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Comment: Revised based on the release of CTRPMICRO-10 to the Production tier.

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 FDAAA Final Rule data elements
    1. .
    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.
  2. Phase 2 -
    3. Planned for end of July or early August 2017, complete implementation:
    Registration web application:  Users will be entering the new/modified
  3. In August 2017, NCI updated the CTRP trial registration website and services to support the capture of all FDAAA Final Rule data elements
    4. directly to CTRP via the Registration web application
  4. .
    1. CTRP Registration REST
    Services:  CTRP REST services will support
    1. services support the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.

Keep in mind the following points:

...

    1. Cancer Center CTRP users can enter the new/modified FDAAA Final Rule data elements

...

  • If you are registering a Device trial, please contact the CTRO.

...

    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 available.
  1. Phase 3 - In August 2017, NCI completed implementation including the following:
    1. 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.

Note

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

SponsorMake this field optional.
Responsible PartyMake 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 ClearanceAdd this data element.
Pediatric Post-market Surveillance

Add this data element.

Product Exported from the U.S.

Add this data element.

FDA Regulated Intervention IndicatorMake this field optional.

Section 801 Indicator

Make this field optional.

 

Changes in IND/IDE data elements:

...