This page provides an overview of the new and updated data elements in CTRP for the FDAAA Final Rule. NCI is implementing changes in the following areas of CTRP in support of the FDAAA Final Rule and ClinicalTrials.gov reporting in two phases:
- Phase 1 - In May 2017, NCI will update CTRP to support capture and output of the FDAAA Final Rule data elements:
- The Protocol Abstraction (PA) web application, used by the CTRO, will capture all new/modified FDAAA Final Rule data elements. Until CTRP Registration is updated, these new/modified FDAAA Final Rule data elements will need to be submitted to the CTRO to update the trial record during new trial/amendment abstractions. Instructions provided below.
- CTRP Abbreviated trial imports from ClinicalTrials.gov will 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) will include the new/modified data elements.
- The CTRP-generated XML file sent to centers after the processing of a new trial or amendment in CTRP will include all the new/modified FDAAA Final Rule data elements
- ClinicalTrials.gov PRS "Upload from NCI CTRP" will import the new/modified data elements, if submitted to the CTRO to update the trial record during new trial/amendment abstraction.
- Exclusions: The CTRP Trial Registration Website and Services will not be able to capture the new/modified data elements directly. The Trial Summary Report (TSR) will not reflect the new/modified FDAAA Final Rule data elements. Until Phase 2 (see below) is released, this information will need to be submitted to the CTRO to update the trial record during new trial/amendment abstractions in CTRP.
- Phase 2 - Planned for end of July or early August 2017, complete implementation:
- Registration web application: Users will be entering the new/modified FDAAA Final Rule data elements directly to CTRP via the Registration web application.
- Registration REST Services: CTRP REST services will support the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.
- Phase 3 - Planned for August 2017, complete implementation:
- The Trial Summary Report (TSR) will include the new/modified data elements if applicable.
- The data warehouse (DW) will have the phase value Early Phase 1 instead of O.
Keep in mind the following points:
- Instructions for FDAAA Final Rule data element submission during Phase 1. Use CTRP for trial registration. Submit the new/modified FDAAA Final Rule data elements to the CTRO to update the trial record during new trial/amendment abstractions. Complete this Microsoft Excel template and submit to the CTRO: FDAAA_Final_Rule_fields-5-2017.xlsx.
- If you are registering a Device trial, please contact the CTRO.
- After Phase 2, the CTRP trial registration website and services will be able to capture all required FDAAA Final Rule data elements, as long as they are submitted to CTRP during new trial/amendment registrations.
- 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 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. |
| 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. |
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
