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RAVE EDC USER
GUIDELINES
iMedidata Rave EDC https://www.imedidata.com
For technical problems with the Rave EDC system, please contact the
iMedidata help desk via e-mail at [email protected] or by telephone.
For your local iMedidata help desk phone number, check
https://www.mdsol.com/en/contact-sales-and-support#contactsupport
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RAVE EDC USER GUIDELINES Rave EDC
Table of Contents
1. General information ................................................................................................................................... 3
2. Navigation ................................................................................................................................................. 3
2.1 Rave EDC .............................................................................................................................................................. 4
2.2 Subject dashboard ............................................................................................................................................... 4
2.3 Add event ............................................................................................................................................................. 5
3. Data completion......................................................................................................................................... 6
3.1 Save data ............................................................................................................................................................. 6
3.2 Change data and comment ................................................................................................................................. 6
3.3 Dates .................................................................................................................................................................... 7
3.4 Missing data ........................................................................................................................................................ 7
3.5 Tables (Log forms)................................................................................................................................................ 8
4. Queries ...................................................................................................................................................... 9
5. EDC tasks ................................................................................................................................................. 11
6. Help ......................................................................................................................................................... 12
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RAVE EDC USER GUIDELINES Rave EDC
1. General information
The data will be collected via the iMedidata Rave EDC system: https://www.imedidata.com/. The system allows
authorized staff members to enter and edit clinical data about their patients on-line.
FOR COMPATIBILITY REASONS, WE RECOMMEND TO USE GOOGLE CHROME FOR ENTERING THE
RAVE EDC SYSTEM. USING INTERNET EXPLORER CAN CAUSE FUNCTIONALITY LOSS.
These guidelines will provide a synopsis of main features available to provide the data. For more in depth
information regarding the functionality of the Rave EDC system, please refer to eLearnings, accessible through
the Tasks pane. An eLearning that has been completed, can always be retaken if necessary.
More information on getting help is detailed in the help section 6 of these guidelines.
For general questions regarding the study, the access rights or the CRF
completion, please refer to study specific CRFs completion guidelines or contact
EORTC via the study-specific e-mail address.
2. Navigation
Once logged on through the main iMedidata page using your unique username and password, you will be
directed to the Rave EDC home page where you will have access to the study once all prerequisite eLearning has
been completed. Following and successfully completing the eLearning post-assessments are required before
getting access to the study database.
To access the EDC module, click on the relevant study icon link. A user is automatically logged out by the system
after a period of inactivity, when that happens the iMedidata login page reappears.
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RAVE EDC USER GUIDELINES Rave EDC
2.1 Rave EDC
You can navigate between studies, modules (such as EDC, lab management and EDC task overview), sites and
subjects from the dropdown menus at the top to perform the following actions:
• Click on your site name to add or modify subjects for that site
• Click 'Add Subject' to enter a new subject
• Click on an existing subject ID to enter or update existing data for that subject
• Click on visit folders to access the forms that need to be entered for that visit
• Click on form names to enter data on a form
2.2 Subject dashboard
When first selecting a subject, the subject dashboard appears. This shows at a glance which data is already
completed, which data is expected, if and where queries are etc. Clicking on any icon takes you to the form in
question.
: A black circle means the form has been entered and has no queries.
: A white circle means the form is expected but has not been entered yet.
: A black/white circle means the data has been partially completed with
some empty fields. In case not all fields on a form are mandatory, this might be
the final state.
: A pencil means data has been entered and is pending signature.
: A speech balloon means one or more queries have been raised.
: A flag means an action is required.
: A checkmark means that that data entry is complete and the data has
been locked.
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2.3 Add event
From the subject dashboard, you can also add events outside of the normal visit structure, i.e. in case of
unscheduled visits, additional lab tests to be reported, end of protocol treatment, end of study, etc. Adding an
event will create a visit folder or a form for further completion. For more information about study specific visit
folders and forms, please refer to study CRFs completion guidelines.
You can return to the dashboard by clicking on the subject ID hyperlink in the top left corner of the CRF screen.
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RAVE EDC USER GUIDELINES Rave EDC
3. Data completion
3.1 Save data
It is important to select ‘Save’ when new data has been entered or previously entered data has been changed.
The save button is located underneath the final data entry field on a page. In case of many data entry fields on a
form, it might be necessary to scroll down before the save button is visible.
3.2 Change data and comment
In case of a data entry error, it is possible to change data that had been entered and saved by selecting the data
point(s) to be updated and entering the new data. A reason for the correction has to be provided (by default,
‘Data Entry Error’ is selected).
A changed field can be identified by the presence of a delta icon. You can access the audit trail for that field by
clicking on the cog icon and selecting ‘Audit history’.
From inside the audit trail, you can add comments by using the Comment field available.
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3.3 Dates
Dates are requested in a dd-MMM-yyyy format. To enter a date, enter one or two digits for the day, select the
month from the dropdown and enter four digits for the year.
A partially unknown date can be entered by entering “UN” if the day is unknown and/or by selecting “UNK” for
an unknown month. Alternatively, by clicking on the calendar icon, you can select the date using the calendar.
This also allows for entering partially unknown dates.
Note that on some CRFs a fully unknown date will be allowed and can be entered as “UN/UNK/UNKN” (with
“UN” for the day, “UNK” for the month and “UNKN” for the unknown year).
3.4 Missing data
In case a numeric or text result is expected to be entered a query will be raised automatically, requesting the
information to be completed. When the information is confirmed in the query answer as not available (for
example, a mandatory assessment was forgotten to be performed), EORTC HQ staff can enter one of the
following missing codes, depending on the reason why the value was not available:
ND – not done
UN – unknown
NA – not applicable
Example: if a Uric acid result is confirmed as not available as the lab test was not done, this result will be coded
as not done with ‘ND’.
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RAVE EDC USER GUIDELINES Rave EDC
3.5 Tables (Log forms)
A log form is used when more than one record of data needs to be reported on a form. For example 1 Adverse
Event form collects multiple AEs, as many as needed.
Log forms look like tables and they allow the addition of new rows in the table, called log lines.
Scroll to right
If not all columns are visible on the page, you can click on an arrow icon which allows you to easily scroll from
left to right. When adding, viewing or editing an entry in a log line, the entry can expand so all the data fields are
fully visible (Portrait view ). To return from portrait view to the overview, click ‘Return to complete view’.
SEARCHING IN LOG LINES
A search field is available allowing to search a certain value in all fields or in a specific field. To initiate a search,
enter a search field value in the text box and click the magnifying glass. To clear the search filters, select ‘Clear
Filter’.
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SORTING COLUMNS ON LOG LINES
The log lines can be sorted based on the column. Click once on the name of the column to sort in ascending
order and click twice to sort in descending order.
ADDITION OF A NEW LOG LINE
To add a log line, click on ‘Add’. If you want to add multiple new lines at once, you can add up to 10 lines at once
by entering the desired number.
INACTIVATE A RECORD
A log line that has been entered can be inactivated from the complete view by selecting the cog icon and
selecting “Inactivate”. The data will remain visible, but is scored through. A reason for inactivation will be
requested.
A log line that has been inactivated can be reactivated by the same procedure. A reason for reactivation will be
requested.
4. Queries
You can answer queries in two ways:
1 Modify the data in the data entry field. When changing entered data, a reason for the change also has to
be selected. Typically, no additional response is required; however in some cases still an actual query
response might be requested (clarification of a situation).
2 If the entered data is correct, you can provide clarification, justification, rationale, … as a user response.
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RAVE EDC USER GUIDELINES Rave EDC
More information about the query (origin and type of
the query, date query was opened) can be viewed by
hovering over the query information bubble.
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5. EDC tasks
The EDC tasks section gives you at any time an overview of pending actions for you to perform such as pages
requiring signature, non-conformant data to be corrected, open queries to be answered or notes to
acknowledge.
To find these tasks, click on ‘Actions’ in the taskbar and select ‘EDC tasks’. This opens the overview, from where
you can navigate through the different tasks and follow the hyperlinks to the actual action items. Filters can be
applied to find back tasks on specific subjects, forms, folders, number of days a query has been open, or any
combination thereof.
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6. Help
Help regarding the use of the iMedidata Rave EDC system is available at any time from the help dropdown menu
at the top right of the screen.
Several help options are available:
Help On This Page takes you to a help page related to the page you are on (for example, if you access
this link from the visit dashboard page, help about that topic shows up).
Help Center takes you to the general help pages, where help regarding any topic is available.
Report A Problem allows you to search for help, or to report a problem directly to iMedidata.
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