• Completion of CITI Human Subjects training is required for all investigators and research team members engaged in the conduct of human subjects research. 
• Training is verified prior to the initial review of a protocol, during any amendment requests, and at continuing review.
• Training must be renewed every three (3) years.
• Team members must complete one of the following the online courses through the Collaborative Institutional Training Initiative (CITI) Program:
  • Human Subjects: Social/Behavioral Research Course
  • Human Subjects: Biomedical Research
  • Human Subjects Course:  Extension Agents
  • Human Subjects: Research Assistants and Team members
• Those involved in an NIH-funded clinical trial must also complete the Good Clinical Practice (GCP) course.  Register by clicking "Add a course" on your CITI page Main Menu and choosing "Good Clinical Practice."

Novelution automatically integrates with the CITI program to verify completion of human subjects training for anyone who has an active profile in the system. 

For accurate reporting of your completed training, ensure that the email address in your Novelution Profile, and the email address in your CITI profile match.  For all NDSU employees, your Novelution profile is set by the University System and can be found by clicking on 'Profile & Settings' > Edit User Profile.  For most faculty, staff and students, this email will be first.last@ndsu.edu; however, if you have another affiliation within the NDUS system (e.g. you are a student at another institution), the domain may be the institution at which you are a student.

Students who are not employed by the university will need to activate their profile by using the Central Authorization System to log into Novelution (i.e. use their NDSU username and password to access Novelution). Without an active profile, the PI must upload a copy of the individual's training certificate to the protocol to be verified by the IRB office.

This is a resource for Graduate Students to use when they are seeking IRB Approval for their research projects that involves Human Subjects. It is the student’s responsibility to receive IRB approval before graduation. Please plan accordingly.

 Discuss with advisor and PI. Get research project approved first.
 Set up Novelution profile.
 Take required appropriate CITI training.
 Make sure all other research team members on the project have also completed required CITI training.
 Submit protocol to IRB to obtain approval.
 Submit with plenty of time before graduation to account for possible revisions that may be needed.

Getting started:

• Make sure you have discussed the research proposal with the PI and they read through and approved it. The PI is ultimately responsible for the research and they have to sign off on it. They should be guiding and helping you along the way.
• Resource: IRB Website located here: IRB Website
• Go into Novelution: Link here. If you already have a Novelution profile then you can skip this process.
• Scroll down to Using Novelution. This will help you set up your Novelution Profile. This needs to be done for all NDSU/NDUS internal people who will be on the research team.

Complete appropriate CITI training.CITI training is time consuming. Plan ahead to complete all necessary trainings before submitting your protocol.

• NDSU CITI training requirements found here.

IRB Tip Sheets for Protocols:

• Link here

Once protocol is started:

• It will show tasks to complete. Tasks will be in the requirements section; which is found at the bottom of the protocol.

Novelution Tasks:

• Green= tasks that are ready to be completed; not that they have been completed.
• Red= the task cannot be done until the one that is in green is completed.

• Tip: If you have a green task and it is related to CITI training, the PI will receive an email and it will state that someone (this means ANYONE; internal or external) is missing CITI training. If it is a:
  • Internal research team members:
    • Please open the CITI system and your Novelution profile.
    • Make sure the emails match
    • You will see this in the Novelution system. The email in here should match the one that is used in CITI.
  • External Research Team Members:
    • For members who are external- they will still need the NDSU CITI training. They will not be in Novelution so the verification is a bit different. Once they have completed the training, they can email any other team member a copy of their certificate. The PI or any other research team member can upload it in that member’s section in the research team panel.

Next Steps:

• Once the protocol has been filled out it can be submitted. The PI and Department Chair have to submit it. Once that happens, it will come to the IRB office. Please give them a few days to review the protocol. If there are any comments from reviewers or required changes that need to be made, they will show up in the reviewed comments section.
• The student can reply to them in the chat feature if that is appropriate to supply clarification. Most often the changes need to happen in the actual protocol. Once the changes/updates happen it needs to be resubmitted. The protocol GOES BACK to the PI for them to hit submit. It does not automatically get resubmitted to the IRB once the student hits submit. Please look at requirements section before asking IRB office. This tells you where your protocol is at.
• Once it gets back to the IRB office, and if there are more changes or updates, communication will continue back and forth through Novelution until it’s ready for approval.
• Once approved, the student will receive an emailed notification approval letter. Hold onto that letter for your records, as the Graduate School will need that letter.

Tips and things to look :

• Student Researchers - NDSU students can log in to Novelution using their NDSU username and password. Student researchers will need to update their Novelution profile with their department before accessing other modules within the system.

Setting Up a Student Novelution

• Outside Members/Researchers - NDSU has agreements with several other outside entities to provide compliance reviews (IBC, IRB, or IACUC). If you are a member of one of these institutions (e.g. USDA, Mayville State University) and need access to Novelution to submit a protocol, please contact the committee administrator. Once given a User Name, follow the these instructions for activating your account and establishing a password: 

Activating an External User Account

• Check the status of your protocol application - The Requirements panel within the Protocol application shows which steps are ready to complete to facilitate the review process. Check to see if training is completed, the department head has approved, or if the protocol is now in the review process.