Medidata Rave

Transcript Medidata Rave

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 connection • Data will be entered at the site by a Rave Clinical Research Associate (CRA role) • No paper case report forms submitted to RTOG

• • • • • • • •

Steps for Registering for the RTOG-1115 Study

www.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

and OPEN.

website for detailed information on RSS, CTEP-IAM, Rave,

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 [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 iMedidata.com -- a faster, simpler way to access all your Medidata studies, Medidata applications and online discussions in one place. You've been invited to activate your new account. Please click on the following link: Rave® 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

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

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

Access Study RTOG-1115

Select the EDC Link to Perform EDC Functions 11

Select a (real) Subject

(from a real site) 12

Select a Folder

(and a Form from a Folder) 13

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.

Select a Form

(from a Folder) 15

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 https://www.ctsu.org/public/CTSUContact.aspx

• RTOG – Protocol Specific Questions go to the Data Managers