1. On the following screen, check “IRB – Human Subjects” if you are PI or research personnel and click Next. Please note that the “GCP – Good Clinical Practice” should also be checked if you are PI or clinical research personnel on a clinical trial.
2. Then, choose the applicable options and click Next. Please note that the “Biomedical Research” or “Social Behavioral Education Sciences” option will fulfill the UVM Human Subjects training requirement.
3. Answer as applicable and click Next. Note: You may leave the additional course options unchecked if none apply and simply click "Next" to continue.
4. Then, choose the “Good Clinical Practice” course if you are PI or clinical research personnel on a clinical trial and click Next. Please note that when you select the “Good Clinical Practice Course for Clinical Trials Involving Investigational Drugs (ICH / international focus)” this is same as “GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)” and the course does include the Biologics component.
5. The course(s) will now be added to your UVM course listing! Click on the newly added course within “University of Vermont Courses” to begin the training.
6. Complete the Integrity Assurance Statement and then begin working through the course modules. Note that you only need to take the modules listed under “Required Modules” to complete the course. Note: The supplemental modules are available to you as a member of the UVM research community.


7. A record of the training completion can be found online.
   

   -Make sure you completed the appropriate course. See the Human Subjects FAQ below for details.

   -The completion list updates every morning, so if you just completed the course today, please wait a day to find your name in the dropdown.

1. On the following screen, check “IACUC - Lab Animals” if you are PI or research personnel and click Next.
2. Then, choose the applicable options and click Next.
3. Answer as applicable and click Next.
4. The course(s) will now be added to your UVM course listing! Click on the newly added course within “University of Vermont Courses” to begin the training.
5. Complete the Integrity Assurance Statement and then begin working through the course modules. Note that you only need to take the modules listed under “Required Modules” to complete the course. Note: Supplemental modules may be available to you as a member of the UVM research community.


6. A record of the training completion can be found online.
   

   -Make sure you completed the appropriate course. See the Laboratory Animals FAQ below for details.

   -The completion list updates every morning, so if you just completed the course today, please wait a day to find your name in the dropdown.

1. On the following screen, check “IBC - Biosafety” if you are PI or research personnel and click Next.
2. Then, choose the applicable options and click Next.
3. Answer as applicable and click Next.
4. Answer as applicable and click Next.
5. Answer as applicable and click Next.
6. Answer as applicable and click Next.
7. The course(s) will now be added to your UVM course listing! Click on the newly added course within “University of Vermont Courses” to begin the training.
8. Complete the Integrity Assurance Statement and then begin working through the course modules. Note that you only need to take the modules listed under “Required Modules” to complete the course. Note: Supplemental modules may be available to you as a member of the UVM research community.


9. A record of the training completion can be found online.
   

   -Make sure you completed the appropriate course. See the Biosafety Research FAQ below for details.

   -The completion list updates every morning, so if you just completed the course today, please wait a day to find your name in the dropdown.

• Please make sure to click "Log In Through My Institution", scroll down to click on “University of Vermont” and use your UVM Net ID and password to sign in.
• If you haven’t updated your password in the past year, you may need to go to https://www.uvm.edu/account/ to change your NetID password or reset a forgotten password.
• If you don’t have an active UVM NetID, you may complete the Request for UVM Net ID for Required Training form and submit it to the RPO.
• If you continue to experience issues with the "Single Sign On" (SSO) for CITI Program Access, then a separate account can be created through the CITI program affiliated with the University of Vermont.
• Return to the main CITI page at https://www.citiprogram.org and click the "Register" button at the top right of the page.
• Step 1: Select Your Organization Affiliation - "University of Vermont".
• Complete the Remaining Registration Steps 2 -7.

• A separate account can be created through the CITI program affiliated with the University of Vermont.
• Go to the main CITI page at https://www.citiprogram.org and click the "Register" button at the top right of the page.
• Step 1: Select Your Organization Affiliation - "University of Vermont".
• Complete the Remaining Registration Steps 2 -7.

          

Who Needs to Complete the Human Subjects in Research Training?   

• All individuals involved in the conduct of research with human subjects, regardless of funding source, must complete the training.  This includes anyone, including consultants and off-site personnel, who have direct contact with subjects or access to the identifiable research data.  Consultants and collaborators from other institutions covered by Federal Assurance with the Office of Human Research Protections at the Department of Health and Human Services may provide certification of training from their own institution if their participation is not on site at UVM or UVM Medical Center. Alternatively, collaborating researchers may add or change their affiliation to UVM through CITI to register their completion. 
• Personnel who are designated as the primary contact person for a specific protocol are required to complete the training regardless of whether they have subject contact or access to subject data so that they understand their regulatory responsibilities. 
• Faculty who are listed as sponsors on student projects, course instructors for class projects, and students who are conducting research are also required to take the training.
• Laboratory technicians are not required to be listed as key personnel on a research protocol if they do not have access to any of the 18 HIPAA identifiers for our local subjects.  Additionally, it is not necessary to list laboratory technicians as key personnel when they are solely working with commercial materials or are working with unidentifiable materials (again with none of the 18 HIPAA identifiers) from another institution.

 Note:  PIs and Faculty Sponsors (if applicable) who are listed on protocols that are deemed to be Exempt are required to take the training, but other listed key personnel are not required to take the training.

 

When should the Training be Done? 

We require that the training be complete for all key personnel listed on new protocols prior to submission.  New approvals will not be released until all individuals involved with human subjects on the project have completed the training. 

 

Which CITI Course(s) Do I Need to Take?

You may currently complete either the "Biomedical Research" or the "Social Behavioral Education Sciences" course. Both courses meet the required training for human subjects research, so you may decide what you want the focus of your content to be.

 

Will Other Training Programs Meet this Requirement?  

Completion of other training programs for local protocols will not meet the Committee’s requirement for training because a significant portion of the program addresses local policies & procedures.   Consultants and collaborators from other institutions covered by Federal Assurance with the Office of Human Research Protections at the Department of Health and Human Services may provide certification of training from their own institution if their participation is not on site at UVM or UVM Medical Center.

 

How do I Document that I have Completed the Training? 

A certificate of completion can be obtained from your CITI main menu at any time. Additionally, you may go to our training completion page to view the list of people who have completed our required training.

 

How Often Do I Need to Be Retrained?

Every three years, all key personnel still listed on an active protocol are required to complete the entire training again.  The IRB will send a reminder as the anniversary nears.  If training expires, that individual will be administratively removed from all active protocols.  If the individual continues to work with human subjects after removal, it will be considered noncompliance. 

 

Are There Other Types of Training?    

The IRB has established a listserve of all active key personnel.  Inclusion in this listserve is mandatory as long as you are working with human subjects.  This listserve is used to disseminate new regulatory information and process changes.

 

What is the passing grade for the required training?

You must achieve an average score of at least 85% across all required modules of the course you're taking.

            

What is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.  Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected.

Is GCP training the same as Human Subject Training?
No. GCP training is a separate training and is not basic human subjects protection training.  GCP principles are specific to clinical trials.

Who is Required to Complete Good Clinical Practice Training?
GCP training is required for all investigators and staff who are involved in the conduct, oversight or management of clinical trials involving Human Subjects irrespective of funding source supporting the research activity.  

Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For more information, see the NIH definition of clinical trial.

Do my lab technicians need to complete GCP training?
Lab technicians who are listed as key personnel are required to complete GCP training.  It is essential that the entire study team be in the mind-set to protect subjects’ rights and assure data integrity from the bench to the bedside.  Lab technicians are equally responsible as other members of a research team for ensuring data integrity.  If a lab technician does not follow good practices and that results in data that cannot be used, then the subject’s participation is for nothing.

Laboratory technicians are not required to be listed as key personnel on a research protocol if they do not have access to any of the 18 HIPAA identifiers for our local subjects.  Additionally, it is not necessary to list laboratory technicians as key personnel when they are solely working with commercial materials or are working with unidentifiable materials (again with none of the 18 HIPAA identifiers) from another institution. 

What are the GCP requirements for collaborators who are listed on my protocol, but are not affiliated with either UVM/UVMMC?
Collaborators are required to complete GCP training through CITI.  If the collaborator has completed CITI at their respective institution, they need to associate that training with the University of Vermont.  CITI instructions to associate with another institution are below.

Add/Change Affiliated Institution

I am a social behavioral researcher, do I need to take GCP?
Yes, GCP training is required for all UVM/UVMMC investigators and clinical trial staff involved in a clinical trial, regardless of funding source.

Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For more information, see the NIH definition of clinical trial.

When should the GCP training be completed?
GCP training must be completed for all key personnel listed on new protocols prior to submission.  New protocol approvals will not be released until all individuals on the protocol have met this requirement.

How Often Do I Need to Retake GCPs?
Every three years, all key personnel still listed on an active clinical trial are required to complete GCPs refresher training.

Which CITI Courses Meet the Requirement?
Take one of the following
-If engaged in international research then the ICH focus course would be more applicable to you.

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)

OR

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)

OR

Social and Behavioral Research

GCP – Social and Behavioral Research Best Practices for Clinical Research

          

Who Needs to Complete the Laboratory Animals Training?   

If you are listed on an active IACUC protocol, either as PI or Key Personnel you are required to take the "General Lab Animal Training" course in addition to any animal-specific courses that you may be working with.

 

When should the Training be Done? 

We require that the training be complete for all key personnel listed on new protocols prior to submission. If training and occupational health are not complete, they will not be listed on the protocol. New approvals will not be released until the PI on the project has completed the training.

 

Which CITI Course(s) Do I Need to Take?

You must complete the General Lab Animal Training course in addition to any animal-specific course(s) for each species that is listed on the protocol. In addition, if there is an IBC protocol associated with the IACUC protocol that you’re working on, you must complete the required IBC training if you are involved in that work. See the Biosafety Research FAQ below for more information. Note for Animal Science Students: Department of Animal Science student working to develop individualized programs with their faculty advisor can take the Animal Science web-based training instead of CITI. These programs apply to farm, laboratory, zoo and companion animals, their interaction with human society and the contribution of animal products, such as milk and meat, to the world food supply. If the role of the student involves responsibilities not typically required of the class, such as husbandry or procedures with the animals, the student would be required to take additional training as appropriate. Please contact RPO to see if this training applies to you.

Will Other Training Programs Meet this Requirement?  

Completion of other training programs for local protocols will not meet the Committee’s requirement for training because a significant portion of the program addresses local policies & procedures. Animal specific courses may meet the UVM’s criteria and transfer over by affiliating your account with our institution, but the General Lab Animal Training will still need to be completed in order to meet UVM’s requirements.

Add/Change Affiliated Institution

 

How do I Document that I have Completed the Training? 

A certificate of completion can be obtained from your CITI main menu at any time. Additionally, you may go to our training completion page to view the list of people who have completed our required training.

 

How Often Do I Need to Be Retrained?

Every three years, all key personnel still listed on an active protocol are required to retake the General Lab Animal Training and the species-specific training(s). The IACUC will send a reminder as the expiration nears. If training expires, that individual will be administratively removed from all active protocols that they are listed on. If the individual continues to work with animals after removal, it will be considered noncompliance.

 

Are There Other Types of Training?    

The IACUC has established a listserve of all active key personnel. Inclusion in this listserve is mandatory as long as you are working on at least one IACUC protocol. This listserve is used to disseminate new regulatory information and process changes.

 

What is the passing grade for the required training?

You must achieve an average score of at least 80% across all required modules of the course you're taking.

          

Who Needs to Complete the Biosafety Research Training ?   

If you are listed on an active IBC protocol, either as PI or Key Personnel, you are required to complete CITI training.

 

When should the Training be Done? 

We require that the training be complete for all key personnel listed on new protocols prior to submission. If training and occupational health are not complete, they will not be listed on the protocol. New approvals will not be released until the PI on the project has completed the training.

 

Which CITI Course(s) Do I Need to Take?

Depending on the level of containment in which you are working, you will need to complete either the BSL-1 or BSL-2 Basic course. Please note that the BSL-2 Basic Course meets all the requirements for BSL-1 work. We encourage those working in BSL-1 containment to complete the BSL-2 training even though it is not required. In addition, if there is an IACUC protocol associated with the IBC protocol that you’re working on, you must complete the required IACUC training if you are involved in that work. See the Laboratory Animals FAQ above for more information. Please note that the BSL-2 classroom training is still required for those listed on protocols that are BSL-2 containment. When adding either the BSL-1 or BSL-2 course, you will be prompted to answer “yes” or “no” to whether you work with blood borne pathogens, select agents/DURC or nanotechnology. If you answer “yes” to any of these questions, the course will be added to your menu for you to take. IBC does not track blood borne pathogens so please check with EHS (Safety@uvm.edu) to see if this is required for. Select agent/DURC and nanotechnology training is required if these materials are listed on your protocol. Please call RPO if you have questions about which trainings you are required to take.

 

Will Other Training Programs Meet this Requirement?  

Completion of other training programs for local protocols will not meet the Committee’s requirement for training because a significant portion of the program addresses local policies & procedures. BSL-1 or BSL-2 trainings are required. Select agent/DURC or Nanotechnology courses may meet the UVM’s criteria and transfer over by affiliating your account with our institution, but the BSL-1 or BSL-2 will still need to be completed in order to meet UVM’s requirements.

Add/Change Affiliated Institution

 

How do I Document that I have Completed the Training? 

A certificate of completion can be obtained from your CITI main menu at any time. Additionally, you may go to our training completion page to view the list of people who have completed our required training.

 

How Often Do I Need to Be Retrained?

Every three years, all key personnel still listed on an active protocol are required to retake the BSL-1 or BSL-2 training as well as Select Agent/DURC and Nanotechnology if applicable. If training expires, that individual will be administratively removed from all active protocols that they are listed on. If the individual continues to work with biohazards after removal, it will be considered noncompliance.

 

Are There Other Types of Training?    

The IBC has established a listserve of all active key personnel. Inclusion in this listserve is mandatory as long as you are working on at least one IBC protocol. This listserve is used to disseminate new regulatory information and process changes.

 

What is the passing grade for the required training?

You must achieve an average score of at least 80% across all required modules of the course you're taking.