What Information Do I Need to Log into InfoEd? (Obtaining UVM Net ID & Password)

A UVM NetID is needed to log into InfoEd to view or submit protocol materials. All UVM employees are issued a UVM NetID upon hire but there are many UVMMC (non-UVM) research key personnel who do not have a UVM NetID. A UVM NetID can be issued to UVMMC personnel for the purposes of access to the InfoEd system through a special process. If you do not have a UVM Net ID, complete and submit the Microsoft Office document icon Request for UVM Net ID for Required Training (DOC) form in order to gain access to InfoEd.

We track approximately 2800 people through our training program of which 900 are UVMMC. During a recent audit, we found that many UVMMC people appear to be inactive and some UVMMC key personnel, after having been assigned a UVM NetID, neglected to follow through with their training and were never added to a protocol. To keep our database clean, we are placing a limit of 30 days after UVM NetID assignment to allow time for people to complete their training and be added to a protocol. We will also be deactivating UVM NetIDs for any persons who appear to be inactive. A UVM NetID can always be reactivated if necessary.

As with any password, you must reset the password that is associated with your UVM NetID on an annual basis. UVM does send a notice of impending expiration, however, this notice goes to a uvm.edu address which most of you are probably not checking. To avoid password expiration should have your new UVM email forwarded to your preferred email address. For more information about email forwarding, visit the UVM TECH TE@M.

If you experience problems with logging into InfoEd, it is likely that your password has expired. Please go to UVM's Account Management page for directions on how to reset your password. If you are still experiencing problems, contact rpo@uvm.edu or call 656-5040.

Will Principal Investigators Be Able to Designate Administrative Staff to Upload Documents and Submit Protocols to the Research Protections Office in Their Stead?

Yes. InfoEd provides a feature for assigning Delegates. Delegating responsibility to a protocol contact to submit protocol materials on the behalf of a principal investigator (PI) through InfoEd requires that the PI understand the delegation functionality.

PIs may request delegation to create/view/edit/submit protocol materials only to a person currently listed on one of their protocols as a contact. The contact role has historically been the person that handled paper submissions, however with electronic submission in the InfoEd system, contacts will be given additional access that they may not currently have. The follow is a list of things you need to know prior to delegating responsibility to the protocol contact.

To allow the contact the ability to submit on the PI’s behalf, the contact must be given system security access that is identical to that of the PI. This means the ability to create/view/edit/submit protocol materials. This person must be trained by the Research Protections Office (RPO) staff prior to this activity.

Delegation is specific to the PI’s body of work, it is not specific to a protocol. Therefore, any contact you delegate will be able to create/view/edit/submit protocol materials for any of your protocols, regardless if they are listed as contacts on all of the protocols or just one protocol. Access cannot be restricted to specific protocols.

If the PI has two or more different contacts across their menu of protocols, the PI may want to request they all be delegated this responsibility. However, the PI will need to manage which contact is responsible for which protocol submissions. We recommend that the only time a submission comes from someone other than the protocol contact is when they are covering for someone’s vacation.

Contacts given this access cannot sign protocol forms on behalf of the PI. All uploaded forms must have the PI’s signature.

Given that the delegation functionality provides for such a high level of access, the listed delegated contact person must always be current. To avoid potential problems, the PI needs to notify RPO as soon as possible of any staff turnover that affects the delegation. You must have an internal process to ensure that the delegated contact person is the appropriate person at all times.

PI's should complete the InfoEd Delegation Request Form. RPO staff will set this delegation for you upon receipt of this request. If you have further questions, contact 656-5040.

RPO staff are working on a process where you as the PI can set your own delegates. We will send a notice when this option is available.

What Does Each InfoEd Status Mean?

New Submission Statuses
Status Definition
In Route PI has sent a protocol submission to the electronic routing system. When “In Route”, the submission package (uploaded documents) is in lockdown and cannot be changed.
In Revision by PI The submission has been returned to the PI to make revisions. PI is able to make needed changes and resubmit the request to the RPO.
RPO Processing The submission package has been received by RPO and data entry has begun.
RPO Received Data Entry has been completed for the Initial Application.

Post Submission Statuses
Status Definition
Pending Committee Review Protocol has been assigned to an IRB reviewer.
Refer to Full Convened Meeting Protocol submission has been given an agenda date.
Refer to Designated (IACUC) Protocol submission has been assigned to committee members for designated review.
Modifications Received Pending final IRB review and sign off.
Modifications Required The protocol requires changes to the submission. A letter will be going out to the PI/Contact notifying them of the details related to the required modifications.
Approved The submission request has been approved. (i.e. Amendments, Continuing Reviews and Initial Applications)
Reviewed The submission has been processed by the RPO. (i.e. Key Personnel, Safety)
Continuing Review Received The RPO has received a Continuing Review Submission.
Closed/Completed Research project has been completed. No more work can be done on this protocol.

 

InfoEd Troubleshooting

  • If you can’t find the protocol you are looking for:
    • You may not be a delegate for the PI of the protocol. Check with RPO.
    • Click “Clear All” before searching so that unwanted search criteria are cleared.
    • Try searching by PI to see all existing records.
  • If you can’t submit your documents:
    • Make sure you have completed any mandatory eforms.
    • Check that you are not in “View Mode”. Someone else may be logged in to the protocol or you could be logged in twice. This occurs when you use the “X” button to close the protocol (instead of “Done”) and then open the protocol again. On the home screen, click the padlock icon next to the protocol to see who is in it. This is where you can log yourself out if needed.
  • If an eform is not working, make sure you are using a compatible web browser (not Internet Explorer)

What if I am unable to log into CITI with an active UVM Net ID?

First Option:

  1. 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.
  2. If you haven’t updated your password in the past year, you may need to go to UVM's Account Management page to change your Net ID password or reset a forgotten password.
  3. If you don’t have an active UVM Net ID, you may complete the Request for UVM Net ID for Required Training form and submit it to the RPO.

Second Option:

  1. 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.
  2. Return to the main CITI Login Page (opens in a new window) and click the "Register" button at the top right of the page.
  3. Step 1: Select Your Organization Affiliation - "University of Vermont".
  4. Complete the Remaining Registration Steps 2 -7.

What if I do not want to complete a Request for UVM Net ID for Required Training form?

  1. A separate account can be created through the CITI program affiliated with the University of Vermont.
  2. Go to the main CITI Login Page (opens in a new window) and click the "Register" button at the top right of the page.
  3. Step 1: Select Your Organization Affiliation - "University of Vermont".
  4. Complete the Remaining Registration Steps 2 -7.

Human Subjects Training

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 IRB Tutorial 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.

Good Clinical Practice Training

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 a clinical trial and the 12 minute podcast "Understanding the Definition of a Clinical Trial and What That Means for You" (MP3). The transcript can be found through the Office of Extramural Research under News & Events  »  Virtual Learning  »  All About Grants Podcasts.

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 a clinical trial and the 12 minute podcast "Understanding the Definition of a Clinical Trial and What That Means for You" (MP3). The transcript can be found through the Office of Extramural Research under News & Events  »  Virtual Learning  »  All About Grants Podcasts.

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

Laboratory Animals Training

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. Also, 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 Training 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 IACUC Tutorial Completion page (requires UVM NetID login) 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

Biosafety Research Training

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 Training above for more information.

Please note that the BSL-2 classroom training entitled "Biosafety for BSL-2 Laboratories" is still required for those listed on protocols that are BSL-2 containment.

When adding either the BSL-1 or BSL-2 course through CITI, 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 at 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 IBC Tutorial 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.