Medidata Rave

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Medidata Rave Start-Up Information
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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
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 Study
www.ctsu.org – Rave tab
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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: [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.
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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?locale=eng
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.htm
Thank you for using iMedidata. For more information please visit
http://www.imedidata.com. 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
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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
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-1115
Select 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
– 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
• https://www.ctsu.org/public/CTSUContact.aspx
• RTOG
– Protocol Specific Questions go to the Data Managers
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