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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