Page History

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• Westat can change the Form OID in Rave once they have the ALS from caDSR. Moving forward for PMI forms, the form OIDs will be abbreviated. Current ones will not be changed.

What’s the quickest quickesThe treatment regimens are just associated with the drug, but it is not specific to the dose level (as is with the TACs).t way to get a form builder account for NCIs new system?

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• On Tier 1, all participants must be treatment naïve. There are even in protocols for Tier 1, patients can have taken some therapy as long as it’s a minimal dose.

In the A3 schema there is an indication that there should be a max of 6 pts enrolled to cohort 4 for a given histology.  How will this be handled in the screening trial and in terms of managing/capping enrollment to cohort 4? 

• This will be handled in MATCHbox. No assignments will be generated for Histology once maximum is reached.

What happens/what is the process when the site leaves the DLAP Scenario ID blank? What happens/what is the process when there’s a blank DLAP Scenario ID under Physician’s choice?

• The site user may not have a scenario ID so they don’t have to populate it. Field is required on the EC form but may be left blank by the site in the event that the data has not yet been entered and confirmed in DLAP.​ There is no correlation between Physicians choice or DLAP.

Is it correct that two Off Treatment forms aren’t needed for a crossover?

• The Off Treatment from does not need to be completed for a Crossover.

The CDE 10948385 is being used to capture the ICD code for Screening and is a text string. Would 6154743 be better as that has a dictionary associated with it that represents the ICD-O-3 topography codes you mentioned?  ​

We are asking so we don’t collect a different data element on the treatment form then what is being collected on the screening form and this would allow Alliance to monitor the rates as well and if we need to do some collapsing of a set of codes to a broader class of “histology/type of cancer” we would be able to evaluate that as we go.

• The fields on the screening protocol are integrated with the disease service. We will consider this option at a future timepoint, but you will have access in MATCHbox to view this data in real-time and export that data.

What is the proposed process if a patient does not consent to banked specimens.? How will each Group relay that information to the NCI so that they do not expect banking material from that patient?

• Groups can have the consent question in OPEN. With this we are also looking into the creation of a custom report to relay information to NCI.

We have consensus that the format you described below would be acceptable, though some concerns/questions have been raised: Can you confirm this method would require updates to the OPEN Checklist to add a field? Can you confirm that sites would only need to “pick” from the list once, after which their selection would be parsed out to populate both the code and name fields.

• No new fields should be needed. We are planning on concatenating like the prior therapy field, just that there might be some updates needed to the CDEs to accommodate the full value. 

With regards to Regimen, can you please confirm if the Regimens presented in the schematic are equivalent to TACs in OPEN? Or are these PMI specific treatment codes. 

• The treatment regimens are just associated with the drug, but it is not specific to the dose level (as is with the TACs).

We are working to develop our Eligibility Checklist for EAY191-C1, and would like to confirm how to accommodate the OPEN required ‘Stratification’ Module which contains stratum and treatment assignment with the ‘Treatment Module 2’ on the PMI EC?
Can the module name be revised on the LPO’s EC?  We would like to change the module name to stratification to support the standard messaging to OPEN from our Randonode.  

• The module name is tied into the integration and there are dependencies on the drop down and suggestions. This would be a global change and impact all groups and would push timelines.

We are planning on using ALS Version 7.0 for EAY191-C1 and want to confirm if that is acceptable?  

• Groups can use 7.0, but will need to migrate to 7.1 or 7.2 when 7.2 comes out.  ​

ComboMATCH Questions

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• NCI still currently working on re-registration requirements.

We are in the process of writing specifications for folder rollout for the ComboMATCH Screening protocol in Rave.  The assumption is that we need to build multiple Steps into Rave.  I have reviewed all the materials, including the test plans and instructions for generating OPEN Checklists, and it appears that there is no plan to have the ability to enter Step 2 registrations in the Screening Study at Go Live.  Is this correct?

• Yes, this is correct. Step 2 is only for re-registration.

We are finishing out study builds for our ComboMATCH treatment trial (EAY191-S3) and our MyeloMATCH treatment trial (MM1YA-S01) and I would like to confirm the correct arm names and/or Treatment Assignment Codes.  Can you please provide the correct names and codes for these two trials?

• MATCHBox the IDs are below, and they give both stratification and randomization.​ List of codes has been sent.
  • EAY191-S3​
  • MM1YA-01

MeyloMATCH Questions

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• There is no ALS for the Rave EC Template. We are using our normal EC template process. The form is built in caDSR II based on our template and that will provide you the form OID.
• The four fields you will need for that form are:
  • Screening Protocol ID
  • Screening Participant ID
  • Cohort
  • Stratum

What data will be entered in OPEN for a new assignment? How will we get that data into Rave? I assume there’s a template form that we’ll need to build out so the data can be pushed into our Rave instance.

• The PMI Project team will address reassignment questions at a future meeting since reassignment was not part of the Phase 1 release.

How is the step information form going to look for a reassessment vs a new assignment? Will a logline still be added showing that specimens were analyzed but that the decision was that they should stay on their current treatment trial? Is a logline added every time they submit something in OPEN or only in some cases?

• A notification will be sent that a treatment is complete, and the patient is eligible for a new tier assignment.
• ​Every new step in OPEN will result in a log line in Rave. If they get reassigned, they have a log line added.  No additional new log lines based on updates or events, only mapped with STEP.

Will our data management staff have access to the EAY191 Source Documents being uploaded to OPEN?  Typically, we have sites upload Path Reports into Rave, however if EA will have access to the Path Reports uploaded to OPEN we could reduce burden on sites and eliminate duplicate data entry.

• Access can be given in OPEN to view the reports, however you will need to view the report patient by patient.

After the initial paper-based process, it sounds like there will be Precision Medicine Specimen Tracking Forms and the other specimen-related forms submitted via Rave (listed below). Should these forms be part of our study build or will they exist in a different Rave “instance”? ​

• Samples Tracking and Manifest Form
• Local Pathology Group Information Form
• CLIA Laboratory Specimen Submission Form
• MyeloMATCH Generic Specimen Submission Form
• Pathology Group Form

• ​MM Generic Specimen submission form will not be part of the Rave study build; this is a place paper form for the STFM which will be part of the study build in the future.​
• The Below forms are targeted to be added to the PMI Screening Protocol as part of Phase II activities.
  • PMI STMF
  • PMI Pathology Group Form
  • PMI CLIA Submission Form

How is our Randonode supposed to be pushed into OPEN?

• A Randonode setup document was provided to explain how RandoNode is supposed to push into OPEN with the initial release.

We are wondering if our data management staff will have access to the EAY191 Source Docs being uploaded into OPEN by sites.  Typically, we have sites upload Path Reports into Rave, however if we willl have access to the Path Reports uploaded to OPEN we could reduce burden on sites and eliminate duplicate data entry.

• Groups can go in and download documents on a patient-by-patient basis. Unfortunately, Mass patient downloads are not available.