Page History

This page provides an overview of the new and updated data elements in CTRP for the FDAAA Final Rule. NCI is implementing changes has been implementing changes in the following areas of CTRP in support of the FDAAA Final Rule and ClinicalTrials.gov reporting in two phases:

1. Phase 1 - In May 2017, NCI will update CTRP updated CTRP to support capture and output of the FDAAA Final Rule data elements:
1. The Protocol Abstraction (PA) web application, used by the CTRO,
will capture all
1. captures all new/modified FDAAA Final Rule data elements. 
Until CTRP Registration is updated, these
1. These new/modified FDAAA Final Rule data elements
will need to be
1. are submitted to
the CTRO
1. the CTRO during this phase to update the trial record during new trial/amendment abstractions. 
Instructions provided below.
2. CTRP Abbreviated trial imports from ClinicalTrials.gov
will include the
1. include the new/modified data elements if already provided on the ClinicalTrials.gov record.
2. Nightly export of NCI-Sponsored trials from CTRP to the ClinicalTrials.gov Protocol Registration System (PRS)
will
1. include the new/modified data elements.
2. The CTRP-generated XML file
sent to centers after
1. that will be available after the processing of a new trial or amendment in CTRP
will include all
1. includes all the new/modified FDAAA Final Rule data elements.
2. The ClinicalTrials.gov PRS "Upload from NCI CTRP"
will import
1. feature imports 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
2. 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.
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:

3. 1. CTRP Registration REST services support
   Registration REST Services: CTRP REST services will support Registration web application: Users will be entering the
   1. the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.
4. PA web application: The XML Required field will be removed. (The XML Required field is not a FDAAA field. It is mentioned on this page only for clarity.)
1. Cancer Center CTRP users can enter the new/modified FDAAA Final Rule data elements
directly to
1. directly in CTRP via the Registration web application. 
2. All FDAAA Final Rule/ClinicalTrials.gov fields are now optional. The "XML Required" field will no longer be
removed
1. available.
   
5. Phase 3 - Planned for In August 2017, complete NCI completed implementation including the following:
   1. The Trial Summary Report (TSR) will include includes the new/modified data elements if applicable.
   2. The data warehouse (DW) will have the phase value Early Phase 1 instead of O.

Keep in mind the following points:

...

• 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.

...

1. 1. 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.

Changes in Sponsor/Responsible Party data elements:

Changes in Regulatory data elements:

Changes in IND/IDE data elements:

...