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Page History
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| Note |
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Some fields will be accessible only to the CTRO as these fields are captured during protocol abstraction. |
Changes in Sponsor/Responsible Party data elements:
Field Label | Description of Change |
|---|---|
| Sponsor | Make this field optional. |
| Responsible Party | Make this field optional. |
Changes in Regulatory data elements:
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. |
Changes in IND/IDE data elements:
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