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Rave 5.6.3 Gap Training for Study Builders Cherie Stabell, Clinical Data Management Himal Desai, Medidata Solutions • Introductions (~4 minutes) • Walk.

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Presentation on theme: "Rave 5.6.3 Gap Training for Study Builders Cherie Stabell, Clinical Data Management Himal Desai, Medidata Solutions • Introductions (~4 minutes) • Walk."— Presentation transcript:

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: https://gentrn563.mdsol.com 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


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