Tag Archives: Disclosure Status

August 2012 SAGE and FIDS Release

New Features

These changes were made as a result of introducing the new Financial Interest Disclosure System (FIDS) which integrates with SAGE.

On the eGC1 PI & Personnel page:

  • eGC1 Preparers can select Investigator status.
  • Disclosure notifications to investigators to complete a disclosure in FIDS can now be sent.
  • Each investigator’s SFI status will display based on the information in FIDS.
  • The PHS FCOI training status will display.
  • The FIDS disclosure status will display.
  • Changes may be made to the PI or personnel after the eGC1 has been approved by OSP.
  • The history of any post-approval PI or personnel changes will be displayed.

On the Certify & Route page:

  •  An eGC1 cannot be completed until all investigators have received disclosure notifications.
  • The Ready to Submit question cannot be answered as “Yes” until all investigators have completed their disclosures in FIDS.
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The Personnel section of the PI, Personnel, & Organizations page lists all individuals who will be participating in the research and indicates their role, investigator status, SFI status, and compliance details.

You may edit this information except when the eGC1 has a status of Routing or In OSP. You should update it whenever personnel join or leave a research project. Any personnel added will need to complete a FIDS disclosure for the eGC1.

Be aware that if your eGC1 is linked to a budget that is also linked to other eGC1s, any changes made to the PI, Personnel, & Organizations page will be reflected on all of the linked eGC1s.

Note: The Approval Flow may change if you add or delete personnel while the eGC1 is still in the approval process.

Add Personnel

Include all personnel who will be participating in the research, but do not include off-campus consultants or subcontractors. SAGE uses the personnel list to determine which campus units need to approve the eGC1.

Also include an individual’s name if:

  • Their participation requires approval by their unit.
  • Their unit is committing cost sharing of any portion of their salary.

The PI is automatically listed first in the personnel section. To add other personnel to the list:

  • Click the Add Personnel link to open the personnel chooser.
  • Enter the Name, UW NetID, or Employee ID (EID) for the person you want to add, and click Search.
  • Click on the desired person’s name with the appropriate title/job/unit combination to select them and automatically return to the page.
  • Select the appropriate role, as described in the Role Type section below.

Delete Personnel

To remove personnel from the list:

  • Click the Delete Personnel link.
  • In the pop-up window, select one or more personnel you wish to delete.
  • Click the Delete button to complete the process and return to the PI, Personnel, & Organizations page.

When you remove investigators from an eGC1, their pending SFI disclosures will be deleted. If they had completed a disclosure, then the system will remove the primary eGC1 information. SAGE will not notify the investigators that they have been removed; you may want to let them know.

Personnel Data Descriptions

  1. Name, Employee ID, Email Address
  2. Selected Unit, Primary Position Unit
  3. Role Type
  4. Investigator
  5. Significant Financial Interest (SFI)
  6. Compliance Details

e g c 1 personnel section columns

Name, Employee ID, Email Address

The Name column displays a person’s Name, Employee ID, and Email Address.  If the person has not yet entered an email address in their FIDS Profile at the time they are added, then the message Email Address Unlisted will appear. There is more information about what this affects in the Disclosure Notifications article.

egc1_personnel_no_email

Selected Unit, Primary Position Unit

The Selected Unit is the organization code and name for the person selected. If the individual has multiple positions/appointments listed, this is the code for the particular position chosen. See Personnel Chooser for more information.

The Primary Position Unit is the organization code and name for the unit that is the person’s primary position.

Role Type

The Role Type for each person added will default to “Key Personnel.” Select the appropriate value from the drop-down:

  • Co-Investigator
  • Key Personnel
  • Fellow
  • Mentor
  • Multiple PI
  • Application PI
  • Other

You can only add one Application PI. For all other roles, you can add more that one person with the same role.  If either of the roles are selected, SAGE will add the Application PI and any Multiple PIs to the Approval Flow.

For any non-UW personnel with a Role Type of Multiple PI, there are additional steps. See the Multiple PIs article for details.

Investigator

The PI is responsible for determining whether key personnel are considered Investigators. For the definition of Investigator, see GIM 10 Significant Financial Interest Disclosure Policy.

When you add personnel, Investigator is marked Yes by default.  For some roles, you may select No if the person is not an Investigator. Select an appropriate value for each person.

For personnel with the role of PI, Co-Investigator, Application PI, or Multiple PI, SAGE automatically sets the Investigator value to Yes and it cannot be edited.

Significant Financial Interest (SFI)

The Significant Financial Interest status is based on information provided by the investigator in the Financial Interest Disclosure System (FIDS).

Value Description
Yes The investigator has completed the primary disclosure for this eGC1. On the primary disclosure and/or a related disclosure, they have indicated that they have SFI (for eGC1s with Public Health Service [PHS] sponsors) or that they have SFI that pertains to this research (non-PHS).
No The investigator has completed the primary disclosure for this eGC1. On neither the primary disclosure nor any related disclosure has the investigator indicated that they have any SFI.
Unknown The investigator has not yet completed their primary disclosure. Their SFI status is unknown until they complete the primary disclosure even if they have completed related disclosures.
Not applicable The person listed is not an investigator.

Compliance Details

The Compliance Details column displays several pieces of information for all personnel listed.

  • PHS (Public Health Services) FCOI training
  • Disclosure Notification
  • Disclosure,  Review and FCOI status
  • Investigator Disclosure History

Any entry in this column displayed in bold font requires action. This may include actions required by the eGC1 preparer, such as sending a disclosure notification, or actions that are required by the investigator, such as needing to take training or complete their disclosure.

PHS FCOI Training Status

Only PHS investigators are required to take the Financial Conflicts of Interest (FCOI) training every four years. If the training has been taken, either the expiration date or PHS FCOI training required will display.

PHS-funded investigators or investigators anticipating receiving PHS funds must complete online FCOI training prior to the expenditure of funds. You can complete an application for routing, with Ready to Submit marked Yes, even if all of the personnel have not yet taken their training.

PHS FCOI training required The eGC1 is for a PHS sponsor, and the investigator has not yet completed the PHS training, or the PHS training has expired.
PHS FCOI training complete. Expires on mm/dd/yy The investigator has taken the PHS training and the expiration date of their training is listed. PHS FCOI training is valid for 4 years.
PHS FCOI training not required The person listed is not an investigator, or the eGC1 does not have a PHS sponsor.

See the Financial Conflicts of Interest Training Web page for additional information.

Disclosure Notification Email Dates

When you have sent a Disclosure Notification email to the investigator, the message “Disclosure D##### Notification sent mm/dd/yyyy” will display, where D##### is the disclosure number and mm/dd/yyyy is the sent date.

Notification dates for any related disclosures the investigator has, in addition to the primary disclosure, will also be listed.

If this eGC1 reaches FCOI Just-in-Time (JIT) status, the date when the JIT Disclosure Notification email was sent will also display: JIT Disclosure D##### Notification sent mm/dd/yyyy

See the JIT section of the FIDS User Guide for more details about the FCOI JIT process, which generally occurs when the proposal is being awarded.

Disclosure Status

All personnel who are listed as investigators on the eGC1 are required to complete a disclosure for that eGC1, regardless of whether the sponsor is PHS or non-PHS.

The Primary Disclosure status always displays first and is in italic font to make it easy to spot. The status for any related disclosures display in order from most recent to oldest.

D#### is the number of the disclosure.

Primary Disclosure Required The person listed is an investigator, and has been notified by email of their obligation to disclose.
No Disclosure Required The person is not an investigator, and therefore is not required to disclose.
Primary Disclosure Notification not Sent The person is an investigator and is required to disclose, but has not yet been notified of the disclosure requirements. If the eGC1 preparer (or anyone with read/write access to the eGC1) clicks on the “Send Disclosure Notifications” button on the PI, Personnel, & Organizations page, the investigator will be notified. The system only sends a notification once to each person. If you complete the eGC1 without sending the notifications, SAGE will automatically send them within a day.
Primary (or Related) Disclosure D#### Submitted mm/dd/yyyy The person is an investigator, and a primary (or related) disclosure has been submitted on the date indicated.

Once an investigator submits a disclosure, its Review Status will also display.

Review Status

The disclosure will be assessed when appropriate for the eGC1, and will be given a status of “Review Required” or “No Review Required” depending on the presence of SFI. For more details about JIT and Disclosure Review Statuses, see the FIDS User Guide.

Waiting for JIT (Just-in-Time) A newly completed disclosure gets Waiting for JIT status, whether or not it has SFI.
Review Required This disclosure requires a review because the investigator has indicated that they have SFI and one of the following is true:

  • The eGC1 has been awarded and/or has a child Funding Action, or
  • The eGC1 is for an After-the-Fact application and is at In OSP or Approved status.
No Review Required At the time the disclosure status was assessed, the investigator’s disclosure did not have any SFI (for PHS funded applications), or did not have any SFI related to this eGC1 (for non-PHS funded applications).
Review Complete The Institutional Official has completed their review of this disclosure.
Pending Answer The Institutional Official has indicated that the review is pending additional information from the investigator.

Once the disclosure has been reviewed, its FCOI Status will also display.

FCOI Status

SFI not related The Institutional Official has determined that the disclosed SFI are not related to the investigator’s institutional activities.
FCOI not found The disclosed SFI are related to the investigator’s institutional activities, but do not constitute any financial conflict of interest.
FCOI Management plan not yet in place The disclosed SFI are related to the investigator’s institutional activities, and constitute a financial conflict of interest. A management plan has not yet been put in place.
FCOI Management plan in place The disclosed SFI are related to the investigator’s institutional activities, and constitute a financial conflict of interest. An FCOI management plan has been completed and is now in place.

Investigator Disclosure History

Clicking this link opens a pop-up window that displays a list of the investigator’s disclosures submitted in the past year. See the One Year Investigator Disclosure History help page for more details.