OCRDC Graphical Layout Features_Katalyst HLS

1. RDC Graphical Layout
Overview
Priya Gehlawat

2. Clinical Planned Events (cont.)
 Page tracking should be turned on for RDC studies.
 Conduct-> Security -> Clinical Study States -> F7->Enter study-> F8
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3. DCM/DCI Structure and Layouts
 Enforce Max Repeats on all repeating question groups that contain a pre-
determined number of expected repeats.
 NOTE: For PDF studies, Log pages should not exceed one page
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4. DCM/DCI Structure and Layouts
 For RDC studies one data type DCM per DCI using qualifying values can be
used depending on the study design.
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5. DCM/DCI Structure and Layouts
 The default responses for height/weight/temp units for all US-based studies will
be ‘IN’, ‘LBS’, and “F” (unless specifically requested). The default unit for studies
outside the US will be ‘CM’, ‘KG’, and “C”.
 NOTE: If your study has multiple sites on multiple continents, do not default any
values, and make these responses enterable.
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6. DCM/DCI Structure and Layouts
 Provide the CDC with the Standard Upper/Lower Bound Ranges. Modify (if
applicable) and assign the Upper/Lower Bounds to appropriate DCM Questions.
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7. DCM/DCI Structure and Layouts
 For local lab pages, LPARMDES will be defaulted for all the tests specified by the
protocol. Text needs to be placed next to each repeat in the database to list the
full lab test name.
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8.  Repeat Default Values

9.  Path for Repeat Default Values

10.  Path for Repeat Default Values

11. DCM/DCI Structure and Layouts
 Layouts will not be modified except for Data Entry proficiency.
Special Instructions should be included in the CRF Completion
Guidelines and should not appear on RDC Screens.
 PDS Core Safety module layouts for RDC Classic and PDF will be
included in DCMs that are copied from the GLIB. These layouts
will only need to be modified when Optional Questions are
ADDED/REMOVED from the DCM.
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12. PDF Layouts and Structure
 For all PDF Layouts only, ensure that the Title Text uses an 11pt.
Arial Font (Bold), and all other text used is 9pt. Arial Font.
 PDS Core Safety Layouts should mirror those in the Data
Standards Catalog.
 For all RDC-PDF studies, both Classic and PDF Layouts need to
created and modified.
 Indicator Questions can be used, but the Default Response must
be left BLANK.
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13. PDF Layouts and Structure
 You can find view the Graphic Layout Tab to see if your Graphic Layout
exists when you copy your DCM into the study. You can also check
Height and Width parameters to ensure the Layout will be Valid.
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14. PDF Layouts and Structure
 Generating a new Graphic Layout
 Special > Graphic Layout > Generate Default Layout From Scratch
 NOTE: These are the Standard DCM Attributes Defined at the Admin Level, and they
should NOT be modified.
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15. PDF Layouts and Structure
 Editing the Graphic Layout
 Special > Graphic Layout > Edit
 Date
 Format > Visual Appearance > Comb
 Enter the following values:
 NOTE: Be sure to add (dd-MMM-yyyy) text to date fields
 NOTE: Be sure to drag your arrow starting above the Entry Field and
through it. The Format String should Auto-populate if done correctly.
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16. PDF Layouts and Structure
 Time
 Format > Visual Appearance > Comb
 Enter the following values:
 NOTE: Be sure to add (24 hour clock) text to time fields
 NOTE: Be sure to drag your arrow starting above the Entry Field and
through it. The Format String should Auto-populate if done correctly.
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17. RDC Screen

18. PDF Layouts and Structure
 Lines/Boxes
 Format> Visual Appearance > Line/Box
NOTE: Be sure to drag your arrow starting above the Entry Field and through it.
 Grouping Objects (Marrying Formatted and Entry Fields)
 Arrange > Group
 NOTE: It is much easier to move objects into place after they are grouped.
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21.  Formatting Entry Fields
 Entry Fields should be modified to be centered above Comb Fields
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24.  Setting the Tab Order
 Display the Tab Order: Order > Display
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25.  Modify the Tab Order: Order > Order By Clicking > Click on each field in
the order of data entry
NOTE: Each field will turn Blue as you are clicking. Once finished, hit the
Exit Button and Save.
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26.  Previewing PDF Layouts
 After modifying the Graphic Layout, you can preview how your module will look in
PDF.
 File > Print Preview > REPORT SERVER
NOTE: You must have Adobe Acrobat 5.0 installed on your system
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28.  Setting the DCM Graphic Layout to “AVAILABLE”
 NOTE: The DCM Graphic Layout must be checked “AVAILABLE” in order to generate
the DCI Graphic Layout
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29.  Conditional Branching Setup in DCM

30.  Conditional Branching Setup in DCM

31.  Conditional Branching Setup in DCM

32.  Conditional Branching Setup in DCM

33.  Conditional Branching Setup in DCM

34.  Generating a DCI Layout
 Special > DCI Layout > Generate Provisional Layout
 NOTE: Form Layout Template = OC_PDF_USL_P34

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36.  Generating the Provisional DCI Form
 Special > DCI Layout > Generate Provisional DCI Form
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37.  Activating the DCI Form Version
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38.  Path for DCI Rules

39.  DCI Rules in Enhanced DCI Book

40.  Path for Interval Rules

41.  DCI Rules in Enhanced DCI Book

42.  Activating the DCI Form Version
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43. Thank you