| TSR Data Elements | XML 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> |
 |
