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

Note

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

Reviewing Trial Submission History

Information

  1. On the Trial Overview menu, click Trial History.

    Tip

    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.

    Submissions tab of the Trial History Information page

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    6782

    Trial History Information – Amended Trial Submission
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    5953
    5953

    If the trial has been rejected or un-rejected, the relevant comment appears in the Milestone column.

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

Editing Trial Submission History

To edit amendment submission details: 

  1. Review trial submission history, as described in Reviewing Trial Submission History.

  2. In the Action column, click the Edit (pencil) icon.

    The Edit Trial History page appears.
    Edit Trial History section of the Trial History Information page
    Edit Trial History Page

  3. 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

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

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

    Info

    The amendment date is generally entered by the trial submitter.

  6. Click Save.

Return to top of page

Downloading Documents

To download trial-related documents for review, click :

  1. Review trial submission history, as described in Reviewing Trial Submission History.
  2. 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

  1. Review trial submission history, as described in Reviewing Trial Submission History.
  2. On the Submissions page, scroll to the bottom of the list of submissions, and then click Show Deleted Documents.

    Submissions tab of Trial History Information page annotated to indicate Show Deleted Documents link

    All deleted documents are displayed.
    Submissions tab of the Trial History Information page with deleted documents shown
  3. To close the Deleted Documents list, click Hide Deleted Documents.

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