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.
Check out the trial before you begin abstraction
Before you begin, be sure check the trial out for processing. See Checking In and Checking Out Trials.
Reviewing and Editing Trial Submission History
All documents associated with trial submissions, including documents that have been deleted, are available for download and review.
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.
Reviewing Trial Submission History
On the Trial Overview menu, click Trial History.
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.
Trial History Information – Amended Trial Submission
If the trial has been rejected or un-rejected, the relevant comment appears in the Milestone column.To view the trial milestones, click the Submission Number link.
Editing Trial Submission History
To edit amendment submission details:
- Review trial submission history, as described in Reviewing Trial Submission History.
In the Action column, click the Edit (pencil) icon.
The Edit Trial History page appears.
Edit Trial History Page
In the Amendment Reason Code drop-down list, select a valid reason code. The following table lists valid reason codes.
Reason Code
Definition
Administrative
Amendment submitted for errors or changes to non-scientific data
Example: A lead organization’s address changesScientific
Amendment submitted for errors or changes to the trial design
Example: A trial advances from Phase 1 to Phase 2Both
Amendment submitted for both administrative and scientific reasons
- To change the amendment order, type the appropriate number in the Amendment Number field.
In the Amendment Date field type or select the amendment date.
The amendment date is generally entered by the trial submitter.
Click Save.
Downloading Documents
To download trial-related documents for review:
- Review trial submission history, as described in Reviewing Trial Submission History.
- 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
- Review trial submission history, as described in Reviewing Trial Submission History.
- On the Submissions page, scroll to the bottom of the list of submissions, and then click Show Deleted Documents.
All deleted documents are displayed.
- To close the Deleted Documents list, click Hide Deleted Documents.
Acknowledging Trial Updates
The Updates tab displays the reason for each update, both for trials updated by a user and imported from ClinicalTrials.gov.
How to Acknowledge Trial Updates
- On the Trial Overview menu, click Trial History.
The Trial History Information page displays the Submissions tab by default. - Click the Updates tab.
The Updates tab displays a record of the updates that have been accepted but not verified to date. The first figure below displays records that have been updated by a CTRP application user. The second one displays records from trials that have been updated as a result of an import from ClinicalTrials.gov. The arrow in the second figure points to an update to the Sponsor. Updates to the Sponsor field flags the trial for abstractor review. Other key fields trigger the flag as well. See Searching for ClinicalTrials.gov Import Logs .
- Review the updated information. To confirm the update in the trial's history, click Acknowledge, and then click OK in the pop-up box to remove the update record from the Updates page.
Viewing Audit Trails
The Protocol Abstraction System records changes that all abstractors make while processing original, amended, and updated trials.
The Audit Trail feature is available for changes to Marker and NCI-Specific information only.
How to View Audit Trails
- 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.
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