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About This Course

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?

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About This Course

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  1. Rave 5.6.3 Gap Training for Study BuildersCherie Stabell, Clinical Data ManagementHimal Desai, Medidata Solutions

  2. About This Course • Housekeeping • Ground Rules

  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

  4. Ground Rules • Let’s have fun • Questions are welcome at all times • Respectful and safe environment • Parking lots for deferred discussion topics

  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

  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

  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

  8. Training Sample Study

  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

  10. Lesson 2: Log Lines • Reactivation of Log Lines • Default Value Delimiters for Log Fields • Hands-on Exercise

  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

  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 | 5Add 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. 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

  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…

  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.

  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

  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

  18. Go Back Link – New • In the Form Details screen, click Go Backto get to the Forms summary screen

  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

  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)

  21. Exercise – Lesson 3 • See page 10

  22. Lesson 4: PDF Generator • New Configuration Settings • Profile Changes to PDF Generator • How Configuration Settings Affect PDFs

  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

  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

  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

  26. Comparison: Rave 5.6.1 and 5.6.3 Settings Blank PDF Setting Annotated eCRF Setting Hyperlinks Proposed items

  27. Lesson 5: Edit Checks and Derivations • Quick Edit Editor • New Check Functions • Other Edit Check Changes • Hands-on Exercise

  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

  29. Quick Edit Editor • On the Check Steps page, click the Quick Edit link

  30. Quick Edit Editor – Example Edit Check Code

  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

  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

  33. Check Functions – New

  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)

  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

  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

  37. Exercise – Lesson 5 • See page 22 • Refer to SLACs handout & Mock eCRFs • Demo study (BLDD3000g_D) has pre-built edit checks

  38. Lesson 6: Amendment Manager & Study Migration • Amendment Manager • Amendment Manager Scheduler • the Study Migration Business ProcesChanges to s • Hands-on Exercise

  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

  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

  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

  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

  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

  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

  45. Exercise – Lesson 6 • See page 29

  46. Lesson 7: Architect Loader • Subset Download Functionality • Results in Excel

  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

  48. Select a Subset Download Select items to download Click to download

  49. Results in Excel Downloaded Items Only

  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

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