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 standard documentation.

Scope of Applicability

All personnel engaged in experimental procedures, surgical procedures, and any other situations involving required monitoring of research animals (i.e. weight loss, tumor size, etc.). Any animal monitoring described in the approved protocol must be documented according to this Standard.

The UNC-CH Institutional Animal Care and Use Committee (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 and/or Division of Comparative Medicine Management.

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 (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 (e.g., 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:

  • 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 - anesthesia details (vital signs – e.g. pulse rate, heart rate. intubation, beginning and end of surgery), name of surgical procedure
  • Postoperative monitoring 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. Approved June 2014
  • Tumor size monitoring to assess tumor burden and overall health. (See Tumor Burden Policy 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 and external regulatory officials.

Documentation Templates:

Exceptions

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

Definitions

IACUC: Institutional Animal Care and Use Committee

DCM: Division of Comparative Medicine

University Standard: The minimum acceptable limits or rules used to achieve Policy implementation, enforceable by the IACUC.

Humane Endpoint: Predetermined physiological signs that define the point at which an experimental animal’s pain and/or distress is terminated.

Related Requirements

External Regulations and Consequences

1 Guide for the Care and Use of Laboratory Animals 2011, Food and Fluid Regulation: Page 31

University Policies, Standards, and Procedures

For more detailed guidance, please refer to the University Policy on the Care and Use of Vertebrate Animals for Research, Training and Teaching Purposes.

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
Sun 7/18/21 12:44 AM
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.
10/21/2020 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 for Research
Last Review
Date on which the most recent document review was completed.
10/21/2020 12:00 AM
Last Revised
Date on which the most recent changes to this document were approved.
10/21/2020 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