If the radiation is an intervention in an applicable clinical trial, it would require registration and results reporting. If the radiation involves an applicable device trial, (see the definition of applicable device trial in the Elaboration of Definitions of Responsible Party and Applicable Clinical Trial document), it may be eligible for delayed registration and results reporting. For additional clarification, please contact ClinicalTrials.gov at register@clinicaltrials.gov or Jarilyn Dupont (jarilyn.dupont@fda.hhs.gov) at the FDA. The ICMJE policy may differ from Federal regulation.