About This Course

Rave 5.6.3 Gap Training for Study Builders

Cherie Stabell, Clinical Data ManagementHimal Desai, Medidata Solutions

© 2009 by Genentech, Inc. – Ver. 1.12

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?

When can I check my e-mails?

Log onto your training computer: Unix ID & password

Log on to: GNE


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. 1.05

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


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


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


Training Sample Study


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


Lesson 2: Log Lines

Reactivation of Log Lines

Default Value Delimiters for Log Fields

Hands-on Exercise


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


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


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


Exercise – Lesson 2

See page 6

Training URL:https://gentrn563.mdsol.com

Login: buildsc_#

Push to Dev (not PROD)

Genentech naming conventions for versions…


Exercise – Lesson 2 – Version Naming Conventions

CCC_R#.#_###_ddMMMyy_AAAwhere 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.


Lesson 3: Navigation and Radio Buttons

Previewing Forms Before Copying to the Global Library Copy Wizard

Go Back Link

Radio Buttons

Hands-on Exercise


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


Go Back Link – New

In the Form Details screen, click Go Back to get to the Forms summary screen


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


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)



See page 10


Lesson 4: PDF Generator

New Configuration Settings

Profile Changes to PDF Generator

How Configuration Settings Affect PDFs


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


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


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


Comparison: Rave 5.6.1 and 5.6.3 Settings

Blank PDF Setting

Annotated eCRF Setting

Proposed items

Hyperlinks


Lesson 5: Edit Checks and Derivations

Quick Edit Editor

New Check Functions

Other Edit Check Changes

Hands-on Exercise


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


Quick Edit Editor

On the Check Steps page, click the Quick Edit link


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|||||||||||||StandardValue|BPS||||||||IsNotEmpty|||||||||||||StandardValue|BPD||||||||IsNotEmpty|||||||||||And|||||||||||And|||||||||||

Check Action |||BPS||||OpenQuery|Systolic Blood Pressure is less than or equal to the Diastolic Blood Pressure. Please review your entries.|Site|


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

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


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


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


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)


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


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



See page 22

Refer to SLACs handout & Mock eCRFs

Demo study (BLDD3000g_D) has pre-built edit checks


Lesson 6: Amendment Manager & Study Migration

Amendment Manager

Amendment Manager Scheduler

the Study Migration Business ProcesChanges to s

Hands-on Exercise


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


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


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


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


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


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



See page 29


Lesson 7: Architect Loader

Subset Download Functionality

Results in Excel


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


Select a Subset Download

Select items to download

Click to download


Results in Excel

Downloaded Items Only


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


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


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)


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


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)


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


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



See page 35

Expected results for 2c – won’t see it


Conclusion

Review

Where to Go From Here


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


Next Steps

Please sign the Group Training Record

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