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Medidata Account Activation & Study Invitation Acceptance

Medidata Rave is a clinical data management system being implemented across the NCI Cancer Therapy Evaluation Program (CTEP) for the entry and management of clinical data for Cooperative Group and a limited number of CTEP-supported network trials. The iMedidata application is a portal application to access Medidata products including Rave. It allows site and Lead Protocol Organization (LPO) users to access studies across multiple Rave URLs by providing a single point of entry. Access to iMedidata and Rave is controlled through the CTEP-IAM system and through role assignments in the CTSU Regulatory Support System (RSS). Most users will use their CTEP-IAM credentials to access iMedidata, and must first set up their iMedidata account so that their IAM and iMedidata accounts can be linked. This document explains how you will initially activate your account in iMedidata. It also explains how to accept a study invitation in iMedidata and identify eLearnings required before Rave access to the study is granted.

To Activate Your iMedidata Account:

1) Ensure that your CTEP-IAM account is up to date and that you have been assigned the appropriate roles in Rave.

2) The first time your site receives approval for a Rave study, you will automatically receive an iMedidata Invitation Email. This is a one-time only email that is generated when you are linked to your first study in iMedidata.

3) Open the iMedidata Invitation Email. a. From: iMedidata-Notification@mdsol.com b. Subject: You have been invited to join iMedidata

Click here

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4) Click on the first link in the email. You must do this within 30 days of receiving the email or the link will expire (if you lose this email or the link expires, contact the CTSU Help Desk at 1-888-823-5923 or CTSUContact@westat.com).

5) Your account profile (CTEP information) will display. a. DO NOT CHANGE IT

6) Enter your time zone and locale information.

a. Select the appropriate time zone for your location/site. b. Locale = Language, so select your language.

7) Do NOT set a PIN code (i.e., leave this blank).

8) Set a password you can remember. You may use your CTEP-IAM password, but remember the

passwords are not synchronized so when you change your CTEP password the iMedidata password will not automatically update. Please note, most users will not log in using their iMedidata password, but using their CTEP-IAM account information (iMedidata requires that you create a password as part of the account activation process).

9) DO NOT CHANGE YOUR USERNAME or EMAIL. You should update your username ONLY if you receive a warning to do so. (Please note that doing so will not change your CTEP-IAM account username.)

10) Set a Security Question.

11) Click on Activate at the bottom of the screen to activate your account.

12) This will bring you to the login screen at <login.imedidata.com>.

13) Sign in to iMedidata using the iMedidata username and password you just established.

14) You will be brought to a screen where you must accept the

username and password again iMedidata account activation.

15) After agreeing to the terms, chttps://login.imedidata.com/selectloginuse your CTEP-IAM credentials to access iMedidata and Rave.

16) The first time you go to the Select Login, you will have to select the also need to do this step the first time you login to the Select Login from another computer, browser, or if you clear your internet cache.

17) Now you may enter your CTEP

17a) If you have not previously activated your account and attempt to login through the Select Login

screen, you will be redirected to the iMedidata activation page and should follow steps #5 to #15 to activate your account.

You will be brought to a screen where you must accept the Terms of Use. Enter your iMedidata again and select “I Agree” to accept the terms and finalize

iMedidata account activation.

After agreeing to the terms, close your browser and enter the following URL into your browser https://login.imedidata.com/selectlogin (Select Login). Bookmark this URL as it will allow you to

IAM credentials to access iMedidata and Rave.

go to the Select Login, you will have to select the CTEP-IAM IdP link. also need to do this step the first time you login to the Select Login from another computer, browser, or if you clear your internet cache.

Now you may enter your CTEP-IAM user name and password into the Select Login screen.

u have not previously activated your account and attempt to login through the Select Login screen, you will be redirected to the iMedidata activation page and should follow steps #5 to #15 to activate your account.

Accept using iMedidata user name & password

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. Enter your iMedidata and select “I Agree” to accept the terms and finalize your

lose your browser and enter the following URL into your browser this URL as it will allow you to

IAM IdP link. You will also need to do this step the first time you login to the Select Login from another computer,

IAM user name and password into the Select Login screen.

u have not previously activated your account and attempt to login through the Select Login screen, you will be redirected to the iMedidata activation page and should follow steps #5 to

name & password

18) You are now at your home screen

pending study invitations and assigned eLearnings will be posted.

19) Click on Accept in the Invitations box NOTE: This step must be completed by each user that needs access to a particular study

20) The study that you have accepted will appear in the Studies section. Any eLearnings that are required to be completed prior

21) Note that you might have additional eLearnings assigned to you that are not required (optional); these will appear in the eLearning box to the right.

22) Once you have completed all required eLearnings, you will notice a Rave EDC link bestudy name in the Studies section.

Click on Rave EDC

at your home screen in iMedidata. Note the Tasks section on the right, where all pending study invitations and assigned eLearnings will be posted.

Accept in the Invitations box to accept the invitation to a given study. must be completed by each user that needs access to a particular study

The study that you have accepted will appear in the Studies section. Any eLearnings that are prior to accessing the study’s database will appear beneath

Note that you might have additional eLearnings assigned to you that are not required (optional); these will appear in the eLearning box to the right.

Once you have completed all required eLearnings, you will notice a Rave EDC link bein the Studies section.

Site is listed for study

Click on Rave EDC

Accept Study Invite

eLearnings

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Note the Tasks section on the right, where all

must be completed by each user that needs access to a particular study.

The study that you have accepted will appear in the Studies section. Any eLearnings that are to accessing the study’s database will appear beneath the study.

Note that you might have additional eLearnings assigned to you that are not required (i.e., are

Once you have completed all required eLearnings, you will notice a Rave EDC link beneath the

listed for

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23) Click on Rave EDC beneath the study name in the center of the screen to enter the study.

24) You should see your site in the site list below the study.

For all subsequent visits to iMedidata:

The <login.imedidata.com> URL used in Step 12 above is not the preferred URL for CTEP users to access iMedidata and Rave. Follow the instructions below to access iMedidata after your initial activation.

1) Go to: https://login.imedidata.com/selectlogin (you should bookmark this URL). Using this URL will allow you to use your CTEP-IAM credentials to log in.

2) When you get to the IAM-SSO (Identity and Access Management Single Sign On) screen, enter your CTEP username and password to access iMedidata. (Note: Unless you use a new computer, browser, or clear your internet cache, future use of https://login.imedidata.com/selectlogin will bring you directly to this IAM-SSO screen.)

To Accept Subsequent Study Invitations:

After your initial account creation is completed, you will receive a Study Invitation Email for each subsequent Rave study your site registers for. This Study Invitation Email is sent at the time your site status is set to ‘approved’ for the study in the RSS and is associated with the study in iMedidata.

1) You will receive a Study Invitation Email. a. From: iMedidata-Notification@mdsol.com b. Subject: iMedidata Invitation

2) Open the Invitation Email.

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Ravi Rajaram, You have been invited by Westat api app to join the iMedidata study S0806. Please login to iMedidata http:// login.imedidata.com to accept this invitation. Thank you for using iMedidata. For more information on iMedidata, please visit http://www.imedidata.com. For support please email helpdesk@mdsol.com. This is a post-only mailing. Replies to this message

3) Do NOT click on the link in the body of the email.

4) Go to https://login.imedidata.com/selectlogin to access the IAM-SSO screen.

5) Enter your CTEP-IAM username and password to access iMedidata.

6) Follow steps 18-24 in the Account Activation section to accept the study invitation and obtain access to the study in Rave.

NOTE: Each user at a site must accept their invitation to join a particular study in iMedidata.

Do not click on this link. See step 4 below.