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| 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> | Delayed Posting Indicator? | <delayed_posting> |
| DMC Appointed? | <has_dmc> | ||
| IND/IDE Study? | <is_ind_study> |
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