introduction to medidata rave

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  • INTRODUCTION TO MEDIDATA RAVE ANGELA SMITH CHRISTINE MCLEOD SWOG STATISTICAL CENTER SEATTLE

    1

  • Background SWOG has had online data

    submission for almost 10 years CRA Workbench website Developed and maintained by the

    Statistical Center Most other Cooperative Groups also

    have their own online data collection systems Also developed and maintained locally

    2

  • Background PRO Allows for customization

    CON Results in disparate systems Requires duplicative effort across

    Groups

    3

  • Background NCI purchased a license from the

    commercial software company Medidata Rave is what Medidata calls their

    electronic data capture (EDC) system All Cooperative Groups are mandated to

    adopt Medidata Rave for new studies Two ways to submit data online: CRA Workbench studies activated before

    4/1/2012 Medidata Rave studies activated after

    4/1/2012

    4

  • 5

    PresenterPresentation NotesSo now you know were not talking about this kind of Rave

  • Background How many of you have heard of

    Medidata Rave? How many of you have used Medidata

    Rave for industry trials or for NCIC MA.32?

    How many of you are still confused by the picture of people dancing?

    6

  • Background Just in case you dont remember our

    every word: Online training videos From Medidata From SWOG Slides available on CRA Workbench Table at Open Forum

    7

  • Background CTSU Help Desk 9:30am 8:30pm ET 1-888-823-5923 ctsucontact@westat.com

    8

    PresenterPresentation NotesYour front line for technical support is the CTSU Help Desk. Their contact information is here, and will be advertised elsewhere in Rave.

  • Overview Accessing Rave Navigating to a study Navigating within a study Form organization Form submission CRA Workbench changes Timeframe

    9

  • 10

    Overview

    PresenterPresentation Notes3 concepts to keep separate: Medidata the company, which operates the iMedidata website, which is a portal to the Rave EDC application.Access Rave through iMedidata

  • Accessing Rave: Activate account Look for an email inviting you to activate

    your new account. Click the link.

    11

    PresenterPresentation NotesThere are a series of steps necessary to activate your account in iMedidata.Step 1: Watch for an email from iMedidata, inviting you to activate your account. Check your Junk mail folder too!

  • Complete the required fields on the iMedidata Account Screen Username: try CTEP IAM username first Password: use CTEP IAM password Security Question, Answer

    12

    Accessing Rave: Activate account

    PresenterPresentation NotesStep 2: Complete the iMedidata Account page

  • Logon to iMedidata using the username and password you just set

    13

    Accessing Rave: Activate account

    PresenterPresentation NotesStep 3: Logon to iMedidata

  • Sign the iMedidata Terms of Use using your CTEP IAM username and password

    14

    Accessing Rave: Activate account

    PresenterPresentation NotesStep 4: You will need to sign this agreement one time.

  • Accessing Rave: Logon For all subsequent logons, reach this

    page through CRA Workbench Medidata Rave link or https://login.imedidata.com/selectlogin

    15

    PresenterPresentation NotesYoure done with account activation!Future logons will be done through this URL. This will be available on the CRA Workbench, and this URL will be included in Rave protocols.

  • Accessing Rave: Logon First Logon, select CTEP-IAM IdP link

    16

    PresenterPresentation NotesThe first time you logon, youll need to select your identity provider, which is CTEP-IAM.

  • Accessing Rave: Logon Logon using your CTEP IAM username and

    password

    17

    PresenterPresentation NotesThen youll be presented with the logon page. This is where youll start for access to Rave from this point on.

  • 18

    PresenterPresentation NotesThe iMedidata webpage.

  • Accessing Rave Accept any pending invitations You will see invitations to studies that your

    site approves You will also get email notifications that these

    invitations have been added Just click accept to access study

    List of studies Studies for which you have accepted

    invitations Search tool available Not accessible until eLearnings satisfied

    19

    PresenterPresentation NotesWhen your site IRB-approves a new Rave study, an invitation to that study will appear in iMedidata.

  • Accessing Rave Note eLearning requirements Required Rave 5.6 EDC Essentials for Clinical Research

    Coordinators (45 min) EDC inspection readiness for Clinical Sites (30

    min) Data Privacy Considerations for Clinical

    Systems (50 min) Optional Rave 5.6 Advanced Rave EDC for Site Users

    (20 min)

    20

    PresenterPresentation NotesA little over 2 hours worth of eLearnings are required for access to your studies in Rave.Only have to take the eLearnings once and they apply to all studies. If youve worked with Rave before and have already taken these eLearnings, then you should not have to take them again.It may be tempting to run these while doing other tasks, but there is a quiz and you have to get 80% to pass (and you have to pass). So pay attention.

  • Questions about Accessing Rave?

    21

  • Navigating to a Study Rave is organized by study No cross-study reports or functions Select a study If multiple sites, select a site

    22

    PresenterPresentation NotesThe study is the top level entrance point in Rave. There are no reports or functions within Rave that combine data from more than one study.Select a study from iMedidata, and if you belong to multiple sites, select a site.

  • Navigating to a Study Study-Site page: Subject List Subjects still enrolled via OPEN Search utility Task Summary (site level): lists subjects

    with outstanding tasks Link to Icon Key on every page (whew!)

    23

    PresenterPresentation NotesThis gets you to the Study-Site page, where you will see a list of patients you have registered to this study (via OPEN), and a summary of tasks that require your attention.Rave is icon-heavy. Luckily there is a link to an icon key on every page.

  • 24

    PresenterPresentation NotesThe rest of this talk will use SWOG study S0820 as an example. Here Ive selected S0820, and my site 99999. In the middle is the Subject List which reflects all the patients this site has registered to this study in OPEN. There is a search tool that can be used to find someone in a large list.On the right is my Task Summary for the study showing my outstanding tasks. I can click on the arrow to expand any one of these and see which patients are affected.The link to the Icon Key is at the bottom of every page in Rave.

  • Navigating Within a Study Select a subject Subject page: Folders and forms Upcoming Visits and Dates Task Summary (Subject level)

    25

    PresenterPresentation NotesTo work on a patient, select the patient from the Subject List and then youll be at the subject page.The main areas on the Subject page include Folders and forms for that patient, upcoming visits and dates, and the patient-specific task summary.

  • 26

    PresenterPresentation NotesFolders and forms in the upper leftUpcoming visits and dates in the middleTasks on the right, now specific to this subjectHierarchical tabs appear as you drill down

  • Questions about Navigating to or within a study?

    27

  • Form Organization Most of the study forms will be

    organized in study-specific folders Paper CRFs will still be part of the

    protocol, but will be for reference only Rave Form Schedule in the protocol

    can help you find your forms

    28

    PresenterPresentation NotesMost study forms will be organized in folders.

    There will still be forms as part of the protocol document, but they are mainly for reference only. They will not be used directly to submit data.

    There will be a Rave Form Schedule in the protocol which will include notes about what folders hold what forms, and when they are displayed.

  • Form Organization Forms in Rave will look different from

    their paper CRF counterparts Question order and content will be the

    same A single paper CRF may become

    multiple forms in Rave

    29

    PresenterPresentation NotesFormatting of Rave forms is limited, so while the question order and content will be the same as the paper CRFs, they may not look alike.A paper form may even become multiple forms in Rave for a variety of reasons.

  • 30

    PresenterPresentation NotesFor example, take the S0820 Onstudy formThis form has 3 distinct sections: patient and disease description

  • 31

    PresenterPresentation NotesWhich spills onto page 2.Then laboratory values

  • 32

    PresenterPresentation NotesThen prior treatment

  • 33

    PresenterPresentation NotesThats a lot of fields to put in one form, so in Rave, this is 3 formsWhen I click on the Onstudy folder, the forms are shown below and the first form is shown by default.Notice that 2 more tabs have also been added, one for the folder, and one for the form.

  • Form Organization Rave allows us to only show you the

    parts of the form that apply to your patient

    Some Rave forms may not appear unless certain questions are answered a certain way

    34

    PresenterPresenta

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