- Phase 1 - In May 2017, NCI updated CTRP to support capture and output of the FDAAA Final Rule data elements:
- The Protocol Abstraction (PA) web application, used by the CTRO, captures all new/modified FDAAA Final Rule data elements. These new/modified FDAAA Final Rule data elements are submitted to the CTRO during this phase to update the trial record during new trial/amendment abstractions.
- CTRP Abbreviated trial imports from ClinicalTrials.gov include the new/modified data elements if already provided on the ClinicalTrials.gov record.
- Nightly export of NCI-Sponsored trials from CTRP to the ClinicalTrials.gov Protocol Registration System (PRS) include the new/modified data elements.
- The CTRP-generated XML file that will be available after the processing of a new trial or amendment in CTRP includes all the new/modified FDAAA Final Rule data elements.
- The ClinicalTrials.gov PRS "Upload from NCI CTRP" feature imports the new/modified data elements, if submitted to the CTRO to update the trial record during new trial/amendment abstraction.
- Phase 2 - In August 2017, NCI updated the CTRP trial registration website and services to support the capture of all FDAAA Final Rule data elements.
- CTRP Registration REST services support the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.
- Cancer Center CTRP users can enter the new/modified FDAAA Final Rule data elements directly in CTRP via the Registration web application.
- All FDAAA Final Rule/ClinicalTrials.gov fields are now optional. The "XML Required" field will no longer be available.
- Phase 3 - In August 2017, NCI completed implementation including the following:
- The Trial Summary Report (TSR) includes the new/modified data elements as applicable.
- The Trial Summary Report (TSR) includes the new/modified data elements as applicable.
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:
- Final Rule Applicable Clinical Trial Checklist: https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf
- Overview of the Final Rule changes: https://prsinfo.clinicaltrials.gov/webinars/finalrule/resources/Final_Rule_Webinar_One_Sept_27_2016.pdf
- Final Rule ClinicalTrials.gov trial registration changes: https://prsinfo.clinicaltrials.gov/webinars/finalrule/resources/Final_Rule_Webinar_Two_Oct_5_2016.pdf
