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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).

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.

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