Page History

This page provides an overview of the changes in CTRP:. For any questions or issues regarding these feature enhancements, please contact the CTRO (NCICTRO@mail.nih.gov).

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
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2. Ability to view all trial details on the Verify screen
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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

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1. Phase 1 - In May 2017, NCI 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, 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.
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.
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.
   
3. 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.
       

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The following tables briefly list the changes in CTRP to support the FDAAA Final Rule.

Changes in Sponsor/Responsible Party data elements:

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Field Label

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Description of Change

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Changes in Regulatory data elements:

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Field Label

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Description of Change

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Add this data element.

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Add this data element.

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Delayed Posting Indicator

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

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Add this data element.

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Add this data element.

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Section 801 Indicator

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Changes in IND/IDE data elements:

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Field Label

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Expanded Access Indicator

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Changes in Trial Status data elements:

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Field Label

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1. 
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For more information on the CTRP Trial Record Verification processes, please visit these CTRP User Guide pages:

https://wiki.nci.nih.gov/display/CTRPdoc/Updating+Trial+Information

https://wiki.nci.nih.gov/display/CTRPdoc/How+to+Verify+Trial+Data

https://wiki.nci.nih.gov/display/CTRPdoc/How+to+Access+the+Trial+Data+Verification+Page

https://wiki.nci.nih.gov/display/CTRPdoc/Amending+Trials

July 2020

Flexible Accrual: Enhanced the CTRP accrual reporting capabilities to include more “Flexible Accrual” reporting options.  Centers can now request to update the default accrual reporting type on a study registered in CTRP.  Changing the default accrual reporting type requires a ticket to be submitted to the CTRO (NCICTRO@mail.nih.gov) for review and approval, before any change is granted.

1. The current default accrual reporting types are as follows:

   Trial Type	Default Accrual Reporting Type
   Complete Interventional	Subject
   Complete Non-Interventional	Subject
   Abbreviated/Imported Interventional	Summary
   Abbreviated/Imported Non-Interventional	Summary

   
   

2. CTRP is also introducing a new accrual reporting type, “Partial Subject.”  Partial Subject accrual requires the reporting of Study Subject ID, Registration Date and Participating Site data only.  The other accrual data fields are optional.  The reporting of Partial Subject accrual also requires a ticket to be submitted to the CTRO (NCICTRO@mail.nih.gov) for review and approval, before any change is granted.
3. Accrual Data Element changes:
   1. Study Subject Birth Date: For any/all ways to report accrual, only the month and year (MM/YYYY) are required to be collected.
   2. Study Subject Country: Required for all methods of reporting accrual (was previously optional)
   3. Disease:
      1. Study Subject: Required
      2. Partial Subject: Not required. However, for ICD-O-3 Disease Codes if Disease is reported, then Site must be reported.
   4. Site: 
      1. Study Subject: Required
      2. Partial Subject: Not required. However, for ICD-O-3 Disease Codes if Site is reported, then Disease must be reported.
   5. Disease Codes: CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.

For more information on the CTRP Accrual process, including Flexible Accrual, Partial Subject accrual and other changes made within the Accrual application (e.g., ability to Delete All Trial Study Subjects,) please visit these CTRP User Guide pages:

https://wiki.nci.nih.gov/display/CTRPdoc/About+Accrual

https://wiki.nci.nih.gov/display/CTRPdoc/Searching+for+Trials+in+Accrual

If you would like to receive future CTRP announcements you may add yourself to the list here: https://list.nih.gov/cgi-bin/wa.exe?SUBED1=ctrp-users-l&A=1

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

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Field Label

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Primary Purpose

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Trial Phase

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

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Model Description

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

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Field Label

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

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Field Label

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Reference information:

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