Rave

What is Medidata RaveAccording to Medidata Solutions, Rave is a web-based system for capturing, managing, and reporting clinical research data. Rave is designed to help organizations "optimize their research investments by streamlining the clinical trial process."

Benefits of the Rave system include:

Electronic Data Capture (EDC) Clinical Data Management User-configurable work flows Sophisticated electronic case report form (eCRF) design Simple and complex edit checking Customizable security parameters Convenient eLearning modules for user training

More information about Medidata Rave is available on the Medidata Solutions web site at: http://www.mdsol.com/products/rave_overview.htm

What is iMedidata?iMedidata is a web portal that provides single-sign on access to all the Medidata applications and eLearning modules that you have permissions to use.

For instance, from the iMedidata portal, you can access the Medidata Rave® application and see the following information:

Study and site invitations. Study issues needing attention (e.g., incomplete forms, open queries). Optional or required eLearning courses.

iMedidata uses secure authentication to ensure the security of data processing and data transfer.

NOTE: All NCI -sponsored cooperative groups using Medidata Rave® for remote data capture will use the iMedidata portal.

Account Activation Requirements

You must meet all of the following requirements to be eligible for an iMedidata account and permissions to use Medidata Rave®:

You must be an active member of the American College of Surgeons Oncology Group (ACOSOG), the Cancer and Leukemia Group B (CALGB), or the North Central Cancer Treatment Group (NCCTG) – collectively known as the Alliance for Clinical Trials in Oncology (Alliance).

Your designated role in the Alliance must provide you permissions to participate in the development, conduct, management, or reporting of an Alliance-sponsored clinical trial or supporting project. Examples of appropriate roles include but are not limited to: CRA , DC , PI , and Study Chair.

Your institution must have received IRB approval for an Alliance-sponsored clinical trial using the Rave application.

Obtaining or Updating Group Membership StatusIf you are not listed as an active member or do not have the correct role designation, please follow the member update procedures for the appropriate legacy group.

ACOSOG – TBD CALGB – Complete and submit a roster update form. NCCTG -- TBD

Account Activation MethodsFirst Time UseThere are a few things that you will need to access Rave® through the iMedidata portal:

A computer An internet Browser (Internet Explorer, Mozilla Firefox, etc) An active Internet connection Complete eLearning Requirements from Medidata

The Sponsor will notify Medidata after you have completed training and are prepared to access Rave for the first time. You have two options to activate your account, Standard User Administration and Enhanced User Administration. For Alliance studies, you will only be concerned with the Enhanced User Administration method.

To activate your account, you will need a 6-digit Personal Identification Number (PIN). You will be provided a PIN by your sponsor (the Alliance). It is important that you keep your PIN confidential, just as you would your bank account PIN. You can use your PIN to recover (recover password section) account information if you forget your username or password.

After you have been assigned a PIN, you will receive a unique Account Activation Code. This code is provided by your Rave account administrator.

Enhanced User AdministrationBy EmailYou will receive a PIN via email and a separate email containing your account activation code, your Login ID, and a link to access the account activation page.

1. Click on the link to launch the account activation page in a web browser.2. When the Account Activation Request screen appears, the Activation Code is

automatically populated. 3. Type in your PIN.4. Click Activate Account.

From the Login PageTo activate your account from the iMedidata homepage:

1. Navigate to the Medidata Rave Login page.2. Click Activate New Account.3. Enter your Activation Code and PIN.4. Click Activate Account.

New PasswordWhen you complete the Account Activation Request, you will be required to create a new password for your account. This happens when you login to iMedidata for the first time or you have forgotten your password.

1. The New Password screen appears by default after the account is activated. 2. Type in a New Password and Confirm the Password. 3. Click Save Password and Continue when you are finished.

LoginFirst Time UseTo log in to Rave® for the first time:

1. Go to http://login.imedidata.com/

2. Enter your User Name (which is provided by the sponsor) and Password.

3. Click Enter to continue.

2. Timeouts.3. Rave® uses a timer to lock inactive users out of the system for security reasons. All unsaved

work is lost whenever after a timeout. There are three types of timeouts:

4. Password Timeouts5. After 60 minutes, you will be prompted to re-enter your password. After you re-enter your

password Rave will return you to the last screen you were working on.

6. Interaction Timeouts7. After 75 minutes, you will be logged out and brought to the Login Page. You will have to Log In

again with your username and password.

8. Web Session Timeouts9. After 90 minutes, you will be logged out and taken to the Login Page. You will need to Log In

again with your username and password.

Assign New PasswordYour password can be changed at any time (note). After you have logged into Rave®:

1. Click the My Profile link located in the top right corner of the web page.2. Click Change Password.3. The Change Password page will appear. Type in your Old Password followed by a New

Password and click Save Password.4. Click Continue when you are finished.5. The Password Changed screen will appear after you successfully complete the previous

steps. It will also notify you when your current password will expire.6. Select Click here to continue… when you are finished.

Recover PasswordCreate New Password

1. From the Log In screen, click the Forgot Password link.2. The Lost Account Information screen will appear. Enter your First Name, Last Name,

and PIN.3. Click Recover Account and the Assign New Password screen will appear to create a new

password

My Profile for iMedidataWhen you click the My Profile link you will be taken to your profile page. From here you will be able to:

Change password Select your time zone <![endif]>

Change your user information (language preference only) <![endif]> Change your lines per page preference <![endif]>

Change passwordSee the Change Password section.

Select your time zoneTo change your time zone preference, click the drop-down list in the Time Zone section of your profile page and select your preferred zone. This time will be the default in the EDC module.

Change your user informationIt is important that you do not change your name, address, email address, or phone number in your profile. If you need to update any of this information, complete and submit a roster update form to the Alliance Central Office. Changes made to your user information do not pass from iMedidata back to the Alliance membership database and could result in access and permission issues in other Alliance applications.

You may, however, change your language preference. To change the language:

1. Click the pencil icon or Edit in the lower right corner of the User Information section.2. Click Save to confirm your changes or Cancel to undo changes.

Navigation HierarchyNavigation StructureIt is helpful to be familiar with the navigation structure of Rave®. The illustration below highlights the general structure of the system.

Home PageSubject Finder Page

Subject PagesStudy Selector PageSite Selector Page

Form PagesAudit Trail Pages

Study and Site ViewThe study and site view is:

Study Site Display

Single Multiple List of sites

Multiple Multiple List of studies. After you select a study, list of subject(s) displays.

Multiple Single List of studies. After you select a study, list of subject(s) displays.

Single

Icon definitions and progressionsThe Icon KeyThrough the EDC module you will find the Icon Key. It is important to become familiar with these icons as they are used regularly throughout the Rave® system. Click the Icon Key link to open and view the icon key window:

Icon ProgressionsLife cycles follow a progression with visual indicators throughout the Rave system. Subjects, Folders, Forms and other items will have an icon attached to indicate its status: The progression is as follows:

Selecting a StudyIn this section we will review the process for selecting a study. You will:

Learn to understand the structure of studies in the Rave® system Learn how to access studies from the Homepage Learn about different study views including

o List displayo And dropdown-display

Understanding the StructureAccess to sites and studies within the Rave system is dependent on your role within The Alliance . For instance if you are a CRA from an affiliate institution, you would have access to only the Rave studies with IRB approval at your site. However if you are a Lead CRA , you would have access to all of the sites and studies within your network.

Your permissions are also based on your role and relation to the study. As a CRA , you will be able to enter, submit, and edit data. You will also be able respond to and resolve queries.

Access Studies from the HomepageWhen you login to the Rave system, depending on your preference, the EDC Module Homepage will appear in either Dropdown or List display.

1. The Study Selector page will appear at login.2. From here, you can access Live and Auxiliary Studies, the search box, pagination,

messages and the Icon Key:

Viewing StudiesYou have two options with the site navigation tools. In either view, your ability to access sites depends on which site group(s) you belong to and which permissions you have been given.

List DisplayTo open the Site Selector Page, click on the name of the Study in which you need to work:

Dropdown-Display1. In the Site Navigation area of the homepage, you can select a study from the drop-down

display:2. Click the Go To icon to the right of the study selector to go to the site selector page.3. If applicable, you will now be able to select your Site from the drop-down list.

You will see a drop down list of studies arranged alphabetically if you are assigned to more than one study. Click Hide Auxiliary Studies to hide non-live studies from your list. However, if you are only assigned to one study, it’s non editable and only that study will display.

If you are only assigned to auxiliary studies, the Show/Hide Aux Studies will be hidden and your drop down list will only contain auxiliary studies.

Selecting SubjectsYour access to subjects in Rave® has restrictions based on several factors including:

The subject’s status in the study Your permission to view and work with the subjects of a specific status What site group or site you belong to

There are several ways to work with subjects in the EDC module. You can select them from:

Last 10 Subjects list Subject listing page Dropdown List Navigation Advanced Subject Search

Last 10 Subjects List

Your Rave homepage contains a list of Last 10 Subjects in the sidebar. The list starts with your most recently accessed subject. To access a subject directly from this list:

1. Go to the homepage. You can use the Home Navigation tab or click the Home icon in the upper right corner to navigate there directly.

2. Click the desired Subject Name from the list located in the sidebar.3. The subject home page for the selected subject will appear.

Subject Listing PageOnce you select a study and site, a subject can be selected from the Subject Listing Page from the site. The subjects will appear in the main area of the page.

From this page:

You can add subjects to the site by clicking Add Subject. You can select Advanced Search to activate the Advanced Search Page.

Drop-down List NavigationYou can search for subjects with the Drop-down Display Site Navigation area. You are able to search for subjects in specific studies with this function on a basic or advanced level. To access subjects with this function:

1. Select a study and site from the Site Navigator on the homepage.2. After you make the appropriate selection, a new field will display allowing you to enter a

Subject Name into the subject field (note).3. Click the Search Icon when you have entered the desired search criteria.

NOTE

No subject found will be displayed if no subject is enrolled that meets the specified criteria.

A list of subjects will be displayed on the Advanced Subject Search Page if multiple subjects are found.

The Subject Homepage will be displayed if the search criteria is met for one subject.

Advanced Subject SearchIf enabled, you will see an Advanced Search link in the Site Navigation portion of your homepage. This feature allows you to search for subjects with predefined parameters. To use the Advanced Search:

1. Select a study from the <![endif]> Site NavigatorOR

you can also access the Advanced Search from the Site Homepage also referred to as the Subject Listing page or Subject Page.

2. The Advanced Search page and the Basic Subject Search field appears after you select a study.

3. Select Advanced Search.4. Enter your desired search criteria and select Search when you are finished.5. Click the link for the subject you want to work with to open the Subject Homepage. <!

[endif]>

The Subject HomepageIn this section you will learn about:

New subjects Subject Homepage

New SubjectsFor this instance of Rave, you will not create subjects as patient registration data will be imported for you from OPEN Registration. (OPEN is the web-based registration system for patient enrollments onto NCI-sponsored Cooperative Group clinical trials. OPEN is managed by the Cancer Trials Support Unit (CTSU).

The Subject HomepageAfter you access a specific patient from your study, the Main Page for that patient will appear. The tab in the navigation bar will now display the ID for the current patient you are viewing. Many of the links and icons on the subject’s page are similar to those from the Site Main Page. There are several differences including:

The SidebarThe Subject Matrix contains forms and folders for the study and subject. These folders are loaded automatically by the system or they may have been added manually by the user. This section of the page also contains the Subject Summary and the eCRF History pertaining to the patient being viewed.

Subject MatrixAs previously, the matrix contains forms and folders relevant to the patient for the study. After you click on the folder name, the first form from that folder will open in a new tab. Forms within that folder will appear in the sidebar. To navigate to another form within that folder, click the desired form below the folder in the sidebar.

Subject SummaryPreconfigured data will display in this section for the visible subject. The study Sponsor (the Alliance) determines what information will display; most often this will include data such as the

patient's initials, gender age, etc. This information is imported or derived from data from OPEN Registration. These fields are read only.

eCRF HistoryThis section contains a list of the last 10 subjects you have accessed in the system. The history will chronologically list the subject and specific forms in order. You can quickly access those recent eCRFs by clicking the desired subject/form to open it in a new tab.

Main AreaThis section that takes up the majority of the landscape contains the Subject Schedule, Task Summary, and the Add Event Drop-Down List. Other controls may be visible depending on your role and permission.

Subject HeaderThe header extends across the top of the Subject Homepage and Sidebar. The header limited study information pertaining to the specified subject such as the subject's initials, ID, etc.

Primary FormThe Primary form, or the Enrollment/Registration Form, will be the first form under the header. These fields will be populated with data from OPEN Registration .These fields are read only.

Subject ScheduleIf enabled for the sutdy, this area lists the visits that are required for subjects. This is a read-only section that serves as a guide to assist with scheduling return visits. The Visit folder will be listed as well as a Target Date in the column next to it.

Note: This feature may not be available for all studies.

Task SummaryThis section displays a list of tasks on the subject level rather than site level. Click the Detail Arrow key to the left of the task or the Pop-Up Window to obtain a more detailed listing of the folders and forms where outstanding tasks/queries exist.

Add EventStudies have a set of default folders and forms, also known as the “default matrix." Each new subject for the study will be assigned the contents of the default matrix. If you need to add additional forms or folders to a subject, they can be added using the Add Event drop-down. This feature will be available if:

Circumstances have occurred outside the given default matrix, such as an unscheduled visit, have occurred that require a new set of folder and/or forms. <![endif]>

Additional and/or optional matrices need to be added to the default matrix for a study.

The study Sponsor (the Alliance) dictates specifications for adding matrices. For example, the sponsor can set the maximum number of matrices that can be added to a study. When you reach that limit, the add event feature will disappear.

Adding a MatrixTo add an additional matrix:

1. From the Add Event drop-down list, select the matrix you want to add.2. Select the Add button.3. The new matrix will appear in the Sidebar. If a number appears in parentheses next to

the folder you just created (i.e., “New Folder (2)?), another instance of that folder or form already exists elsewhere in the matrix.

Reusable FoldersReusable folders display once in the Sidebar and function in the add event matrix if the reusable folder is a parent folder:

The first time the matrix is selected from the Add Event drop-down and is added to the Sidebar with related folders and forms defined by the matrix.

All subsequent additions for any matrix where the folder is a parent and uses the previously added folder. Folders and forms defined within the matrix are added to the pre-existing parent in the Sidebar.

MessagesEmail may be sent out to a user or a group of users for some queries, protocol deviations, or if users are locked out of the system. The system may also place a copy of this email in the Messages section at the bottom of the Rave homepage or top right of any page. You can click the Delete button on the bottom right of the message window to remove the message.

Email ConfirmationConfirmation of read emails sent from the Rave system may be enabled. If the receiver has not read the email, the system will re-send the same message at preset intervals until the read receipt confirmation is received. These types of emails will go to your email account and not the Rave messages system. To confirm receipt of an email message sent to you:

1. Open the email message sent to you from Rave.2. After reading the contents of the message, select the link located at bottom of the

email.3. The Email Confirmation page will be generated by the Rave system, confirming your

submission.

Form Layout

Forms are used for data entry in the EDC module. Standard forms have rows containing questions with data entry fields to answer. In this section, we will explore the items and features you will see in a standard form page layout including:

Headings and titles Form questions Data entry fields Data entry field control types

o Data entry iconso Additionl controls such as icons and links

Working with Form DataData can be entered for a new subject after the subject is enrolled through OPEN Registration and the Primary Form (Enrollment Form) is complete. To enter data into an eCRF:

1. Access a Form from the Subject’s Homepage by clicking on the folder in the matrix.2. The first form in the folder will open.

o If you need to work with a different form within the folder, subsequent forms will appear under the folder in the Sidebar and are available after the folder is open.

o Note: Some forms and fields have edit checks programmed to validate the data on the form or to cross-check against other forms. For this reason, it is recommended that you complete forms in order to avoid generating unnecessary system queries.

3. After you have entered information into the data fields, click Save to preserve changes or Cancel to close the form and erase any changes you have made. If you navigate away from the page without selecting either of these options, the system will generate an alert message notifying you that you are about to proceed without saving your changes.

o When you click Save, the page will reload and display feedback about validity of the entered data.

o The data entry fields will display the Never Touched icon until data is entered, saved, and accepted.

Form SubmissionWhen you submit an eCRF, the Rave system may generate a confirmation message on the form.. In some cases, successfully submitted forms may have a redirect function associated which will display the confirmation message and a link to another form that requires your attention.

Editing DataYou can edit completed or submitted data, as long as it has not been locked by the sponsor (the Alliance). To edit data:

1. Open the form that needs to be edited.2. Select the Edit link (the pencil icon) on the far right of the data row that needs to be

edited OR select the Edit link at the top of the form to edit more than one field at a time.

3. The Form will reload and the data entry fields will be available for edits. o The study may be configured to require an explanation for changes made to the

data. If this is the case, a drop-down list will appear and provide possible reasons for the change. You will need to make a selection before your edits can be accepted.

4. Select Save to preserve your changes or Cancel to close the form without saving edits.5. Edited fields will now have a delta icon next to the data point to indicate a change was

made to the data and the changes will be documented in the Audit Trail.

Audit TrailAny changes that are made to fields in a form are tracked in an audit trail. Authorized users are able to view the Audit Trail. To access the Audit Trail:

1. Select the Data Status icon next to the data field.2. The Audit Trail will appear in a new tab.3. In addition to viewing Audit details:

o The Audit Navigation tab will indicated that you’re viewing and audit trail. To return to the form of the original data point, you can click the form name tab at the top of the screen.

o The Parent Record link allows you to quickly navigate to the audit trail of the “parent” of the current data-point.

o The Sibling Drop-down allows you to navigate to the audit trail for other data-points within the same form by selecting another data point for the drop-down list.

The Audit Trail will include the following the action that was performed on the data-point, the user who performed the action and the date and time of action. Audit Trail Report times are always stored in Greenwich Mean Time (GMT).

Log FormsA Log Form is used when multiple instances of the same data are required. It is used to add additional records or entries to one form. Each entry is called a Log Line. A form can have a non-log field and log fields together. Log Lines can also be kept within their own form. They can be viewed in portrait or landscape mode.

Landscape ModeForms viewed in Landscape Mode will display in a single horizontal row for each log line. Each row will contain details for each log line.

You enter data in Log Forms just as you would on other forms. You can Add a new Log Line or Inactivate the log line by selecting the links below the fields in each row. You may be required to state the reason for inactivation to save the change.

Portrait ModeLog lines will look like standard forms. You will enter data as described in the Entering Form Data section and click Save when you are finished. After you have saved your changes, the view will convert to Landscape Mode.

To re-open the log line, select any of the data value links. The Portrait Mode will reactivate for edits.

Accessing Previous VisitsForms can be configured to provide quick access to data collected on previous visits. If the form has this function enabled, a link to the previous visit is displayed in the middle at the top of the main area in the Date Navigation Tool. As you are editing these forms it is important to know that:

You cannot edit the previous Visit Date or any data on a current visit form. Previous visit forms are identified by record data and time that displays on the top of

the data form. The system will retrieve other active forms for the patients with the same form name if

the form date is prior to the current date. They will display in reverse chronological order by record date on the eCRF form.

Date Navigation ToolThe date navigation tool allows you to move between visit dates.

eCRF AttachmentsFor configured fields, you can upload files or images into Rave and associate it with a field in an eCRF for a subject.

Upload a File1. Click the Browse button.2. The Chose File browser window will appear. Locate and select the file you need.3. Click Open.4. After you complete the rest of the form and select Save, a link (displayed as the

filename) to the uploaded file will be displayed in the eCRF.

View Uploaded File or ImageClick the filename link on the eCRF. You have the option to either Open or Save the image.

Remove or Replace Uploaded File1. Select the Edit (pencil) icon.2. To remove the file, check the box next to Remove. To replace the file, select Browse and

upload a different file.3. Select Save when you are finished.

QueriesIn this section, you will learn about the types of queries in the Rave® system and how to respond to queries appropriately.

Query TypesManual Queries Manual queries are created by the Data Coordinator (DC) or the Quality Review Specialist (QAS) in the EDC module on data point(s) in question. When a Manual Query is created, the field will turn a highlighted pink. A query message indicating what data is needed to resolve the query will display. The data entry field will be open for editing. The DC or QAS may require you to provide additional information or notes to resolve the query. If additional information is required, a drop-down list or free text box may appear for you to enter a response for the query.

System QueriesSome fields or forms contain preconfigured logic checks. If you enter data that does not meet the criteria in these logic checks or if you do not enter data in a required field, a System Query

is automatically generated. Most System Queries only require you to correct the data.. If additional information is required, a drop-down list or free text box may appear for you to enter a response for the query.

When the System Query is activated, the field will turn a highlighted pink and the non-conformant icon will appear. A query message indicating what required data is needed to resolve the query will display and the data entry field will still be open for editing.

Responding to QueriesThere are different types of responses depending on the requirements of the query that is triggered.

Data Change OnlyNo additional response is required but you will need to modify the information in the data entry field to satisfy the required data type.

Additional Response RequiredYou will need to include additional information in the text box that appears on the left side of the screen. You can also modify the data entered.

Respond to Open QueriesTo respond to open queries:

1. Open the Form Page with the open query. The data entry field will be available for editing.2. Modify the data entry field with correct data. If the response text box and/or the dropdown list

is open for additional information, you will need to provide additional information pertaining to the open query. If you do not provide a required response or corrected data has not been entered, the system will not close the query.

3. Select Save to respond to the open query or click Cancel to close without saving changes.

Printing eCRFsRave allows you to print an eCRF as it is displayed on your screen. You may print at any time, before or after data entry. You have two output options for printing your eCRF. You can:

Print an eCRF directly to your computer’s printer, or Export the eCRF to a PDF that can be printed or stored for later.

Print an eCRFTo print an eCRF:

1. Open the form you want to print in the EDC module2. Select Printable Version in the lower left of the main area. Your computer system’s print

dialogue box will appear.3. Select a printer and any special print options, and then click Print.

Export a PDFTo create a PDF of an eCRF:

1. Open the form you want to create a PDF for in the EDC module.2. Select View PDF in the lower left of the main area. The PDF window will open.3. Click Print to print the eCRF as a PDF document., OR click Save to save the eCRF.