Training Jan 2010

Joke De Wever & Jillian Harrison

MINDACT: patient registration, MINDACT: patient registration, randomisation and completion of randomisation and completion of

CRFs in VISTA-RDC 4.0CRFs in VISTA-RDC 4.0

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 patientRegistering 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

Send form

Patient is ineligible

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 Sample management and shipment generationgeneration

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 statusLog 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 patientsEnrolling/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 correctionsQueries & 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

2. if applicable, mark query as ‘Ready to send’2. if applicable, mark query as ‘Ready to send’

1. answer query (new value or comment)1. answer query (new value or comment)

3. save3. save

Send answers on queries

Persons authorized to approve and send e-CRF, can also send answered queries

2. Click on the ‘Approve & send’ button. All queries that were marked as ‘Ready to send’ will be sent.

2. Click on the ‘Approve & send’ button. All queries that were marked as ‘Ready to send’ will be sent.

1. Enter your password1. Enter your password

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. Select the form in the tab ‘Sent’

2. Create the data correction

3. Send the data correction in the tab ‘Queries’ by entering your password and clicking on the ‘Approve & send’ button

4. 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 PDFPrint 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-RDCSwitching 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 off-line

This will also be the case for any outstanding subsequent randomisations (R-C or R-E)

D0 Pts in screening

Stop registration IDDI

From day 0 all new patients will be

registered in RDC 4.0 and have all steps in

RDC 4.0

IDD

I p

latf

orm

Pts with enrollment pending

Enrolled patients

Pts with genomicresults

RD

C 4

.0

-20 d

-56 d

-600 d

Switch after genomic results

+ 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

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