This section provides definitions for the milestones used in CTRP and the rules for recording them.
Milestone Definitions
Milestone | Definition |
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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 |
- The Late Rejection Date applies to both original and amendment submissions. ↩
Milestone Rules
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 |
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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. |
Verification Pending and a Submitter TSR Feedback Date milestone has not been recorded | Initial Abstraction Verified Date. |
Abstraction Verified Response | On-going Abstraction Verified Date |
Abstraction Verified No Response | On-going Abstraction Verified Date |
Abstracted | Trial Summary Report Date. |
Submission Terminated | Submission Reactivated Date. This is the only milestone that you can record after the Submission Terminated Date. |
If the most current processing status is this... | You can not record this milestone |
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Submitted | Trial Summary Report Date |
Accepted | Trial Summary Report Date |
This date... | Must precede this date |
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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 |
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QC Start Date |
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Trial Summary Report Date |
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Submitter Trial Summary Report Feedback Date |
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Initial Abstraction Verified Date |
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Initial Submission to ClinicalTrials.gov |
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On-going Abstraction Verified Date |
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Late Rejection Date |
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Ready for QC Date |
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Submission Terminated Date | The trial has been rejected |