Processing Trial History Information - Include v4.4

All documents associated with trial submissions, including documents that have been deleted, are available for download and review.

Reviewing Trial Submission History

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Overview menu, click Trial History. The Trial History Information page appears.

   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.

4. To view the trial milestones, click the Submission Number link.

Editing Trial Submission History

To edit amendment submission details: 

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. 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.)

4. On the Trial Overview menu, click Trial History. The Trial History Information page appears.

5. In the Action column, click the Edit (pencil) icon. The Edit Trial History page appears.

   
   Edit Trial History Page
   
   

6. 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 changes
   Scientific	Amendment submitted for errors or changes to the trial design Example: A trial advances from Phase 1 to Phase 2
   Both	Amendment submitted for both administrative and scientific reasons

7. To change the amendment order, type the appropriate number in the Amendment Number field.

8. In the Amendment Date field type or select the amendment date.

   The amendment date is generally entered by the trial submitter.

9. Click Save.

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Downloading Documents

Accessing Deleted Documents

The system maintains documents even after abstractors have deleted them.

How to Access Deleted Documents

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Overview menu, click Trial History. The Trial History Information page appears.

4. On the Submissions page, scroll to the bottom of the list of submissions, and then click Show Deleted Documents.
   
   
   
   All deleted documents are displayed.
   
5. To close the Deleted Documents list, click Hide Deleted Documents.

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

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. 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.)

4. On the Trial Overview menu, click Trial History, and then 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 .

5. 
   
   
6. 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.

The Protocol Abstraction System records changes that all abstractors make while processing original, amended, and updated trials.

How to View Audit Trails

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Overview menu, click Trial History, and then click the Audit Trail tab. The Audit Trail page appears.
   

4. In the Audited Object field, select either NCI-Specific Information or Markers.
5. 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.
6. Click View Audit Trial. The Audit Trail page displays the audit trail records you requested.
   
7. 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.