MINDACT: patient registration, randomisation and completion of CRFs in VISTA-RDC 4.0

1. MINDACT: patient registration, randomisation and completion of CRFs in VISTA-RDC 4.0 Training Jan 2010 Joke De Wever & Jillian Harrison

2. 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

3. 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

4. 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

5. Login to VISTA-RDC and select study • http://rdc.eortc.be • Use ORTA password as before • Select study 10041

6. 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

7. Registering a new patient

8. Step 1: Entering patient data and obtaining SeqID • Click on ‘Register patient’ • The registration screen appears • Enter the requested data and click on ‘register’

9. 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’.

10. 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

11. 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

12. 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

13. 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’

14. 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.

15. Sample management and shipment generation

16. 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

17. 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’

18. 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’

19. 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’

20. 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.

21. Logging samples cont. • Click send

22. 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

23. 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’

24. 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

25. 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

26. 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

27. Log lymph node status

28. 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

29. 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’

30. Enrolling/randomising patients

31. 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

32. 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

33. 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

34. 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

35. 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.

36. Queries & Data corrections

37. 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

38. Queries

39. Answer queries 3. save 1. answer query (new value or comment) 2. if applicable, mark query as ‘Ready to send’

40. Send answers on queries 1. Enter your password 2. Click on the ‘Approve & send’ button. All queries that were marked as ‘Ready to send’ will be sent. Persons authorized to approve and send e-CRF, can also send answered queries

41. 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

42. Correct / clarify data on a form A request for data correction can be created on forms that have been sent • 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

43. 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

44. Print to PDF

45. 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

46. Save a CRF to PDF (2) • PDF document is displayed and can be printed or saved

47. Switching to VISTA-RDC

48. 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

49. 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

50. 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)