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Field Label	Description of Change
Sponsor	Make this field optional.
Responsible Party	Make this field optional.

Field Label	Description of Change
Trial Oversight Authority Country and Trial Oversight Authority Organization Name	Remove the fields for these data elements.
Studies a U.S. FDA-regulated Drug Product	Add this data element.
Studies a U.S. FDA-regulated Device Product	Add this data element.
Delayed Posting Indicator	Rename the field for this data element to Unapproved/Uncleared Device. Make this field optional.
Post Prior to U.S. FDA Approval or Clearance	Add this data element.
Pediatric Post-market Surveillance	Add this data element.
Product Exported from the U.S.	Add this data element.
FDA Regulated Intervention Indicator	Make this field optional.
Section 801 Indicator	Make this field optional.

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