How do I register for an IBC CITI course / training?

1. Log into CITI (choose "Log In Through My Organization" and type North Dakota State University).
2. Scroll all the way down to the bottom of the main page.  There’s a gray box with rounded corners titled: Learner Tools for North Dakota State University.  Click the top option, Add a Course.
3. On the next page, Lab Animal Research.
4. The next thing that will come up is the list of all the IBC CITI courses available to everyone at NDSU.  This is where you’ll select the specie(s) you work with.  
   1. Basic Biosafety Training Course
      • Required for all projects
   2. If working with Recombinant or Synthetic Nucleic Acid Molecules:
      • Complete the NIH Recombinant DNA Guidelines course.
   3. If working with human blood, bodily fluids, tissues, cells or cell lines: 
      • Complete the OSHA Bloodborne Pathogens course.

How can I find all my IBC protocols?

Log into Novelution.  Then from the IBC tab, select Search IBC Protocols.  Type your name in the PI/Co-PI box. If you are a unit manager, this process would be the same, as unit managers are automatically listed as research team members when their facility is selected as a research location.

Do I need to notify the IACUC office when I’ve submitted modifications requested by reviewers?

You do not need to notify the administrator after you have submitted requested modifications.  The Novelution system will automatically notify the administrator when you submit the modifications.

Why are there so many of the same review comment?

The Novelution system requires a review comment be entered by the administrator when indicating modifications are required for designated member review.

This means each time the protocol goes back and forth between the reviewers and the PI, an additional comment will be added. It’s usually something to the effect of “Modifications needed.”

In addition to this comment from the administrator, often each of the reviewers will add a similar comment, because the Novelution system requires a comment be added.

These comments do not need to be specifically addressed, only the substantive comments left by the reviewers.

Keep in mind you may respond to the review comments in the Review Comments conversation portion, but you are also required to add any additional substantive information to the corresponding area of the protocol to officially add it. The protocol cannot be approved without doing this.

How do I add to my research team?

1. Click the blue Amend box at the top of the protocol.
2. Click blue Request box in the New Amendment or Annual Review portion.
3. This will take you to the new Amendment / Annual Renewal revision.  Select Amendment.
4. Go to the Panel shortcuts menu on the left-hand side of the protocol.  Select Research team from Panel shortcuts.
5. Click blue Add Researcher button and go through usual steps to add the individual(s) to your team.
6. Click blue Review and Submit button.

When they don’t have an NDSU email:

Check the box indicating the person you are adding is an external user, fill out their information and save. This will add them to the protocol. Go back to Step 5 above.

The individual you added will receive an email to complete their Novelution profile. https://erac.ndsu.edu/

Do not email or call the IACUC, IBC or IRB office to make personnel changes.  You will be re-directed to submit an amendment with the instructions above.

Can reviewers see my responses to them in the Review Comment conversation bubbles?

Reviewers can see the comments, but do not get a notification of them.  If you need to send information directly to a reviewer or have a question for them, notify the administrator and they will facilitate the communication.

Is there a way to speed up the review process?

There is not a way to make the review process faster for IACUC, IRB or IBC, for any reason. 

I submitted an amendment adding a member to my research team. Why are pre-submission requirements for someone who was already approved to work on the protocol holding up the approval process?

This person's training has expired since the protocol was approved.  They would have received an email from CITI notifying them their training was nearing expiration.  Training is a hard stop for the approval process at any stage.  The expired training will need to be renewed prior to the amendment moving on in the approval process. 

Why can't I see review comments?

Usually, this is because of the way the comments are sorted.  Just above the Review Comments area, there is a drop down where you can select how the review comments are filtered and which ones you see.  If you can't see unresolved review comments, you'll want to sort this by Open or All.  

I'm leaving NDSU. What happens to my protocols?

If the work is going to continue at NDSU with a researcher from NDSU, submit an amendment to change the PI.  If the project will not continue, submit a request to terminate the protocol.

When I respond to reviewer comments / make modifications to my protocol, do I have to resubmit the entire protocol?

When you respond to review comments and submit your responses, the Novelution system will automatically make the entire protocol available to reviewers.  

I can see reviewer comments, but can't I respond to them? When can I start responding?

This most likely means some, but not all the reviewers have completed their review of the protocol or amendment.  You will not be able to officially respond to the comments until all reviewers have made their determination and the protocol has been sent back to you for modifications.  You are encouraged to start formulating your responses to the review comments as soon as you start seeing them. 

I need to renew my protocol. Do I need to fill out everything all over again?

No.  If you need to renew your protocol, simply click the blue copy button at the top of the protocol.  

How can I check which trainings my research team is missing? iacuc

***FOR IACUC PROTOCOLS:

1. Select Requirements from Panel Shortcuts in protocol within the protocol.

2. Hover over the blue circle with question mark by each individual’s name. This will give a list of missing trainings for that person.

ALL research team members need Working with the IACUC Investigators, Staff and Students CITI training. In addition, they need species specific CITI training(s).  Here are some examples: 

• • If working with laboratory mice or rats: 
    • Complete the Rodent Research Course.
  • If working with live vertebrates (non-wildlife, non-rodent):
    •   Complete the Working with the IACUC Course.
  • If working with live vertebrate wildlife animals: 
    • Complete the Wildlife Research Course.
  • If working in extension and may use live vertebrate animals for demonstration/exhibition:
    • Complete the Extension Agents course.
• Complete species-specific CITI training, ex.:

• • Working with Mice in Research Settings

• • Working with Genetically Modified Mice in Research Settings

• • Working with Cattle Amphibians in Research Settings

• • Working with Cattle in Agricultural Research Settings

• • Working with Sheep and Goats in Research Settings

Etc. (these are only a few examples)

***FOR IBC PROTOCOLS:

. Select Requirements from Panel Shortcuts in protocol within the protocol.

2. Hover over the blue circle with question mark by each individual’s name. This will give a list of missing trainings for that person.

ALL research team members need to complete the Basic Biosafety Training Course.  In addition, they need project specific CITI training(s).   

• • If working with Recombinant or Synthetic Nucleic Acid Molecules:
    • Complete the NIH Recombinant DNA Guidelines course.
  • If working with human blood, bodily fluids, tissues, cells or cell lines: 
    • Complete the OSHA Bloodborne Pathogens course.

REMEMBER: training is a HARD STOP for the approval process!

How can I see the status of my protocol or amendment?

To check the status of your protocol or submitted amendment, click on the small blue down arrow to the left of the protocol number at the top of the protocol.  The most common statuses you will see are: 

• Review Pending
  • This can mean several things.  You will see this status most commonly when the protocol is waiting for reviewers to be assigned and after reviewers have been assigned during the designated reviewer's review period.
• Draft Submission Pending
  • A protocol with this status has not been officially submitted by the PI.  It is common for PI's to think it has been submitted, but they have forgotten to click the blue submit box at the bottom of the protocol.
• PI Certification Pending
  • If the protocol or amendment is submitted by a student, the PI will receive a notification that they need to certify the protocol.
  • If the protocol is submitted by the PI, clicking the blue submit box at the bottom of the protocol will submit and certify the protocol. 
• Pre-Submission Requirements
  • This one is very common. This usually means either the Novelution system or IACUC administrator needs to check off the OHS requirement (IACUC protocols), CITI training or both for one or more research team member prior to having reviewers assigned. When the Novelution system moves a protocol to pre-submission requirements, the administrator does not receive any sort of notification, so is unaware of this status. 

     Here's how to check if CITI training is why the protocol is being held up in the approval process: 

1. Select Requirements from Panel Shortcuts within the protocol.
2. Hover over the blue circle with question mark by each individual's name. This gives the list of missing training(s)

• REMEMBER: training is a HARD STOP for the approval process!

What do I do if I know there has been a protocol deviation or adverse event, but I’m not comfortable speaking up to my advisor or PI?

Please know the Research Integrity, Security and Compliance team is here to help you achieve success in every way possible. Please reach out to us if you have any concerns about any possible protocol deviations or adverse events taking place. We will handle the situation on your behalf and if you prefer, your anonymity will be protected. We encourage you to speak up if you feel something isn’t happening the way it should.

How do I find the most recent review comments?

 1. Navigate into your protocol.

2. Click Review Comments from the Panel Shortcuts to navigate to the comments.

3. To sort by date to see the most recent comments, click the Date column. Clicking once will put the most recent comments on top. Clicking twice will put the oldest comments on top.

How do I download a protocol?

1. Navigate to the protocol.
2. Click the cloud / arrow icon in the upper right corner
3. Select which fields you want included. The double arrow will give you all fields.
4. Select Download.  

How do I find the most recent review comments?

 1. Navigate into your protocol.

2. Click Review Comments from the Panel Shortcuts to navigate to the comments.

3. To sort by date to see the most recent comments, click the Date column. Clicking once will put the most recent comments on top. Clicking twice will put the oldest comments on top.

How do I get a copy of my approval letter?

To download a copy of the approval letter:

1. Navigate into the protocol in Novelution.
2. Click on the IACUC / IRB / IBC Correspondence panel on the left side.
3. Click on the appropriate correspondence.
4. Click on the blue eye icon on the right.
5. Click on IACUC / IRB / IBC Approval Letter.pdf link in the Upload Attachments area.

This will download your approval letter.

How can I check which trainings my research team is missing? iacuc

***FOR IACUC PROTOCOLS:

1. Select Requirements from Panel Shortcuts in protocol within the protocol.

2. Hover over the blue circle with question mark by each individual’s name. This will give a list of missing trainings for that person.

ALL research team members need Working with the IACUC Investigators, Staff and Students CITI training. In addition, they need species specific CITI training(s).  Here are some examples: 

• • If working with laboratory mice or rats: 
    • Complete the Rodent Research Course.
  • If working with live vertebrates (non-wildlife, non-rodent):
    •   Complete the Working with the IACUC Course.
  • If working with live vertebrate wildlife animals: 
    • Complete the Wildlife Research Course.
  • If working in extension and may use live vertebrate animals for demonstration/exhibition:
    • Complete the Extension Agents course.
• Complete species-specific CITI training, ex.:

• • Working with Mice in Research Settings

• • Working with Genetically Modified Mice in Research Settings

• • Working with Cattle Amphibians in Research Settings

• • Working with Cattle in Agricultural Research Settings

• • Working with Sheep and Goats in Research Settings

Etc. (these are only a few examples)

***FOR IBC PROTOCOLS:

. Select Requirements from Panel Shortcuts in protocol within the protocol.

2. Hover over the blue circle with question mark by each individual’s name. This will give a list of missing trainings for that person.

ALL research team members need to complete the Basic Biosafety Training Course.  In addition, they need project specific CITI training(s).   

• • If working with Recombinant or Synthetic Nucleic Acid Molecules:
    • Complete the NIH Recombinant DNA Guidelines course.
  • If working with human blood, bodily fluids, tissues, cells or cell lines: 
    • Complete the OSHA Bloodborne Pathogens course.

REMEMBER: training is a HARD STOP for the approval process!

What do I do if I know there has been a protocol deviation or adverse event, but I’m not comfortable speaking up to my advisor or PI?

Please know the Research Integrity, Security and Compliance team is here to help you achieve success in every way possible. Please reach out to us if you have any concerns about any possible protocol deviations or adverse events taking place. We will handle the situation on your behalf and if you prefer, your anonymity will be protected. We encourage you to speak up if you feel something isn’t happening the way it should.

Why can't I find my CITI Training in Vector?

IACUC, IRB and IBC trainings are not housed or completed via Vector.  Vector is only for the NDSU required annual trainings.  The process to complete and verify your CITI trainings has not changed. 

I got an email from Novelution saying I'm missing CITI training. How Can I see what I'm missing?

There are two ways to check which CITI trainings you're missing:

FROM WITHIN THE PROTOCOL:

1. Select Requirements from Panel Shortcuts within the protocol.
2. Hover over the blue circle with question mark by each individual's name. This gives the list of missing training(s)

3. REMEMBER: training is a HARD STOP for the approval process!

BY LOGGING IN TO CITI:

1. Log in to CITI.
2. Click My Courses at the top. Then scroll down.
3. Click the blue View Courses box.
4. Scroll all the way down to the bottom.  Inside the gray box titled Learner Tools for North Dakota State University, click View Previously Completed Coursework.
5. This will show you all the courses you have taken and renewed.  From here you will be able to see if any courses are due now or expired.
6. REMEMBER: training is a HARD STOP for the approval process!