Tag Archives: Review Status

May 2015 Maintenance Release

Revised Disclosure Review Statuses

A new Review Status of “Pending Answer” has been added so that the SFI disclosure reviewers in the Office of Research can identify those disclosures whose review is pending additional information from the investigator. The Review Status of “Duplicate” was removed, and all disclosures in that status were moved to “No Review Required” status.

Disclosure Notification Changes

In order to ensure attention is drawn to situations where an investigator may not be receiving a disclosure notification email, there are some changes being introduced to the eGC1s in SAGE.

  • Providing visibility when an investigator’s email address is missing which means no disclosure notification can be sent. When no email address is available, the eGC1 Preparer will be sent an email they can forward to the investigator.
  • Requiring the eGC1 Preparer’s email address, used for key notifications.
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Once you complete a disclosure, the system assigns it a Review Status based on several factors.

A primary disclosure for an eGC1 initially has a status of Waiting for JIT, regardless of whether the disclosure includes SFI. The disclosure remains in this status until the appropriate time to review it. The disclosure’s status then changes to:

  • Review Required status if it has SFI, or
  • No Review Required, if it does not have SFI

The status change occurs when:

  • An After-the-Fact eGC1 reaches In OSP or Approved status, or
  • OSP creates a Funding Action for an eGC1 (other than After-the-Fact ones)

When you complete a disclosure for CoMotion, HSD/IRB, or just SFI, the system will assign a status.  If the disclosure has SFI, the status is Waiting for JIT; if no SFI, the status is No Review Required.

The Institutional Official will look at disclosures in Waiting for JIT status as needed. At the time of review, the disclosure status would change to:

  • Pending Answer if the Institutional Official has requested information about this disclosure from the investigator
  • Review Complete when the Institutional Official has completed their review of this disclosure

March 2013

  • New Action Items section: Investigators can easily see what they need to do next in the new Action Items section on the FIDS Profile page. This section lists investigators’ pending disclosures and easily allows the creation of new ones.
  • SFI Updates: When an existing Significant Financial Interest (SFI) is updated or deleted, any related disclosure which has not yet reached the Review Complete or No Review Required status will reflect the changes.
    • The Institutional Official will review the most current SFI and disclosures which have deleted SFI.
    • A new section in the disclosure will display information about the deleted SFI.
  • Edit Disclosures: Investigators can now edit any disclosure that is not in Review Complete or No Review Required status. This means related research activities can be selected/deselected, and on disclosures for non-Public Health Service (PHS) sponsored eGC1s, and Center for Commercialization (C4C) and Human Subjects Division (HSD) activities, SFI can be selected or deselected.
  • FCOI displayed: The Institutional Official can check a box to indicate which SFI in a disclosure are financial conflicts of interest (FCOI). Investigators will be able to view but not change this indication.
  • Later review: The determination of whether a review is required for primary eGC1 disclosures with no SFI will occur as part of the Just in Time (JIT) process instead of when the disclosure is submitted.
  • New history section: Changes in status and SFI now display in a new History section on the Disclosure Summary page and on a page the Institutional Official views.
  • Concurrency: When multiple people are editing a disclosure, only the first person to save their changes will be able to save. Subsequent users will not be able to save their updates until the page is refreshed and displays the first person’s changes.
  • Review Statuses displayed: The Disclosures section on the Profile page will now display the Review Statuses of each disclosure: Review Required, Waiting for JIT, No Review Required, Duplicate, or Review Complete.
  • Related Sponsored Research Projects: By default, only the primary eGC1 will be selected in the Related Sponsored Research Projects section of a disclosure. You will have to manually select other eGC1s that are related to the disclosure.
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The Disclosures section lists all of your pending and completed disclosures. The following image shows an example list.

disclosure section

The values listed for existing disclosures are:

  • Disclosure ID: automatically generated by FIDS. For completed disclosures, you may click the Disclosure IDs to see read-only views of your point-in-time disclosures. If your disclosure’s status is Review Complete or No Review Required, you may edit it. You will see an Edit this Disclosure button at the bottom of the page.
  • eGC1 Number: the primary eGC1 linked with this disclosure. Your disclosure status will appear on the PI, Personnel, & Organizations page of this eGC1. You will see “(not available)” displayed for disclosures that do not have a primary eGC1.
  • Date Disclosed: when you completed the disclosure.
  • Status
    • Disclosure Required: you need to complete this disclosure.
    • Disclosure Complete: you have completed this disclosure.
  • Review Status
    • Review Required: generally, this indicates the disclosure has related SFI, and the reviewer needs to review this disclosure now
    • Waiting for JIT (Just in Time):  the system will assess the need for review at the appropriate time
    • No Review Required: generally, this indicates no related SFI, and therefore no review is needed
    • Pending Answer: the reviewer needs information from the investigator; this status is set by the reviewers
    • Review Complete: the reviewer completed reviewing the disclosure

For more information, see the Disclosure Review Statuses section.

Notes:

  • If an investigator on an eGC1 is removed, their pending disclosure will be deleted from their FIDS profile within 24 hours.
  • If a person’s investigator setting is changed from Yes to No, any completed disclosure will be disassociated from the eGC1, and as needed, the disclosure’s status will be reset to Waiting for JIT.