Medidata Rave Start-Up Information

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Medidata Rave Start-Up Information
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Medidata RaveMedidata Rave is a registered
trademark of Medidata Solutions Worldwide

• A web based electronic data collection system
  (EDC)
• Only requires a web browser and internet
  connection
• Data will be entered at the site by a Rave
  Clinical Research Associate (CRA role)
• No paper case report forms submitted to RTOG

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Steps for Registering for the RTOG-1115
Studywww.ctsu.org Rave tab

• Obtain authorization for your site through the
  Regulatory Support System (RSS). Refer to the
  RSSQuickFactsSheet.pdf file for details. This
  web-enabled system is managed by the CTSU.
• Obtain CTEP-IAM accounts for site coordinators
  and investigators. Refer to the
  CTEP-IAM_FactSheet.pdf file for details.
• Patients are registered for a study using the
  Oncology Patient Enrollment Network (OPEN) after
  sites have been authorized in RSS.
• The enrollment information entered in OPEN will
  automatically be posted to the RTOG-1115 Rave
  database.
• Access to iMedidata and Rave is controlled
  through the CTEP-IAM system and through role
  assignments made in the RSS system.
• The first time your site receives approval for a
  Rave study, you will receive an iMedidata
  Invitation email that will enable you to login
  to that Rave database as either a CRA or an
  Investigator, depending on the role that was
  assigned in RSS.
• Refer to the Rave_Activate_iMedidata_Account.pdf
  file for details.
• Review the www.ctsu.org website for detailed
  information on RSS, CTEP-IAM, Rave, and OPEN.

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Rave Account Activation

• Once your site has RSS authorization and users
  have been registered with a CTEP-IAM account,
  users will receive an email invitation from
  iMedidata-Notification_at_mdsol.com to set up their
  Rave account. Make sure this email is not in a
  Junk or Spam mailbox.
• Click on the link inside the email and follow the
  instructions provided. Remember your login name
  and password for future access to Rave.

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Rave Account Activation Invitation Email

• Dear User,
• Welcome to iMedidata.com -- a faster, simpler way
  to access all your Medidata Rave studies,
  Medidata applications and online discussions in
  one place. You've been invited to activate your
  new account. Please click on the following link
• http//www.imedidata.com/users/......../activation
  ?localeeng
• If clicking the link above does not work, copy
  and paste the URL in a new browser window
  instead.
• If you are a current user of Rave and would like
  a brief tutorial on connecting your Rave account
  to iMedidata, please click on the following
  video
• http//www.imedidata.com/WebHelpVideos_ENG/init.ht
  m
• Thank you for using iMedidata. For more
  information please visit http//www.imedidata.com.
  For support with your new account, please email
  helpdesk_at_mdsol.com.
• This is a post-only mailing. Replies to this
  message are not monitored or answered.
• Medidata Solutions Worldwide

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Accept Study Invitation and Perform eLearnings

• After login, there will be an invitation to join
  the RTOG-1115 study. Accept this invitation.
• A list of eLearning modules will then be on your
  welcome screen.
• Click each module to run the associated course.
  After completion of required course(s), you will
  have access to your assigned study.
• Credit for taking the eLearning modules will
  apply to all Cooperative Groups Rave studies.
• Users have required eLearning modules and
  optional eLearning modules

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eLearning Modules

• Modules for CRAs
• EDC Essentials for Clinical Research Coordinators
  (required) 45 min
• EDC Inspection Readiness for Clinical Sites
  (optional) 30 min
• Data Privacy Considerations for Clinical Sites
  (optional) 50 min
• Modules for Investigators
• EDC Essentials for Investigators with Data Entry
  (required) 50 min
• EDC Inspection Readiness for Clinical Sites
  (optional) 30 min
• Data Privacy Considerations for Clinical Sites
  (optional) 50 min

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Access Study RTOG-1115Select the EDC Link to
Perform EDC Functions
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Select a (real) Subject (from a real site)
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Select a Folder (and a Form from a Folder)
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New Folders and Forms will Appear Automatically

• Refer to Section 12 of the RTOG-1115 protocol for
  detailed information regarding what folders and
  forms are used for this study.
• As information is added to forms, additional
  forms and folders will appear for the subject
  (patient).
• For example, when the Work Up form is completed
  in the Baseline folder (with a valid response to
  the Performance Status field) and the Save
  button is pressed, then the next series of
  folders and forms will be populated for that
  subject.
• Another example, if in the Month 3 Visit folder,
  the user indicates on the Follow Up form that
  adverse events have occurred or continued, then
  an Adverse Events form will be added to the Month
  3 Visit folder.

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Select a Form (from a Folder)
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Respond to Queries
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Questions ?

• CTSU Help Desk
• 900 AM-530PM EST - (1-888-823-5923)
• Support for Rave Navigation, Rave Functionality,
  iMedidata Navigation, eLearning Assistance,
  Account Access
• Extended hours 530-830PM
• General Rave Navigation and General Account
  Support
• https//www.ctsu.org/public/CTSUContact.aspx
• RTOG
• Protocol Specific Questions go to the Data
  Managers