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
Applies to all University of North Carolina at Chapel Hill ("University" or "UNC-Chapel Hill") 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-Chapel Hill 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