eDMS Disclosure Profile
Purpose
All Mount Sinai principal investigators, co-investigators, mentors, and key personnel must complete their eDMS Disclosure Profile, disclosing all financial interests that they may have outside of employment at Mount Sinai. This eDMS Disclosure Profile is required to be completed within 45 days of hire, annually, and updated throughout the year (within 30 days) if there are changes to your financial interests.
Financial interests that are disclosed on your eDMS Disclosure Profile automatically import to the Research Trigger Form.
Office
Office of Industry Engagement and Conflicts of Interest (“COI Office”)
Access
- Go to eDisclosure Management System (eDMS)
- Select the “COI” tab on the menu
- Click “Edit Disclosure Profile”
System Link
eDisclosure Management System (eDMS)
Support
Application Questions – Contact the Conflict of Interest Hotline at (212) 241-0845 or Conflicts.of.Interest@mssm.edu.
Technical Support – Email request to esupport@mssm.edu
Reference Guide
For step-by-step guidance, refer to – How to Complete the eDMS Disclosure Profile
Triggering Event (TE)
Purpose
Every time a project is submitted, and at the time of continuing review of an existing project, the Triggering Event (TE) must be completed in eDisclosure Management System (eDMS).
Completion of the Triggering Event generates:
- A Triggering Event (TE) number, also referred to as the TE #
- This Triggering Event (TE) number required for subsequent IRB/RUTH and GCO /InfoEd submissions
- The Research Trigger Form (project-specific form)
- Personnel listed on the Triggering Event (TE) form will receive an email notification requesting completion of this Research Trigger Form (project-specific disclosure form) via eDisclosure Management System (eDMS)
Please Note: the Suspension and Debarment (S&D) Form is not included as part of the Triggering Event (TE).
Who needs to be listed on the Triggering Event form?
When creating a Triggering Event (TE), all the project investigators (all co-investigators and key study personnel) must be included as research personnel. GCO and PPHS regulations differ so be sure to adhere to both sets of regulations. Please refer to GCO Investigator and PPHS Investigator definitions when completing the Triggering Event (TE) form. Additional information can be found below under “Reference Guides.”
When does a Triggering Event need to be updated?
- Start of every research study/project
- At the time of IRB continuing review and/or annual GCO submission
- When personnel changes or study funding changes occur
Office
Office of Industry Engagement and Conflicts of Interest (“COI Office”)
Creating a Triggering Event (TE)
- Go to eDisclosure Management System (eDMS)
- Select “COI” tab
- Select “Triggering Events”
- Select “Create Triggering Event”
Access
Mount Sinai Network user name and password.
System Link
eDisclosure Management System (eDMS)
Support
Application Questions – Contact the Conflict of Interest Hotline at (212) 241-0845 or Conflicts.of.Interest@mssm.edu. Technical Support – Email request to esupport@mssm.edu
Reference Guide
For step-by-step guidance on creating the Triggering Event (TE), and to view the ISMMS policy on who must complete Research Trigger Forms on eDisclosure Management System (eDMS), refer to the following:
Research Trigger Form
Purpose
The Research Trigger Form is used to determine whether any financial interests pose actual or perceived conflicts with a proposed research project. This disclosure form is required for EVERY grant and industry sponsored research study.
Federal Conflict of Interest (COI) regulations require that all investigators submit conflict disclosures. The term “investigator” applies to all individuals involved in research, regardless of job title, who are responsible for the design, conduct, or reporting of the study and who are granted a significant degree of independence in their work. Investigators and key personnel who are listed on the Triggering Event (TE) form will receive an email notification to complete the Research Trigger Form.
ISMMS’ policy is that the following personnel always meet this definition:
- Principal Investigator
- Key Personnel
- Anyone with a role that includes the word “Investigator” (Example: Sub-Investigator)
- Primary Mentor on a Fellowship or Mentored Career Development Award
- Faculty Personnel, either key or non-key
Other ISMMS personnel may meet the Investigator definition. ISMMS leaves the following to the discretion of the PI:
- Other Significant Contributor
- Consultant
- Non-faculty, non-key personnel
The Research Trigger Form must be submitted and updated under the following circumstances:
- At the start of every research study/project
- At the time of project continuing review
- When changes occur to financial interests
For more information, refer to Triggering Event (TE) Instructions and the Financial Conflict of Interest in Research Policy.
Office
Office of Industry Engagement and Conflicts of Interest Office (“COI Office”)
Access
To access the Research Trigger Form, click on the link provided in the automatically generated email.
OR
- Login to eDisclosure Management System (eDMS)
- Select “COI”
- Review your eDMS Disclosure Profile and make any updates as necessary
- Click “Complete Disclosure Profile Update”
Click “update” on each open research project to answer the Research Trigger Form for each project Prerequisites:
- Financial Conflict of Interest in Research Training must be completed in CITI Program every FOUR years.
- eDMS Disclosure Profile must be completed in eDisclosure Management System (eDMS).
- A Triggering Event(TE Form) must be submitted for the specific project in eDisclosure Management System (eDMS)
System Link
eDisclosure Management System (eDMS)
Support
Application Questions – Contact the Conflict of Interest Hotline at (212) 241-0845 or Conflicts.of.Interest@mssm.edu.
Technical Support – Email request to esupport@mssm.edu.
Reference Guides
Step-by-Step Instructions