This page provides an overview of the new and updated data elements in CTRP for the FDAAA Final Rule. NCI has been implementing changes in the following areas of CTRP in support of the FDAAA Final Rule and ClinicalTrials.gov reporting:
For questions at any time, contact ncictro@mail.nih.gov.
The following tables briefly list the changes in CTRP to support the FDAAA Final Rule.
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:
Field Label | Description of Change |
---|---|
Expanded Access Indicator | Rename the field for this data element to Availability of Expanded Access. In this data element, add new value Unknown. |
Exempt Indicator | Remove the field for this data element. |
Expanded Access Record | Add this data element. |
Changes in Trial Status data elements:
Field Label | Description of Change |
---|---|
Trial Start Date | In this data element, require the full date if the type is Actual. Update the current process to properly populate this date value when importing or exporting a ClinicalTrials.gov study. |
Primary Completion Date | In this data element, require the full date if the type is Actual. |
Completion Date | In this data element, require the full date if the type is Actual. |
Changes in Trial Design data elements (abstracted by the CTRO):
Field Label | Description of Change |
---|---|
Primary Purpose | In this data element, add new value Device Feasibility. |
Trial Phase | In this data element, rename the value 0 to Early Phase 1 (or Phase 0). |
Intervention Model | Rename the field for this data element to Interventional Study Model. In this data element, add new value Sequential Assignment. |
Model Description | Add this data element. |
Masking | Remove the field for this data element. |
Masking Role(s) | Rename the field for this data element to Masking. Rename Subject check box to Participant. Rename Caregiver check box to Care Provider. Add check box No Masking. |
Masking Description | Add this data element. |
Study Classification | Remove the field for this data element. |
Changes in Outcome Measure data elements (abstracted by the CTRO):
Field Label | Description of Change |
---|---|
Safety Issue | Remove the field for this data element. |
Changes in Eligibility Criteria data elements (abstracted by the CTRO):
Field Label | Description of Change |
---|---|
Gender | Rename the field for this data element to Sex. In this data element, rename the value Both to All. |
Gender | Add this data element. |
Gender Eligibility Description | Add this data element. |
Reference information: