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:
- Select Requirements from Panel Shortcuts within the protocol.
- 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!
BY LOGGING IN TO CITI:
- Log in to CITI.
- Click My Courses at the top. Then scroll down.
- Click the blue View Courses box.
- 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.
- 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.
- REMEMBER: training is a HARD STOP for the approval process!
Why can't I find my CITI Training in Vector?
IACUC 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.
How do I know if I need an IACUC protocol?
- Does the project include animals owned by NDSU?
- Does the project include NDSU personnel?
- Is the project taking place on NDSU property?
If the answer to at least two of these is yes, you need an IACUC protocol.
How do I add to my research team?
- Click the blue Amend box at the top of the protocol.
- Click blue Request box in the New Amendment or Annual Review portion.
- This will take you to the new Amendment / Annual Renewal revision. Select Amendment.
- Go to the Panel shortcuts menu on the left-hand side of the protocol. Select Research team from Panel shortcuts.
- Click blue Add Researcher button and go through usual steps to add the individual(s) to your team.
- 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 office to make personnel changes. You will be re-directed to submit an amendment with the instructions above.
Do not email or call the IACUC office to add personnel to your research team. You will be referred back to the above instructions.
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 are there so many of the same review comment?
The Novelution system requires a review comment be entered by the IACUC 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 can I check which trainings my research team is missing?
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.
- If working with laboratory mice or rats:
- 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)
REMEMBER: training is a HARD STOP for the approval process!
My IACUC protocol shows there are pre-submission requirements. What does that mean?
This usually means either the Novelution system or IACUC administrator needs to check off the OHS requirement, 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 IACUC 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:
- Select Requirements from Panel Shortcuts within the protocol.
- 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!
How do I update my training log?
- Add any new training to your training log. Make sure to save the new log with a file name that reflects your name and the date you are uploading it, so it’s easy to find your most recent log. Like this: firstname.lastname.month-day-year
- Upload new training log to your Novelution profile.
- In your profile, select the Add IACUC Species Training Log
- Select the file, or drag and drop the file you want added in the purple Drop files here or click to choose box.
- Click the blue Save button.
- Scroll to the very bottom of your profile – click the blue check mark / Save button
- In each protocol the research team member is part of:
- go to the Research Team panel.
- Click on the blue square in the right-most column titled Action.
- Towards the bottom of the pop up, there will be a blue Select button. Click that and choose the new training log.
- Click Save. This will attach the new training log to the protocol.
Please add the date it was most recently updated to the file name.
How do I get a blank training log?
You can download a copy of the Individual Training Log from Research and Creative Activity website’s All Forms page:
https://www.ndsu.edu/research/about_rca/all_rca_forms/#c596707
How do I get a copy of my approval letter?
You can download a copy of the approval letter by:
- Navigate into the protocol in Novelution.
- Click on the IACUC Correspondence panel on the left side.
- Click on the appropriate correspondence.
- Click on the blue eye icon on the right.
- Click on IACUC Approval Letter.pdf link in the Upload Attachments area.
This will download your approval letter.
What do I/my research team need to be added to an IACUC protocol?
To be added to a protocol involving animals:
- Complete your Novelution profile. You will receive an email from the Novelution system when your PI / advisor adds you to the protocol, if you do not already have a Novelution profile. This is where all your training documentation is stored, so it’s important to complete this step first.
- Complete the Occupational Health and Safety (OHS) process. This process can take up to 21 days, so plan accordingly.
- Complete a training log reflecting you are trained and proficient in all responsibilities listed for you in the Responsibilities portion of the Research Team Panel of the protocol.
- Complete general CITI training:
- 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.
- If working with laboratory mice or rats:
- 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)
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 update or add my training log?
- Add the new training to your training log.
- Upload it to your Novelution profile. Make sure to save it with your name and current date.
- If you are not already a research team member on a protocol, you’re done.
- If you are a research team member on a protocol:
- go into the protocol
- go to the Research Team panel
- click the blue edit box on the far-right side of your row
- click the blue select box next to Species Training Log
- select the appropriate (most recent) training log
- click save in the pop-up box
- click save at the bottom of the protocol
- do this for each protocol you are a research team member
It tells me a research team member’s training log is missing. What do I do?
To add a training log:
- Go into the protocol
- Go to the Research Team panel
- Click the blue edit box on the far-right side
- Click the blue select box next to Species Training Log
- Select the appropriate (most recent) training log
- Click save in the pop-up box
- Click save at the bottom of the protocol
How do I download a protocol?
- Navigate to the protocol.
- Click the cloud / arrow icon in the upper right corner
- Select which fields you want included. The double arrow will give you all fields.
- Select Download.
What is the process of an AV consult?
The process is the same as the review process. It occurs between the AV and the PI, rather than designated reviewers and the PI, like the review process.
How does the IACUC administrator know when I’ve completed training?
The Novelution and CITI systems ‘talk’ to each other in the early morning hours. In this process, the Novelution system will automatically check off any completed CITI training. It is not necessary to send the IACUC administrator your completion certificates.
The ONLY way these two programs can accurately report your completed training is if the email address listed in your Novelution profile, and the email address in your CITI Profile are exactly the same.
Your Novelution profile uses the email set by the University System, and can be found by:
- Clicking on 'Profile & Settings"
- Edit User Profile
- For most faculty, staff and students, this will be your first.last@ndsu.edu; however, if you have another affilation 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 OR @ndus.edu.
- If you notice these do not match, change the email you use for your CITI account to the email you use for your Novelution account.
How do I find my protocols?
Once you’re logged in, navigate to Search IACUC Protocols under the IACUC tab.
If you know the protocol number, you can enter it into the Protocol # or Title box. You can also search by your name in Personnel or your PI’s name in PI/Co-PI. If you are part of the research team, the protocol(s) will appear in the search results. If you are not, it will not appear.
Is it true IACUC protocol approvals are three months out?
No. The average approval period is 28 days. This is dependent on the timeliness of responses to the reviewers comments and the number of re-reviews the protocol requires.
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.
How do I register for a CITI course / training?
- Log into CITI.
- 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.
- On the next page, Lab Animal Research.
- The next thing that will come up is the list of all the IACUC CITI courses available to everyone at NDSU. This is where you’ll select the specie(s) you work with. You will also need to select Working with the IACUC Course.
Novelution tells me my research team members do not have their species training log. What do I do?
- Go to the Research Team panel in the protocol.
- Click on the blue box on the right-most column labeled Action.
- Click the blue Select box.
- Click the appropriate training log.
- Click save.
How does the protocol review process work?
Is there a way to speed up the review process?
There is not a way expedite the IACUC review process, for any reason.
What is holding up my protocol?
The most common reason protocols are held up is becuase of missing requirements, either training or OHS requirements. To know what's missing, scroll to the Requirements portion of the protocol. Hover over the blue circle with a question mark, this will let you know which CITI training that indiviudal is missing . If there is the same blue circle with question mark stating Upload OHS Training, the OHS requirement needs to be checked off. If they have completed it (done through the Safety Office), there is no further action needed. If they have not, the supervisor will need to begin the process by completing the Hazard and Risk Assessment form. This could be the reason your protocol is 'stuck' in pre-submission requirements. The IACUC administrator does not recieve any sort of notification of this.
What does review pending mean?
Reveiw pending can have a couple meanings for IACUC protocols.
1. Waiting for the IACUC Committee chair to assign reviewers (occurs roughly every 7-10 days)
2. The protocol is being reviewed by designated reviewers.
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, 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 IACUC 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:
- Select Requirements from Panel Shortcuts within the protocol.
- 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!
How do I transfer animals?
From the Panel Shortcuts on the left side of the protocol, select Animal Acquisitions. Complete this panel and submit for approval.
I can see reviewer comments, but can't I respond to them? When can I start responding?
This most likely means sum, 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.
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 IACUC administrator and they will facilitate the communication.
Do I have to submit a new protocol? Can't we just extend it?
No. Federal regulations state you must submit a new protocol for review and approval every three years.
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.
Can I respond to the review comments in the conversation bubbles?
You can use the chat bubbles to communicate with reviewers. However, any information in this area is not an official part of the protocol. If you are making a substantive change, it MUST be in the appropriate area of 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.
How do I check why I'm getting a validation error?
When you’re not sure why you’re getting a validation error, you can click on the error and it will take you to that area of the protocol. When you open it up and run the validation check again, it will let you know the validation issue.
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.
How can I find all my protocols?
Log into Novelution. Then from the IACUC tab, select Search IACUC 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.
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 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.
FYIs
- Save your training log: firstname.lastname.month-day-year
- This will make it obvious which log is most recent.
- It’s important to list the species each member of the research team will be working with if there are multiple species on the protocol. This determines the training the system will require for each individual. If you don’t specifically state which species they’ll be working with, the system will require OHS documentation and CITI trainings for every individual for each of the species listed on the protocol.
- Even though you submit an official amendment to add to your research team, it is an administrative approval and does not need to go through the approval process the way other amendments do. As long as those you are adding have all their training and requirements completed, it should be approved within a day or two.
- No additional changes of any kind can be made when a protocol or amendment are in the review process.
- It is a good idea to write a training component into your protocol for the ability to train research team members as you add them.
- When a protocol is in pre-submission requirement status, usually due to missing training or other requirements, the IACUC administrator is not notified by Novelution. It is the responsibility of the PI to follow up on clearing the requirement.
- If you are an advisor to a group that uses animals for educational / outreach events, make sure everyone who needs to have access to the protocol does, and make sure everyone who will have ccontact with the animlas for the outreach / educational events is on the prtoocol, even if this turn over happens every year.