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I. Purpose:

Detailed records are the primary means of documenting individual/herd health as well as compliance with AACUC approved protocols. For this reason, Montana State University’s Agricultural Animal Care and Use Committee (AACUC) created this policy to help investigators, instructors, staff, and students understand the expectations for record keeping.

II. Scope:

This policy applies to individuals working with animals under AACUC oversight in research facilities associated with Montana State University.

III. Guidance:

A. Veterinary Records: The Guide for the Care and Use of Agricultural Animals in Research and Teaching states the necessity for maintaining veterinary medical records. Information within the medical record should be sufficiently comprehensive to demonstrate the delivery of adequate health care.                        

    1. Medical records are typically maintained by veterinarians and their staff; however, several individuals may make entries (e.g., veterinary staff, husbandry staff, research staff, trained students). All consulting veterinarians providing medical care need to maintain adequate medical records. The provision of veterinary care must then be communicated to the AACUC Program Veterinarian (e.g., email, phone, direct communication).
    2. Individual medical records should be kept for all species although group records may be acceptable when groups of animals all have similar diagnoses, procedures, or treatments. Any animal or subgroup of animals diagnosed, treated, or managed differently from the rest should have its own record. Group records may also be appropriate for routine husbandry, preventative health care and other minor procedures.
    3. Medical records should be current, legible, dated, and indicate the originator of entry (e.g., initials, signature). Any format is acceptable if all appropriate information is included.
    4. Medical records should include but are not limited to the following:
      • Animal or group identification (may include PI name, AACUC protocol reference number, species, animal identification number).
      • Descriptions of any illness, injury, distress, and/or behavioral abnormalities and the resolution of the noted problem.                                           
      • Differential, Suspected, or Confirmed diagnosis as appropriate.
      • Dates, details, and results (if appropriate) of all observations, examinations, diagnostics, tests, and other such procedures.
      • Dates and other details regarding all treatments including the name, dose, route, frequency, and duration of treatment.
      • Details for re-evaluation if necessary
      • Description of any surgical procedures (if applicable) and appropriate pre-, peri-, or post-operative care.
      • Any actions taken to alleviate pain and distress (pharmacological and non- pharmacological interventions)                   
      • Documentation of euthanasia or other disposition.
      • Necropsy findings (if applicable)       
      • Any preventative/routine health procedures as appropriate for species (e.g., vaccination, examination, diagnostics)

B. Research Records: Research records encompass all aspects of the AACUC approved protocol involving animal-related work and animal health or condition. Detailed research records are necessary to ensure demonstrable compliance with AACUC approved activities. These records also confirm the scientific merit of the work and aid in reproducibility of experiments and procedures.

    1. Research records are typically maintained by the investigator(s) and their staff. The extent of detail required to document research records varies based on the nature of the work and procedures/manipulations performed.
    2. Individual research records should be kept for all species. Group records may be acceptable (when groups of animals all have similar diagnoses, procedures, or treatments). Any animal or subgroup of animals diagnosed, treated, or managed differently from the rest should have its own record. Group research records may be appropriate for routine and other minor procedures/manipulations.
    3. Research records should be current, legible, dated, and indicate the originator of entry (e.g., initials, signature). Any format (e.g., lab notebook, field journal, electronic) is acceptable as long as all appropriate information is included.

Research records should include, but are not limited to, the following:

    • Animal or group identification (may include PI name, AACUC protocol reference number, species, identification number, experimental treatment)
    • Date and description of all procedures/manipulations, Time (AM/PM) should be included for all time-sensitive observations (e.g., evaluations, post-operative monitoring), treatments (e.g., pain medication, antibiotics, experimental drugs), and/or procedures (e.g., imaging, blood draw, biopsy)
    • All drugs, therapeutic agents, or other experimental agents administered as part of the study (e.g., name, dose, volume, and route)
    • Description of any surgical procedures and identification of surgeon(s)
    • Description of anesthesia or sedation, include any pre-, peri-, or post-operative monitoring as outlined in the AACUC-approved protocol include a description of drug administration (i.e., name, dose, volume, route, and time)
    • Any clinical observations as required per AACUC approved protocol.
    • Any unexpected outcomes, morbidity and mortality. All unexpected outcomes, morbidity and mortality should be reported to the AACUC Program Coordinator and Program Veterinarian using the AACUC Adverse Event Reporting Form.
    • Date and description of prolonged restraint
    • Date and description of any food/water restriction
    • Date and description of special diets administered and special feeding and/or watering requirement.
    • Controlled Drug Log/Inventory (if applicable)
    • Documentation of euthanasia or other disposition (if applicable)

C. Husbandry Records: The Guide for the Care and Use of Agricultural Animals in Research and Teaching states the necessity for adequate husbandry programs. To meet these expectations, records should be kept by facilities overseeing animals’ care to ensure husbandry requirements are being carried out. Husbandry records should include but are not limited to the following:

    1. Animal observations – animals are typically observed daily by trained caretakers; however, frequency may increase (e.g., post-operative, parturition) or decrease (maintained on range or pasture) depending on the circumstances of the facility. For those animals maintained on range or pasture, observations should be frequent enough to detect illness or injury in a timely fashion, recognize the need for emergency action, and ensure adequate availability of feed and water.
    2. Animal or group identification numbers.
    3. Provision of adequate housing and availability of feed and water.
    4. Any unexpected facility issues impacting animal care. All unexpected facility issues that may affect or impair animals housed within the facility should be reported to the facility manager and Program Veterinarian.

D. Record Retention and Availability: All records and reports must be:

    1. Maintained and held for: A minimum of 3 years from the date:
      • That an animal is disposed of, or euthanized
      • Of completion of the AACUC approved protocol
      • Of completion of the AACUC -approved significant change to a protocol
    1. Longer than 3 years if:
      • Necessary to comply with any applicable Federal, State, or local law
      • The research facility or project investigator is notified, in writing, that specified records must be retained pending completion of an investigation.

 

References:

American Dairy Science Association, the American Society of Animal Science, and the Poultry Science Association.

Guide for the Care and Use of Agricultural Animals in Research and Teaching. Fourth Edition. Champaign, IL. 2020

Medical Records for Animals Used in Research, Teaching and Testing: Public Statement from the American College of Laboratory Animal Medicine. American College of Laboratory Animal Medicine, 2007.

 

AACUC Approval Date:8/22/23

Review Date:8/22/23

Issue Date: 9/1/23