NIH | National Cancer Institute | NCI Wiki  

Error rendering macro 'rw-search'

null

Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

NCI requires that Trial Owners, Trial Submitters, and members of the Clinical Trials Reporting Office (CTRO) verify their open trial records for trials that are not complete at least twice per year to ensure that information is accurate and up-to-date. requests the verification of all trial data in CTRP at least every 6 months. The Data Verification due date is determined based on the following:

  • Date the last data abstraction was verified (both new registration and amendment submissions) in CTRP.
  • Date the last Update was submitted in CTRP.
  • Date the last Data Verification was performed in CTRP

This request This requirement applies to Interventional trials that have the following attributes:

  • Trial processing status Processing Status is either: 
    • Abstraction Verified - No Response
    • Abstraction Verified - Response
  • Trial status Status is anything other than the following:
    • Withdrawn
    • Administratively Complete
    • Complete
  • The CTRP Registration application sends Trial Owners, Trial Submitters, and Site Administrators a verification reminder on the first day of each month a monthly basis listing any trials that meet Trial Verification requirements: Within 30 days of their Verification Due Date (6 months past the trials Record Verification Date) or past due. 

...

CTRO staff members are responsible for verifying the types of trials below. Trial owners and submitters are responsible for verifying all others.

...

Each time a trial is verified, the CTRP Registration application records the Date, Verification Method and Verified By. This is true for original as well as updated trials. The Trial Data Verifications history can be found on the Trial Details and Update/Verify Trial Data pages.

...