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Page History
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The Trial History page displays trial submission, update, and audit trail tabs, from which you can edit submissions, download documents, acknowledge updates, and search audit trails.
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Reviewing and Editing Trial Submission History
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Reviewing Trial Submission History
Search for the trial of interest.For instructions, refer to
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In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Overview menu, click Trial History. The Trial History Information page appears.
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You can sort the list of submissions by the Date, Type, Submitter, and Documents columns by clicking the column headers. Click the column headers a second time to reverse the sort order. |
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To view the trial milestones, click the Submission Number link.
Editing Trial Submission History
To edit amendment submission details:
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Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
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In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
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On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
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On the Trial Overview menu, click Trial History. The Trial History Information page appears.
In the Action column, click the Edit (pencil) icon. The Edit Trial History page appears.
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In the Amendment Reason Code drop-down list, select a valid reason code. The following table lists valid reason codes.
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Reason Code
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Definition
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Administrative
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Amendment submitted for errors or changes to non-scientific data
Example: A lead organization’s address changes
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Scientific
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Amendment submitted for errors or changes to the trial design
Example: A trial advances from Phase 1 to Phase 2
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Both
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Amendment submitted for both administrative and scientific reasons
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In the Amendment Date field type or select the amendment date.
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The amendment date is generally entered by the trial submitter. |
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Click Save.
Downloading Documents
To download trial-related documents for review:
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Overview menu, click Trial History. The Trial History Information page appears.
- Click the document links in the Documents column.
Accessing Deleted Documents
The system maintains documents even after abstractors have deleted them.
How to Access Deleted Documents
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Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
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In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
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On the Trial Overview menu, click Trial History. The Trial History Information page appears.
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the following pages:
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Acknowledging Trial Updates
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How to Acknowledge Trial Updates
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Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
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In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
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On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
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Viewing Audit Trails
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The Protocol Abstraction System records changes that all abstractors make while processing original, amended, and updated trials.
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The Audit Trail feature is available for changes to Marker and NCI-Specific information only. |
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Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Overview menu, click Trial History, and then click the Audit Trail tab. The Audit Trail page appears.
- In the Audited Object field, select either NCI-Specific Information or Markers.
- In the Start and End Date fields, enter the start and end dates (time range) over which you want to view changes to the trial.
- Click View Audit Trial. The Audit Trail page displays the audit trail records you requested.
- To export the audit trail, at the bottom of the page, click either CSV (comma-separated values), Excel, or XML (extensible markup language) as your target format.
