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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• Cohort and Stratum are being populated in OPEN through a group lookup window that is being populated with the Cohort and stratum that was assigned to the patient at screening.
• No curation activities are required or should be managed for the Cohort & Stratum CDEs/ fields. These are non-enumerated fields that should be used as already specified on the PMI EC Template.

ComboMATCH Questions

Why are prior treatment fields included for this trial when these are all treatment naive patients? Are you expecting them to enter prior treatment for other cancers if they’ve had any?

• 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

Our studies have a planned follow up after the treatment completion and PMI Off Treatment forms. These will be used to roll out follow up folders in Rave. Will NRG receive information that a patient is assigned to a different ComboMATCH protocol, and will we receive notification our follow up should be stopped?

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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

Why are the topography, morphology, and grade fields all required? They are mostly not applicable to the disease for this trial, especially grade. Seems like that would be “N/A” for all patients. If they must enter topography and morphology, can we at least narrow down the lists to the few things that are applicable?​

• SWOG can decide if they want to collect these questions on their MM Screening Protocol EC form in the caDSR II during form build activities. This field will be marked as optional in OPEN:  If data is present, it will be pushed.​
• The 'Morphology' field is required for the MyeloMATCH protocols, specifically "9860/3"; SWOG can default the value for this field in OPEN.​

OPEN/Rave Questions

It seems none of us at SWOG have the right Rave roles to upload the central study ALS. It says we can’t create a new Project in Architect without creating them in iMedidata first, like we do when we build a new study. Can you find out what RAVE role CTSU uses to upload central study ALS?

• Going forward Central Study xGlobal CFs-Matchbox will be used for PMI trials, and if it is created in iMedidata it will allow you to invite users and restrict access for PMI central study via iMedidata. SAE integration central study is also in iMedidata
• Regarding your question about permission to create Project directly in Rave, the user should be assigned a Security Role that has ‘Create’ Action flag checked for Architect Project in Core Configuration.

How will the screening ID, cohort, and stratum fields be validated on the treatment trial OPEN forms to ensure the correct responses were entered? Will these be auto filled on the form in some way, or will there be an edit check that needs to be configured for these fields?

• Configured group look up windows based on the screening patient ID that was entered.
• For crossover – Step 2. In OPEN they would need to create a step 2 enrollment or enter patient ID of step 1 of the treatment protocol.

We also wanted to verify which form these fields (Screening protocol ID, Screening participant ID, Cohort, Stratum) were expected to be populated in Rave. Alliance does not currently use the Eligibility Checklist form in Rave so we want to make sure we understand where these fields are expected. I believe Shauna Hillman has been working with others regarding some Rave questions, but I wanted to note we still need this information from the OPEN form processing side as well. We need to make a code change on our end to send this information to Rave so we need this information as soon as possible to be ready by the OEWG deadline.

• Groups are expected to populate the screening protocol ID, screening participant ID cohort and stratum fields in Rave.

 Will we be receiving an ALS for the Rave Eligibility Checklist Form?  This is a new form for Alliance. 

• 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.