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For instructions about recording the progress of a trial along its processing life cycle
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About Milestones
Milestones are used to record the progress of a trial along its processing life cycle and to establish the processing status. The system establishes some milestones at specific events during the process. For example, it sets the trial processing status to "Submitted" for a trial that has not yet been validated, and to "Accepted" once the trial has been validated and accepted.
The system records milestones as sets by submission number. For example, an original trial has one set of milestones (one submission), but an amended trial may have two or more submissions. Each subsequent submission has its own set of recorded milestones.
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Viewing and Adding Milestones
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Because milestones indicate the progress of a trial, you can view, but not change recorded milestones. However, you can add records throughout the life cycle of the trial submission. You can not add milestones to trials that are currently on hold.
For trials with one or more amendments, the system displays milestones in sets, one for each submission. You can add milestones only when the Submission Number is the Active Milestone set, as shown below.
If you select an Inactive Submission set, that is, one that contains a previous submission, you can not add new milestones. In the figure below, the selected Submission Number is 5 (out of 6 submissions).
An abstractor can reject an amendment submission without rejecting the whole trial.
If an abstractor has rejected an amendment submission, the system displays the last Active milestone set by default, as shown below.
How to View and Add Milestones
- In any list of trial search results, click the NCI Trial Identifier link for the trial of interest.
- On the Trial Overview menu, click Trial Milestones. The Trial Milestones page appears and displays all milestones recorded to date.
- To add a milestone, in the Add Milestone section at the bottom of the page, select the milestone you want to add from the drop-down list. The following sections list valid milestones, processing statuses, and the rules for recording them. For milestone definitions, see Trial milestone definitions.
- In the Date field, enter the milestone date. The system enters the current date by default.
In the Comment field, type the action that triggered the milestone, or any comments about the event. The comments field is limited to 200 characters.
- Click Add Milestone.
If you are adding Late Rejection milestone to an amended trial, the system gives you a choice.
- If this message appears, select Reject Entire Trial or select Reject This Amendment Only.
The system displays the milestone at the bottom of the list of milestones in the Trial Milestones section of the page. - Repeat the steps above after you complete each abstraction update as appropriate.
, refer to the following pages:
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Also refer to Milestone Definitions and Recording Rules.
Un-rejecting a Trial
A Super Abstractor can un-reject a trial that has a processing status of Rejected.
How to Un-reject a Trial
- In any list of trial search results, click the NCI Trial Identifier link for the trial of interest.
- On the Trial Overview menu, click Trial Milestones. The Trial Milestones page appears and displays all milestones recorded to date.
- In the Add Milestone section at the bottom of the page, click Un-Reject Trial. The system prompts you to provide a comment.
- Type a comment and click OK. The system appends your comment (along with a date/time-stamp and your user name) to the comments for the previously active milestone. The system displays information about this un-reject operation on the Trial Milestones page and on the Submissions tab of the Trial History Information page.
Milestone Recording Rules
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Milestone Definitions
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The following table lists processing milestones and their definitions.
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Trial Processing Life Cycle
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| MultiExcerptName | triallfecycle |
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The following diagram illustrates the typical life cycle of a trial and the relationship between actions and processing statuses:
Trial Summary Report Life Cycle
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