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This section provides definitions for the milestones used in CTRP and the rules for recording them.

Milestone Definitions

The following table lists processing milestones and their definitions.

Milestone

Definition

Submission Received Date

Date the trial was successfully submitted via the NCI CTRP Registration Site

Submission Acceptance Date

Date the document specialist accepted the trial submission for validation

Submission Rejection Date

Date the document specialist rejected the trial submission during validation

Administrative Processing Start Date

Date of initial abstraction of administrative details

Administrative Processing Completed Date

Date the abstraction of administrative details was completed

Scientific Processing Start Date

Date of initial abstraction of the scientific details

Scientific Processing Completed Date

Date the abstraction of scientific details was completed

Ready for Administrative QC Date

Date the trial abstraction of administrative data was completed and available for Quality Control (QC) of the administrative data

Ready for Scientific QC Date

Date the trial abstraction of scientific data was completed and available for Quality Control (QC) of the scientific data

Administrative QC Start Date

Date of initial QC of administrative data

Scientific QC Start Date

Date of initial QC of scientific data

Administrative QC Start Date

Date of initial QC of the administrative data

Scientific QC Start Date

Date of initial QC of the scientific data

Administrative QC Completed Date

Date that QC of the administrative data was completed

Scientific QC Completed Date

Date that QC of the scientific data was completed

Ready for Trial Summary Report Date

Date the abstraction was completed. The system adds this milestone automatically.


Trial Summary Report Date

Date the Trial Summary Report was sent to the principal investigator or trial submitter. The system adds this milestone automatically.

Special treatment of TSRs for Abbreviated Trials

The system does not send Trial Summary Reports for Abbreviated Trials. You can download the TSRs for these trials from the Trial Related Documents page as needed.

Submitter Trial Summary Report Feedback Date

Date input was received by a document specialist from a principal investigator or trial submitter regarding data contained on the Trial Summary Report

Initial Abstraction Verified Date

Date the document specialist recorded that the abstracted data was verified upon receipt of the submitter's TSR feedback. Equal to the TSR Sent Date plus six business days if the most current processing status is Abstracted. TSR feedback is due within five business days following the TSR Sent Date. The Initial Abstraction Verified Date can be later if no feedback is received.

(A business day is any weekday that is not a Federal holiday. For a list of Federal holidays, refer to the U.S. Office of Personnel Management's list of Federal Holidays.)

On-going Abstraction Verified Date

Date the document specialist recorded that abstracted data was verified, following a post-verified status when there has been an abstraction update or a delay in the submitter's feedback

Late Rejection Date

Date the document specialist rejected the trial submission at any time after initial trial acceptance 1

Submission Terminated Date

Date the document specialist stopped the trial submission process

Submission Reactivated Date

Date the document specialist resumed the trial submission process

  1. The Late Rejection Date applies to both original and amendment submissions. ↩

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Milestone Rules

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Your ability to record milestones depends on trial processing statuses. The following diagram illustrates the basic workflow of trial processing statuses. The rules that follow it provide more detailed information about the order in which you can record the milestones.

Diagram showing workflow for recording trial milestones

The following rules determine the order in which you can record the milestones:

  • You can record most milestones multiple times per trial, following the order of the trial submission processing life cycle. However, you can add the following milestones only once per trial submission:
    • Submission Received Date
    • Submission Rejection Date
    • Initial Abstraction Verified Date
    • Initial Submission to ClinicalTrials.gov
  • You cannot record milestones with a future date.
  • Each milestone date must follow the preceding milestone date. 

If the most current processing status is this...

You can record this milestone

Submitted

Submission Received Date

Accepted and all Administrative and Scientific abstraction activities have been completed

QC Completed Date. 

Recording this milestone sets the trial processing status to Abstracted and Trial Verification Date to the date that you record this milestone.

Verification Pending and a Submitter TSR Feedback Date milestone has been recorded

Initial Abstraction Verified Date.
Recording the Initial Abstraction Verified Date manually sets the trial processing status to Abstraction Verified Response.

Verification Pending and a Submitter TSR Feedback Date milestone has not been recorded

Initial Abstraction Verified Date.
Recording the Initial Abstraction Verified Date manually sets the trial processing status to Abstraction Verified No Response.

Abstraction Verified Response

On-going Abstraction Verified Date

Abstraction Verified No Response

On-going Abstraction Verified Date

Abstracted

Trial Summary Report Date.
Recording the Trial Summary Report Date changes the processing status to Verification Pending

Submission Terminated

Submission Reactivated Date. This is the only milestone that you can record after the Submission Terminated Date.
Recording this milestone returns the trial to its previous milestone.

If the most current processing status is this...

You can not record this milestone

Submitted

Trial Summary Report Date

Accepted

Trial Summary Report Date

This date...

Must precede this date

Ready for Administrative QC Date

Administrative QC Start Date

Ready for Scientific QC Date

Scientific QC Start Date

Administrative QC Start Date

Administrative QC Completion Date

Scientific QC Start Date

Scientific QC Completion Date

TSR Date

Submitter TSR Feedback Date

Administrative Processing Start Date

Administrative Processing Completed Date

Scientific Processing Start Date

Scientific Processing Completed Date

Submission Terminated Date

Submission Reactivated Date

You can not record this milestone...

If this is true

QC Start Date

  • an on-hold state is not terminated

Trial Summary Report Date

  • an on-hold state is not terminated
  • the trial is in the Inbox

Submitter Trial Summary Report Feedback Date

  • an on-hold state is not terminated
  • the trial is in the Inbox

Initial Abstraction Verified Date

  • an on-hold state is not terminated
  • the trial is in the Inbox

Initial Submission to ClinicalTrials.gov

  • an on-hold state is not terminated
  • the trial is in the Inbox

On-going Abstraction Verified Date

  • an on-hold state is not terminated
  • the trial is in the Inbox

Late Rejection Date

  • an on-hold state is not terminated
  • the trial is in the Inbox

Ready for QC Date

  • Scientific Processing Completed Date has not been recorded, and
  • Administrative Processing Completed Date has not been recorded

Submission Terminated Date

The trial has been rejected

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