is the header block. All objects in the header block appear in the header of a DCI Form Layout created from this template. In the illustration, a Comment prompt and field are the lowest objects in the template's header block.
The work area below the separator is a holding area. This is different than the equivalent region in a DCI Form Layout, which, if viewed in an editor, would contain DCMs. When you build a DCI Form based on a template, the objects in the holding area disappear. For instance, in the above illustration, the Study Site prompt and field are in the holding area, so they would not appear in a DCI Form created from this template. However, you can drag any of the out-of-bounds objects into the header block, or drag any header object into the holding area.
Figure 11-9 Template Editor Detail Showing Footer Workspace
To switch from the header workspace to the footer workspace, click the icon labeled Footer in the toolbar, or select View, then choose Show Footer. The editor switches to the footer workspace. Like the header workspace, the footer workspace contains two regions, separated by a horizontal line. In Figure 11-9, "Template Editor Detail Showing Footer Workspace" the separator is 1.7 cm from the top workspace. The horizontal line is a separator that marks the lower margin of the template. The work space above the separator is the footer block. The top of the workspace is where the footer block begins at the bottom of the page. All objects in the footer block appear in the footer of a DCI Form Layout created from this template.
The work area below the separator is a holding area. All objects in the holding area are absent in DCI Forms derived from the template. You can move any of the objects into the footer block, or drag any footer object into the holding area.
You can change the overall height of the Form Layout Template when you define the height of its headers, footers, and the DCM region. You can also change the width of the layout. Select Block, then choose Set Block Size to open the Set Block Size dialog box. Note that you cannot directly change the value in the Form Template Height field. When you click the OK button, the editor adjusts the values to equal the sum of the other three heights.
You can create a PDF of your layout without creating a completely functional DCI Form. The PDF shows all of the layout's masks and prompts. The Oracle Clinical Reports Server has a Transform tool for converting DCI Form objects into PDFs, and opening the result in your browser's Adobe Acrobat Reader plug-in. Note that the operation might take a while, and that the screen is inactive in the meantime.
Form Layout Templates can have enterable fields in their headers and footers. You can control the order in which a user tabs through a DCI Form's output. From the menu, select Order. Then select one of the ordering methods. For more information about ordering, see "Setting Cursor Visitation Order".
This section contains the following topics:
You must create conditional blocks in the graphic layout editor for any indicator or conditional branching definitions that you want to be in effect for RDC Onsite data entry using your graphic layouts. For a comparison of indicator and conditional branching functionality, see "Designing Response-Dependent Branching". You must define indicator or conditional branching before you can create conditional blocks in the layout.
In both cases, the default graphic layout creates conditional blocks that include only the target Question.
In indicator branching, you must add the remaining Questions in the Question Group to the conditional block. Do not add any other Questions to the conditional block or remove any of the Question Group Questions. During data entry the cursor always moves to the next Question in the Question Group when the remaining Questions become active.
In conditional branching, you must define a conditional block for the target Question that includes the complete set of Questions that should be answered or skipped, depending on the response to the source Question. The conditional block can include the remaining Questions in the target Question's Question Group and/or Questions in different Question Groups in the same DCM.
You can also change the order of the Questions in the conditional block, including moving the target Question to a position other than first in the block. During data entry the cursor always goes first to the Question that appears first (topmost and leftmost) in the block when the conditional block Questions become enterable.
These are the required steps:
Define indicator branching in a Question Group or conditional branching in a DCM; see "Defining Indicator Branching" and "Defining Conditional Branching".
Choose whether to hide or gray-out conditional blocks in HTML data entry using the Represent Disabled Blocks setting in DCI Form Local Study Settings; see "Configuring Study-Level DCI Form Settings".
Generate or update the DCM graphic layout; see "Generating Default DCM Graphic Layouts".
Create the conditional blocks; see "Creating Conditional Blocks".
Edit the conditional block if necessary.
You must create all target conditional blocks for a given source Question at the same time. For indicator branching there is only one conditional block, but conditional branching may have many, one for each target Question.
To create conditional blocks for an indicator or conditional source Question:
In the Maintain Study DCMs or Global Library DCMs window, select the DCM containing the Question identified as conditional or indicator and navigate to the Special menu, Graphic Layout, and then Edit.
In the Layout Editor, open the Conditional Block menu and select Create Conditional Blocks. The system displays a list of all source Questions that do not yet have defined graphic target blocks, their Question Group name and a check box indicating whether or not the Question is an indicator Question. If the indicator Question check box is not selected, the Question is defined as a source Question for a conditional branch.
Select a source Question from the list and click OK.
For indicator Questions, the system creates a single conditional block consisting of the remaining Questions in the Question Group.
For conditional branch source Questions, the system creates a conditional block for each target Question specified for the selected source Question. The block contains only the target Question, if possible, given the horizontal placement of fields in the layout. Additional Questions are included if they are on the same horizontal plane as the target Question. This is an invalid condition that you must correct. You must also make sure that the Begin and End Block lines do not overlap prompt or response objects; see "Invalid Conditional Block Conditions".
If the target Question is part of a repeating Question Group, the begin block is before the first repeat, and the end block is after the last repeat.
For each conditional block, the system creates color-coded highlighting and separators and removes the highlighting and separators for any previously selected source Question; see "Conditional Block Display".
Edit the layout, if required. In addition to normal editing available for the rest of the DCM layout, you can add and remove Questions from conditional blocks used in conditional branching (but not in indicator branching):
Drag Begin or End Block lines to include or exclude Questions in the conditional block.
Drag prompt or response objects above or below the Begin Block and End Block lines to include or exclude them in the conditional block.
Save your layout. Oracle Clinical executes a set of validation checks, and then reports all failed conditions to you for correction; see "Invalid Conditional Block Conditions".
You can either save the layout in an invalid state and correct the invalid conditions later, or cancel and continue with your edits.
The DCM Graphic Layout Editor represents conditional block objects as follows:
The Begin Block and End Block lines mark the beginning and end of the conditional block and include the name of the source or indicator Question. You may need the Zoom feature to read the text.
Color highlighting:
The source Question appears in magenta.
The target Questions appear in green.
The remaining Questions appear in orange.
If the Show All source Questions option (available from the Conditional Block menu) is in effect, the DCM Layout Editor distinguishes the currently selected source Question from the other source Questions with different colored highlighting.
Note:
You can remove the color highlighting by selecting Clear Highlighting from the Conditional Block menu and restore it by selecting Show Conditional Blocks from the Conditional Block menu.If a block spans pages, dashed lines indicate each page break.
Options from the Conditional Block menu include:
Show Conditional Blocks displays, with color highlighting, conditional blocks for one or more source Questions that you select.
This feature allows "fall-through" Question sequencing like Oracle Clinical and RDC Classical Data Entry. Creating conditional blocks automatically includes an end-of-block demarcation before the next target Question. At the end of each block, branching goes to the next visible, enabled field.
The editor redraws the end-of-block line as a dashed line, allowing the Questioning to continue to the next immediate Question rather than branching to the next target Question.
If you select the Suppress Branch option after selecting an object that has no end-of-block line, or selects no object at all, the Editor prompts you to select an end-of-block line before continuing.
It is possible to nest conditional blocks that are the targets of one source Question inside a conditional block of another source Question if the inside, or child blocks can never become enterable unless the outside, or parent block is enterable. The child blocks must be the targets of a different source Question than the parent block. All conditional blocks for one source Question must be contained in a single conditional block for the other source Question.
The system displays only Questions that are contained directly in the selected conditional block: the parent block displays only the Questions that are not included in the child blocks. Each child block displays the Questions included in the child block.
It is possible to create conditional blocks that result in invalid layout generations. When you save your work, the system validates the conditional blocks. If there are invalid conditions, the system generates the invalid blocks anyway, issuing an error message, and saves your work. You can then re-position fields to fix the problems.
The following conditions are invalid:
The source Question is on the same horizontal plane as Questions in the target blocks. The system cannot generate a line to physically separate the source Question from the set's Questions.
The Begin and End Block lines overlap other objects (prompts or fields).
An indicator Question target block includes Questions from another Question Group or does not include all Questions in the Question Group.
A repeating Question Group is intersected by a Begin Block line or an End Block line.
Two Begin Block lines or two End Block lines appear in succession, representing overlapping blocks for the same source Question.
Two Begin Block lines from different source Questions or two End Block lines from different source Questions appear in succession AND the blocks for one source Question are not wholly contained within a single parent conditional block for the other source Question.
A Begin Block line for a conditional block appears before (above) the End Block line for the same conditional block.
A target Question lies outside of its originally defined target block.
A source Question lies within one of its own target blocks.
These actions have no impact on the content of the conditional blocks:
Repositioning block objects within the block.
Changing tab order.
This section describes the tasks available from the Conditional Block menu items. Figure 11-10, "The Conditional Block Menu in the Graphic DCM Layout Editor" illustrates the Conditional Branch menu in a form with a defined source Question (magenta color), a target Question (green color), and a conditional block of Questions (orange). In RDC Onsite, if the user selects the target response, the CRF displays or activates the target and block Questions.
Figure 11-10 The Conditional Block Menu in the Graphic DCM Layout Editor
The following lists describe the DCM Graphic Layout Editor's Conditional Block menu items:
Show All source Questions highlights all source Questions in the color magenta. The DCM Layout Editor highlights all source Questions in magenta, whether their conditional blocks are defined or not.
Show Source and target Questions displays the list of all source Questions in the DCM, whether their conditional blocks are defined or not. Select as many Questions as you want. The system then displays all selected source Questions in magenta and their target Questions in green.
Clear Highlighting turns off all highlighting; see "Conditional Block Display".
Create Conditional Blocks makes the target Question(s) for one indicator or conditional branching source Question conditional. See "Creating Conditional Blocks" for more information.
Delete Conditional Blocks makes the target Question(s) for one indicator or conditional branching source Question be no longer conditional. This option undoes the work of the Create Conditional Blocks option.
Show Conditional Blocks displays a list of source Questions for which conditional blocks have already been created. Select as many Questions as you want. The system then displays all selected source Questions in magenta and their target Questions in green.
Suppress Branch Ordinarily, when a branching condition is satisfied, a single block is enabled for data entry. When data entry for that block is complete, the branch skips over the remaining blocks. However, by using the 'Suppress Branch' option at the end of a block, you can enable the target block and one or more of the following blocks. For example, if you have three blocks and the first two blocks end with a suppress branch condition, you have three possible ways to enable the conditional blocks:
If the target Question is in Block 1, Blocks 1, 2, and 3 are enabled
If the target Question is in Block 2, Blocks 2 and 3 are enabled
If the target Question is in Block 3, only Block 3 is enabled
To suppress the branch at the end of a block, select the End Block line and click Suppress Branch. The system redraws the End Block line as a dashed line.
The DCI Layout Editor does not display conditional blocks. To see which conditional blocks are included in a DCI Form Version, navigate to Definition, then DCIs. In the Maintain Study DCIs window, click DCI Form Versions and then Show Conditional Blocks.
Here are problems you may encounter when working with Graphic Layouts, and possible solutions to each one:
Check My Oracle Support for troubleshooting tips.
If generating a Provisional DCI Form fails with the error "FRM-41213: Unable to connect to the report server", it indicates that the Maintain DCIs Form cannot communicate with the Report Server to process a PDF generation request.
This can be caused if a previous job failed in such a way to cause the current connection from your session to the Reports Server to be disconnected. Try logging out and then logging back in. If this does not work, have an Administrator check if the Reports Server is running.
If you have Administrator privileges, log on to the Reports Server Computer. From the Start menu, select Control Panel, choose Services, check that the Reports Server has a status of STARTED. If not, start it. If you cannot start it, make sure Oracle Discover 4i Service is stopped.
If you navigate to the Special menu, select DCI Layout, then choose Generate Provisional DCI Form, you may get the message:
FRM-41214: Unable to run the report
and followed by error message 777100: Either the PDF for the DCI Form failed to be generated, or the URL of its location is incorrect.
In that case, check these details:
Is the DCI Form Layout valid? To check, open the Provisional DCI Form Layout in the editor, and run File, and then Validate. Fix any errors, and then try again to generate the DCI Form.
Was the Reports job successful? The job may have run on the Reports Server instance, but failed because Reports thought that its input was invalid. If the job failed, ask the Queue Manager for details. Typical failure messages contain comments like these:
Object 'Rectangle_3751' is not fully enclosed by its enclosing object 'Body'.This occurs when the Form Layout Generator places an object too close to a boundary. Go back to the DCM Graphic Layout, and move objects in from the boundaries of the DCM Layout Region.
Body area is beyond print area. This occurs when the page selected for generating the DCI Form is not enough to hold the DCI Layouts. Choose a larger Page Definition.
BLOCK#_1_ is empty. This occurs when there are empty blocks in DCM and DCI Layouts. Remove the empty blocks through layout editor and retry DCI Form generation. Usually you will get this if the DCM Graphic Layouts are generated with small first block heights.
Image is not found. This occurs when Reports Server cannot find the image that was added to the DCI Layout. Check that the \Software\Oracle\9iDS_HOME\RDC_DCIF_IMAGES registry value is set on Web Server and Reports Server. This is the UNC path specification of the directory where you store DCI Layout images.
Does the Form Layout have any empty pages? To check, open the Provisional DCI Form Layout in the editor. If there are any empty pages, the system returns this error.
Is the output more than 20 pages? Due to technical limitations, the DCI Form may not generate. Try reducing the number of pages to less than 20.
Try running a reference codelist report to a file. Navigate to Admin, then Reports, and Reference Codelists. Select a reference codelist to print, click Job Details, and change destination to FILE. If this does not work, see the Reports Server troubleshooting guide on Metalink.
If you have Administrator privileges, you can try these possibilities:
Open Windows Explorer to the XMLTEMP directory. Generate the Provisional DCI Form and watch for the creation of the file PDFGENDCIIDVERSIONS_SN First 10 characters of OC ACCOUNT timestamp MI:SStemp.xml. If xml exists, save the file to a different folder before exiting the Maintain DCIs window. If it does not exist, check registry setting OPA_XMLTEMP_UNC, described below.
Are the required registry values set? The report that generates the PDF reads these registry values on the Reports Server:
\Software\Oracle\9iDS_HOME\OPA_XMLTEMP_HTTP
This is the URL of the directory into which XML is downloaded, and PDF is written to be uploaded.
\Software\Oracle\9iDS_HOME\OPA_XMLTEMP_UNC
This is the UNC pathspec of the directory into which XML is downloaded, and PDF is written to be uploaded.
\Software\Oracle\9iDS_HOME\RDC_DCIF_IMAGES
This is the UNC pathspec of the directory in which image GIF files are to be found, for incorporation into the generated PDF.
Is the directory pointed to by OPA_XMLTEMP_UNC shared, with read and write permissions, to the account used to set up the Report Server? Log on to the Reports Server computer as domain\opareps. Check that the path specified by the value of registry setting OPA_XMLTEMP_UNC exists. Copy the registry value to the clipboard, then look for the value using Window Explorer. If not, correct the value.
Is the directory pointed to by RDC_DCIF_IMAGES shared, with read permissions to the account used to set up the Report Server? Log on to the Reports Server computer as domain\account_used_to_set_up_the_Report_Server. Check that the path specified by the value of registry setting RDC_DCIF_IMAGES exists. Copy the value to the clipboard, then look for the value using Window Explorer. If not, correct the value.
Was the generated PDF document placed into the XMLTEMP directory? You must perform this test before exiting the DCI Form. Look in the directory of the registry setting OPA_XMLTEMP_UNC value. PDFGENDCIIDVERSIONS_SN First 10 characters of OC ACCOUNT timestamp MI:SStemp.xml.
Is the Reports Server started as the account used to set up the Reports Server initially? Log on to the Reports Server, from Control Panel, then Services, and check the property of the Oracle Reports Server to see if it is started as domain\account_used_to_set_up_the_Report_Server.
If you try to generate a Provisional DCI Form through the Special menu in the Maintain DCIs window, and the system returns control to you without returning either an error message or a DCI Form, check the init.ora file for the database.
If the init.ora file contains one or more utl_file_dir parameter definitions, but does not contain a utl_file_dir parameter definition for the directory <opahome>/oc/xmltemp (which is the directory that Oracle Clinical uses during DCI Form generation), you need to add that parameter to the init.ora file.
During Oracle Clinical installation, the directory <opahome>/oc/xmltemp is created. For example, if your opa home directory is usr/opapps, then the directory usr/opapps/oc/xmltemp is created. Add a utl_file_dir parameter definition for this directory as follows:
Add the following two lines to the init.ora file, immediately before or after the other utl_file_dir parameter definitions:
UTL_FILE_DIR = /usr/opapps/oc/xmltemp
UTL_FILE_DIR = /usr/opapps/oc/xmltemp/
The second line is the same as the first except for the slash at the end. This line is necessary because of a bug: Oracle Clinical currently includes an extra slash in its references to files in the XMLTEMP directory.
Stop and restart the database.
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