Standard on Animal Monitoring and Record Keeping

Title

University of North Carolina at Chapel Hill Standard on Animal Monitoring and Record Keeping

Introduction

Purpose

The standards and procedures described below provide guidance to all researchers and animal handlers for the maintenance of required monitoring documentation as outlined in an Institutional Animal Care and Use Committee (IACUC) approved protocol.

Scope of Applicability

Applies to all personnel engaged in experimental procedures, surgical procedures, and any other situations involving required monitoring of research animals (i.e., weight loss, body condition scoring, tumor size, etc.). Any animal monitoring described in the approved protocol must be documented according to this Standard and available to IACUC and federal and accreditation reviewers.

The UNC-CH IACUC expects that anyone involved in animal work at the University will comply with this Standard. Requests for exceptions to this Standard must be reviewed and approved by the IACUC.

Standard

Written records are a standard form of documentation, which verify experimental procedures and protocol compliance. As part of an effective animal care and use program, research personnel working with animals must develop and maintain accurate study records. Specific parameters (e.g., body weight measurements, clinical signs, tumor size, etc.) outlined in an approved protocol must be documented with attention given to the type of monitoring, frequency and duration outlined in the approved protocol. For example, the statement in the approved protocol ‘We will monitor the animal daily after surgery,’ requires written documentation of the daily observation.)

Regulatory and accrediting agencies expect proper documentation of animal care and use as a means for the institution to ensure compliance with research protocols and clinical care procedures. The extent of records varies based on the nature of the procedure.

At a minimum, records of the procedure should consist of the following:

  • Protocol ID
  • Animal ID
  • Date of procedure
  • Type of procedure
  • Administration of anesthetics/analgesics and other drugs (name of agent, dose, route, frequency per approved protocol
  • Surgical records
    • name of surgical procedure
    • vital parameters - e.g., pulse rate, heart rate)
    • anesthesia details (agents, dosage, route, frequency)
    • intubation details, time for beginning and end of surgery
    • analgesia details, agents, dosage, route, frequency
  • Postoperative monitoring frequency per protocol

Any deviations from the approved protocol due to emergency need must be documented, explained, and reported to the IACUC. Permanent changes, including deviations made following an official veterinary consultation, require an amendment to the approved protocol.

The following are some examples of documentation/records that must be maintained if the activity is described in the approved protocol:

  • Body weight monitoring: recorded as described in protocol
  • Body Condition Score (BCS)
  • Tumor Monitoring
    • size - to assess tumor burden and overall health
    • ulceration, necrosis
    • See the Standard on Tumor Production and Cancer Research In Mice and Rats for more information
  • Food and Fluid Regulation: Body weights must be recorded at least weekly or more frequently according to the approved protocol. Written records must be maintained for each animal to document daily food and fluid consumption, hydration status, and any behavioral and clinical changes used as criteria for temporary or permanent removal of an animal from a protocol.1
  • Humane endpoint monitoring as described in protocol (e.g., animals will be monitored two times per day until symptoms develop and thereafter three times per day. Symptoms may include scruffy coat, eye discharge, mildly reduced activity level, and hunched posture.)

Note: All records must be available for review at any time by IACUC, veterinarians, external regulatory officials, and accrediting agencies.

Documentation Templates:

Exceptions

  • Requests for exceptions to this Standard must be reviewed and approved by the IACUC.

Related Requirements

External Regulations and Consequences

University Policies, Standards, and Procedures

Contact Information

Contact Information Table
Subject Contact Telephone Email

Animal Health/Veterinary Concerns/Questions

DCM Veterinary Services

919-843-3407

 

Protocol Information

Office of Animal Care and Use

919-966-5569

iacuc@med.unc.edu

Important Dates

  • Effective Date and title of Approver: 06/2014; UNC IACUC
  • Revision and Review Dates, Change notes, title of Reviewer or Approver: Placed on University Standard Template 09/2018; UNC IACUC

Approved by: UNC IACUC

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Details

Article ID: 132190
Created
Thu 4/8/21 9:25 PM
Modified
Fri 6/17/22 3:21 PM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
10/20/2021 12:00 AM
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Vice Chancellor
Last Review
Date on which the most recent document review was completed.
04/20/2022 12:00 AM
Last Revised
Date on which the most recent changes to this document were approved.
04/20/2022 12:00 AM
Next Review
Date on which the next document review is due.
04/20/2023 12:00 AM
Origination
Date on which the original version of this document was first made official.
09/10/2019 12:00 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Research-Institutional Animal Care & Use Committee