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Rave 5.6.3 Gap Training for Study Builders Cherie Stabell, Clinical Data Management Himal Desai, Medidata Solutions.

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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."— Presentation transcript:

1 Rave Gap Training for Study Builders Cherie Stabell, Clinical Data Management Himal Desai, Medidata Solutions

2 © 2009 by Genentech, Inc. – Ver About This Course  Housekeeping  Ground Rules

3 © 2009 by Genentech, Inc. – Ver 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

4 © 2009 by Genentech, Inc. – Ver Ground Rules  Let’s have fun  Questions are welcome at all times  Respectful and safe environment  Parking lots for deferred discussion topics

5 © Genentech Inc. – Ver Lesson 1: Introduction  Purpose of this Training  Learning Objectives in this Training  Sample Study Used in this Training  Training Prerequisites  Rave Resources

6 © 2009 by Genentech, Inc. – Ver 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

7 © 2009 by Genentech, Inc. – Ver 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

8 © 2009 by Genentech, Inc. – Ver Training Sample Study

9 © 2009 by Genentech, Inc. – Ver Rave 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  Medidata Rave Release Notes  Medidata’s Cumulative Rave Known Issues list

10 © Genentech Inc. – Ver Lesson 2: Log Lines  Reactivation of Log Lines  Default Value Delimiters for Log Fields  Hands-on Exercise

11 © 2009 by Genentech, Inc. – Ver 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

12 © 2009 by Genentech, Inc. – Ver 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

13 © 2009 by Genentech, Inc. – Ver Default Repeat Log Forms in 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

14 © 2009 by Genentech, Inc. – Ver Exercise – Lesson 2  See page 6  Training URL: https://gentrn563.mdsol.com  Login: buildsc_#  Push to Dev (not PROD)  Genentech naming conventions for versions…

15 © 2009 by Genentech, Inc. – Ver 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.

16 © Genentech Inc. – Ver Lesson 3: Navigation and Radio Buttons  Previewing Forms Before Copying to the Global Library Copy Wizard  Go Back Link  Radio Buttons  Hands-on Exercise

17 © 2009 by Genentech, Inc. – Ver 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

18 © 2009 by Genentech, Inc. – Ver Go Back Link – New  In the Form Details screen, click Go Back to get to the Forms summary screen

19 © 2009 by Genentech, Inc. – Ver 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

20 © 2009 by Genentech, Inc. – Ver 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)

21 © 2009 by Genentech, Inc. – Ver Exercise – Lesson 3  See page 10

22 © Genentech Inc. – Ver Lesson 4: PDF Generator  New Configuration Settings  Profile Changes to PDF Generator  How Configuration Settings Affect PDFs

23 © 2009 by Genentech, Inc. – Ver New PDF Generator Settings in Rave  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

24 © 2009 by Genentech, Inc. – Ver Profile Changes for PDF Generator  Blank PDF Setting—uses settings from Rave  Annotated eCRF Setting—uses new settings in Rave  Select the profile when you configure a PDF file

25 © 2009 by Genentech, Inc. – Ver 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

26 © 2009 by Genentech, Inc. – Ver Comparison: Rave and Settings Blank PDF Setting Annotated eCRF Setting Proposed items Hyperlinks

27 © Genentech Inc. – Ver Lesson 5: Edit Checks and Derivations  Quick Edit Editor  New Check Functions  Other Edit Check Changes  Hands-on Exercise

28 © 2009 by Genentech, Inc. – Ver 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

29 © 2009 by Genentech, Inc. – Ver Quick Edit Editor  On the Check Steps page, click the Quick Edit link

30 © 2009 by Genentech, Inc. – Ver 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|

31 © 2009 by Genentech, Inc. – Ver 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

32 © 2009 by Genentech, Inc. – Ver 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

33 © 2009 by Genentech, Inc. – Ver 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

34 © 2009 by Genentech, Inc. – Ver 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)

35 © 2009 by Genentech, Inc. – Ver 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

36 © 2009 by Genentech, Inc. – Ver 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

37 © 2009 by Genentech, Inc. – Ver Exercise – Lesson 5  See page 22  Refer to SLACs handout & Mock eCRFs  Demo study (BLDD3000g_D) has pre-built edit checks

38 © Genentech Inc. – Ver Lesson 6: Amendment Manager & Study Migration  Amendment Manager  Amendment Manager Scheduler  the Study Migration Business ProcesChanges to s  Hands-on Exercise

39 © 2009 by Genentech, Inc. – Ver Amendment Manager  No major enhancements in Rave  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

40 © 2009 by Genentech, Inc. – Ver 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

41 © 2009 by Genentech, Inc. – Ver Launching the Scheduler  Click Amendment Manager Scheduler  Migration job queue shows only jobs that have not yet completed  See Participant Guide p Migration Properties

42 © 2009 by Genentech, Inc. – Ver 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

43 © 2009 by Genentech, Inc. – Ver 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

44 © 2009 by Genentech, Inc. – Ver 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

45 © 2009 by Genentech, Inc. – Ver Exercise – Lesson 6  See page 29

46 © Genentech Inc. – Ver Lesson 7: Architect Loader  Subset Download Functionality  Results in Excel

47 © 2009 by Genentech, Inc. – Ver 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

48 © 2009 by Genentech, Inc. – Ver Select a Subset Download Select items to download Click to download

49 © 2009 by Genentech, Inc. – Ver Results in Excel Downloaded Items Only

50 © Genentech Inc. – Ver 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

51 © 2009 by Genentech, Inc. – Ver 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

52 © 2009 by Genentech, Inc. – Ver 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)

53 © 2009 by Genentech, Inc. – Ver 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

54 © 2009 by Genentech, Inc. – Ver 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)

55 © 2009 by Genentech, Inc. – Ver 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

56 © 2009 by Genentech, Inc. – Ver 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

57 © 2009 by Genentech, Inc. – Ver Exercise – Lesson 8  See page 35  Expected results for 2c – won’t see it

58 © Genentech Inc. – Ver Conclusion  Review  Where to Go From Here

59 © 2009 by Genentech, Inc. – Ver 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

60 © 2009 by Genentech, Inc. – Ver Next Steps  Please sign the Group Training Record


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