EDC Training: Rave Basics for Development

1 EDC training : Rave Basics for DevelopmentLeader Guide to Participant Guide [5 Oct 09]Confidential and ProprietaryCopyright 2009 Genentech, Inc. This document isproprietary and confidential. It remains the property ofGenentech, Inc. at all times. No part of this document may beused, reproduced, or transmitted in any form or by any means,electronic or mechanical, including photocopying and recording,for any purpose without express consent of Genentech, Inc. iiEDC training : Rave Basics for DevelopmentACKNOWLEDGMENTSThis version of this guide owes its inception to the efforts of the EDC team at Genentech and Development Learning Solutions. Cover Photo Patient Profiles (left to right) Ben, Pulmozyme Patient At birth Ben weighed in at over nine pounds and, by all accounts, seemed to be a healthy six months old and after two hospitalizations for pneumonia, Ben was diagnosed with cysticfibrosis (CF).

2 At 18 months old Ben had a two-week hospital stay for CF, and at the age of twoBen started Pulmozyme therapy as part of his treatment regimen. Now 13, Ben is a lively sev-enth-grader with a voracious appetite for life. He has a passion for math, movies, computergames and wizard stories. An avid snowboarder and surfer, Ben is also a right defender andright mid-fielder on his competitive soccer team. Ben s family reports that his daily treatmentregimen is under an hour and, with the assistance of Pulmozyme therapy, Ben enjoys the life ofan active teenage and Alison, Nutropin Patients Nutropin is indicated for growth hormone deficiency in children and adults, growth failureassociated with chronic renal insufficiency, and short stature associated with Turner Syndrome. Jane, Rituxan Patient Six years ago, in 1998, Jane discovered a lump on her collarbone.

3 Thinking it was some type ofmuscular inflammation, she went to the doctor to have it examined. The doctors performed abiopsy on the lump and discovered that she had non-Hodgkin s lymphoma. After telling her fam-ily that she had non-Hodgkin s lymphoma, her daughter, who had just started working atGenentech, mentioned that her company had recently launched a new drug for non-Hodgkin slymphoma, Rituxan. Jane started taking Rituxan and soon discovered that her tumor wasshrinking. After a year, she was in remission and went off of Rituxan. Jane credits her daughter snew job at Genentech for helping her find the drug that helped treat her Date5 Oct 09 Amendment History Genentech, Inc. LESSON iiiiAcknowledgmentsiiiClass PreparationixInstructor InformationxRave RolesxRave User GroupsxiiNAVIGATING RAVE11 Introduction2 About Medidata Rave2 What You Will Learn in the Rave Basics Training3 Sample Study Used in this Training5 training Prerequisites5 EDC Help Desk52 Key Rave Concepts7 Rave and Genentech EDC Studies7 Rave Architecture: EDC and Related Modules8 Integration with Other Genentech Systems113 Getting Started16 Obtain a Rave User Account16 Log Into Rave19 Rave Home Page22 Customize Your Rave Settings25 Log Out of Rave284 Basic Navigation29 Organization of Study Data29 Navigation Tips34 Select a Study37 Study Page38 View a Site39 Site Page41 Rave s Online Help425 Viewing Subject Information43 About Subjects43 View a Subject43 Subject Page Calendar View44ivLESSON EDC training .

4 Rave Basics for DevelopmentSubject Page Grid View47 Search for a Subject496 Viewing eCRFs Associated with a Subject53 About eCRFs53eCRF Page54 View eCRFs587 Working with eCRFs67 Introducing Queries67 Introducing Sticky Notes69 View the Audit Trail71 Get Help for eCRFs73 Print eCRFs748 Viewing Reports76 About Reports76 Start the Reporter Module76 List of Rave Reports78 Run Reports81 Class Project #192 Conclusion to Section 193 What You Have Learned in This Section93 Where To Go From Here93 Break94iWORKING WITH CLINICAL DATA959 Clinical Data Life Cycle96 Overview of the Clinical Data Life Cycle96 Submit Phase97 Verify Phase97 Freeze Phase98 Sign-Off Phase98 Lock Phase98 Summary of Requirements9910 Submitting Clinical Data100 About Submitting Clinical Data in Rave100 Adding Subjects104 Genentech, Inc. LESSON vSteps for Submitting eCRF Data106 Submit eCRF Data for a Subject109 Add Events (Unscheduled Visits)

5 113 Submit Local Lab Forms11411 Using Log eCRFs118 About Log eCRFs118 Submit Data for Log eCRFs120 Inactivate a Log Line12212 Reporting Adverse Events in Rave124 About Adverse Events124 Business Process for Serious Adverse Event Reporting125 Adverse Events Folder in Rave125 Submit an Adverse Event12613 Using Queries132 About Queries132 Respond to Queries136 Open Manual Queries138 Cancel Manual Queries141 Handle the Query Response14314 Using Sticky Notes145 About Sticky Notes145 Acknowledge a Sticky Note146 Add a Sticky Note14715 Inactivating eCRFs150 Inactivate eCRFs and Folders150 Subject Administration151 Inactivate and Activate Folders152 Inactivate and Activate eCRFs153 Add Forms and Folders15616 Verifying Data159 About Data Verification159 Verify Data160 Unverify Data161 Batch Verify Using the Grid View162viLESSON EDC training : Rave Basics for Development17 Freezing Data164 About Freezing Data164 Freeze Data165 Unfreeze Data166 Batch Freeze Using the Grid View16718 Signing off Data169 About Electronic Signatures169 Sign Off Subjects170 Sign Off Individual eCRFs171 Batch Sign Off Using the Grid View17219 Locking Data173 About Locking Data173 Lock Data174 Unlock Data175 Batch Lock Using the Grid View176 Class Project #2178 Conclusion to Section 2179 training Review179 Where To Go From Here179iGlossary 181iIndex 191 Genentech, Inc.

6 LESSON ixCLASS PREPARATIONP rior to the day of the class, contact the EDC Help Desk to:iObtain a sufficient number of copies of the EDC Rave Basics Participant GuideiReserve a training facility with:iInstructor s computer that is connected to an overhead projectoriInternet access from all attendees computersOn the day of the class, you need the following:iDry erase agenda poster and peniParticipant name placardsiEDC Rave Basics Instructor s GuideiEDC Rave Basics Participant GuideiRave Basics for Development PowerPoint PresentationiTraining Signoff Form (if applicable)iEDC User Account Management and training FormsiTraining Evaluation FormsOn the day of the class, you will need to complete the following tasks:iAssign each attendee a unique training user number that correlates with the user accounts that they will use to log into Rave. Assign yourself a blank subject (to demo submitting data), and assign all learners a blank subject in a specific the leader s machine:iOpen the PowerPoint presentation.

7 On the title page, specify your leader name, role, and the class date. Verify that the title page is displayed that you can view the Rave login screen by entering the training URL ( ) into the browser address that you can log into Rave with each of the user accounts / roles that you will be using during the training : CRC, CRA, PI, and that the data in the training sample study are correct (refreshed).iFrom each learner s machine:iConfirm that you can view the Rave login screen by entering the training URL ( ) into the browser address that you can log into Rave with each of the user accounts / roles that the attendee will be using during the training : CRC, CRA, and others if EDC training : Rave Basics for DevelopmentINSTRUCTOR INFORMATIONRave RolesThe following table shows some Rave roles used at Genentech (in the production environment) and the types of users assigned to RolesRole NameUsed ByCASAC linical Applications Systems AnalystCRAC linical Site ManagerCRCSite Coordinators.

8 Data Entry Trial ManagerDMProject Data ManagerINTDevIT Integrations SupportLDMLab Data ManagerPIStudy Investigators. Data Entry clinical data providers, such as Reading Centers. Data Entry SpecialistSPAS tatistical ProgrammerVIEWAll other users (examples: Medical Director, Biostat-isticians)Timing EstimatesEstimated duration for Development attendees: about 4 following timeline provides an approximation of the time needed to complete each lesson. Individual classes may vary based on the size of the group, time to answer questions and provide extra assistance, length of breaks, and other 1: Navigating RaveStart the class (8 mins) (8 mins) Rave Concepts (12 mins) Started (16 mins) Navigation (13 mins) Subject Information (12 mins) eCRFs Associated with a Subject (11 mins) Reports (11 mins) Project #1 (6 mins)Section 2: Navigating Data Life Cycle (4 mins) Clinical Data (19 mins) Log eCRFs (10 mins) Adverse Events in Rave (13 mins) Queries (20 mins) Sticky Notes (8 mins) eCRFs (10 mins) Data (7 mins) Data (6 mins) off Data (6 mins) Data (6 mins) Project #2 (10 mins)Wrap up Section 2 (8 mins) Genentech, Inc.

9 LESSON xiRave User GroupsThe following table shows some of the user groups defined at Genentech. Most users (including training users) are associated with the user group called User GroupsUser GroupUsers Have Access ToUserEDC and Reporter modules, usually, a data entry AdminAll modules used by Genentech except AdminAll modules used by Genentech except the Architect and Configuration module. Usually, this user is in the PDIT group who would need to access most modules to trouble-shoot, re-create issues, and identify causes and solutions to module, PDF Generator, Report Administration and Reporter. Able to generate PDF files, create forms and edit checks in Architect, create and execute migration, and access clinical data and view AdminConfiguration module to perform the core configuration or updates to these AdminEDC Module, PDF Generator, Report Administration, and Reporter module.

10 Able to access clinical data, assign other users access to specific reports or assign access to reports at specific levels, and view Admin User Administration module only. Able to create users, lock out or unlock users, inactivate users, and assign, un-assign and re-assign users to user groups, roles and study sites, and receive User-related Admin Architect, EDC, Global Library, Lab Administration, Site Administration and Reporter modules. Able to create, edit and delete Lab global objects, add or modify Lab Settings via Architect, create forms and edit checks in Architect, add, edit and delete items in the Standard Study, assign local labs to the study via Site Administration, access clinical data for all studies within the site group; and view reports. Global Librarian Architect, EDC, Global Library, and Reporter modules. Able to add, edit or delete items in the EDC Standard Study, access clinical data, and view EDC training : Rave Basics for DevelopmentSODA Int AdminArchitect, Site Administration and User Administration modules.