Credentialing Process for University of Vermont Clinical Research Personnel

Researchimage250x160_000Physicians and other clinicians carrying out diagnosis, prognosis or treatment of patients at UVM Medical Center are credentialed through standardized protocols administered by the UVM Medical Center Medical Staff Office (MSO).  UVM employees involved in clinical research who are not credentialed through the MSO will be credentialed through the Office of Clinical Trials Research (OCTR) and on boarded through the UVM Medical Center Human Resources Department.  The Director of the OCTR at UVM, in coordination with the sponsoring UVM Medical Center director, will be responsible for approving credentialing at UVM and forwarding the credentialed employee to UVM Medical Center Human Resources Department for on boarding and identification.  The sponsoring UVM Medical Center director will be responsible for ongoing monitoring and oversight of the UVM research employees in their area(s). 

It is mandatory for University of Vermont (UVM) employees involved in clinical research activities at The University of Vermont Medical Center (UVMMC) to complete and submit the credentialing documents to the Office of Clinical Trials Research (OCTR).  This includes working on projects involving direct patient interaction, retrieving blood, tissue, or health record data review.

OCTR is responsible for collecting the required credentialing files for UVM clinical research staff.  This registration function assures that research staff will have the appropriate orientation, competency, and oversight before participating in research activities.  Once these files are complete, the UVM staff member will be notified that a research badge has been issued at the UVMMC Human Resources Department.  This badge must be worn at all times when the researcher is working in a University of Vermont Medical Center location. 

To ensure we are diligent in maintaining and keeping our files current, the UVMMC research badge expires annually on June 30th.

UVM Researcher Credentialing Process (Initial and Renewal)

Links for Credentialing

Frequently Asked Questions

I completed Credentialing Checklist items within the last 6 months, do I need to complete the Checklist again?

The following items will need to be uploaded to complete the Re-Credentialing requirements for FY'18:

2017 Mandatories - proof of completion

2017 Performance Evaluation

Proof of IRB certification (has been completed within past 3 years)

Proof of completion of Good Clinical Practices from CITI (this is a new requirement for FY18)

All of these items need to be uploaded into the FY’18 checklist in order to complete the research credentialing requirements for the new fiscal year.

What are the requirements for needing the Good Clinical Practices?

We will be requiring that all investigators and staff engaged in Human Subject’s research at UVM and the UVM Medical Center complete Good Clinical Practice training effective July 1, 2017.

The University of Vermont has contracted with the Collaborative Institutional Training Initiative (CITI) to provide online educational modules in the responsible conduct of research.  GCP training is one of several free research training modules (including the UVM Protection of Human Subjects in Research Tutorial)  available to our research community.  These training resources can be accessed using the login and registration instructions below.

Additional information regarding GCP training, access to CITI training and FAQ’s can be found on the IRB website.

http://www.uvm.edu/irb/?Page=training_faqs.html

CITI Login and Registration Instructions

Instructions for participating in the CITI RCR training program follow.

To access the CITI online training courses:

  1. Go to https://www.citiprogram.org/ Choose to "Log in via SSO" (single sign on)  and scroll down to click on the link for the University of Vermont. Login with your UVM NetID and password.
  2. Go through the registration process and choose the Good Clinical Practice Course, US FDA
  3. The course allows users to save their work and come back to it later.  It will take several hours to complete.

Courses that meet our institutional GCP Training requirement are:

U.S. FDA Focus

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices
  • GCP FDA Refresher (The refresher should be taken every 3 years subsequent to the completion of the course above)

ICH Focus

  • GCP for Clinical Trials with Investigational Drugs and Biologics
  • GCP ICH Refresher (The refresher should be taken every 3 years subsequent to the completion of the course above)

As a Clinical Researcher, you are required to ensure that you are compliant with this institutional requirement. The deadline for compliance with this requirement is July 1, 2017. The deadline for NIH Funded researchers and research staff was January 1, 2017.

I completed the Credentialing Checklist items, but the submit button is Disabled. How do I proceed?

If the SUBMIT button is disabled, please verify that all fields are completed. If there is an empty Upload field that is not applicable, please upload a pdf that indicates "not applicable".

How do I obtain a UVMMC M number and access to the mandatories?

A UVM Medical Center supervisor for the department or research PI where the research is conducted will send a request to UVM Medical Center IS Security. Please provide the following information:

  • Name
  • Last four digits of your social security number
  • Date of birth
  • Job title
  • Name of person you report to
  • UVM Department
  • Work number
  • Campus address

How do I print a copy of my completed UVMMC Mandatories?

I am a faculty member and my position doesn't require an annual job performance?   

  • A faculty member may submit an Appointment Letter from the Dean or Department Chair.

I am a physician at UVM Medical Center, do I need to submit credentialing documents?  

  • No, a physician has already completed credentialing for the Medical Center through the Medical Staff Office and does not need to submit additional documentation through UVM OCTR.

How do I obtain access to PRISM?      

  • A UVM Medical Center Supervisor for the department where the research is conducted will submit a PRISM Access Request. 

I am a hospital employee who is also a UVM Employee or Student engaged in research, do I need to be credentialed and be issued a UVM Medical Center Research Badge?

  • Yes, as UVM employee or student engaged in research you are not performing in your role as a UVM Medical Center employee.  It is a regulatory requirement that you represent yourself appropriately in each of your roles.  Additionally, you need to ensure you have separate IT access for each of your role.