Will Groups receive a central patient ID?
What is the mechanism for transfer of the three separate fields the protocol ID, cohort ID, and stratum ID to Groups randonode? What set up is needed on Group side?
For crossovers from cohort 1 to cohort 2 (Group study EAY191-N2) are patients expected to submit PMI Off Treatment standard form and go back to central study?
How long will it take for the patient to be able to come down the pipeline to re-enter our study as cohort 2 candidate? EAY191-N2 study will have a second eligibility checklist in OPEN for these patients.
The sequence of events would be:
If yes to above, how will patients on EAY191-N2 that discontinue treatment for reasons other than progression, go into Follow up, have a progression, proceed to crossover to cohort 2? How will that be handled since PMI Off Treatment form was submitted with a reason other than progression? Also, what about those to progressed but do not want to consent to cross over to cohort 2?
If patients need to go through central study when crossing from cohort 1 to 2, how is crossover from treatment 1 to treatment 2 within the same cohort handled like we have in NRG study EAY191-N4? At what point PMI Off Treatment standard form needs to be submitted?
OIDs should be abbreviations of the form, is there any way to keep this in mind in the future and for any forms that aren’t finalized yet?
What’s the 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?
Where (what folder) does this EC template need to be in? Can it be in the Enrollment Folder with the other enrollment forms (Demography, Step Information, and Treatment Assignment)?
For the ineligible status, is there a new field to use to ensure proper set up?
What is the form OID for the EC template?
How are the permissible values for the Cohort and Stratum CDEs added for each treatment trial? Are we responsible for submitting a request to the CBIIT curation team or will these be added in another way to ensure screening trial and treatment trial groups are using the same permissible values?
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?
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?
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?
Is it correct that two Off Treatment forms aren’t needed 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.
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?
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.
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.
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.
We are planning on using ALS Version 7.0 for EAY191-C1 and want to confirm if that is acceptable?
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?
Does NRG need to share data from our ComboMATCH studies? Is there a mechanism for that and in what format our data needs to be?
What is the max number of steps to build into ComboMATCH. Has this been determined already?
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?
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?
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?
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?
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?
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.
Will we be receiving an ALS for the Rave Eligibility Checklist Form? This is a new form for Alliance.
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.
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?
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.
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”?
How is our Randonode supposed to be pushed into OPEN?
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.