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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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Before you begin, be sure check the trial out for processing. See Checking In and Checking Out Trials. |
Reviewing and Editing Trial Submission History
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| MultiExcerptName | historysubmissions |
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All documents associated with trial submissions, including documents that have been deleted, are available for download and review.
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The system did not maintain all original documents associated with an original or amendment trial submission prior to PA v3.9 release. For example, if an abstractor downloaded, and then edited and resubmitted a document prior to this release, only the edited version appears in the Documents column; the original version is unavailable. The same is true of documents submitted with trial updates. |
How to Review and Edit Trial Submission History Information
On the Trial Overview menu, click Trial History.
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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.
To edit amendment submission details, in the Action column, click the Edit (pencil) icon.
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In the Amendment Reason Code drop-down list, select a valid reason code. The following table lists valid reason codes.
Reason Code | Definition |
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Administrative | Amendment submitted for errors or changes to non-scientific data |
Scientific | Amendment submitted for errors or changes to the trial design |
Both | 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, 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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Acknowledging Trial Updates
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| MultiExcerptName | historyupdates |
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How to Acknowledge Trial Updates
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For instructions, refer to the following pages:
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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 for which you want to view the audit trail. For detailed instructions, see Searching for Trials.
- Click the NCI Trial Identifier link.
- On the Trial Overview menu, click Trial History, and then click the Audit Trail tab.
The Trial 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.
