Medidata Rave Start-Up Information 1

Medidata Rave Start-Up Information
Medidata Rave®
Medidata Rave is a registered trademark of Medidata Solutions Worldwide
• A web based electronic data collection
system (EDC)
• Only requires a web browser and internet
• Data will be entered at the site by a Rave
Clinical Research Associate (CRA role)
• No paper case report forms submitted to
Steps for Registering for the
RTOG-1115 Study – 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 website for detailed information on RSS, CTEP-IAM, Rave,
and OPEN.
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: [email protected] 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.
Rave Account Activation Invitation Email
Dear User,
Welcome to -- 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:
If clicking the link above does not work, copy and paste the URL in a new browser window
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:
Thank you for using iMedidata. For more information please visit For support with your new account, please email
[email protected]
This is a post-only mailing. Replies to this message are not monitored or answered.
Medidata Solutions Worldwide
Accept Study Invitation and
Perform eLearnings
• After login, there will be an invitation to join the RTOG1115 study. Accept this invitation.
• A list of eLearning modules will then be on your welcome
• 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
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
– EDC Inspection Readiness for Clinical Sites (optional) – 30 min
– Data Privacy Considerations for Clinical Sites (optional) – 50 min
Access Study RTOG-1115
Select the EDC Link to Perform EDC Functions
Select a (real) Subject
(from a real site)
Select a Folder
(and a Form from a Folder)
New Folders and Forms will Appear
• Refer to Section 12 of the RTOG-1115 protocol for detailed
information regarding what folders and forms are used for this
• 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.
Select a Form
(from a Folder)
Respond to Queries
Questions ?
• CTSU Help Desk
– 9:00 AM-5:30PM EST - (1-888-823-5923)
• Support for Rave Navigation, Rave Functionality, iMedidata Navigation,
eLearning Assistance, Account Access
– Extended hours 5:30-8:30PM
• General Rave Navigation and General Account Support
– Protocol Specific Questions go to the Data Managers