Rave 5.6.3 Gap Training for Study Builders
Cherie Stabell, Clinical Data Management
Himal Desai, Medidata Solutions
About This Course
 Housekeeping
 Ground Rules
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Housekeeping
 Where are the bathrooms?
 When will we take breaks?
 Where is the break room?
 Will my cell phone or PDA be ringing?
 When can I check my e-mails?
 Log onto your training computer:
 Unix ID & password
 Log on to: GNE
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Ground Rules
 Let’s have fun
 Questions are welcome at all times
 Respectful and safe environment
 Parking lots for deferred discussion topics
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Lesson 1: Introduction
 Purpose of this Training
 Learning Objectives in this Training
 Sample Study Used in this Training
 Training Prerequisites
 Rave 5.6.3 Resources
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Purpose of this Training
 Scope:
 Architect
 Architect Loader
 PDF Generator Modules
 New and changed features of the Rave 5.6.3 software
 new functionality
 changed functionality
 fixes to prior known issues
(See Participant Guide p. 3)
 Enable you to use these features successfully in your job
 Genentech conventions and best practices that have already
been determined for new / changed functionality
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Learning Objectives in this Training
Understand and hands-on experience with:
 log line changes
 Architect navigation changes
 radio button changes
 Publish in Place (new)
 PDF Generator changes
 Edit check and derivation changes
 Amendment Manager Scheduler (new)
 Architect Loader changes
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Training Sample Study
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Rave 5.6.3 Resources
 Demo study (BLDD3000g_D) in training environment
 Livelink path [Might Change]:
Genentech Livelink > Departments > Genentech Informatics
> CIT Product Development IT> Projects > Rave >
Rave-EDC > Docs > Rave 5.6.3
 Medidata Rave 5.6.3 Release Notes
 Medidata’s Cumulative Rave 5.6.3 Known Issues list
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Lesson 2: Log Lines
 Reactivation of Log Lines
 Default Value Delimiters for Log Fields
 Hands-on Exercise
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Reactivation of Log Lines - New
 Users who can inactivate a log line can now reactivate it
 When reactivated, all relevant edit checks run automatically,
including any associated custom functions
 Automatic (cannot be turned off) once environment is
upgraded to Rave 5.6.3
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Restricting Default Repeat Log Forms - New
 With Rave 5.6.3, for default repeat log forms, you can
restrict the number of log lines by adding a pipe delimiter
( | ) as the terminating character in the list of default values
 Genentech’s convention is to always build this way
 Example:
1|2|3|4|5
Add terminating delimiter character:
1|2|3|4|5|
 Implications:
 EDC users cannot add new log lines to a default repeat form
 EDC users cannot inactivate or reactivate log lines in a default repeat
form
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Default Repeat Log Forms in 5.6.1 Studies
 If a default repeat log form was configured with a terminating
delimiter character in Rave 5.6.1, the character was ignored
 When the study is migrated to Rave 5.6.3:
 Terminating character will be stripped out automatically during upgrade
 Existing default repeat log forms will behave exactly as they did
in the Rave 5.6.1 environment (that is, without restrictions)
 Any inactivated log lines will remain inactivated
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Exercise – Lesson 2
 See page 6
 Training URL:
https://gentrn563.mdsol.com
 Login: buildsc_#
 Push to Dev (not PROD)
 Genentech naming conventions for versions…
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Exercise – Lesson 2 – Version Naming Conventions
 CCC_R#.#_###_ddMMMyy_AAA
where
 CCC
Environment where the version will be pushed (DEV, TRN, TST, or PRD).
 R#.#
Draft from which the version was published.
 ###
Sequential number of versions published on that date.
 ddMMMyy
Date on which the version was created,
 AAA
Initials of the study builder who created the version.
 For example: DEV_R1_001_21SEP09_ABC
 Underscores are used to separate these different parts
of the version name.
 When new versions are created in Rave, they are assigned a
Version number by the system. This number becomes the identifier
within the system for each published version of a study, with
the most recent version listed at the top.
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Lesson 3: Navigation and Radio Buttons
 Previewing Forms Before Copying to
the Global Library Copy Wizard
 Go Back Link
 Radio Buttons
 Hands-on Exercise
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Form Preview in the Global Copy Wizard – New
 Preview forms before you copy them to the Global Library
 Works for selected fields and dictionary entries
 DEMO: Click Form Preview
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Go Back Link – New
 In the Form Details screen, click Go Back
to get to the Forms summary screen
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Deselectable Radio Buttons – New
 Before, once an EDC user selected a single radio button,
then at least one radio button in the group needed to be
selected
 Users can now deselect any radio button on any form
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Vertical Radio Buttons – New
 Previously, all radio buttons were horizontal
 Can now use vertical radio buttons
 Configure in the Form Details screen – select RadioButton (Vertical)
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Exercise – Lesson 3
 See page 10
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Lesson 4: PDF Generator
 New Configuration Settings
 Profile Changes to PDF Generator
 How Configuration Settings
Affect PDFs
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New PDF Generator Settings in Rave 5.6.3
 Can display the full folder path in the PDF header
for blank and data PDFs
 Ability to include the Field OID in an annotated PDF
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Profile Changes for PDF Generator
 Blank PDF Setting—uses settings from Rave 5.6.1
 Annotated eCRF Setting—uses new settings in Rave 5.6.3
 Select the profile when you configure a PDF file
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Proposed Settings in Annotated eCRF
 Following proposed items have been requested:
 Field Label
 SAS Label
 Values (Data Dictionary Values)
 Pre-Filled Values (defaulted fields)
 Field OID
 Proposed settings have not yet been approved
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Comparison: Rave 5.6.1 and 5.6.3 Settings
Blank PDF Setting
Hyperlinks
Annotated eCRF Setting
Proposed items
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Lesson 5: Edit Checks and Derivations
 Quick Edit Editor
 New Check Functions
 Other Edit Check Changes
 Hands-on Exercise
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Quick Edit Editor - New
 Directly modify edit check code in a text editor
 Rapidly create edit checks
 Copy and paste code between edit checks and projects
 Available for any edit check that you can modify,
including inactive edit checks in a draft
 Not Available
 For system edit checks or for edit checks in a CRF version
 If your role has Read Only Architect security for Stage 2
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Quick Edit Editor
 On the Check Steps page, click the Quick Edit link
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Quick Edit Editor – Example Edit Check Code
Section
Code Example
Edit Check Name
|GE_BPS_GREATER_BPD|True|False
Check Step(s)
||StandardValue|BPS||||||||
||StandardValue|BPD||||||||
IsLessThanOrEqualTo|||||||||||
||StandardValue|BPS||||||||
IsNotEmpty|||||||||||
||StandardValue|BPD||||||||
IsNotEmpty|||||||||||
And|||||||||||
And|||||||||||
Check Action
|||BPS||||OpenQuery|Systolic Blood Pressure is less
than or equal to the Diastolic Blood Pressure. Please
review your entries.|Site|
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Quick Edit Editor – Syntax
Section
Syntax Notation
Edit Check Name
|CheckName|CheckActive|BypassDuringMigration
Check Step(s)
CheckFunction|StaticValue|DataFormat|VariableOID|
FolderOID|FormOID|FieldOID|RecordPosition|CustomFunction|
LogicalRecordPosition|FormRepeatNumber|FolderRepeatNumber
Check Action
CheckName|FolderOID|FormOID|FieldOID|VariableOID|
RecordPosition|PageRepeatNumber|InstanceRepeatNumber|
ActionType|ActionString|ActionOptions|ActionScript
 Formatted with a syntax that uses a pipe (|) delimiter
 Syntax parallels the columns in Architect Loader,
with the delimiter representing a cell boundary
 Click in the editor to see the token for that location
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Use the Quick Edit Editor To…
 Modify edit check code
 Make your edits carefully in the free-form text editor
 Syntax checker catches errors
 Create new edit checks rapidly
 Change the Edit Check Name, save it as a new edit check,
then change the code as needed
 Copy to Clipboard
 Select text, copy to the Clipboard, and then paste into
another edit check—within the same project or between projects
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Check Functions – New
Operates on
Check Functions
Numbers
Add
(numeric data values
and /or numeric constants)
Subtract
Multiply
Divide
Date
(date fields)
AddDay
AddMonth
AddYear
DaySpan
Age
Time
(date/time fields)
AddSec
AddMin
AddHour
TimeSpan
Strings
StringAdd – not used
Forms
IsActive (Boolean)
IsPresent (Boolean) – not used
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Filtering Based on Test Requirement Levels
 For edit checks and derivations that have been copied
from another source, can filter edit checks by testing level
 Retesting requirements are included in Architect Loader
downloads (NeedsRetesting and RetestingReason columns)
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Other Check Function Changes
 Sorting
 Sort edit checks by clicking Name or Bypass during Migration columns
 Forms drop-down list is sorted alphabetically
 Reordering Check Steps
 Change the order of check steps using the Reorder button
 Confirm Variable Attribute Changes
 If you change an attribute of a variable that is referenced by edit checks
and/or derivations, Architect prompts you to confirm changes
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Other Check Function Changes (continued)
 Use Max Add – Add Matrix edit check
 Use Max Add option to prohibit or allow the edit check to add matrices
beyond the maximum specified for the matrix
 Edit Check Log Report
 Track and troubleshoot performance issues for edit checks
 Rave standard report that is currently undergoing the validation process
 Logical Record Position (LRP)
 Functionality will not be implemented yet
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Exercise – Lesson 5
 See page 22
 Refer to SLACs handout & Mock eCRFs
 Demo study (BLDD3000g_D) has pre-built edit
checks
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Lesson 6: Amendment Manager & Study Migration
 Amendment Manager
 Amendment Manager Scheduler
 the Study Migration Business
ProcesChanges to s
 Hands-on Exercise
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Amendment Manager
 No major enhancements in Rave 5.6.3
 Fixes to some of the known issues
 When preparing to migrate a study in the Amendment
Manager, consult the latest Rave 5.6.3 Known Issues list
for current problems with Amendment Manager
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Amendment Manager Scheduler - New
 Schedule CRF migration jobs in advance
 Migration jobs wait in a job queue until configured start time
 Amendment Manager Scheduler fires the job and saves
the results in a log with:
 job status
 whether the job succeeded or failed
 Jobs execute independently
 If you have three scheduled migration jobs and the second job fails,
the third job will execute regardless
 Need Lead CASA security role
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Launching the Scheduler
 Click Amendment Manager Scheduler
 Migration job queue shows only jobs that
have not yet completed
 See Participant Guide p. 28 - Migration Properties
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Filtering the Migration Job Queue
 You can filter jobs individually or in combination
 By default, no filters are set
 Filter by study
 Select a study from the drop-down list
 Filter by job status
 Select Active, Inactive, or Both
 Filter by job number
 Enter the job number and click Search
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Migration Job Tasks
 Add
 On the Amendment Manager Scheduler main page,
click Add Schedule and specify
– Job #
– Start Date / Time
– End Date / Time
 Edit
 Any migration job in the job queue that has not already completed
 Inactivate
 Any migration job in the job queue that has not already completed
 Delete
 Any migration job in the job queue that has not already completed
 However, if there is only one schedule for the job, it cannot be deleted
 Showing Migration Job Details
 In the migration jobs list, hover the mouse over one of the data values in the list
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Study Migration Business Process
 Currently undergoing review based on proposed changes
 Pilot of the new process expected Q1
 Current business process remains in effect
until recommended changes, if any, are approved
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Exercise – Lesson 6
 See page 29
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Lesson 7: Architect Loader
 Subset Download Functionality
 Results in Excel
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Subset Download in Architect Loader - New
 Select and download a partial draft
(selected subset of study components)
 Download button moved from Drafts Settings
to Draft Summary / Download
 Protect Worksheets option allows you to create a spreadsheet
with protected worksheets (to prevent users from changing
important data)
 you can subsequently remove the protection if necessary
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Select a Subset Download
Select items
to download
Click to download
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Results in Excel
Downloaded Items Only
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Lesson 8: Publish in Place
 About Publish in Place
 Overwriting an Existing CRF Version
 Restoring a CRF Version
 Locking a CRF Version
 Recommendations for Using
Publish in Place
 Hands-on Exercise
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Publish in Place – New
 Overwrite an existing CRF Version with
an existing CRF Draft
 Minimize the number of CRF versions
 Can lock a CRF version to prevent it from being
overwritten
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Overwriting a CRF Version
 Click Overwrite and confirm
 After overwriting a CRF version, Architect adds this event
to the Version History
 Can restore the draft to its original state
(under a different name)
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Overwriting a CRF Version (continued)
 Changes in CRF Draft are not immediately displayed in
the EDC module (see handout)
 Until a subject is refreshed, the EDC module displays
an In Doubt icon
next to affected EDC subjects
 Once refreshed…
 changes are displayed
 all edit checks and derivations are re-run
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Restoring a CRF Version
 On the Version details page, in the Version History box,
click the Restore as Draft button
next to CRF version to
restore
 When prompted, enter a different draft name
(unique within the project)
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Locking a Draft
 Lock a CRF version to ensure that it cannot be overwritten
 Production is Automatically Locked
 Select (check) the Lock CRF Version check box
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Planning Group Recommendations for Publish in Place
 For UAT, always publish and push a new CRF version
 In P1 and P2, do not use Overwrite in/during UAT
 Lead CASA must lock the CRF version that is pushed to UAT
 As a best practice, lock and unlock your own version only
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Exercise – Lesson 8
 See page 35
 Expected results for 2c – won’t see it
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Conclusion
 Review
 Where to Go From Here
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What Was Covered in This Training
 log line changes
 Architect navigation changes
 radio button changes
 Publish in Place (new)
 PDF Generator changes
 Edit check and derivation changes
 Amendment Manager Scheduler (new)
 Architect Loader changes
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Next Steps
 Please sign the Group Training Record
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