Transcript MINDACT patient registration, randomisation and completion

MINDACT: patient registration,
randomisation and completion of
CRFs in VISTA-RDC 4.0
Training Jan 2010
Joke De Wever & Jillian Harrison
Overview

Introduction to changes

Registering new patients and completing
screening data

Sending samples and confirmation of successful
genomic test

Enrolling/randomising patients

Electronic queries and data correction

Save CRF as PDF

Switch to new system
Changes in software systems

IDDI web based platform will no longer be used to
screen, enrol and randomise patients

This will be done in VISTA-RDC; new version will
be released

Sample management and tracking will also be
managed in VISTA-RDC

CRFs will be completed in VISTA-RDC as before
VISTA-RDC 4.0 - What’s new?

Patient registration

New tab for management of samples and
shipments

Changes in layout

Electronic queries

Request for data correction
Login to VISTA-RDC and select study

http://rdc.eortc.be

Use ORTA password as before

Select study 10041
View or select existing patients

If you have access to
patients from more than 1
institution select the
institution

You will see nb of patients
with requested / incomplete
/ complete forms and with
queries

You can select an
individual patient by
entering the SeqID
Registering a new patient
Step 1: Entering patient data and
obtaining SeqID

Click on ‘Register patient’

The registration screen appears

Enter the requested data and click on ‘register’
Step 2: fill in registration form

The registration form will appear and the Seqid is
displayed.

Enter the requested data in the white fields.

Fields in yellow can not be completed, they will be
automatically completed upon saving as
‘complete’.
Step 3: Save form as complete

Once all information is provided, save the form as
complete by ticking the ‘complete’ box and
clicking on ‘Save’

Note that calculated variables are now completed
Step 4: Eligibility check

Before sending the form, you must check the
eligibility by clicking on ‘Check Eligibility’
Note that this button will only appear once the form was
saved as complete
If data were modified, you will need to save the data
first before checking the eligibility
Result eligibility check
Patient is eligible
Patient is ineligible
 Send form

Wrong data provided


correct data, save
and check eligibility
Patient truly
ineligible  send form
Step 5: send form

Once the eligibility has been checked, users that
have the right to send forms, can send the form

You will be prompted to enter your password

After sending, the form is visible in the tab ‘Sent’
Copies of registration forms

After sending a registration (RG) form an editable
copy of the form (crg) will automatically appear in
the incomplete forms tab.

You must open the crg form, check and send this
copy. If you notice that any of the data you send
initially is not correct you can use these forms
(crg) to correct it.
Sample management and shipment
generation
Sending samples

Centres can log samples as they become
available

Each centre will have a planned weekly shipment
day and time as before (same day and time as in
web platform)

If at least 1 sample is logged and associated with
an eligible patient. This will trigger the next
shipment . An automatic email is sent to inform
the centre and courier of the pick-up
Register the sample in ‘Samples’ tab

Independently of each other centers need to
complete both the RG2 to provide some
information about the tumour sample obtained
AND

Log the sample as available in the ‘Samples’ tab
Tabs
‘Register patient’
‘Manage patients’
‘Samples’
Logging samples

When a biopsy is successfully obtained you go to
the ‘Samples’ tab and log the sample

This is done by clicking on ‘Add Sample’
Logging samples cont.

selecting the SeqID of your patient from the list of
available SeqIDs of patients registered in your
Institute
!Be careful to select/type the correct SeqID!

For MINDACT you can enter the number of
biopsies obtained in the ‘Type’ field

Once you have selected the SeqID complete the
SampleID in the applicable box and save by
clicking ‘create’
Logging samples cont.

This will log the sample as available and therefore it
will trigger a sample collection on the next possible
collection day if the patient is still eligible

Once the shipment email has been sent

The centre fixes the list of samples in the shipment
by clicking on the ‘Send’ button and therefore
changing the status of the shipment from the ‘in
preparation’ section to the ‘in transit’ section.
Logging samples cont.

Click send
Sending samples cont.

Print the list of samples in the shipment for the
courier

If a mistake is made after a shipment is sent and
appears ‘in transit’ (sample listed in a shipment but
not sent or sample sent but not listed) centres
should contact the EORTC and we can move a
sample between sent shipments
Delaying the sending of samples

Centres can move samples out of a shipment and
into the following week’s shipment

This is done by changing the status of a sample
from ‘OK’ to ‘delay’
Delaying the sending of samples cont.

This will move the sample out of the current
shipment and into the following week’s shipment

This can be done up until when the shipment is
sent and moves to ‘in transit’ /when the courier
arrives
Shipment collection by courier

The automatic email to create a shipment will be
sent the afternoon before the shipment, as before

The email will no longer list the individual
samples

You should click ‘send’ to fix the list of samples
just before the courier arrives or whenever most
convenient

Print out the final list and give a copy to the
courier
Delaying a shipment collection date

If a routine shipment falls on a public holiday the
centre can move the collection day forward
e.g. if the routine collection day is Tue the centre
can postpone the collection to Thur by changing
the planned collection date

The next weeks planned shipment will return
automatically to the routine day e.g. Tue
Log lymph node status
Recording lymph node status (RG 3)

As soon as lymph node status is available you
should record the status by completing RG3 in
the section ‘requested forms’ in the tab ‘Blank’

Logging the lymph node status, if the patient is
eligible, will trigger the genomic test to be
performed
Notification that patient can be enrolled

Once the genomic test has been performed
successfully you will receive an email to inform
you that the patient can be enrolled

Then you complete the enrolment checklist (RG5)
which will appear in the ‘requested forms’ section
in the tab ‘Blank’
Enrolling/randomising patients
Enrollment checklist

Once you input all of the data, check eligibility as
before and send the form

On sending the form the clinical risk will be
calculated using the Adjuvant! Online module and
the clinical risk compared to the genomic risk

If the patient is discordant then they will be
randomised for treatment decision
Risk classification and randomisation results

After you have sent the enrolment checklist, the
“results” form can be created. Complete the date
of enrolment. Upon saving the form as complete,
the clinical, genomic and randomisation results
will be visible on the form

If the patient is enrolled successfully then all
other CRFs will become visible in the ‘blank’ tab
in the other forms section

The next randomisation checklist, if applicable,
will be requested in the ‘requested forms’ section
Subsequent randomisations - chemotherapy

If treatment decision is chemotherapy, complete
the chemotherapy checklist (RG 6)

You can select if the patient will be randomised for
chemotherapy or not, as before

If a lymph node negative patient is randomised to
the anthracycline arm then an additional form will
appear in the ‘requested forms’ section for you to
communicate which anthracycline regimen the
patient will receive

If a lymph node positive patient is randomised to
the anthracycline arm then they will be allocated to
FEC-D
Subsequent randomisations – endocrine therapy

If the patient the patient is hormone receptor
positive, complete the endocrine therapy
checklist (RG 8)

You can select if the patient will be randomised
for endocrine therapy or not, as before
Ineligible patient

If the data entered on a registration form make
the patient ineligible, send the registration form

In case the next registration step can not be done
(e.g. Log tumor sample form can not be
completed because it was not possible to obtain
sample), click on ‘not applicable’ in the section
Requested forms of the tab ‘Blank’ and enter the
reason.
Queries & Data corrections
Electronic queries

Previously EORTC DMs send paper query forms
via email on sent data

In RDC 4.0 we will use electronic queries so
instead of query forms being sent by email,
queries will appear in the ‘Queries’ tab in RDC

Queries will be displayed underneath the box
being queried
Queries
Answer queries
3. save
1. answer query (new value or comment)
2. if applicable, mark query as ‘Ready to send’
Send answers on queries
Persons authorized to approve and send e-CRF, can also
send answered queries
1. Enter your password
2. Click on the ‘Approve &
send’ button. All queries that
were marked as ‘Ready to
send’ will be sent.
Data Correction

Data Correction: request to change data that were
already sent to EORTC study database


In the past: data correction form (paper)
Now: in VISTA RDC

Correct / clarify data on the form

Correct patient data
Correct / clarify data on a form
A request for data correction can be created on
forms that have been sent
1.
2.
3.
4.
Select the form in the tab ‘Sent’
Create the data correction
Send the data correction in the tab ‘Queries’ by entering your
password and clicking on the ‘Approve & send’ button
The EORTC DM will modify the database
A comment about a form can be created in the
same way by clicking on ‘Form comment’ in the
header of the e-CRF
Data Correction: Correct patient data
Example: date of birth wrong
Tab Queries – section ‘Other queries’ – click on ‘Correct patient data’
To send the request for correction
of patient data, enter your
password & click the ‘Approve &
Send’ button
Print to PDF
Save a CRF to PDF (1)

Forms can be saved as PDF document

To do this:

Open the form in view-mode
Click on save as PDF

Pick up the PDF

Save a CRF to PDF (2)

PDF document is displayed and can be printed or
saved
Switching to VISTA-RDC
Switch to VISTA-RDC

Planned for Wed 20th Jan – end of day, confirmation
to follow

Initially new patient registration will be blocked in
the IDDI web platform

When you click to register a new patient a pop-up
will redirect you to VISTA-RDC

However existing patients in screening and already
enrolled must continue to be screened, enrolled
and randomised in this system
Switch to VISTA-RDC cont.

Approximately 3 weeks later when all patients
registered in the IDDI platform have received the
genomic test result, all patients will be switched
from the IDDI web platform to VISTA-RDC and the
IDDI web platform switch off

We will communicate the date nearer the time
Switch to VISTA-RDC cont.

During the time that both systems are operating
centres should try enrol all patients in screening
and to perform any possible outstanding
randomisations

Patients who are registered and being screened in
the IDDI web platform who are not enrolled before
the switch to RDC 4.0 will be available to be
enrolled in RDC 4.0 once the IDDI platform is offline

This will also be the case for any outstanding
subsequent randomisations (R-C or R-E)
IDDI platform
-600 d
-56 d
Enrolled patients
Pts with genomic
results
Pts with enrollment
pending
-20 d
Pts in screening
D0
Stop registration IDDI
Switch after genomic results
RDC 4.0
+ 20 d
On day 20 all patients with genomic test result will be
switch to RDC 4.0 for enrollment
All enrolled patients will
be switch to RDC 4.0 for
subsequent
randomizations
From day 0 all new
patients will be
registered in RDC 4.0
and have all steps in
RDC 4.0
Switch to VISTA-RDC cont.

On the afternoon of the switch which is planned
to happen late afternoon centres may experience
problems logging onto the IDDI web platform

This should not last more than 10 minutes
Switch to VISTA-RDC sent queries

Up to the switch you should continue to answer
as many outstanding queries as possible

Paper queries that were not answered yet will be
switched to electronic queries at the time of the
switch. They must be answered in VISTA RDC.

However if we receive a completed paper query
form after the switch, the queries will be switched
back to paper and closed
Activation of new centres

Information previously collected in the IDDI web
platform for centre activation will be collected in a
different way:
e.g. centre receipt of initial drug supply

More information will be provided to the NCC/Gs
about this in the near future

NCCs will communicate this to their sites which
are in the activation process