Do lab draws that don’t change the plan of care (only for data collection) need to be reported?

Unless the method for drawing the specimen includes an applicable clinical device trial in human subjects, the Elaboration of Definitions of Responsible Party and Applicable Clinical Trial document suggests for purposes only of the requirements under 402(j) of the PHS Act, the definition of human subject does not apply to de‐identified human specimens. 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.