1. Rave Gap Training for Study Builders Cherie Stabell, Clinical Data Management Himal Desai, Medidata Solutions
• Introductions (~4 minutes)
• Walk through PPT slides (extemporaneous)
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

2. Housekeeping Ground Rules About This Course
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

3. Where are the bathrooms? When will we take breaks?
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 s?
Log onto your training computer:
Unix ID & password
Log on to: GNE
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

4. Questions are welcome at all times Respectful and safe environment
Ground Rules
Let’s have fun
Questions are welcome at all times
Respectful and safe environment
Parking lots for deferred discussion topics
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

5. Purpose of this Training Learning Objectives in this Training
Lesson 1: Introduction
Purpose of this Training
Learning Objectives in this Training
Sample Study Used in this Training
Training Prerequisites
Rave Resources
Summarize the learning objectives of Lesson 1. (Participant Guide pp. 1-4)
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

6. Purpose of this Training
Scope:
Architect
Architect Loader
PDF Generator Modules
New and changed features of the Rave 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
Summarize the course purpose.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

7. 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
Summarize the course learning objectives
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

8. Training Sample Study
Describe the training sample study (Participant Guide p. 5).
Provides commonly-used functionality.
Generalized but not comprehensive.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

9. 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 Release Notes
Medidata’s Cumulative Rave Known Issues list
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

10. Reactivation of Log Lines Default Value Delimiters for Log Fields
Lesson 2: Log Lines
Reactivation of Log Lines
Default Value Delimiters for Log Fields
Hands-on Exercise
Summarize the learning objectives of Lesson 2. (Participant Guide pp. 5-6)
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

11. 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
For log lines that were inactivated in the previous environment, the Reactivate link will be displayed automatically.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

12. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

13. 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 environment (that is, without restrictions)
Any inactivated log lines will remain inactivated
In general, this change will not be retroactively implemented in existing studies.
Can submit an EDC Amendment and Study Migration form. If approved, to enable restrictions, you need to manually add the terminating delimiter to the list of default values.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

14. Genentech naming conventions for versions…
Exercise – Lesson 2
See page 6
Training URL:
Login: buildsc_#
Push to Dev (not PROD)
Genentech naming conventions for versions…
Direct learners to complete the exercise.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

15. 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.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

16. Lesson 3: Navigation and Radio Buttons
Previewing Forms Before Copying to the Global Library Copy Wizard
Go Back Link
Radio Buttons
Hands-on Exercise
Summarize the learning objectives of Lesson 3. (Participant Guide pp. 7-10)
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

17. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

18. Go Back Link – New
In the Form Details screen, click Go Back to get to the Forms summary screen
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

19. 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
If at least one radio button is selected, an edit check can be configured to check for empty values and fire a query to prompt the user to make a selection.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

20. 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)
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

21. Exercise – Lesson 3 See page 10
Direct learners to complete the exercise.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

22. New Configuration Settings Profile Changes to PDF Generator
Lesson 4: PDF Generator
New Configuration Settings
Profile Changes to PDF Generator
How Configuration Settings Affect PDFs
Summarize the learning objectives of Lesson 4. (Participant Guide pp )
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

23. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

24. 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
Annotated eCRF Setting—based on recommendations from a team that studied this feature
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

25. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

26. Comparison: Rave 5.6.1 and 5.6.3 Settings
Blank PDF Setting
Annotated eCRF Setting
Hyperlinks
Circled numbers on the first page are hyperlinks to get you to the second page.
Proposed items
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

27. Lesson 5: Edit Checks and Derivations
Quick Edit Editor
New Check Functions
Other Edit Check Changes
Hands-on Exercise
Summarize the learning objectives of Lesson 5. (Participant Guide pp )
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

28. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

29. Quick Edit Editor On the Check Steps page, click the Quick Edit link
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

30. 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|||||||||||
IsNotEmpty|||||||||||
And|||||||||||
Check Action
|||BPS||||OpenQuery|Systolic Blood Pressure is less than or equal to the Diastolic Blood Pressure. Please review your entries.|Site|
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

31. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

32. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

33. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

34. 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)
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

35. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

36. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

37. Refer to SLACs handout & Mock eCRFs
Exercise – Lesson 5
See page 22
Refer to SLACs handout & Mock eCRFs
Demo study (BLDD3000g_D) has pre-built edit checks
Direct learners to complete the exercise.
DEMO the Timespan check function
Let learners try the exercises and follow up with any questions.
BMI Formula: weight/ ((height x height) x 10000) (because height is in cm)
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

38. Lesson 6: Amendment Manager & Study Migration
Amendment Manager Scheduler
the Study Migration Business ProcesChanges to s
Hands-on Exercise
Summarize the learning objectives of Lesson 6. (Participant Guide pp )
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

39. 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 Known Issues list for current problems with Amendment Manager
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

40. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

41. Launching the Scheduler
Click Amendment Manager Scheduler
Migration job queue shows only jobs that have not yet completed
See Participant Guide p Migration Properties
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

42. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

43. Migration Job Tasks Add Edit Inactivate Delete
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
Delete
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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

44. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

45. Exercise – Lesson 6 See page 29
Direct learners to complete the exercise.
(optional) Skip Step #5.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

46. Lesson 7: Architect Loader
Subset Download Functionality
Results in Excel
Summarize the learning objectives of Lesson 7. (Participant Guide pp )
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

47. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

48. Select a Subset Download
Select items to download
Click to download
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

49. Results in Excel Downloaded Items Only
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

50. 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
Summarize the learning objectives of Lesson 8. (Participant Guide pp )
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

51. Overwrite an existing CRF Version with an existing CRF Draft
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
Best practices document and job aid being developed for SSF
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

52. 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)
adding new study components from the source that do not yet exist in the target
removing any study components in the target that do not exist in the source
overwriting properties for study components that exist in both (components share an OID)
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

53. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

54. 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)
Architect restores the newly-named draft from the source version and updates subjects associate with the overwritten CRF version.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

55. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

56. 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
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

57. Expected results for 2c – won’t see it
Exercise – Lesson 8
See page 35
Expected results for 2c – won’t see it
Direct learners to complete the exercise.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

58. Conclusion Review Where to Go From Here
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

59. 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
Recap what was covered.
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management

60. Please sign the Group Training Record
Next Steps
Please sign the Group Training Record
Direct learners to sign the Group Training Record
Rave Gap Training for Study Builders ver. 1.1
Clinical Data Management