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Rave 5.6.3 Gap Training for Study Builders Cherie Stabell, Clinical Data Management Himal Desai, Medidata Solutions
© 2009 by Genentech, Inc. – Ver. 1.1 2 About This Course Housekeeping Ground Rules
© 2009 by Genentech, Inc. – Ver. 1.1 3 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. 1.1 4 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. 1.0 5 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. 1.1 6 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. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 8 Training Sample Study
© 2009 by Genentech, Inc. – Ver. 1.1 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 5.6.3 Release Notes Medidata’s Cumulative Rave 5.6.3 Known Issues list
© Genentech Inc. – Ver. 1.0 10 Lesson 2: Log Lines Reactivation of Log Lines Default Value Delimiters for Log Fields Hands-on Exercise
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 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 5.6.1 environment (that is, without restrictions) Any inactivated log lines will remain inactivated
© 2009 by Genentech, Inc. – Ver. 1.1 14 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. 1.1 15 Exercise – Lesson 2 – Version Naming Conventions CCC_R#.#_###_ddMMMyy_AAA where CCCEnvironment 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. ddMMMyyDate on which the version was created, AAAInitials 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. 1.0 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
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 18 Go Back Link – New In the Form Details screen, click Go Back to get to the Forms summary screen
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 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)
© 2009 by Genentech, Inc. – Ver. 1.1 21 Exercise – Lesson 3 See page 10
© Genentech Inc. – Ver. 1.0 22 Lesson 4: PDF Generator New Configuration Settings Profile Changes to PDF Generator How Configuration Settings Affect PDFs
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 26 Comparison: Rave 5.6.1 and 5.6.3 Settings Blank PDF Setting Annotated eCRF Setting Proposed items Hyperlinks
© Genentech Inc. – Ver. 1.0 27 Lesson 5: Edit Checks and Derivations Quick Edit Editor New Check Functions Other Edit Check Changes Hands-on Exercise
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 29 Quick Edit Editor On the Check Steps page, click the Quick Edit link
© 2009 by Genentech, Inc. – Ver. 1.1 30 Quick Edit Editor – Example Edit Check Code SectionCode 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||||||||||| 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. 1.1 31 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 SectionSyntax 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. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 33 Check Functions – New Operates onCheck 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. 1.1 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)
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 37 Exercise – Lesson 5 See page 22 Refer to SLACs handout & Mock eCRFs Demo study (BLDD3000g_D) has pre-built edit checks
© Genentech Inc. – Ver. 1.0 38 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. 1.1 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 5.6.3 Known Issues list for current problems with Amendment Manager
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 41 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. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 43 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. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 45 Exercise – Lesson 6 See page 29
© Genentech Inc. – Ver. 1.0 46 Lesson 7: Architect Loader Subset Download Functionality Results in Excel
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 48 Select a Subset Download Select items to download Click to download
© 2009 by Genentech, Inc. – Ver. 1.1 49 Results in Excel Downloaded Items Only
© Genentech Inc. – Ver. 1.0 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
© 2009 by Genentech, Inc. – Ver. 1.1 51 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. 1.1 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)
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 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)
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 57 Exercise – Lesson 8 See page 35 Expected results for 2c – won’t see it
© Genentech Inc. – Ver. 1.0 58 Conclusion Review Where to Go From Here
© 2009 by Genentech, Inc. – Ver. 1.1 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
© 2009 by Genentech, Inc. – Ver. 1.1 60 Next Steps Please sign the Group Training Record
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