Training Archive

Scenario One:

Dr. A. Nonymouse has multiple protocols and uses some unique mouse lines to accomplish their research. Dr. Nonymouse maintains their unique mouse lines on a departmentally funded breeding protocol as the mouse lines are not available from commercial vendors. During a Post Approval Monitoring (PAM) walkthrough, a PAM Compliance Analyst noticed a cage side rodent medical record (a.k.a., pink card) indicating that a survival surgery had been performed. When reviewing the protocol listed on the cage card, it was discovered that the cage was assigned to the breeding protocol, which doesn't include survival surgeries. After discussing the case with the Nonymouse Laboratory, it was determined that the mice were used for studies approved on a different protocol - the PI's experimental protocol.

What step(s) need to be taken?
1. The PI needs to submit a self-report to the IACUC describing what occurred (i.e., a failure to transfer animals prior to initiating procedures).
2. The PI needs to sign an IACUC form stating that the lab will not make the same error in the future.
3. The lab must transfer all of their animals to the CCM holding protocol while the incident is investigated by the IACUC.

Learner Feedback: The use of animals assigned to the wrong protocol needs to be discussed by the IACUC Chairs Subcommittee. Providing a PI self-report by selecting the IACUC Self-Report form on the IACUC Forms page, with a plan to prevent future incidents aids in the discussion of the incident. Option B is not correct, though certain non-compliance events may involve laboratory personnel signing off that they have read and understood policies, SOPs, protocol changes, etc. Prior to asking the laboratory for any kind of follow-up action items, the IACUC would first seek to collect more information on what occurred. Option C is not correct, as it would be an unnecessarily punitive measure that could place a substantial burden on the laboratory as well as CCM. In instances such as these the goal isn’t to punish laboratories or delay research, but to ensure that the IACUC has all the information it needs to help the laboratory identify a viable corrective action plan.

How are cages transferred to different protocols?
1. In AOPs, submit a transfer request.
2. Cross out the old protocol and write the desired protocol on the cage card and cage side documentation.
3. Remove all cage side documentation so that the protocol assignment is ambiguous.

Learner Feedback: Please see the CCM website -> Resources -> AOPs Information -> Submitting Animal Transfer for details on how to complete a transfer. Please note that transfers can take up to 2 business days as they are subject to veterinary review, so please plan accordingly! If you have any questions, please contact CCM_AOPS_Support@northwestern.edu. Option B is not correct, as the animals would not be appropriately accounted for in AOPs. Per the regulatory bodies, although animal number justifications are estimated, we are required to accurately track animal use numbers. Crossing out the protocol at the cage level is not appropriate until the transfer is approved by CCM reviewers. The cage card protocol will be updated after approvals are issued, transfer is marked completed in AOPS and updated barcode stickers are printed and placed on the cages. Labs can update the number of animals per cage using AOPS or using the tablet. As a cage remains active in the facility, the animal numbers within can change frequently. The number of animals in each cage is accurate at the time of cage creation. If a lab is wishing to transfer them to an alternative protocol, they should ensure the cages being transferred have an accurate count in each cage within AOPS prior to the transfer submission being made. That will ensure the correct usage is applied to the receiving study. Option C is not correct, as all animals must be identified and be assigned to an animal study protocol at all times. If separating animals, please be sure to fill out the separation cage card as described on the CCM website under Resources, SOPs, Cage Cards, CCM Separated Card.

When can I perform procedures on the cage that I wish to transfer?
1. When the transfer in AOPs is approved (not merely submitted), as signified by the availability of an updated barcode label with the new protocol number.
2. As soon as I submit the transfer request.
3. Prior to submitting the transfer request, as long as the transfer request is submitted prior to deactivating the cage card.

Learner Feedback: Please review the animal transfer process on the CCM Website under Billing & Procurement -> Animal transfers. If you have any questions, please contact CCM_AOPS_Support@northwestern.edu. Option B is not correct, since transfers are subject to veterinary review to ensure that the transfer is appropriate and must be approved prior to initiating studies. Option C is not correct, since transfers must be approved prior to initiating the new studies.

Scenario Two:

Dr. A. Nonymouse and Dr. W. Ildcat are collaborating on a project that uses a strain of mice that Dr. A. Nonymouse developed and bred in house. Each PI has their own protocol to accomplish their specific aims of the project.

What steps need to be taken for Dr. Ildcat to utilize Dr. Nonymouse's strain?
1. Dr. Ildcat must identify the strain in the approved animal study protocol.
2. Dr. Nonymouse or lab member with transfer rights must submit a lab animal transfer in AOPS.
3. Dr. Ildcat’s lab must wait for CCM approval of the transfer prior to initiating.
4. All of the above.

Learner Feedback: Regardless of species, animal transfers must be complete prior to initiating work described on the animal study protocol to which the animals are being transferred. Please be sure to check that the animals are assigned to the correct protocol and verify that the correct procedures are approved on the protocol prior to initiating work.

Scenario Three:

When reconciling the protocol's approved animal numbers with the animal usage tracked in AOPS, what animals need to be counted?

All animals used in association with each approved protocol must be counted. This holds true for research, testing, teaching, and holding protocols.
Neonates not yet weaned or used prior to weaning, including any pups generated and not used.
All zebrafish after 72 hours fertilization.
All of the above.

Learner Feedback: Per the Policy on Animal Numbers Justification and Accounting for Animals, identifying and tracking animal use is necessary to ensure that the number of animals used does not exceed the animal numbers approved in the ASP. These activities are also required to fulfill federal obligations for reporting animal use numbers and to assure compliance with IACUC approved protocols with the following exceptions:

Embryos/fetal mammals are not counted, however, their use must be justified in the ASP if they are manipulated or used in any way before birth.
Stillborn or cannibalized animals do not need to be counted.

Please see the CCM website, navigating to Resources, AOPS Information, and a presentation on Self-Reporting Culled Pre-Adults discussing how to count animals used prior to weaning in AOPS.

Scenario Four:

When preparing a de novo and adjusting the protocol for the next three years of animal studies, what changes to animal numbers does the IACUC expect to see?

Remove all completed experimental groups.
Add experimental groups to be completed over the next three years.
Include any animal numbers and their related experimental groups for animals currently on study.
All of the above.

Learner Feedback: The correct answer is All of the above. A de novo, also known as a triennial renewal, should be updated for what the laboratory plans to complete over the next three-year approval period. A de novo may be initiated 90 days prior to the expiration of a protocol as long as there is not a pending amendment open for the protocol. Since the de novo may be reviewed while the protocol is still active, there is an understanding that there may be some overlap between the work actively being completed on the existing protocol and de novo approval. Therefore, it is recommended to adjust the de novo for what the laboratory plans to complete during the next three-year approval period, and to include any on-going studies. For example, if a lab currently has 100 animals on study while the de novo is under review, and the lab plans to use an additional 1,000 animals during the next three-year approval period, then the laboratory should ensure that the protocol has 1,100 animals justified on the de novo submission. Please see our de novo guide and/or reach out to the IACUC Office for assistance with your de novo submission.

Scenario Five:

Dr. A. Nonymouse was previously approved to bring mice to his laboratory space in Building A. However, the University received a grant to upgrade the research areas, causing Dr. Nonymouse to move his laboratory space to Building B. Does IACUC approval for animal use automatically transfer to the new building?

Learner Feedback: No. OLAW FAQ E1 indicates that the IACUC is responsible for oversight of all animal study-related activities regardless of how long or where the activity occurs. Inspection must occur prior to use of the space and subsequently semi-annually. Even though a laboratory may have been previously approved to utilize a space in one building, IACUC approval would not automatically transfer to an equivalent space in a different building. A change in laboratory location amendment must be submitted and approved prior to use for each applicable protocol.

Scenario Six:

Dr. A. Nonymouse recently received approval for a new procedure that allows the lab to either shave or use a chemical depilatory agent to remove the hair on their mice prior to conducting the rest of the procedure. When using a chemical depilatory agent, how long should the substance remain on the animal's skin to be effective and safe for the animal?

A. 5 minutes

B. They do not need to remove the depilatory agent - it is not harmful

C. 15-30 seconds

D. 2 minutes

Learner Feedback: 15-30 seconds. Chemical depilatory agents can harm an animal's skin if left on for an extended contact time. Per the Guidelines on the Use of Chemical Depilatory Agents: Apply a thin, solid layer of the agent to the desired area using a gloved finger or a cotton swab, allowing a contact time of 15-30 seconds (do not leave animals unattended during this time). Once the contact time has been reached, wipe the area with a clean cotton swab/gauze with warm water until all the agent has been removed. These steps may be repeated one additional time if subsequent hair removal is required. For more information, please refer to the aforementioned guideline on the CCM website (Resources/SOPs/Veterinary Services/Rodents).

Scenario Seven:

Dr. A. Nonymouse conducts survival surgeries on rodents and will often complete five surgeries in one day. How should Dr. Nonymouse prepare their surgical instruments for the day?

A. Autoclave separate instrument packs for each animal.

B. Autoclave one instrument pack to be used for all animals - re-sterilization of instruments is not required for animals from the same cage.

C. Autoclave one instrument pack to be used for all animals, re-sterilizing with a hot bead sterilizer between animals and utilizing tips-only technique.

D. A hot bead sterilizer may be used as the sole means to sterilize the instruments.

E. Both A and C.

Learner Feedback: Both A and C are correct. Per the Guidelines for Rodent Survival Surgery, it is acceptable to utilize a new sterile instrument pack for each animal; alternatively, tips-only technique may be used for subsequent animals, but instrument tips must be sterilized between animals using hot bead sterilization or a chemical sterilant. All chemicals must be rinsed from instruments with sterile water or saline before contacting animals. B is incorrect as all rodent survival surgeries must be performed using aseptic technique, but as stated in answer C, a hot bead sterilizer may be used in between animals for a tips-only technique approach for multiple animals. D is incorrect - a hot bead sterilizer may not be used as the sole means to sterilize instruments. All rodent surgeries must start with fully sterilized instruments, through means such as an autoclave or a chemical sterilant (e.g., ethylene oxide) for materials that cannot withstand dry heat sterilization per the Guidelines for Sterilization of Surgical Supplies.

Scenario Eight:

Dr. A. Nonymouse is onboarding new staff members and training them in new procedures. A new staff member would like to use their cell phone to record the procedure for reference. What should Dr. Nonymouse consider regarding the recording of animals used in research?

A. Videos and photographs must be produced with attention to professional conduct and concern for animal welfare.

B. Videos and photos should contain only the area of research interest.

C. Never store the audiovisual recordings on an unsecured cloud or social media account.

D. Advanced notification to IACUC Office and CCM is required if visual and/or audio will be presented outside of NU; this activity must be approved by the IACUC Office in consultation with CCM.

E. All of the above.

Learner Feedback: Answer E is correct! Photographs, videos, or other digital media must be taken with attention to professional conduct and concern for animal welfare. Audiovisual recordings of animals or animal research should not be automatically directed or posted to an external site (e.g., the Cloud, social media accounts) as they can be used out of context by those who oppose working with animals in biomedical research. More detail can be found in the IACUC Policy on Photography and Videotaping Animals or Vivarium, which applies to anyone accessing CCM, satellites, laboratory spaces, or any other space in which research animals are used. Dr. Nonymouse could request a Post-Approval Monitoring education event for his lab members to learn more!

Scenario Nine:

Dr. A. Nonymouse is onboarding new staff to maintain their breeding colony. The new staff members have been asked to setup harem breeding as approved in their animal study protocol. How many animals are permitted to be in the cage during the harem breeding scheme?

Two males, two females, and 20 pups.
One male and more than two females.
One male and more than two females, one of which is visibly pregnant.
One male and six females.

Learner Feedback: Answer #2 is correct, if there are no more than five animals in a ventilated cage or no more than four animals greater than 25 grams in a static cage. #1 is incorrect as multiple males in a breeding cage can lead to aggression. Additionally, if the total number of pups exceeds 16, one female and litter must be removed to a separate cage when the older litter is 10 days of age. #3 is incorrect because harem breeding requires the separation of a visibly pregnant female - they must be separated until a trio breeding density is reached in the original cage. #4 is incorrect since the total number of mice exceeds the maximum density allowed in one cage. For more information on mouse breeding and housing density, please see the Mouse Breeding and Housing Density Policy. For density information for other rodent species, please refer to the CCM Rodent Housing Density SOP and overcrowding flowchart found on the CCM website's Resources page under SOPs -> Rodents.

Scenario Ten:

Dr. A. Nonymouse conducts survival surgeries on multiple cohorts of animals at a time. During his procedure he starts with an autoclaved pouch of instruments and then moves to tips only technique to maintain sterility. After completion of the procedure, it is time for him to suture the animal. How should Dr. Nonymouse handle the suture material?

A. Reuse the same suture material on multiple animals to save on supply cost.
B. Use a new pouch of suture material for each animal.
C. Reuse the same suture material on multiple animals but clean the suture material with alcohol in between animals.
D. Use a sterile suture needle for each animal and thread sterilized suture material from a spool onto the needle to control the suture tail length.
E. Both B and D.

Learner Feedback: It’s E, as both B and D are correct. Per the Guidelines for Rodent Survival Surgery, instruments must be handled in such a manner that they remain sterile. A and C are incorrect as using cost as a justification is not an appropriate reason why aseptic technique is not followed. Additionally, suture material is not appropriately re-sterilized when in contact with alcohol as bacteria from the previous animal has been picked up when the suture tail passes through the animal. Placing the suture in alcohol will not return the suture material to its initial sterilized state post packaging.

Scenario Eleven:

Dr. W. Ildcat has a rodent animal model that will develop an ambulatory restriction in their hind legs that will last the duration of the study (up to 60 days). Due to this expected health outcome, Dr. Ildcat provides long term supplemental feed on the cage floor when the outcome is observed for the duration of the study. What does Dr. Ildcat need to do to implement this?

A. No justification is required in the protocol. Start the Feed and Fluid Log and cage side documentation within the vivarium. Administer supplemental food within a container. Clean/replace container and provisions twice weekly.

B. Submit an amendment to include justification for the supplemental feed within the protocol. Once approved, implement the Feed and Fluid Log and cage side documentation within the vivarium. Administer supplemental food within a container. Clean/replace container and provisions twice weekly.

C. Submit an amendment to include justification for the supplemental feed within the protocol. Once approved, implement the Feed and Fluid Log and cage side documentation within the vivarium. Administer supplemental food within a container. CCM will change/clean the container and feed the animals for us.

D. Submit an amendment to include justification for the supplemental feed within the protocol. Provide supplemental feed on the cage floor and clean twice a year.

Learner Feedback: The correct answer is response B. Per the Policy on Feeding Rodents from Cage Floor: "Rodents may be fed from the cage floor if scientifically justified, such as when the rodents have been experimentally manipulated or due to expected health conditions that make it difficult or impossible to access food provided in the wire bar lid. The justification for this practice and the description of this feeding procedure must be included and approved in the animal study protocol.” This specifically applies to “rodents requiring long-term feeding from the cage floor (i.e., greater than one week), or those that are given powdered or moist/liquid diets must have food provided in a container. The containers must be replaced or sanitized at least twice weekly. Fresh food must also be provided at least twice weekly.” The twice weekly container sanitization and provision of fresh food is documented on the feed and fluid log, and each cage is identified with a blue special husbandry card. Answers A is incorrect, as the Policy requires justification in the animal study protocol. C is incorrect as the PI and the PI’s laboratory are responsible for providing a sanitized container and fresh feed at least twice weekly. D is incorrect supplemental feed on the cage floor must be in a container and must be sanitized at least twice weekly. The CCM Feed and Fluid Log and blue special husbandry card information can be found on the CCM Website under resources, Forms or Standard Operating Procedure (SOPs) - Animal Care, respectively.

Scenario Twelve:

Dr. A Nonymouse is new to Northwestern and is starting up their lab with a small team of research assistants and post-doctoral fellows. Some lab members come with previous animal experience, and some lab members are completely new to animal work. The PI has an approved animal study protocol and everyone has been added as personnel having completed Occupation Health and Safety Enrollment, as well as all the required AALAS Learning Library Courses for basic mouse work. What steps should the PI take to ensure lab members are trained on procedures they are assigned to in the protocol?

A. Nothing, the lab members can figure it out with a little guidance.

B. Engage the CCM training office for basic procedure training.

C. An experienced lab member may provide on the job training in specific laboratory procedures personnel are assigned to on an approved protocol. On-the-job training must be documented on an in-lab training record.

D. Both B and C.

Learner Feedback: Answer D, both B and C are correct! Per the Laboratory Personnel (In-Lab) Training Record SOP, “The Guide for the Care and Use of Laboratory Animals states that all personnel involved with the care and use of animals must be adequately educated, trained, and/or qualified in basic principles of laboratory animal science to help ensure high-quality science and animal wellbeing. The Guide also stipulates that the IACUC is responsible for providing oversight and for evaluating the effectiveness of the training program. In addition, the U.S. Government Principle VIII states that investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. The Laboratory Personnel (In-Lab) Training Record Form serves to capture animal-related procedure training provided by the Principal Investigator (PI) or designee that is not captured by CCM or the AALAS Learning Library.” Engaging the CCM Training Office for procedure training is an excellent resource and training provided by CCM is captured in myHR and eIACUC and does not need to be double documented in the in-lab training form. Lab members receiving training from experienced personnel must document their training and competency on an in-lab training form. Personnel that come to Northwestern with previous experience on a specific procedure must complete the in-lab training document after having performed the procedure with limited supervision and complete the “performed with limited supervision” column and “justification for accelerated training” section. All lab members must have an in-lab training form with the top section completed indicating that they know where a copy of The Guide for the Care and Use of Laboratory Animals is located, as well as they have read and understood all the protocols on which they have been approved to conduct work on. In-lab training records are reviewed during semi-annual inspections, Post-Approval Monitoring visits, and at the request of the IACUC or regulatory bodies. Answer A is incorrect as it is not appropriate to conduct animal procedures without proper training.

Scenario Thirteen:

Dr. W. Ildcat is creating an administration of substance procedure for an upcoming vector injection on rodent models. Dr. Ildcat wants to add the option of anesthesia in the event awake manual restraint techniques does not go as planned. However, this procedure type does not allow the lab to embed an anesthetic regimen. What is the best method for Dr. Ildcat to implement the anesthetic regimen?

A. Provide detailed instructions regarding anesthetic drugs the lab may use within the procedure and “Additional Substances” table.

B. Create a separate anesthetic regimen procedure.

Learner Feedback. Answer B is correct. The anesthetic regimen procedure type includes required fields to ensure animals are monitored and fully recovered from anesthesia. However, in eIACUC some procedures have a place to insert a full anesthetic regimen (e.g., surgeries) and some do not (e.g., administration of substances). For procedures that do not allow for the insertion of the full anesthetic regimen procedure, one must be added to the 1.0 Procedures section of the experimental group. Approved Animal Procedures (AAPs) are an exception to this rule, and their individual instructions must be followed for use. Answer A is incorrect because the administration of substances procedure type does not include a place to embed the anesthetic regimen procedure.

Scenario Fourteen:

Dr. W. Ildcat and staff are performing a routine surgical procedure. They verify the procedure is approved in their protocol, all members have been appropriately trained and set up their space following aseptic technique. During the procedure a member of the lab notices the animal's vitals appear abnormal and the animal starts to decline. The lab member alerts the fellow staff of the abnormality, but intervention does not appear to be working. How should the laboratory proceed in this scenario?

A. Call a member of the veterinary staff via the emergency contact phone number

B. Continue to try and stabilize the patient

C. Do nothing, the patient will stabilize on their own

D. Both A and B are correct

Learner Feedback: The correct answer is D, call a member of the veterinary staff via the emergency contact phone number and continue to try and stabilize the patient.

Scenario Fifteen:

Dr. A. Nonymouse manages a large breeding colony of mice and several breeders are no longer producing litters and are ready to retire. How many animals may Dr. Nonymouse euthanize with CO2 at one time?

A. Dr. Nonymouse may combine compatible animals into one cage as long as they are able to make normal postural movements.

B. Dr. Nonymouse may combine as many animals without regard to compatibility into a cage as he can fit to save time.

Learner Feedback: The correct answer is A. Ideally, animals will be euthanized in their home cage. However, the IACUC Euthanasia Policy indicates that incompatible animals and species are not to be combined and follow the CCM SOP Carbon Dioxide Euthanasia-Rodents. Although a specific number of animals per cage/chamber is not listed, the following must be considered:

Euthanize rodents in their home cage or place animals with other compatible animals to minimize stress.
Provide sufficient floor space so that the rodents can make normal postural adjustments.
Multiple layers of animals are not permitted.
Do not mix species (e.g. mice and rats) or incompatible animals (e.g. adult males from multiple cages) in the same cage/chamber.

Answer B is incorrect as saving time is not a justification to combine animals without consideration of the above points. Adult males from different cages are prone to fighting, while combining too many animals into one cage can prevent normal postural movements, adding stress to the procedure. CO2 euthanasia must be followed by a secondary method of euthanasia such as cervical dislocation. Please review your protocol on what methods of euthanasia are approved. If you have questions about the euthanasia process, please reach out to CCM for additional information and training.

From the CCM Contacts Page: If emergency involves an Animal Health problem please provide: Animal species, Animal identification number (cage card if rodent) and the principal investigator's name.

Scenario Sixteen:

Dr. W. Ildcat has a time point that unfortunately fell on a summer day where the temperature is 100°F+ with a real feel heat index of 115°F. Dr. Idlcat has decided to wear shorts and sandals to work. What must Dr. Idlcat do prior to entering the CCM facility to check on their animals?

A. Nothing. It’s too hot to wear anything else.

B. Change into pants and closed toed shoes. Don additional PPE based on the specific area of CCM being entered.

Learner Feedback: The correct answer is B. Per the CCM SOP: Personal Protective Equipment: Long pants and closed-toe shoes must be worn inside CCM animal facilities; Personnel working with laboratory animals must always wear required PPE; Comply with any additional PPE requirements posted on animal holding room (AHR) doors, procedure rooms (PR), cages or corridors .

Additionally, the Research Safety Laboratory Safety and Chemical Hygiene plan includes: “Cover unprotected skin whenever possible. Suitable clothing shall be worn in the laboratory space; shorts are not appropriate...Wear substantial closed-toed shoes in the laboratory space to protect against chemical splashes or broken glass. Do not wear sandals, cloth sport shoes, perforated shoes, or open-toed shoes.” (5.3.1 Clothing). Dr. Idlcat must either change into pants or borrow scrubs from CCM and change into closed-toed shoes prior to entering the facility and follow appropriate PPE requirement for the specific area of the CCM facility they are visiting.

Scenario Seventeen:

Dr. A. Nonymouse is currently studying an inflammation model. They are interested in expanding their research to encompass aging animals, moving their sequence and timing from several weeks to a range of several months to over a year. The current approved protocol does not list animals may be aged for several months to over a year in any of their experimental groups. Can Dr. Nonymouse move forward with aging the animals for several months to over a year without submitting an amendment?

A. Yes

B. No

Learner Feedback: The correct answer is B. No. A change to the experimental sequence and timing would require an amendment submission and approval prior to moving forward with the new timeline for the animals on study. For aging models, it is also recommended to create a supportive care procedure. As a note, several age-related diseases including arthritis, osteoporosis or cognitive decline may be observed in aging animals. Models that provide medical challenges should include colony management, close observation and supportive care to ensure optimal animal health as animals age. Mice over the age of 1 year are considered to be aged and can be affected by normal progressive impairments and health conditions. Some conditions commonly observed in an aged colony include dermatitis, increased weight gain or loss, unkept fur, slightly hunched stance, decreased body temperature and mild difficulty ambulating. If any clinical condition is observed, please contact the CCM veterinary staff for animal evaluation.

Scenario Eighteen:

Dr. A. Nonymouse is collaborating with some researchers that work at a different institution on a rodent study. The researchers plan to come visit Northwestern to observe some of the procedures being conducted by Dr. Nonymouse and their lab. What will the visiting researcher need to do in order to visit the areas where animal work occurs?

A. Each visiting researcher will need to stop by the CCM Training Office to let them know they are here for a visit, review the IACUC – Vivarium Visitor Policy, will not handle animals while visiting Northwestern, and ensure they are always accompanied by Dr. Nonymouse.

B. Each visiting researcher will need to submit a CCM Hazard Information and Visitor Declaration of Compliance Forms 24 hours before the date of visitation, review the IACUC – Vivarium Visitor Policy, will not handle animals while visiting Northwestern, and ensure they are always accompanied by Dr. Nonymouse.

C. Each visiting researcher will need to submit a Visitor Hazard and Declaration of Compliance Form before the date of visitation and review the IACUC – Vivarium Visitor Policy. Once those have been completed, they can handle animals while visiting Northwestern if they are accompanied by Dr. Nonymouse.

Learner Feedback: The correct answer is B. All visitor requests must be submitted to the CCM Quality and Training Office 24 hours before the date of visitation. The signed CCM Hazard Information and Visitor Declaration of Compliance Forms may be submitted beforehand by email or brought to the CCM office. Additionally, all visitors and volunteers are required to complete the Risk Management Visitor and Volunteer Lab Agreement and submit the signed agreement to risk@northwestern.edu. Depending on the species and the purpose of the visit, documentation of one or more test results may be required. Visitors must always be accompanied and directly supervised by the Principal Investigator, Executive Director or their designee and must abide by all personal protective equipment guidelines and animal facility rules and regulations. If designees other than the Executive Director or Principal Investigator will be serving as a visitor guide, they must sign and print their name under the “Name of Guide” portion of the Visitor Hazard Form. Please also note that visitors are not permitted to handle animals, take photographs or video/audio recordings while in the animal facility. For more information, please see the IACUC Vivarium Visitor Policy and the CCM Hazard Information and Visitor Declaration of Compliance Forms.

Scenario Nineteen:

Dr. A Nonymouse has a murine subcutaneous tumor study at 60 days post injection that has been getting flagged with health reports requiring the labs to assess their animals for humane endpoints. The protocol indicates that the animals will be kept on study for up to 90 days, but the monitoring description indicates animals will be removed from study if one of the following criteria are met: tumor size greater than 2.0 cm, tumor ulceration diameter greater than ~5.0 mm, animals with a body condition score less than 2 or animals that are unable to ambulate, groom properly, or are otherwise showing signs of pain or distress. How do the PI and laboratory staff address the health reports?

A. Keep the animals on study for another 30 days

B. Assess the animals for humane endpoints and remove animals from study if they meet any one of the humane endpoint criteria

Learner Feedback: The correct answer is B. Animal Study Protocols must consider not only experimental endpoints, but also humane endpoints. Experimental endpoints are the desired point at which all data are collected, the aims of an experimental study have been achieved, and the study is concluded. While humane endpoints are the earliest scientifically justified point at which the level of pain or distress in an experimental animal must be alleviated. In this scenario, answer A is incorrect because even though the protocol is approved to have an animal on study for up to 90 days, once an animal has reached the humane endpoint(s) described in the animal study protocol, it must be removed from study to alleviate its pain and distress. As a reminder, if you are unsure if your animals have reached a humane endpoint, please contact the CCM Veterinary team to evaluate the animal. Please review the new IACUC Guideline: Humane Endpoint Criteria for Rodent Tumor Studies for more information applicable to this scenario. Additionally, the cages must include rodent medical records (pink cards) that include a general description of the non-surgical experimentally induced health condition. With tumor studies, it is helpful for that description to include the experimental and humane endpoints as described in your protocol to assist with CCM’s evaluation of animal health as to what is experimentally expected. Please see the Policy on Medical Records for Rodents for more information. In this scenario an Avery label could be created that includes: SC flank tumor injection of ____cells. Exp endpoint: up to 90 days, Humane endpoints: tumor > 2.0 cm, ulcer diameter >5.0 mm, BCS< 2, failure to ambulate, groom properly, in pain or distress. The PAM team would be happy to assist with creating label templates to streamline cage side documentation.

Scenario Twenty:

Dr. O. Strich is starting a recently approved behavioral experiment to implement controlled water deprivation. This technique, when used in the past, has motivated mice to perform assigned behavioral tasks when receiving water rewards. The lab would like to restrict access to an ad libitum water rack in the animal housing room for this cohort. The lab has informed CCM of the need for a rack not attached to a water source so that the lab may control access to water for mice after experimental procedures.

What else does the lab need to do, to maintain this water restriction according to the IACUC Policy Fasted Animals and Animals on Special or Restricted Diets or Fluids?

A. Nothing, once CCM provides the special housing rack the lab can continue their research.

B. The lab needs to fill out a special husbandry cage card, monthly feed/fluid log and document cage checks on log once every 24 hours.

C. The lab needs to fill out a feed and fluid log and log daily cage checks on a Pink Card.

D. The lab needs to fill out a special husbandry cage card, monthly feed/fluid log and document cage checks when they feel like checking.

Learner Feedback: The correct answer is “B.” If your lab implements IACUC approved water restriction within your animal colony, it is crucial to fill out a special husbandry cage card (provided in animal housing room by CCM) and document cage checks via the feed and fluid log every 24 hours, regardless of when water is supplied to the animals. Per the Monthly Feed/Fluid Log: If cages are found with insufficient levels of special diets or fluids, or restricted or fasted animals were not checked within the last 24 hours, CCM will attempt to contact research personnel listed on the monthly log. If logs are not maintained by the lab to ensure daily cage checks are performed and adequate specialized feed/water are provided to animal CCM will provide standard diet and RO water appropriate for the species.

While the CCM husbandry staff provides daily care and oversight to the research animals, it is ultimately the lab's responsibility to assess the daily cage side status of animals on restricted diets or fluids.

You can access and download the Monthly Feed/Fluid Log and follow the Instructions for Special or Restricted Diet and Fluid Log, along with other relevant SOPs regarding special diets.

Scenario Twenty-One:

Dr. A Nonymouse wants to add retro-orbital bleeds to their mouse protocol. Dr. Nonymouse is eager to begin conducting the procedure as soon as possible. Dr. Nonymouse was thrilled to see that there is an approved animal procedure (AAP) that outlines Retro-orbital Bleeds for Mice. What are the steps they must complete prior to initiating this procedure on the animals on their protocol?

A. Prior to conducting the procedure, Dr. Nonymouse must submit an amendment to add the AAP to their protocol. Once they have submitted the amendment, they can begin completing the procedure.

B. Nothing. The AAP is an approved animal procedure so no further steps are required.

C. Prior to conducting the procedure, Dr. Nonymouse must submit an amendment to add the AAP to their protocol. To add the AAP to the protocol, they must complete the Protocol Instructions outlined on the AAP. Dr. Nonymouse must wait until the amendment is approved by the Committee prior to initiating these procedures.

Learner Feedback: The correct answer is C. AAPs are standard procedures reviewed by the IACUC with specific protocol instructions to minimize data entry and streamline protocol review for laboratories wishing to utilize AAPs. Although an AAP is a standard procedure reviewed and approved by the IACUC, it cannot be performed until it is reviewed and approved in context of the protocol to which the animals are assigned. Therefore, A and B are incorrect as they have not been approved within the protocol the laboratory is intending to use. Prior to conducting the procedure, Dr. Nonymouse must submit an amendment to add the AAP to their protocol by following the Protocol Instructions outlined on the AAP and await approval. Please note that each AAP specifies where and how it should be cited in your Approved Animal Study Protocol (ASP). Once the amendment is approved, the procedure has been added to the protocol and can now be conducted. Ensure to document training and competency in your in-lab training by a senior or experienced lab member in the procedure to be performed. Some AAPs have specific training requirements, please ensure to review and adhere to those requirements. Please visit the AAP website to see what procedures are available that could be utilized for your research, minimizing the data entry required in the protocol.

Scenario Twenty-Two:

Dr. Wildcat is starting two new experimental procedures recently approved within their animal study protocol (ASP). The lab is performing a minor survival surgery procedure (tumor implantation) and a non-surgical procedure (IP injection) on two mouse cohorts. What cage-side level documentation is required once the respective procedures are done on both cohorts?

Nothing, all information may be kept within lab notebooks.
The surgical procedure would need to be documented via Pink Card, maintained at cage-side level, and must include information regarding analgesics administration and supportive care. At a minimum this should include the drug name, date, time, dose, and route.
Both the surgical and non-surgical experimental procedures must be documented via the Pink Card and maintained at cage-side level. Including information regarding analgesics administration and supportive care. At a minimum this should include the drug name, date, time, dose, and route.

Learner Feedback: The correct answer is 2. Per The Guide for the Care and Use of Laboratory Animals (The Guide) ,“Medical records are a key element of the veterinary care program and are considered critical for documenting animal well-being as well as tracking animal care and use at a facility.” The Policy on Medical Records for Rodents specifies that surgical procedures must be documented on an Investigator Rodent Health Record (“Pink Card”) and maintained at the cage level by research personnel. Surgery type, Analgesia, and Post-Operative Care must be documented on the Pink Card and maintained at the cage level by research personnel. At minimum analgesic administration should include the drug name, date, time, dose, and route. Information regarding non-surgical experiments that do not induce health conditions or disease models may be kept solely in laboratory notebooks unless otherwise required by your specific protocol. Please note that laboratory documents may be requested for review by various regulatory agencies, IACUC members, and/or CCM personnel.

Scenario Twenty-Three:

Dr. Wildcat is working with a new genetically modified mouse line. The lab has noticed when mice from this line are startled or stressed seizure activity ensues. Upon looking at the vendor description of the line, seizures are noted as a rare phenotypical expression. What course of action must the Wildcat lab take?

Nothing, the mice are fine.
A general description of the expected phenotype must be documented via the Pink Card and maintained at the cage-side level and the Animal Study Protocol (ASP) updated to reflect the expected phenotypical expression and supportive care plan (if applicable).
Treatment and/or supportive care details must be captured via the Pink Card and maintained at the cage-side level.

Learner Feedback: The correct answer is “2.” Per The Guide for the Care and Use of Laboratory Animals (The Guide), “Medical records are a key element of the veterinary care program and are considered critical for documenting animal well-being as well as tracking animal care and use at a facility.” The Policy on Medical Records for Rodents specifies that non-surgical experimentally induced health conditions or disease models (i.e., conditions caused by experimental manipulation) that are expected must have a general description of the model identified on an Investigator Rodent Health Record (“Pink Card”) at the cage level by research personnel.

Examples of non-surgical experimentally induced health conditions or disease models include rectal prolapse, induction of hind limb paralysis, and genetically engineered models needing chronic treatment or supportive care. Lab personnel must follow the care and monitoring described in the approved ASP and should maintain clinical care monitoring for non-surgical experimentally induced diseases in lab notes or via Pink Card. Answer “C” is only incorrect if your Animal Study Protocol (ASP) does not include that additional animal documentation will be maintained at the cage-side level via Pink Card. Refer to your ASP for documentation guidance. Please note that laboratory documents may be requested for review by various regulatory agencies, IACUC members, and/or CCM personnel.

Scenario Twenty-Four:

Dr. A. Nonymouse is training new laboratory members on their protocols and managing a mouse colony. Technician N. Ewbie notices that a couple cages have singly housed mice, the lab member is confused because he recalls from his AALAS Learning Library training, that mice should be socially housed whenever possible. What are reasons that animals could be singly housed?

A. Social incompatibility

B. Last animal remaining in a cage

C. Experimental reasons justified in the animal study protocol

D. All of the above

Learner Feedback: The correct answer is D. All of the above. As stated in the Animal Enrichment and Social Housing Policy, animals “social animals should be housed in stable pairs or groups of compatible individuals unless they must be housed alone for experimental reasons or because of social incompatibility (The Guide).” If animals are incompatible (fighting, single animal of a sex from a natal group at weaning) or the last remaining in a cage (e.g. cage mates removed for study or humane endpoints). If an experiment requires single housing by design, that must be justified and approved in the animal study protocol on the animal care exceptions page.

Dr. Nonymouse explains to N. Ewbie that the two cages that are singly housed were separated due to fighting, and provided the lab member CCM Rodent Standard of Care Fight Wounds fact sheet and reviewed the information to assist in their training.

Scenario Twenty-Five:

Dr. Tox is submitting a new experimental procedure for IACUC review that involves the administration of tamoxifen via oral (gavage) route. What cage-side level documentation is required once the procedure is approved within the animal study protocol (ASP)?

A. Nothing, all information relating to tamoxifen administration may be kept within lab notebooks.

B. Special Husbandry (Blue Card) must be maintained at the cage-side level and include applicable information regarding the route of administration, start and end dates for tamoxifen usage, and dose information documented on the Monthly Feed and Fluid Log (for Investigator Maintained Animals).

C. Treatment with Special Husbandry (Fuchsia Card) must be maintained at the cage-side level and include applicable information regarding the route of administration, start and end dates for tamoxifen usage, and dose information. The card must be removed after study animals have received the last administration of tamoxifen.

Learner Feedback: The correct answer is “C”. All lab personnel who still need to complete ALL training “Safely Working With Tamoxifen and its Metabolites” should have received a reminder email. Please ensure to complete this training by September 30th, 2024. It focuses on administration methods, collection/disposal of hazardous waste, required documentation, handling of rodents, contact bedding, caging, and equipment exposed to tamoxifen.

"Treatment with Special Handling" (Fuchsia Card) must be used to document tamoxifen or other agents that require special handling. The lab must place the card cage-side at

the initiation of treatment and remove it after the study animals have received the last dose of tamoxifen.

The "Monthly Feed and Fluid Log (for Investigator Maintained Animals)" should not be utilized for oral (gavage) administration of tamoxifen as this route does not utilize a special diet or fluids. Please ensure lab personnel has reviewed ALL training “WORKING WITH THE LABORATORY MOUSE” section on the oral (gavage) route before administration. If lab personnel has questions regarding administration and physical restraint methods the CCM Training Office.

Please note that laboratory documents may be requested for review by various regulatory agencies, IACUC members, and/or CCM personnel. Tamoxifen has cytotoxic and mutagenic properties, is strongly teratogenic, and therefore is a potential human carcinogen. Please report all emergencies, injuries, or spills to Research Safety.

Scenario Twenty-Six:

Dr. Tox is submitting a new experimental procedure for IACUC review that involves administration of tamoxifen via oral (feed/drinking water) route. What cage-side level documentation is required once the procedure is approved within the animal study protocol (ASP)?

A. Nothing, all information relating to Tamoxifen administration may be kept within lab notebooks.

B. Treatment with Special Husbandry (Fuchsia Card) documentation must be maintained at the cage-side level and include applicable information regarding the route of administration, start and end dates for tamoxifen usage, and dose information. A corresponding Monthly Feed and Fluid Log is to be maintained at the room level.

C. Special Husbandry (Blue Card) must be maintained at the cage-side level and include applicable information regarding the route of administration, start and end dates for tamoxifen usage.

Learner Feedback: The correct answer is “B”. All lab personnel who still need to complete ALL training “Safely Working With Tamoxifen and its Metabolites” should have received a reminder email. Please ensure to complete this training by September 30th, 2024. It focuses on administration methods, collection/disposal of hazardous waste, required documentation, handling of rodents, contact bedding, caging, and equipment exposed to tamoxifen.

"Treatment with Special Handling" (Fuchsia Card) has now replaced the Special Husbandry (Blue Card) for documentation of tamoxifen or other agents that require special handling. The lab must place the card cage-side at the initiation of treatment and remove it after the study animals have received the last administration of Tamoxifen. The "Monthly Feed and Fluid Log (for Investigator Maintained Animals)" must be utilized for oral (feed/drinking water) administration of Tamoxifen as this route does require specialized diet or fluids.