About Rave EDC

Rave EDC streamlines the clinical trial data collection and management process. Subject
data is routinely collected and stored in source files at the site as usual. The clinical data
is entered into Rave EDC electronic Case Report Forms, or eCRFs, by the site staff. Edit
checks automatically validate the data, so data cleaning begins instantly. Monitoring
visits can be scheduled efficiently as the data is available in real time. Data Managers
can also review the data and issue queries so that the data can be locked.

Rave EDC Workflow

Here are some roles typically configured within an EDC study: Clinical Research
Coordinator, Monitor or Clinical Research Associate, Data Manager, and Principal
Investigator. Some studies may have more roles or have different tasks performed by
each role. Your study sponsor customizes the tasks that each role can perform within
Rave EDC.

Click each role to learn more.

Clinical Research Coordinator

I'm Jane Maloney, the Clinical Research Coordinator. I add subjects into Rave and enter
data as the clinical trial moves forward. I also log information such as adverse events
and unscheduled visits. Sometimes, I have to edit saved data and answer queries about
the study data asked by the sponsor.

Monitor

I'm Petra Clark, the Monitor. I ensure that the study is compliant with the protocol, and
also verify the data in Rave EDC is consistent with site source documentation. If there is
missing or inconsistent data, I raise queries to the site and note protocol deviations.

Data Manager

I'm Masaki Yamamoto, the Data Manager. Once Jane enters the subject data, I review
and clean it. When I have a query, I send it to the site in Rave EDC. After all queries are
answered, I freeze and lock the data to prevent further changes. If there are any
deviations from the protocol for the subject, I will note them as well.

Principal Investigator

I'm Dr. Devi Patel, the Principal Investigator. I'm responsible for the overall conduct of a
clinical trial. After Jane enters the data into Medidata Rave and resolves all queries
asked by the sponsor, I review the eCRFs and electronically sign them. I also may
respond to queries from the Monitor and enter or edit subject data myself.

Rave EDC Home Page

Regardless of your role, you need to know some standard features to help you use Rave
EDC effectively. When I log into Rave, I see my Rave EDC home page. My sponsor
configured this page based on my role, so yours may look different. My sidebar contains
Installed Modules such as Reporter, the last 10 subjects I accessed, and links to a
number of Resources. The links in the upper-right corner provide me with access to
system messages, my profile and online help.

Click the icons to learn more.

Messages

View messages sent to you through the Rave system. Click a message to view it.
Depending on your setup, your messages may also display on your Rave EDC home
page.

Navigation to Studies, Sites and Subjects

Before I show you how to navigate in Rave EDC, it is important to understand the
relationships between studies, sites, and subjects.

The navigation in Rave EDC is setup in a hierarchy. For example, my sponsor runs the
Betterall study at two sites: Medidata Hospital and MDS Clinic. As new subjects are
enrolled at each site, they are added to the study in Rave. I manage subject data at the
Medidata Hospital site, so in Rave EDC, I navigate to the Betterall study, Medidata
Hospital site and then select the subject that I need. Your navigation may be different,
depending on how many studies and sites are available to you as determined by your
sponsor.

I am involved in multiple studies, so my home page lists the studies for me to choose. I
can search for a study - this search function is also available when selecting sites and
subjects - or I can simply click a study from the page.

If you have access to a single study, your home page should automatically list the sites
you have access to. Similar to selecting a study, I click a site from the list.

Notice that as I move to a different page, the navigation tabs automatically update to
indicate my current location. I can click any tab to jump to its respective location or
click Home to return to the EDC home page.
Since I selected a site, I see a list of subjects associated with that site. If you only have
a single study and site, your Rave EDC home page will open directly to this page. I click
a subject identifier to view the subject's home page. This page may look different from
yours, depending on your role and study configuration.

Click the icons to learn more.

Subject Matrix

The Subject Matrix consists of a set of folders and eCRFs pertaining to the study. I click
a folder to access a form. By default, the first form within the selected folder displays. I
use the sidebar to navigate to a different form within the folder, if needed.

Add Events

Use Add Events to include additional matrices or required forms and folders as needed.
For example, if a subject arrives for an unscheduled visit, I will select this form and click
Add. During the data cleaning process, the Add Events feature may be disabled.

Grid View

Depending on your permissions, you may view all the subject's folders and forms in a
matrix. You can click any icon to go directly to the form to view and edit the data. Click
this link to return to the Grid View. The overall status of each form is indicated by the
status icon. Forms without status icons have no saved data. Based on your role
permissions, you can select a column header or the row header to perform batch
actions. Click this link to go back to the Calendar View.

Task Summary

The Task Summary provides a quick glance of pending tasks for the subject. Expand a
task to see the list of forms that require your attention. Click the link to navigate to the
form. Task Summary can also be configured to display on Site and Study level.

Rave Status Icons

Status Icons in Rave indicate the life cycle of subjects, folders, forms, and fields. Icons
follow a logical progression, starting with the "never touched" status and progressing
toward the "complete", "entry lock" and "locked" statuses. In between, you may
see other icons to indicate data that is not conformant, queried, in need of verification
or review, or in need of a signature.

The Icon Status Hierarchy governs which status is displayed over another. For example,
the Requires Verification status is higher in the hierarchy than the Entry Lock status.
With respect to the life cycle of status icon progression, eCRF data is suggested to be
reviewed before it is locked. An Open Query status takes precedence over a Requires
Verification status, and a Non Conformant status is the highest over all other statuses.

The icons you see depend on a combination of the Icon Status Hierarchy and your Role.
For example, Jane, the Clinical Research Coordinator, will not see data verification icons.
The icons that are displayed to each role will be determined by your sponsor.

Entering and Editing eCRFs

As the study progresses, I access each subject's eCRFs to view and edit data.
Throughout the study I may use queries and audit trails to help me manage subject
data.

Let's start with entering and editing eCRFs. There are three types of forms in Rave EDC:

Standard Form

First, there are standard forms. To enter data, I simply type in the fields and select the
appropriate choices, then Save. Notice the status icons have changed - these icons
change to the next status in the icon hierarchy as configured for my study and
permissions. Also notice this Entry Lock icon did not change. This is a Derivation field
used to calculate a value based on one or more existing data points. For example, this
field is derived from calculating the Informed Consent and the Date of Birth data points.
To edit, I click the Pencil, choose a reason for the change - these reasons are configured
by my sponsor - edit the data, and then Save. A delta icon appears indicating that a
change was made to the original data point.

Portrait Log Form

Next are portrait log forms, which are used when multiple records are collected on a
single form, such as a log of adverse events. Each log line is a collection of data points.
Adding a new log line or editing an existing log line expands the eCRF to portrait view,
where I see and edit the data points individually. What is different with these log lines is
how status icons appear. In the portrait view, each data point has its own status. Upon
returning to the Complete View, I see the status highest in the icon hierarchy.

Landscape Log Form

Finally, for landscape log forms, I can add or edit log lines directly in Complete View. In
this view, each status icon represents the overall status for all data points in each
record. Depending on configuration and roles, for both portrait and landscape logs I
may be able to Inactivate and Reactivate log lines. To inactivate, I select a log line
number, choose a reason, and click Inactivate. I can follow the same steps to reactivate
a log line.

Depending on your role, you may see some of these checkboxes, which indicate specific
data cleaning actions that need to be performed. These include verify, review, freeze
and lock.

Queries

There are two types of queries: system-generated and manual.

System-generated Query

A system-generated query appears immediately if data is omitted or inconsistent.

Simply choose the reason for the change, adjust the data as needed and save.

Manual Queries

Manual queries appear when a sponsor user requests more information about the data
after they review it. Let's look at a query example between Jane, the Clinical Research
Coordinator, and Masaki, the Data Manager. After the Clinical Research Coordinator
enters eCRF data, the Data Manager will review it, in line with the study requirements.
He will open a query on a data point where he requires more information. When she
sees the query, she will answer it and adjust the data if needed. He may re-query the
same data point, if needed. Once he is satisfied, he will close the query.

Audit Trails

Now, I will talk about Audit Trails.

All changes made to subject data are tracked in the audit trail. Depending on your
permission, you can view a data point's audit trail by clicking the Data Status icon. The
audit trail includes what action was performed, who performed it and when, with the
most recent action displayed on top.

Exercise

Let's work through an exercise that encompasses what you've learned so far. If you
need help, simply click "HELP ME" and I will guide you along.

Summary

So far, you've learned about Rave EDC and its workflow based on four typical roles, how
to navigate, and how to manage eCRFs and subject data in Rave EDC. Next, you will
learn how to perform tasks specific to your role. Click Next to get started.
Clinical Research Associates Workflow
Introduction and Objectives

Hi, I am Petra Clark, the Monitor. I ensure the quality and accuracy of the data captured
during clinical trials. After Jane or Dr. Patel enters data through Rave EDC, I verify the
data with source documents. While verifying the data, I raise queries about data that I
need more clarification about, and manage those queries until they are resolved.
Furthermore, I'll show you other features in Rave that help with my day-to-day
workflow, such as the Grid View. Keep in mind that your permissions and access may
differ than what you see throughout this course.

Verify Data

As the Monitor, I verify the data against the original source document. First, I will
discuss the Verify action; later, I'll show you how to perform the action in Rave.

Verify Data
While I am at a site, I may compare the data captured in Rave with the documentation
where the data was originally collected, such as paper case report forms. Source
Document Verification is the process of verifying such documentation for accuracy. In
Rave EDC, the Requires Verification status icon will appear near each data point
that I must verify. If data in this field changes after it is verified, the data point must be
verified again.

Verifying Data
Now, that we have discussed the Verify data cleaning action, let's walk through how to
perform it on the different form types. Though each form type behaves somewhat
differently, there are some similarities.

First, on each form type, the Verify checkbox is situated to the right of each data point.
My sponsor configures which data cleaning actions I will perform, so yours may be
different.

Second, you can Verify data by checking the box next to the appropriate data point,
and then saving the form. You can also perform data cleaning on multiple data points,
as applicable. This action will roll the status up to the next one in the Rave hierarchy.

Next, each eCRF has a batch action checkbox in the header, used to perform the
appropriate action on the applicable data point in one click.

Finally, depending on the study protocol and your permissions, actions may be undone
by unchecking the box, which will roll the status down to the previous one in the Rave
hierarchy. I will speak more about how your permissions may impact your workflow a
little later.

Now, let's see how data cleaning is performed on standard, landscape log, and portrait
log forms, as well as when the actions are disabled. We'll use the Task Summary to
navigate through EDC. Click each icon to learn more.

Standard Form
Under Requiring Verification in the Task Summary is where I'll see the forms I need
to verify. For standard forms, simply check the desired action on the chosen data points
and then Save.

Landscape Log Form

Verifying data on a landscape log form is a bit different than on a standard form. The
action is performed on each log line rather than on individual fields. On the chosen log
lines, check the appropriate actions and then Save.

Portrait Log Forms

Performing the actions on a portrait log form can be done in two ways.

In Complete view, check the verify action and then Save, similar to a landscape log
form. Notice that the checkboxes are still enabled, meaning I can undo this action, if
needed.

Alternatively, individual data points can be verified as opposed to the entire log line.
First, click any data point within that log line. From here, check the desired actions on
the chosen data points and then Save, similar to a standard form. When the page
refreshes to Complete View, recall that the log line displays the status icon highest in
the hierarchy for the entire record.

Disabled Action
You may encounter some disabled checkboxes while performing data cleaning actions.
Preconditions or permissions are a couple of reason why this may happen, as
configured by your sponsor. For example: My sponsor gave me permission to verify
eCRFs, but also configured Rave so that data needs to be entered on the field before it
can be verified. The Verify checkbox is disabled for now, but once data is in the
appropriate status the Verify checkbox is enabled. This is an example of a
precondition.

If I do not have permission to perform an action - for example, I am not allowed to

unverify a data point once I have verified it, or when the data point does not require
verification- the checkbox will remain disabled.
Another reason that may prevent me from cleaning the data is due to another user, for
example, the Investigator, applying signatures to eCRFs. During that process, the Save
button is disabled, meaning I cannot save any actions I perform. I must refresh the
page when the process is complete, so the appropriate controls are enabled.

Exercise: Verifying Data

Let's pause for a short exercise.

Here, you will practice Verifying Data.

Click Start to begin.

Query Management on eCRFs

During the course of the study, I will verify that the data in Rave EDC is consistent with
site source documentation. If there is missing or inconsistent data, I will raise queries to
the site.

Recall that there are two types of queries: system-generated and manual. While
system-generated queries automatically fire from the edit checks, manual queries are
the ones I raise to the site, to gather more information.

I can open queries, re-query the response, and close queries once I am satisfied with
the information. I may also need to cancel a query in some cases. Recall that the Task
Summary is used to view eCRFs requiring action, so you will see it used here for each
query action. Click each icon to learn more.

Open Queries

While I was verifying data that Jane, the Clinical Research Coordinator, has entered on
the Medical History form, I see that the type of breakout wasn't on either the eCRF or
the source document. To open a query on a standard form, click the plus icon to the
right of the field where the query will be placed. I will select Open Query from the
marking type drop down list, choose the appropriate Marking Group and enter the
query message. The sponsor configures these marking groups, so yours may be
different.

Since I need Jane to reply, I will leave Require Response checked. Upon saving the
form, the query is marked on the data point and the entire data point is highlighted.

Now, I will move on to a different form. On the Adverse Events log form, the
"symptom is ongoing" box is checked for this data point, but on the source document it
is not checked.
I need Jane to clarify this data point. Recall that this is a portrait log form, meaning I
can click any data point to show the line in portrait mode. From here, I will click the plus
icon. Again, I will choose Open Query, the appropriate Marking Group, enter the query,
leave Require Response Checked, and then Save.

Finally I need to query the Pharmacokinetics form. This is a landscape log form, so
queries are marked a little differently. I will still click the plus icon, but notice that there
is an extra drop down list: this list matches the headers of each column. I will select the
data point on which the query should be marked, and then complete the query.

Upon save, the query is listed below the applicable log line. The data point I have
queried is indicated as a header. I can query another data point on this same log line by
repeating the steps but choosing a different data point.

Re-Query

Once the designated recipient answers a query, I may need further communication or
clarification of the information. This is called Re-Querying the data point. In the Task
Summary I see that the Medical History form was answered.

I sent Jane a query to clarify the Medical History reported for this subject's adverse
event. I see her reply, but I still need to communicate more information. I will click this
drop down menu underneath the response, select Re-Query, enter my response, keep
the Require Response box checked, and then Save.

Close Queries

I can close a query once I am satisfied with the responses or the discrepancy is
resolved. Here, I have reviewed Jane's answer, and am satisfied with it. I will click the
drop down menu within the responded query, select Close Query, and then Save. The
page will refresh and the query is no longer highlighted.

Cancel Queries

If I opened a query in error, no longer need it, or it is simply no longer applicable, I can
cancel the query as long as I have the permissions to cancel it and it hasn't been
answered. In the query area, click the Cancel checkbox and then Save.

Exercise: Queries

We've covered quite a bit of information so far, so let's pause for a short exercise. Here,
you will practice Opening a Query.
Click Start to begin.

The Grid View

On the Subject home page is a link to the Grid View, which allows me to do various
things, such as see the statuses for all eCRFs for this subject and set actions on multiple
eCRFs. Recall that the folders and sub-folders are displayed in the columns, the forms
are in the rows, and status icons indicate the overall status of forms.

For this subject, I need to mark that I have verified forms in the Screening folder and
some Vital Signs forms. First, I'll work on the Screening folder. I will select the
Screening column header, click Verify, Set, and then Save. The status icons will update
to reflect their new statuses.

Now, I will work on the Vital Signs forms. I will select the Vital Signs row header, choose
Verify, Set, and then Save. Notice the status icons for Day 10 and 20 Vital Signs haven't
changed. This is because the forms weren't ready to be verified. In cases where you set
actions to forms that aren't ready to have that action taken on them, the form will not
accept that action and the icon will not change.

As is the same with individual forms, I may reverse actions for forms here in the Grid
View. Let's say that I have to unverify all of the Vital Signs forms. I will choose all
related forms, choose Verify, but now I will select Clear, and then Save. The icons will
revert to the lower status.

To take action on all forms, I can click the All link, choose Verify and click Set or Clear.
In this case, I will choose Set and then click Save.

Exercise

Let's work through an exercise that covers what you've learned in this module. If you
need help, simply click "HELP ME" and I will guide you along.

Click the Next button to begin.

Summary

We have covered a lot of information today. We've verified subject data on different
types of forms, and also raised and managed queries on eCRFs. We've also walked
through how to perform batch actions using the Grid View.

Next, you will take an assessment based on the information we have covered here.

Good Luck!