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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
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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
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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
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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
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Login to VISTA-RDC and select study
http://rdc.eortc.be
Use ORTA password as before
Select study 10041
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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
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Registering a new patientRegistering a new patient
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Step 1: Entering patient data and obtaining SeqID
Click on ‘Register patient’
The registration screen appears Enter the requested data and click on ‘register’
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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’.
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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
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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
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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
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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’
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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.
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Sample management and shipment Sample management and shipment generationgeneration
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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
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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’
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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’
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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’
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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.
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Logging samples cont.
Click send
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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
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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’
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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
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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
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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
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Log lymph node statusLog lymph node status
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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
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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’
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Enrolling/randomising patientsEnrolling/randomising patients
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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
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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
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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
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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
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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.
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Queries & Data correctionsQueries & Data corrections
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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
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Queries
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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
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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
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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
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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
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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
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Print to PDFPrint to PDF
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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
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Save a CRF to PDF (2)
PDF document is displayed and can be printed or saved
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Switching to VISTA-RDCSwitching to VISTA-RDC
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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
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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
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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)
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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
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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
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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
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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