Page History

This page provides an overview of the changes in CTRP:

September 2020

• CTRP Trial Record Verification: Improved the user experience for CTRP trial owners, trial submitters and site administrators with Verifying, Updating and/or Amending their trial records. Key highlights from this enhancement include:
  1. New page highlighting all Trials Needing Verification
     Image Added
     
  2. Ability to view all trial details on the Verify screen
     Image Added
  3. Simplified workflow allowing users to Verify, Update or Amend trials within same form
  4. New monthly email notification for alerting trial owners, trial submitters,
     and site administrators of Trials Needing Verification
     

...

1. 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. 
2. CTRP Abbreviated trial imports from ClinicalTrials.gov include the new/modified data elements if already provided on the ClinicalTrials.gov record.
3. Nightly export of NCI-Sponsored trials from CTRP to the ClinicalTrials.gov Protocol Registration System (PRS) include the new/modified data elements.
4. 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.
5. 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.

...

1. CTRP Registration REST services support the submission of the new/modified FDAAA Final Rule data elements directly to CTRP via the REST services.
2. Cancer Center CTRP users can enter the new/modified FDAAA Final Rule data elements directly in CTRP via the Registration web application. 
3. All FDAAA Final Rule/ClinicalTrials.gov fields are now optional. The "XML Required" field will no longer be available.
   

• 1. Image Added
     

August 2020

• Flexible Accrual:

...

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:

...

Field Label

...

Description of Change

...

Changes in Regulatory data elements:

...

Field Label

...

Description of Change

...

Add this data element.

...

.

...

Delayed Posting Indicator

...

Rename the field for this data element to Unapproved/Uncleared Device. Make this field optional.

...

Add this data element.

...

Add this data element.

...

Section 801 Indicator

...

Changes in IND/IDE data elements:

...

Field Label

...

Expanded Access Indicator

...

Changes in Trial Status data elements:

...

Field Label

...

Changes in Trial Design data elements (abstracted by the CTRO):

...

Field Label

...

Primary Purpose

...

Trial Phase

...

Rename the field for this data element to Interventional Study Model. In this data element, add new value Sequential Assignment.

...

Model Description

...

Changes in Outcome Measure data elements (abstracted by the CTRO):

...

Field Label

...

Changes in Eligibility Criteria data elements (abstracted by the CTRO):

...

Field Label

...

Reference information:

...