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 TSR Data ElementsXML Data Elements
Studies a U.S. FDA-regulated Drug Product<fda_regulated_drug>
Studies a U.S. FDA-regulated Device Product<fda_regulated_device>
Unapproved/Uncleared Device?<delayed_posting>
Post Prior to U.S. FDA Approval or Clearance <post_prior_to_approval>
Pediatric Post-market Surveillance<ped_postmarket_surv>
Product Exported from the U.S.<exported_from_us>
FDA Regulated Intervention?<is_fda_regulated>
Section 801?<is_section_801>
DMC Appointed?<has_dmc>
IND/IDE Study?<is_ind_study>