Record Management in Animal Research

Why Keep Records?

• Federal laws and regulations require documentation of the care and treatment of laboratory animals.
• University policies require certain records to be maintained and available for review by veterinary staff and IACUC oversight.
• Research accuracy and integrity may be impacted by incomplete or careless record keeping.
• Good animal welfare is dependent on the timely and accurate care and treatment of laboratory animals to minimize pain and distress.

• Individual records are required for non-rodent animals; group records may be used for rodents.
• Breeding colony
• Anesthesia/Analgesia
• Surgery/Post-procedural records
• Food/Water restriction protocols
• Neoplasia
• Controlled drugs

Record Retention and Availability

Most medical and animal procedural records should be kept for the duration of the research activity and for an additional 3 years. Medical and surgical records must be maintained in or near the animal room readily available for inspection by veterinary staff and IACUC oversight.

Breeding Colony Records

Rodent breeding colonies require accurate record keeping to maintain genetic integrity and reduce wasteful over- or under-breeding. The types of records needed for breeding colonies can include cage cards, computerized or paper record keeping systems and weaning records.

Cage cards should include the following information:

Breeding cage card example

• Dam and sire IDs/ birthdates/genotype               
• Date paired/set up                         
• Cage ID number
• IACUC #
• Pup birth dates
• Disposition of litter (wean/died)

In addition to cage cards, a centralized record keeping system should be used to keep track of mating pair set-ups and breeding outcomes. Various types of colony management systems exist including commercial products, free databases and templates, or you can create your own.

Information to be included in centralized breeding records:

• Dam and sire IDs/ birthdates/genotype(s)         
• Date paired/set up                         
• Date of birth/number of pups
• Disposition of litter (wean/died)                                                              
• Pedigree
• Tracking number
• Vendor or stock number
• Disposition
• Breeding/Performance history
• Noted Problems
• Breeding system used

Weaning Records

A record of the number of pups weaned in the colony should be maintained for both experimental and IACUC purposes. In addition, weaning records should indicate the following:

• Pup ID
• Date of birth
• Strain/Genotype information
• Dam and sire IDs                            
• Designated use of pup (e.g., experimental, breeding, euthanasia)

Genotyping of mice typically uses tail tip or ear punch tissue samples although other tissue samples may be acceptable. DNA yield from tail tissue has been shown to be highest in 10-21 day old rodents. More information on rodent genotyping maybe found athttps://www.research.psu.edu/arp/husbandry-breeding/rodent-genotyping.html.

Please note, for rodent genotyping at PSU:

• Pups less than 3.5 weeks of age - No general anesthesia required.
• Pups greater than 3.5 weeks of age – General anesthesia required.
• Not more than 5 mm of tail tissue should be collected and bleeding must be controlled.

Anesthesia/Analgesia/Surgical Records

Investigators are responsible for maintaining accurate records of anesthesia, surgery and postoperative care (including analgesic administration). Records serve as documentation that the procedures were conducted humanely and by appropriately trained individuals. Individual records are not necessary for groups of rodents treated similarly.  Records should be kept in the animal room or an accessible area nearby and will be examined by the IACUC every 6 months. Records of anesthesia/analgesia and peri-procedural care document adequate veterinary care and the alleviation of pain and distress during the conduct of these procedures.

• Physiological monitoring of an animal during general anesthesia is required and must continue until the animal is returned to its home cage.
• Anesthetic or analgesic drug treatments should be recorded so that a total dose is recorded or can be calculated (e.g., total mg or a volume plus a concentration).
• Anesthetic and analgesic administration records may be included within the surgical record.
• An external heat source such as a warm, water circulating pad should be used to maintain animal body temperature during anesthesia.

Information to Include on Surgical Records

Sample templates for surgical and post-operative monitoring records are available at https://www.research.psu.edu/arp/surgery/record-keeping.html. Surgical records must include the following information:

• Date of surgery
• Name of surgeon
• Animal identification i.e., number or group name
• A description of the surgical procedure*
• Name(s), dosage(s) and route(s) of anesthetic and analgesic drugs administered
• Names and dosages of experimental agents administered
• Post-operative monitoring that clearly documents daily observation and health status for seven days or under the surgical wound is healed and complications resolved
• Medical treatments administered during or after surgery

*Surgical records should be kept in a notebook. It is strongly recommended that a detailed description of each surgical procedure be kept in the front of the notebook. Rather than rewriting the surgical description on each record, provide the name of the procedure that corresponds to the description provided in the front of the notebook. Also record any deviation from the detailed description.

Post-operative/procedural monitoring

Animals recovering from general anesthesia must be monitored continuously until able to right themselves (i.e., sternal recumbency) as shown in this photo. In addition, animals must be observed and evaluated at least once a day for seven days or until the surgical wound is healed and complications resolved.
Post-operative monitoring records must be kept accessible in the animal room and will be examined every 6 months by the IACUC.

Controlled Drug Records

Certain drugs used for anesthesia, analgesia, and euthanasia are regulated by the DEA (Drug Enforcement Administration) because of the potential for abuse.  Investigators using these drugs are responsible for complying with applicable regulations including storage in a substantial locked cabinet or safe and maintenance of written records accounting for quantities received and dispensed. Investigators who will be using controlled drugs must apply to the DEA for the appropriate license. Controlled drug records will be examined by the IACUC every 6 months.

Food and Water Restriction Protocols

Food and/or fluid restriction that deviates from normal husbandry care must be described in the IACUC proposal. Records for protocols in which an animals access to food and/or water is limited should include the following information:

• The approved restriction schedule
• The time/date and amount, if applicable, of latest feeding/watering
• Documentation that approved monitoring was conducted
• Contact information for responsible personnel (including phone)

In addition, cages should be clearly marked so animal caretakers and veterinary staff can identify which animals are included in the restriction protocol.

Experimental Neoplasia Protocols

Animals who are expected to develop internal or external tumors/neoplasia must be monitored as described in an approved IACUC protocol.  Humane endpoints used to prevent unnecessary animal suffering due to tumor growth must be described in the IACUC protocol. Monitoring records should be kept within the housing room until the death of the animal. Records must contain the following information:

• IACUC protocol number.
• Identification of the animals.
• Dates of monitoring.
• Tumor size, body weights, body condition scoring or other parameters used to evaluate the animals condition.
• Name of person(s) monitoring the animals.

Humane Endpoints

Humane endpoints are predetermined physiological or behavioral signs that define the point at which an experimental animals pain and/or

distress is ended or reduced by taking actions such as euthanizing the animal, terminating a painful

Endpoints: Death and Moribundity While certain types of studies have historically used death of the animal as an experimental endpoint, this is now rarely accepted and investigators must present conclusive evidence to support the use of death as an endpoint. The term moribund refers to an animal that is near death or in the process of dying. Animals in this state are often unresponsive and unaware of stimuli and so beyond awareness of suffering. However, an animal may have experienced much pain and distress prior to reaching a moribund state. Stating that animals will be euthanized when they become moribund is not an appropriate humane endpoint as this may not reduce any suffering that the animal will experience. The purpose of identifying endpoints is to prevent or minimize animal pain and distress.

procedure or giving treatment to relieve pain and/or distress. The establishment of humane endpoints before starting an experiment allows an investigator to prevent unnecessary animal pain and distress while ensuring accurate and timely data collection.
To be effective, humane endpoints must be clearly defined and based on objective criteria. Non-specific signs of illness such as inactivity, hunched posture or a rough coat are an indication that an animal should be examined more closely. By themselves these signs do not often constitute an endpoint. Familiarity with the animal model in use is necessary to select endpoints that are both humane and scientifically sound.
Investigators should include the following when describing how humane endpoints will be used in their IACUC protocols:

• A precise definition of the humane endpoint(s), including specific assessment criteria (e.g., body weight, body condition score, tumor size).
• The frequency of animal observation and assessment.
• The training of personnel responsible for observation and assessment.
• The action(s) taken when an animal reaches a humane endpoint.

Frequency of observations

Normal, healthy experimental animals must be observed at least once a day. Animals in studies involving pain and/or distress will often require more frequent observations to effectively determine the time at which a specific endpoint has been reached. An appropriate monitoring schedule must be specified in the IACUC protocol for each study.

Your Responsibilities When Working With Laboratory Animals

Treat all animals with respect and dignity.

Use only methods and/or procedures approved for your IACUC protocol.

Keep accurate and complete records.

Follow security, hazardous waste and disease prevention instructions.

Ask for help if you need it.