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• How should the Lead Organization (LO) report accrual in each of the following?
  • Patient transfers INTO the lead org site from a participating site (the patient becomes a LO site patient treated by a LO site investigator)
    • The patient would not have enrolled to the study under LO site investigators
  • Patient transfers FROM the LO site to a participating site (the patient is no longer being treated by a LO site investigator at the LO site)
    • The patient would have enrolled to the study under a LO site investigator
• How do I register an a multi-site, non-NCI Designated Cancer Center or Industry led Observational study in CTRP that doesn't have an NCT ID 
  (not registered in ClinicalTrials.gov and Lead Org doesn’t plan to register it in ClinicalTrials.gov)?
  
  • Please contact the CTRO NCICTRO@mail.nih.gov to request assistance with registering Observational studies without an NCT ID
• Is the inclusion of Expanded Access trials on the CTRP DT4 still optional? 
  • The reporting of an Expanded Access trial on a center-specific CTRP-generated DT4 is still at the discretion of the cancer center
  • If you have an Expanded Access trial registered in CTRP that you would like to exclude from your CTRP-generated Data Table 4 report, please send a message to the CTRO (NCICTRO@mail.nih.gov) to request exclusion
• With Expanded Access protocols being in DT4, will single patient expanded access (compassionate use protocols) also be included?
  • No, single patient compassionate use studies are out of scope for CTRP

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