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Rave 5.6.3 Gap Training for Study Builders Cherie Stabell, Clinical Data Management Himal Desai, Medidata Solutions. About This Course. Housekeeping Ground Rules. Housekeeping. Where are the bathrooms? When will we take breaks? Where is the break room? Will my cell phone or PDA be ringing? - PowerPoint PPT Presentation
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Rave 5.6.3 Gap Training for Study Builders
Cherie Stabell, Clinical Data ManagementHimal Desai, Medidata Solutions
© 2009 by Genentech, Inc. – Ver. 1.12
About This Course
Housekeeping
Ground Rules
© 2009 by Genentech, Inc. – Ver. 1.13
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
© 2009 by Genentech, Inc. – Ver. 1.14
Ground Rules
Let’s have fun
Questions are welcome at all times
Respectful and safe environment
Parking lots for deferred discussion topics
© Genentech Inc. – Ver. 1.05
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
© 2009 by Genentech, Inc. – Ver. 1.16
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
© 2009 by Genentech, Inc. – Ver. 1.17
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
© 2009 by Genentech, Inc. – Ver. 1.18
Training Sample Study
© 2009 by Genentech, Inc. – Ver. 1.19
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
© Genentech Inc. – Ver. 1.010
Lesson 2: Log Lines
Reactivation of Log Lines
Default Value Delimiters for Log Fields
Hands-on Exercise
© 2009 by Genentech, Inc. – Ver. 1.111
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
© 2009 by Genentech, Inc. – Ver. 1.112
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
© 2009 by Genentech, Inc. – Ver. 1.113
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
© 2009 by Genentech, Inc. – Ver. 1.114
Exercise – Lesson 2
See page 6
Training URL:https://gentrn563.mdsol.com
Login: buildsc_#
Push to Dev (not PROD)
Genentech naming conventions for versions…
© 2009 by Genentech, Inc. – Ver. 1.115
Exercise – Lesson 2 – Version Naming Conventions
CCC_R#.#_###_ddMMMyy_AAAwhere 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.
© Genentech Inc. – Ver. 1.016
Lesson 3: Navigation and Radio Buttons
Previewing Forms Before Copying to the Global Library Copy Wizard
Go Back Link
Radio Buttons
Hands-on Exercise
© 2009 by Genentech, Inc. – Ver. 1.117
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
© 2009 by Genentech, Inc. – Ver. 1.118
Go Back Link – New
In the Form Details screen, click Go Back to get to the Forms summary screen
© 2009 by Genentech, Inc. – Ver. 1.119
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
© 2009 by Genentech, Inc. – Ver. 1.120
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)
© 2009 by Genentech, Inc. – Ver. 1.121
Exercise – Lesson 3
See page 10
© Genentech Inc. – Ver. 1.022
Lesson 4: PDF Generator
New Configuration Settings
Profile Changes to PDF Generator
How Configuration Settings Affect PDFs
© 2009 by Genentech, Inc. – Ver. 1.123
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
© 2009 by Genentech, Inc. – Ver. 1.124
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
© 2009 by Genentech, Inc. – Ver. 1.125
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
© 2009 by Genentech, Inc. – Ver. 1.126
Comparison: Rave 5.6.1 and 5.6.3 Settings
Blank PDF Setting
Annotated eCRF Setting
Proposed items
Hyperlinks
© Genentech Inc. – Ver. 1.027
Lesson 5: Edit Checks and Derivations
Quick Edit Editor
New Check Functions
Other Edit Check Changes
Hands-on Exercise
© 2009 by Genentech, Inc. – Ver. 1.128
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
© 2009 by Genentech, Inc. – Ver. 1.129
Quick Edit Editor
On the Check Steps page, click the Quick Edit link
© 2009 by Genentech, Inc. – Ver. 1.130
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|
© 2009 by Genentech, Inc. – Ver. 1.131
Quick Edit Editor – Syntax
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
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
© 2009 by Genentech, Inc. – Ver. 1.132
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
© 2009 by Genentech, Inc. – Ver. 1.133
Check Functions – New
Operates on Check Functions
Numbers (numeric data values and /or numeric constants)
Add
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
© 2009 by Genentech, Inc. – Ver. 1.134
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)
© 2009 by Genentech, Inc. – Ver. 1.135
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
© 2009 by Genentech, Inc. – Ver. 1.136
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
© 2009 by Genentech, Inc. – Ver. 1.137
Exercise – Lesson 5
See page 22
Refer to SLACs handout & Mock eCRFs
Demo study (BLDD3000g_D) has pre-built edit checks
© Genentech Inc. – Ver. 1.038
Lesson 6: Amendment Manager & Study Migration
Amendment Manager
Amendment Manager Scheduler
the Study Migration Business ProcesChanges to s
Hands-on Exercise
© 2009 by Genentech, Inc. – Ver. 1.139
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
© 2009 by Genentech, Inc. – Ver. 1.140
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
© 2009 by Genentech, Inc. – Ver. 1.141
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
© 2009 by Genentech, Inc. – Ver. 1.142
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
© 2009 by Genentech, Inc. – Ver. 1.143
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
© 2009 by Genentech, Inc. – Ver. 1.144
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
© 2009 by Genentech, Inc. – Ver. 1.145
Exercise – Lesson 6
See page 29
© Genentech Inc. – Ver. 1.046
Lesson 7: Architect Loader
Subset Download Functionality
Results in Excel
© 2009 by Genentech, Inc. – Ver. 1.147
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
© 2009 by Genentech, Inc. – Ver. 1.148
Select a Subset Download
Select items to download
Click to download
© 2009 by Genentech, Inc. – Ver. 1.149
Results in Excel
Downloaded Items Only
© Genentech Inc. – Ver. 1.050
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
© 2009 by Genentech, Inc. – Ver. 1.151
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
© 2009 by Genentech, Inc. – Ver. 1.152
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)
© 2009 by Genentech, Inc. – Ver. 1.153
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
© 2009 by Genentech, Inc. – Ver. 1.154
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)
© 2009 by Genentech, Inc. – Ver. 1.155
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
© 2009 by Genentech, Inc. – Ver. 1.156
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
© 2009 by Genentech, Inc. – Ver. 1.157
Exercise – Lesson 8
See page 35
Expected results for 2c – won’t see it
© Genentech Inc. – Ver. 1.058
Conclusion
Review
Where to Go From Here
© 2009 by Genentech, Inc. – Ver. 1.159
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
© 2009 by Genentech, Inc. – Ver. 1.160
Next Steps
Please sign the Group Training Record