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  • Crossover is for disease-based cohorts and going from cohort 1 to cohort 2 is for drug exposure-based cohorts. The latter requires reassignment. For crossover, once they have enrolled to the first step and gotten their treatment assignment and patient progresses, they are eligible for a crossover.
  • They would:
    • Enroll to step 2 on the treatment protocol
    • Assign a crossover treatment

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?

  • 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 way to get a form builder account for NCIs new system?

  • The best thing to do is to contact caDSR.RA@mail.nih.gov so we can respond and assist. Everyone that had a Form Builder account in the old system has one in the new system, but we will need to work with them to make sure they can sign on and request curation if needed.

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)?

  • The EC template can be placed in the enrollment folder.

For the ineligible status, is there a new field to use to ensure proper set up?

  • This test case is now optional.

What is the form OID for the EC template?

  • Form OID will be part of their form build in caDSR II.

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?

  • 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.

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