Maintaining DCM Graphic Layouts

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.

For more information, see:

• Generating Default DCM Graphic Layouts
  
• DCM Graphic Layout Statuses
  

Generating Default DCM Graphic Layouts

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:

Generate Default From Scratch

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. If you want to save a previous DCM layout versions you have to create a new DCM Subset Layout (a new row in the DCM window.)

1. 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.

2. 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 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.

Generate Default from Character 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.

Update from DVG 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.

Edit

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.

Browse Layout

From the Special menu, select Graphic Layout to view the Graphic Layout for the selected DCM Layout.

DCM Graphic Layout Statuses

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.