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What is the proposed process if a 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?
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- The treatment regimens are just associated with the drug, but it is not specific to the dose level (as is with the TACs).
ComboMATCH Questions
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.
