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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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• 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.

ComboMATCH Questions

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